Susan London

High-dose cyclophosphamide is safe and effective when given as prophylaxis for chronic graft-versus-host disease (GVHD) to patients who have undergone transplantation of mobilized blood cells, finds a phase 2 trial reported in Blood.

Investigators led by Dr. Marco Mielcarek, medical director of the Adult Blood and Marrow Transplant Program and an oncologist at the Fred Hutchinson Cancer Research Center in Seattle, Washington, enrolled in the trial 43 patients with high-risk hematologic malignancies.

The patients underwent myeloablative conditioning followed by transplantation with growth factor–mobilized blood cells from related or unrelated donors, and were given high-dose cyclophosphamide on two early posttransplantation days.

Main results showed that the cumulative 1-year incidence of chronic GVHD was 16%, less than half of the roughly 35% seen historically with conventional immunosuppression.

Moreover, cyclophosphamide did not appear to compromise engraftment or control of the underlying malignancy. Only a single patient, one with an HLA-mismatched donor, had failure of primary engraftment; after amendment of the protocol to require HLA matching, there were no additional cases. Just 17% of patients experienced a recurrence of their malignancy by 2 years.

Taken together, the findings suggest that high-dose cyclophosphamide—as combined with two myeloablative conditioning options (to accommodate different malignancies) and with posttransplantation cyclosporine (to reduce the risk of acute GVHD)—may eliminate most of the drawbacks to using mobilized blood cells for transplantation, according to the investigators.

“If these findings are confirmed in future studies, HLA-matched mobilized blood cell transplantation may gain even greater acceptance and further replace marrow as a source of stem cells for most indications,” they maintain.

The patients studied had a median age of 43 years, and slightly more than half were in remission without minimal residual disease.

Blood cells were mobilized with granulocyte colony-stimulating factor (G-CSF). Overall, 28% of patients received grafts from related donors, while 72% received grafts from unrelated donors.

For pretransplant conditioning, patients received fludarabine and targeted busulfan, or total body irradiation with use of a minimum dose of 12 Gy.

The patients were given cyclophosphamide at 50 mg/kg per day on days 3 and 4 after transplantation. This was followed by cyclosporine starting on day 5.

The cumulative 1-year incidence of chronic GVHD as defined by National Institutes of Health criteria (i.e., that requiring systemic immunosuppressive therapy)—the trial’s primary endpoint—was 16%, which fell just short of the goal of 15% the investigators were aiming for (Blood. 2016;127:1502-8). Analyses failed to identify any predictors of this outcome.

Although the estimated cumulative incidence of grade 2 acute GVHD was high, at 77%, none of the patients developed grade 3 or 4 acute GVHD, according to the investigators, who disclosed that they had no competing financial interests.

The single patient who experienced failure of primary engraftment had familial myelodysplastic syndrome and had received a graft from an HLA A-antigen–mismatched unrelated donor.

The 2-year cumulative incidence of nonrelapse mortality was 14%, and the 2-year cumulative incidence of recurrent malignancy was 17%. Projected overall survival was 70%.

Among the 42 patients having at least a year of follow-up, 50% were alive and free of relapse without any systemic immunosuppression at 1 year after transplantation.

High-dose cyclophosphamide is safe and effective when given as prophylaxis for chronic graft-versus-host disease (GVHD) to patients who have undergone transplantation of mobilized blood cells, finds a phase 2 trial reported in Blood.

Investigators led by Dr. Marco Mielcarek, medical director of the Adult Blood and Marrow Transplant Program and an oncologist at the Fred Hutchinson Cancer Research Center in Seattle, Washington, enrolled in the trial 43 patients with high-risk hematologic malignancies.

The patients underwent myeloablative conditioning followed by transplantation with growth factor–mobilized blood cells from related or unrelated donors, and were given high-dose cyclophosphamide on two early posttransplantation days.

Main results showed that the cumulative 1-year incidence of chronic GVHD was 16%, less than half of the roughly 35% seen historically with conventional immunosuppression.

Moreover, cyclophosphamide did not appear to compromise engraftment or control of the underlying malignancy. Only a single patient, one with an HLA-mismatched donor, had failure of primary engraftment; after amendment of the protocol to require HLA matching, there were no additional cases. Just 17% of patients experienced a recurrence of their malignancy by 2 years.

Taken together, the findings suggest that high-dose cyclophosphamide—as combined with two myeloablative conditioning options (to accommodate different malignancies) and with posttransplantation cyclosporine (to reduce the risk of acute GVHD)—may eliminate most of the drawbacks to using mobilized blood cells for transplantation, according to the investigators.

“If these findings are confirmed in future studies, HLA-matched mobilized blood cell transplantation may gain even greater acceptance and further replace marrow as a source of stem cells for most indications,” they maintain.

The patients studied had a median age of 43 years, and slightly more than half were in remission without minimal residual disease.

Blood cells were mobilized with granulocyte colony-stimulating factor (G-CSF). Overall, 28% of patients received grafts from related donors, while 72% received grafts from unrelated donors.

For pretransplant conditioning, patients received fludarabine and targeted busulfan, or total body irradiation with use of a minimum dose of 12 Gy.

The patients were given cyclophosphamide at 50 mg/kg per day on days 3 and 4 after transplantation. This was followed by cyclosporine starting on day 5.

The cumulative 1-year incidence of chronic GVHD as defined by National Institutes of Health criteria (i.e., that requiring systemic immunosuppressive therapy)—the trial’s primary endpoint—was 16%, which fell just short of the goal of 15% the investigators were aiming for (Blood. 2016;127:1502-8). Analyses failed to identify any predictors of this outcome.

Although the estimated cumulative incidence of grade 2 acute GVHD was high, at 77%, none of the patients developed grade 3 or 4 acute GVHD, according to the investigators, who disclosed that they had no competing financial interests.

The single patient who experienced failure of primary engraftment had familial myelodysplastic syndrome and had received a graft from an HLA A-antigen–mismatched unrelated donor.

The 2-year cumulative incidence of nonrelapse mortality was 14%, and the 2-year cumulative incidence of recurrent malignancy was 17%. Projected overall survival was 70%.

Among the 42 patients having at least a year of follow-up, 50% were alive and free of relapse without any systemic immunosuppression at 1 year after transplantation.

High-dose cyclophosphamide is safe and effective when given as prophylaxis for chronic graft-versus-host disease (GVHD) to patients who have undergone transplantation of mobilized blood cells, finds a phase 2 trial reported in Blood.

Investigators led by Dr. Marco Mielcarek, medical director of the Adult Blood and Marrow Transplant Program and an oncologist at the Fred Hutchinson Cancer Research Center in Seattle, Washington, enrolled in the trial 43 patients with high-risk hematologic malignancies.

The patients underwent myeloablative conditioning followed by transplantation with growth factor–mobilized blood cells from related or unrelated donors, and were given high-dose cyclophosphamide on two early posttransplantation days.

Main results showed that the cumulative 1-year incidence of chronic GVHD was 16%, less than half of the roughly 35% seen historically with conventional immunosuppression.

Moreover, cyclophosphamide did not appear to compromise engraftment or control of the underlying malignancy. Only a single patient, one with an HLA-mismatched donor, had failure of primary engraftment; after amendment of the protocol to require HLA matching, there were no additional cases. Just 17% of patients experienced a recurrence of their malignancy by 2 years.

Taken together, the findings suggest that high-dose cyclophosphamide—as combined with two myeloablative conditioning options (to accommodate different malignancies) and with posttransplantation cyclosporine (to reduce the risk of acute GVHD)—may eliminate most of the drawbacks to using mobilized blood cells for transplantation, according to the investigators.

“If these findings are confirmed in future studies, HLA-matched mobilized blood cell transplantation may gain even greater acceptance and further replace marrow as a source of stem cells for most indications,” they maintain.

The patients studied had a median age of 43 years, and slightly more than half were in remission without minimal residual disease.

Blood cells were mobilized with granulocyte colony-stimulating factor (G-CSF). Overall, 28% of patients received grafts from related donors, while 72% received grafts from unrelated donors.

For pretransplant conditioning, patients received fludarabine and targeted busulfan, or total body irradiation with use of a minimum dose of 12 Gy.

The patients were given cyclophosphamide at 50 mg/kg per day on days 3 and 4 after transplantation. This was followed by cyclosporine starting on day 5.

The cumulative 1-year incidence of chronic GVHD as defined by National Institutes of Health criteria (i.e., that requiring systemic immunosuppressive therapy)—the trial’s primary endpoint—was 16%, which fell just short of the goal of 15% the investigators were aiming for (Blood. 2016;127:1502-8). Analyses failed to identify any predictors of this outcome.

Although the estimated cumulative incidence of grade 2 acute GVHD was high, at 77%, none of the patients developed grade 3 or 4 acute GVHD, according to the investigators, who disclosed that they had no competing financial interests.

The single patient who experienced failure of primary engraftment had familial myelodysplastic syndrome and had received a graft from an HLA A-antigen–mismatched unrelated donor.

The 2-year cumulative incidence of nonrelapse mortality was 14%, and the 2-year cumulative incidence of recurrent malignancy was 17%. Projected overall survival was 70%.

Among the 42 patients having at least a year of follow-up, 50% were alive and free of relapse without any systemic immunosuppression at 1 year after transplantation.

SCOTTSDALE, ARIZ. – Patients with head and neck cancer have substantial disparities in presentation, treatment, and outcomes according to their health insurance status, suggest results of a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

The analysis of more than 50,000 patients from the Surveillance, Epidemiology, and End Results (SEER) registry found that relative to counterparts with insurance, those with Medicaid or no insurance had more advanced disease at presentation.

Additionally, the Medicaid and uninsured patients were 23% and 32% less likely, respectively, to receive radiation therapy, and the uninsured were 23% less to receive surgery, according to data reported in a session and related press briefing.

Both overall and cancer-specific survival were worse for these two groups as well. And when compared with each other, the Medicaid patients actually had poorer overall survival than the uninsured, and similar cause-specific survival.

“We noted important disparities among Medicaid and uninsured cancer patients with head and neck malignancies in the United States,” said lead author Dr. Thomas M. Churilla of the Fox Chase Cancer Center in Philadelphia. “We hypothesize that lack of access to primary care and dental providers may be one of the reasons why patients are presenting with more locally advanced disease.”

The Patient Protection and Affordable Care Act aims to address lack of insurance in part by expanding Medicaid, he noted. However, “given the excess in cancer mortality seen in the Medicaid group and striking similarity with the uninsured group, expansions in Medicaid may have limited effect on outcomes among head and neck cancer patients without further study into figuring out which patient, provider, and health care system factors may be underlying these differences.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, asked, “In your data set, do you have any information on the length of insurance coverage? We see a fair number of patients who come in with no insurance but ultimately get enrolled in Medicaid. Would they have been included in the Medicaid group or the insured group in this study?”

The SEER database does not provide that information, Dr. Churilla said. “The inability to tell the length of insurance coverage is an important limitation of our study, and it may limit our inferences to tell the difference between these two groups,” he acknowledged, adding that the database also lacks information about other important potential confounders, including systemic therapies; risk factors such as smoking, alcohol intake, and human papillomavirus status; and the size, type, and experience of the treating center.

A session attendee said, “You showed that uninsured patients did better than Medicaid patients. Is this possibly due to the uninsured getting free care rather than [clinicians] needing to follow Medicaid-approved treatment?”

“We are scratching our heads a little bit with this one as well, but I think some of the difference may be due in part to the age differences,” Dr. Churilla replied. “The Medicaid patients on average were older than uninsured patients, so perhaps more competing causes of death leading to a difference in overall survival yet similar cancer-specific survival.”

For the study, the investigators analyzed outcomes among 53,848 patients who had primary squamous cell carcinoma of the oral cavity, pharynx, or larynx diagnosed during 2007-2012. Overall, 80% were insured (through private insurance or Medicare), 15% had Medicaid, and 5% were uninsured.

Results showed that patients with Medicaid or no insurance had more advanced cancer at presentation than insured peers. For example, 56% and 59% of patients with Medicaid and no insurance, respectively, had stage 4 disease, compared with 43% of insured patients.

In multivariate analyses adjusted for socioeconomic characteristics, clinical factors (including stage), and treatments, the likelihood of receiving external-beam radiation therapy was lower for the Medicaid group (hazard ratio, 0.77; P less than .001) and the uninsured group (HR, 0.68; P less than .001). Additionally, the uninsured were less likely to receive cancer-directed surgery, defined as at least a wide local excision (HR, 0.77; P less than .001).

In addition, both Medicaid and uninsured patients had poorer overall survival (HRs, 1.54 and 1.49) and cancer-specific survival (HRs, 1.59 and 1.66) relative to insured counterparts.

Findings were generally the same after propensity score weighting and in a sensitivity analysis that excluded all patients aged 65 or older because of their Medicare eligibility.

Addressing the observed disparities for the uninsured patients will require action on both the clinician and policy levels, Dr. Churilla said.

“One of the first steps is awareness among both dental and medical communities and trying to provide social services and financial counseling to help these patients enroll in certain programs such as Medicaid that they may be eligible for,” he elaborated. “And then I think the rest of it really lies with national policy – how do we expand coverage to help get these people the health care that they need and the appropriate services that they require.”

SCOTTSDALE, ARIZ. – Patients with head and neck cancer have substantial disparities in presentation, treatment, and outcomes according to their health insurance status, suggest results of a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

The analysis of more than 50,000 patients from the Surveillance, Epidemiology, and End Results (SEER) registry found that relative to counterparts with insurance, those with Medicaid or no insurance had more advanced disease at presentation.

Additionally, the Medicaid and uninsured patients were 23% and 32% less likely, respectively, to receive radiation therapy, and the uninsured were 23% less to receive surgery, according to data reported in a session and related press briefing.

Both overall and cancer-specific survival were worse for these two groups as well. And when compared with each other, the Medicaid patients actually had poorer overall survival than the uninsured, and similar cause-specific survival.

“We noted important disparities among Medicaid and uninsured cancer patients with head and neck malignancies in the United States,” said lead author Dr. Thomas M. Churilla of the Fox Chase Cancer Center in Philadelphia. “We hypothesize that lack of access to primary care and dental providers may be one of the reasons why patients are presenting with more locally advanced disease.”

The Patient Protection and Affordable Care Act aims to address lack of insurance in part by expanding Medicaid, he noted. However, “given the excess in cancer mortality seen in the Medicaid group and striking similarity with the uninsured group, expansions in Medicaid may have limited effect on outcomes among head and neck cancer patients without further study into figuring out which patient, provider, and health care system factors may be underlying these differences.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, asked, “In your data set, do you have any information on the length of insurance coverage? We see a fair number of patients who come in with no insurance but ultimately get enrolled in Medicaid. Would they have been included in the Medicaid group or the insured group in this study?”

The SEER database does not provide that information, Dr. Churilla said. “The inability to tell the length of insurance coverage is an important limitation of our study, and it may limit our inferences to tell the difference between these two groups,” he acknowledged, adding that the database also lacks information about other important potential confounders, including systemic therapies; risk factors such as smoking, alcohol intake, and human papillomavirus status; and the size, type, and experience of the treating center.

A session attendee said, “You showed that uninsured patients did better than Medicaid patients. Is this possibly due to the uninsured getting free care rather than [clinicians] needing to follow Medicaid-approved treatment?”

“We are scratching our heads a little bit with this one as well, but I think some of the difference may be due in part to the age differences,” Dr. Churilla replied. “The Medicaid patients on average were older than uninsured patients, so perhaps more competing causes of death leading to a difference in overall survival yet similar cancer-specific survival.”

For the study, the investigators analyzed outcomes among 53,848 patients who had primary squamous cell carcinoma of the oral cavity, pharynx, or larynx diagnosed during 2007-2012. Overall, 80% were insured (through private insurance or Medicare), 15% had Medicaid, and 5% were uninsured.

Results showed that patients with Medicaid or no insurance had more advanced cancer at presentation than insured peers. For example, 56% and 59% of patients with Medicaid and no insurance, respectively, had stage 4 disease, compared with 43% of insured patients.

In multivariate analyses adjusted for socioeconomic characteristics, clinical factors (including stage), and treatments, the likelihood of receiving external-beam radiation therapy was lower for the Medicaid group (hazard ratio, 0.77; P less than .001) and the uninsured group (HR, 0.68; P less than .001). Additionally, the uninsured were less likely to receive cancer-directed surgery, defined as at least a wide local excision (HR, 0.77; P less than .001).

In addition, both Medicaid and uninsured patients had poorer overall survival (HRs, 1.54 and 1.49) and cancer-specific survival (HRs, 1.59 and 1.66) relative to insured counterparts.

Findings were generally the same after propensity score weighting and in a sensitivity analysis that excluded all patients aged 65 or older because of their Medicare eligibility.

Addressing the observed disparities for the uninsured patients will require action on both the clinician and policy levels, Dr. Churilla said.

“One of the first steps is awareness among both dental and medical communities and trying to provide social services and financial counseling to help these patients enroll in certain programs such as Medicaid that they may be eligible for,” he elaborated. “And then I think the rest of it really lies with national policy – how do we expand coverage to help get these people the health care that they need and the appropriate services that they require.”

SCOTTSDALE, ARIZ. – Patients with head and neck cancer have substantial disparities in presentation, treatment, and outcomes according to their health insurance status, suggest results of a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

The analysis of more than 50,000 patients from the Surveillance, Epidemiology, and End Results (SEER) registry found that relative to counterparts with insurance, those with Medicaid or no insurance had more advanced disease at presentation.

Additionally, the Medicaid and uninsured patients were 23% and 32% less likely, respectively, to receive radiation therapy, and the uninsured were 23% less to receive surgery, according to data reported in a session and related press briefing.

Both overall and cancer-specific survival were worse for these two groups as well. And when compared with each other, the Medicaid patients actually had poorer overall survival than the uninsured, and similar cause-specific survival.

“We noted important disparities among Medicaid and uninsured cancer patients with head and neck malignancies in the United States,” said lead author Dr. Thomas M. Churilla of the Fox Chase Cancer Center in Philadelphia. “We hypothesize that lack of access to primary care and dental providers may be one of the reasons why patients are presenting with more locally advanced disease.”

The Patient Protection and Affordable Care Act aims to address lack of insurance in part by expanding Medicaid, he noted. However, “given the excess in cancer mortality seen in the Medicaid group and striking similarity with the uninsured group, expansions in Medicaid may have limited effect on outcomes among head and neck cancer patients without further study into figuring out which patient, provider, and health care system factors may be underlying these differences.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, asked, “In your data set, do you have any information on the length of insurance coverage? We see a fair number of patients who come in with no insurance but ultimately get enrolled in Medicaid. Would they have been included in the Medicaid group or the insured group in this study?”

The SEER database does not provide that information, Dr. Churilla said. “The inability to tell the length of insurance coverage is an important limitation of our study, and it may limit our inferences to tell the difference between these two groups,” he acknowledged, adding that the database also lacks information about other important potential confounders, including systemic therapies; risk factors such as smoking, alcohol intake, and human papillomavirus status; and the size, type, and experience of the treating center.

A session attendee said, “You showed that uninsured patients did better than Medicaid patients. Is this possibly due to the uninsured getting free care rather than [clinicians] needing to follow Medicaid-approved treatment?”

“We are scratching our heads a little bit with this one as well, but I think some of the difference may be due in part to the age differences,” Dr. Churilla replied. “The Medicaid patients on average were older than uninsured patients, so perhaps more competing causes of death leading to a difference in overall survival yet similar cancer-specific survival.”

For the study, the investigators analyzed outcomes among 53,848 patients who had primary squamous cell carcinoma of the oral cavity, pharynx, or larynx diagnosed during 2007-2012. Overall, 80% were insured (through private insurance or Medicare), 15% had Medicaid, and 5% were uninsured.

Results showed that patients with Medicaid or no insurance had more advanced cancer at presentation than insured peers. For example, 56% and 59% of patients with Medicaid and no insurance, respectively, had stage 4 disease, compared with 43% of insured patients.

In multivariate analyses adjusted for socioeconomic characteristics, clinical factors (including stage), and treatments, the likelihood of receiving external-beam radiation therapy was lower for the Medicaid group (hazard ratio, 0.77; P less than .001) and the uninsured group (HR, 0.68; P less than .001). Additionally, the uninsured were less likely to receive cancer-directed surgery, defined as at least a wide local excision (HR, 0.77; P less than .001).

In addition, both Medicaid and uninsured patients had poorer overall survival (HRs, 1.54 and 1.49) and cancer-specific survival (HRs, 1.59 and 1.66) relative to insured counterparts.

Findings were generally the same after propensity score weighting and in a sensitivity analysis that excluded all patients aged 65 or older because of their Medicare eligibility.

Addressing the observed disparities for the uninsured patients will require action on both the clinician and policy levels, Dr. Churilla said.

“One of the first steps is awareness among both dental and medical communities and trying to provide social services and financial counseling to help these patients enroll in certain programs such as Medicaid that they may be eligible for,” he elaborated. “And then I think the rest of it really lies with national policy – how do we expand coverage to help get these people the health care that they need and the appropriate services that they require.”

SCOTTSDALE, ARIZ. – Patients with head and neck cancer undergoing radiation therapy do not have better survival if given induction chemotherapy instead of concurrent chemotherapy, finds a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

Using the National Cancer Data Base, Dr. Daniel W. Bowles and his colleagues analyzed outcomes for 8,003 patients treated for nonmetastatic but more advanced disease with one of these two approaches.

Results reported in a poster session and related press briefing showed that the patients given induction chemotherapy were more likely to receive radiation doses lower than those recommended in guidelines and lived, on average, about 13 months less.

“The use of induction chemotherapy is not supported by this analysis,” commented Dr. Bowles, director of cancer research at the University of Colorado at Denver, Aurora, and staff physician at the Denver VA Medical Center.

The study – the largest yet to compare the two approaches and specifically in a cohort of patients with more advanced disease – adds to others that have hinted at inferior outcomes with induction chemotherapy as compared with concurrent chemotherapy, the standard of care.

“Recently, there have been several randomized controlled studies that have looked at induction chemotherapy followed by concurrent chemoradiation versus concurrent chemoradiation alone,” he elaborated. “These studies have had somewhat varied results, but have been critiqued as being underpowered and [the possibility] that no survival benefit was seen in the induction chemotherapy arm perhaps because there were too many low-risk cancers that were included in these studies, including patients who have stage III cancer or patients who had N0 to N2a disease.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, commented, “I think this study adds to the growing data that I would say is now nearly overwhelming that induction chemotherapy, other than in maybe very selected cases, has essentially no role in the treatment of head and neck cancer patients in a routine setting and outside of the setting of a clinical trial.”

The investigators included in their analysis patients with stage Tis-T4,N2b-3,M0 squamous cell carcinoma of the oropharynx, hypopharynx, or larynx diagnosed between 2003 and 2011 and treated with external-beam radiation therapy, without surgery.

Analyses were based on 1,907 patients given induction chemotherapy (starting 43 to 98 days before radiation therapy) and 6,086 patients given concurrent chemotherapy (starting within 7 days of radiation therapy).

In univariate analyses, median overall survival was 52.1 months with induction chemotherapy versus 64.9 months with concurrent chemotherapy, reported Dr. Bowles, who disclosed that he had no relevant conflicts of interest. The difference translated to a 14% higher risk of death with the former (hazard ratio, 1.14; P less than .01).

In multivariate analysis, survival did not differ significantly between the two chemotherapy approaches in the cohort as a whole or in various subgroups of patients having especially advanced disease: those with T4 or N3 disease, with N3 disease only, or with T4N3 disease. Repeating analyses after propensity score matching yielded essentially the same results.

“We couldn’t identify any specific subgroups that appeared to benefit with regards to overall survival,” Dr. Bowles commented, while also noting some caveats.

“One potential limitation from looking at the National Cancer Data Base is that they only provide information about overall survival. We don’t know about cancer-specific survival, so you can’t say based on these data whether there is a progression-free survival benefit. The other question is how this affects quality of life,” he elaborated. “Those are important questions, [whether] induction chemotherapy would benefit anyone with regards to those outcomes. We just don’t have that data from the National Cancer Data Base.”

In other study findings, compared with peers given concurrent chemotherapy, patients given induction chemotherapy were more likely to receive a radiation dose less than the minimum of 66 Gy recommended by the National Comprehensive Cancer Network and the American Society for Radiation Oncology (20.9% vs. 14.9%, P less than .01).

In multivariate analyses, patients given induction chemotherapy were still less likely to receive guideline-concordant doses of radiation (odds ratio, 1.42; P less than .01), and receipt of such doses was associated with an increased risk of death (HR, 1.76; P less than .01).

SCOTTSDALE, ARIZ. – Patients with head and neck cancer undergoing radiation therapy do not have better survival if given induction chemotherapy instead of concurrent chemotherapy, finds a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

Using the National Cancer Data Base, Dr. Daniel W. Bowles and his colleagues analyzed outcomes for 8,003 patients treated for nonmetastatic but more advanced disease with one of these two approaches.

Results reported in a poster session and related press briefing showed that the patients given induction chemotherapy were more likely to receive radiation doses lower than those recommended in guidelines and lived, on average, about 13 months less.

“The use of induction chemotherapy is not supported by this analysis,” commented Dr. Bowles, director of cancer research at the University of Colorado at Denver, Aurora, and staff physician at the Denver VA Medical Center.

The study – the largest yet to compare the two approaches and specifically in a cohort of patients with more advanced disease – adds to others that have hinted at inferior outcomes with induction chemotherapy as compared with concurrent chemotherapy, the standard of care.

“Recently, there have been several randomized controlled studies that have looked at induction chemotherapy followed by concurrent chemoradiation versus concurrent chemoradiation alone,” he elaborated. “These studies have had somewhat varied results, but have been critiqued as being underpowered and [the possibility] that no survival benefit was seen in the induction chemotherapy arm perhaps because there were too many low-risk cancers that were included in these studies, including patients who have stage III cancer or patients who had N0 to N2a disease.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, commented, “I think this study adds to the growing data that I would say is now nearly overwhelming that induction chemotherapy, other than in maybe very selected cases, has essentially no role in the treatment of head and neck cancer patients in a routine setting and outside of the setting of a clinical trial.”

The investigators included in their analysis patients with stage Tis-T4,N2b-3,M0 squamous cell carcinoma of the oropharynx, hypopharynx, or larynx diagnosed between 2003 and 2011 and treated with external-beam radiation therapy, without surgery.

Analyses were based on 1,907 patients given induction chemotherapy (starting 43 to 98 days before radiation therapy) and 6,086 patients given concurrent chemotherapy (starting within 7 days of radiation therapy).

In univariate analyses, median overall survival was 52.1 months with induction chemotherapy versus 64.9 months with concurrent chemotherapy, reported Dr. Bowles, who disclosed that he had no relevant conflicts of interest. The difference translated to a 14% higher risk of death with the former (hazard ratio, 1.14; P less than .01).

In multivariate analysis, survival did not differ significantly between the two chemotherapy approaches in the cohort as a whole or in various subgroups of patients having especially advanced disease: those with T4 or N3 disease, with N3 disease only, or with T4N3 disease. Repeating analyses after propensity score matching yielded essentially the same results.

“We couldn’t identify any specific subgroups that appeared to benefit with regards to overall survival,” Dr. Bowles commented, while also noting some caveats.

“One potential limitation from looking at the National Cancer Data Base is that they only provide information about overall survival. We don’t know about cancer-specific survival, so you can’t say based on these data whether there is a progression-free survival benefit. The other question is how this affects quality of life,” he elaborated. “Those are important questions, [whether] induction chemotherapy would benefit anyone with regards to those outcomes. We just don’t have that data from the National Cancer Data Base.”

In other study findings, compared with peers given concurrent chemotherapy, patients given induction chemotherapy were more likely to receive a radiation dose less than the minimum of 66 Gy recommended by the National Comprehensive Cancer Network and the American Society for Radiation Oncology (20.9% vs. 14.9%, P less than .01).

In multivariate analyses, patients given induction chemotherapy were still less likely to receive guideline-concordant doses of radiation (odds ratio, 1.42; P less than .01), and receipt of such doses was associated with an increased risk of death (HR, 1.76; P less than .01).

SCOTTSDALE, ARIZ. – Patients with head and neck cancer undergoing radiation therapy do not have better survival if given induction chemotherapy instead of concurrent chemotherapy, finds a cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

Using the National Cancer Data Base, Dr. Daniel W. Bowles and his colleagues analyzed outcomes for 8,003 patients treated for nonmetastatic but more advanced disease with one of these two approaches.

Results reported in a poster session and related press briefing showed that the patients given induction chemotherapy were more likely to receive radiation doses lower than those recommended in guidelines and lived, on average, about 13 months less.

“The use of induction chemotherapy is not supported by this analysis,” commented Dr. Bowles, director of cancer research at the University of Colorado at Denver, Aurora, and staff physician at the Denver VA Medical Center.

The study – the largest yet to compare the two approaches and specifically in a cohort of patients with more advanced disease – adds to others that have hinted at inferior outcomes with induction chemotherapy as compared with concurrent chemotherapy, the standard of care.

“Recently, there have been several randomized controlled studies that have looked at induction chemotherapy followed by concurrent chemoradiation versus concurrent chemoradiation alone,” he elaborated. “These studies have had somewhat varied results, but have been critiqued as being underpowered and [the possibility] that no survival benefit was seen in the induction chemotherapy arm perhaps because there were too many low-risk cancers that were included in these studies, including patients who have stage III cancer or patients who had N0 to N2a disease.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, commented, “I think this study adds to the growing data that I would say is now nearly overwhelming that induction chemotherapy, other than in maybe very selected cases, has essentially no role in the treatment of head and neck cancer patients in a routine setting and outside of the setting of a clinical trial.”

The investigators included in their analysis patients with stage Tis-T4,N2b-3,M0 squamous cell carcinoma of the oropharynx, hypopharynx, or larynx diagnosed between 2003 and 2011 and treated with external-beam radiation therapy, without surgery.

Analyses were based on 1,907 patients given induction chemotherapy (starting 43 to 98 days before radiation therapy) and 6,086 patients given concurrent chemotherapy (starting within 7 days of radiation therapy).

In univariate analyses, median overall survival was 52.1 months with induction chemotherapy versus 64.9 months with concurrent chemotherapy, reported Dr. Bowles, who disclosed that he had no relevant conflicts of interest. The difference translated to a 14% higher risk of death with the former (hazard ratio, 1.14; P less than .01).

In multivariate analysis, survival did not differ significantly between the two chemotherapy approaches in the cohort as a whole or in various subgroups of patients having especially advanced disease: those with T4 or N3 disease, with N3 disease only, or with T4N3 disease. Repeating analyses after propensity score matching yielded essentially the same results.

“We couldn’t identify any specific subgroups that appeared to benefit with regards to overall survival,” Dr. Bowles commented, while also noting some caveats.

“One potential limitation from looking at the National Cancer Data Base is that they only provide information about overall survival. We don’t know about cancer-specific survival, so you can’t say based on these data whether there is a progression-free survival benefit. The other question is how this affects quality of life,” he elaborated. “Those are important questions, [whether] induction chemotherapy would benefit anyone with regards to those outcomes. We just don’t have that data from the National Cancer Data Base.”

In other study findings, compared with peers given concurrent chemotherapy, patients given induction chemotherapy were more likely to receive a radiation dose less than the minimum of 66 Gy recommended by the National Comprehensive Cancer Network and the American Society for Radiation Oncology (20.9% vs. 14.9%, P less than .01).

In multivariate analyses, patients given induction chemotherapy were still less likely to receive guideline-concordant doses of radiation (odds ratio, 1.42; P less than .01), and receipt of such doses was associated with an increased risk of death (HR, 1.76; P less than .01).

SCOTTSDALE, ARIZ. – Oncologists should consider not only age, but also comorbidities and disease extent when deciding whether to offer concurrent chemoradiation to older adults with locally advanced head and neck cancer, suggests a cohort study using data from the National Cancer Data Base.

The study of 4,042 patients aged 71 years or older found that adding chemotherapy to radiation therapy (RT) reduced the risk of death by at least one-fourth overall, according to results reported in a poster session and related press briefing at the Multidisciplinary Head and Neck Cancer Symposium.

In further analysis, benefit was limited to those who were aged 81 years or younger with low comorbidity and more advanced disease.

“Does age matter? The answer to that question is yes and no,” commented senior author Dr. Sana Karam of the University of Colorado at Denver, Aurora. “The physician needs to use his or her clinical judgment.”

“Don’t just look at the age of the patient,” she advised. “In this day and age where patients are healthier and living longer, give them the benefit of curative intent with the addition of chemo. Assess the patient clinically. If they are not healthy; their comorbidity score, KPS, ECOG, whatever you are using in your practice, is poor; or if they have earlier-stage disease, early T, no bulky nodes, then it’s okay to just give RT alone. But the addition of chemotherapy can improve survival dramatically” for other patients.

The new findings are likely to temper those of the pivotal MACH-NC (Meta-Analysis of Chemotherapy in Head and Neck Cancers). That analysis found little to no survival benefit from adding concurrent chemotherapy to radiation therapy in patients aged 71 years or older, but only 4% of the included patients fell into this age-group.

“So it was very underpowered, but yet, it has set our clinical practice guidelines,” Dr. Karam noted at the meeting cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology. “And we know from many of our clinical trials this is a patient population that’s generally heavily underrepresented on clinical trials.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, commented, “Your data are very important because we all know the MACH-NC meta-analysis is used by our colleagues in Europe to support not using chemotherapy in elderly patients,” she added. “And in fact your data suggest it’s really not age, but comorbidity” that should be considered.

Dr. Gourin and colleagues performed a similar analysis, but instead used the Surveillance, Epidemiology, and End Results (SEER) Medicare database. Their results suggested that the impact of adding concurrent chemotherapy to radiation depended on the site: Patients with oropharynx cancer benefited, but those with larynx cancer actually fared worse because of late toxicity.

“Did you find any difference when you drilled down between larynx and hypopharynx and oropharynx?” she asked.

“We found that the overall survival benefit was regardless of the subsite,” Dr. Karam replied, noting that the patient populations in the two cohorts differed somewhat. “Unfortunately, we don’t have clear-cut variables for toxicity, but what we did look at is time to completion of RT, and we found that patients who did get concurrent chemoradiation had a longer time to completion of RT, suggesting perhaps more treatment breaks maybe. … But still, despite the treatment breaks, even after controlling for that, we still found an overall survival advantage, regardless of the subsite.”

At her institution, patients are already being treated with a tailored approach, Dr. Gourin commented. “We have young patients who are so sick that they are not great candidates for chemotherapy, and then we have old patients who are healthier than I am who are great candidates for chemotherapy. So I would say that we have been doing what Dr. Karam suggests, which is looking at age not as a number, but rather comorbidity and the overall functional status of the patient.”

“That’s why I really liked your study: It’s great to see that in writing, because I know that colleagues in other countries that I talk to about health care reform and how to cut costs, they actually use the MACH-NC to define who gets treated and who doesn’t,” she added.

For their analysis, Dr. Karam and colleagues identified patients in the database given a diagnosis of locally advanced cancer of the oropharynx, larynx, or hypopharynx between 1998 and 2011 who were treated with radiation therapy.

Overall, 53% received chemotherapy concurrently, defined as starting it in the 14 days before or 14 days after initiation of the radiation therapy, according to Dr. Karam.

The specific agents given could not be ascertained, she acknowledged. “Unfortunately, the NCDB does not give us data in regard to the type of chemotherapy, and they only started collecting cetuximab data in 2013.”

With a median follow-up of 19 months, the unadjusted 5-year overall survival rate was 15.2% with radiation therapy alone and 30.3% with concurrent chemoradiation (hazard ratio, 0.59; P less than .001). Benefit fell only slightly after multivariate adjustment (HR, 0.63; P less than .001).

Findings were similar in a propensity-matched analysis, which showed an 18.1% survival with radiation therapy alone versus 26.4% with concurrent chemoradiation (HR, 0.73; P less than .001).

On recursive partitioning analysis, chemoradiation was associated with better survival among patients 81 years of age or younger who had low comorbidity based on Charlson-Deyo score and either T1-2,N2-3 disease or T3-4,N0-3 disease.

There was no survival benefit in patients older than age 81. And among patients aged 71-80, there was no benefit for those having less advanced disease (stage T1-2,N1) and low comorbidity, or having more advanced disease (T3-4,N1+ disease) and high comorbidity.

SCOTTSDALE, ARIZ. – Oncologists should consider not only age, but also comorbidities and disease extent when deciding whether to offer concurrent chemoradiation to older adults with locally advanced head and neck cancer, suggests a cohort study using data from the National Cancer Data Base.

The study of 4,042 patients aged 71 years or older found that adding chemotherapy to radiation therapy (RT) reduced the risk of death by at least one-fourth overall, according to results reported in a poster session and related press briefing at the Multidisciplinary Head and Neck Cancer Symposium.

In further analysis, benefit was limited to those who were aged 81 years or younger with low comorbidity and more advanced disease.

“Does age matter? The answer to that question is yes and no,” commented senior author Dr. Sana Karam of the University of Colorado at Denver, Aurora. “The physician needs to use his or her clinical judgment.”

“Don’t just look at the age of the patient,” she advised. “In this day and age where patients are healthier and living longer, give them the benefit of curative intent with the addition of chemo. Assess the patient clinically. If they are not healthy; their comorbidity score, KPS, ECOG, whatever you are using in your practice, is poor; or if they have earlier-stage disease, early T, no bulky nodes, then it’s okay to just give RT alone. But the addition of chemotherapy can improve survival dramatically” for other patients.

The new findings are likely to temper those of the pivotal MACH-NC (Meta-Analysis of Chemotherapy in Head and Neck Cancers). That analysis found little to no survival benefit from adding concurrent chemotherapy to radiation therapy in patients aged 71 years or older, but only 4% of the included patients fell into this age-group.

“So it was very underpowered, but yet, it has set our clinical practice guidelines,” Dr. Karam noted at the meeting cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology. “And we know from many of our clinical trials this is a patient population that’s generally heavily underrepresented on clinical trials.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, commented, “Your data are very important because we all know the MACH-NC meta-analysis is used by our colleagues in Europe to support not using chemotherapy in elderly patients,” she added. “And in fact your data suggest it’s really not age, but comorbidity” that should be considered.

Dr. Gourin and colleagues performed a similar analysis, but instead used the Surveillance, Epidemiology, and End Results (SEER) Medicare database. Their results suggested that the impact of adding concurrent chemotherapy to radiation depended on the site: Patients with oropharynx cancer benefited, but those with larynx cancer actually fared worse because of late toxicity.

“Did you find any difference when you drilled down between larynx and hypopharynx and oropharynx?” she asked.

“We found that the overall survival benefit was regardless of the subsite,” Dr. Karam replied, noting that the patient populations in the two cohorts differed somewhat. “Unfortunately, we don’t have clear-cut variables for toxicity, but what we did look at is time to completion of RT, and we found that patients who did get concurrent chemoradiation had a longer time to completion of RT, suggesting perhaps more treatment breaks maybe. … But still, despite the treatment breaks, even after controlling for that, we still found an overall survival advantage, regardless of the subsite.”

At her institution, patients are already being treated with a tailored approach, Dr. Gourin commented. “We have young patients who are so sick that they are not great candidates for chemotherapy, and then we have old patients who are healthier than I am who are great candidates for chemotherapy. So I would say that we have been doing what Dr. Karam suggests, which is looking at age not as a number, but rather comorbidity and the overall functional status of the patient.”

“That’s why I really liked your study: It’s great to see that in writing, because I know that colleagues in other countries that I talk to about health care reform and how to cut costs, they actually use the MACH-NC to define who gets treated and who doesn’t,” she added.

For their analysis, Dr. Karam and colleagues identified patients in the database given a diagnosis of locally advanced cancer of the oropharynx, larynx, or hypopharynx between 1998 and 2011 who were treated with radiation therapy.

Overall, 53% received chemotherapy concurrently, defined as starting it in the 14 days before or 14 days after initiation of the radiation therapy, according to Dr. Karam.

The specific agents given could not be ascertained, she acknowledged. “Unfortunately, the NCDB does not give us data in regard to the type of chemotherapy, and they only started collecting cetuximab data in 2013.”

With a median follow-up of 19 months, the unadjusted 5-year overall survival rate was 15.2% with radiation therapy alone and 30.3% with concurrent chemoradiation (hazard ratio, 0.59; P less than .001). Benefit fell only slightly after multivariate adjustment (HR, 0.63; P less than .001).

Findings were similar in a propensity-matched analysis, which showed an 18.1% survival with radiation therapy alone versus 26.4% with concurrent chemoradiation (HR, 0.73; P less than .001).

On recursive partitioning analysis, chemoradiation was associated with better survival among patients 81 years of age or younger who had low comorbidity based on Charlson-Deyo score and either T1-2,N2-3 disease or T3-4,N0-3 disease.

There was no survival benefit in patients older than age 81. And among patients aged 71-80, there was no benefit for those having less advanced disease (stage T1-2,N1) and low comorbidity, or having more advanced disease (T3-4,N1+ disease) and high comorbidity.

SCOTTSDALE, ARIZ. – Oncologists should consider not only age, but also comorbidities and disease extent when deciding whether to offer concurrent chemoradiation to older adults with locally advanced head and neck cancer, suggests a cohort study using data from the National Cancer Data Base.

The study of 4,042 patients aged 71 years or older found that adding chemotherapy to radiation therapy (RT) reduced the risk of death by at least one-fourth overall, according to results reported in a poster session and related press briefing at the Multidisciplinary Head and Neck Cancer Symposium.

In further analysis, benefit was limited to those who were aged 81 years or younger with low comorbidity and more advanced disease.

“Does age matter? The answer to that question is yes and no,” commented senior author Dr. Sana Karam of the University of Colorado at Denver, Aurora. “The physician needs to use his or her clinical judgment.”

“Don’t just look at the age of the patient,” she advised. “In this day and age where patients are healthier and living longer, give them the benefit of curative intent with the addition of chemo. Assess the patient clinically. If they are not healthy; their comorbidity score, KPS, ECOG, whatever you are using in your practice, is poor; or if they have earlier-stage disease, early T, no bulky nodes, then it’s okay to just give RT alone. But the addition of chemotherapy can improve survival dramatically” for other patients.

The new findings are likely to temper those of the pivotal MACH-NC (Meta-Analysis of Chemotherapy in Head and Neck Cancers). That analysis found little to no survival benefit from adding concurrent chemotherapy to radiation therapy in patients aged 71 years or older, but only 4% of the included patients fell into this age-group.

“So it was very underpowered, but yet, it has set our clinical practice guidelines,” Dr. Karam noted at the meeting cosponsored by the American Society for Radiation Oncology and the American Society of Clinical Oncology. “And we know from many of our clinical trials this is a patient population that’s generally heavily underrepresented on clinical trials.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, commented, “Your data are very important because we all know the MACH-NC meta-analysis is used by our colleagues in Europe to support not using chemotherapy in elderly patients,” she added. “And in fact your data suggest it’s really not age, but comorbidity” that should be considered.

Dr. Gourin and colleagues performed a similar analysis, but instead used the Surveillance, Epidemiology, and End Results (SEER) Medicare database. Their results suggested that the impact of adding concurrent chemotherapy to radiation depended on the site: Patients with oropharynx cancer benefited, but those with larynx cancer actually fared worse because of late toxicity.

“Did you find any difference when you drilled down between larynx and hypopharynx and oropharynx?” she asked.

“We found that the overall survival benefit was regardless of the subsite,” Dr. Karam replied, noting that the patient populations in the two cohorts differed somewhat. “Unfortunately, we don’t have clear-cut variables for toxicity, but what we did look at is time to completion of RT, and we found that patients who did get concurrent chemoradiation had a longer time to completion of RT, suggesting perhaps more treatment breaks maybe. … But still, despite the treatment breaks, even after controlling for that, we still found an overall survival advantage, regardless of the subsite.”

At her institution, patients are already being treated with a tailored approach, Dr. Gourin commented. “We have young patients who are so sick that they are not great candidates for chemotherapy, and then we have old patients who are healthier than I am who are great candidates for chemotherapy. So I would say that we have been doing what Dr. Karam suggests, which is looking at age not as a number, but rather comorbidity and the overall functional status of the patient.”

“That’s why I really liked your study: It’s great to see that in writing, because I know that colleagues in other countries that I talk to about health care reform and how to cut costs, they actually use the MACH-NC to define who gets treated and who doesn’t,” she added.

For their analysis, Dr. Karam and colleagues identified patients in the database given a diagnosis of locally advanced cancer of the oropharynx, larynx, or hypopharynx between 1998 and 2011 who were treated with radiation therapy.

Overall, 53% received chemotherapy concurrently, defined as starting it in the 14 days before or 14 days after initiation of the radiation therapy, according to Dr. Karam.

The specific agents given could not be ascertained, she acknowledged. “Unfortunately, the NCDB does not give us data in regard to the type of chemotherapy, and they only started collecting cetuximab data in 2013.”

With a median follow-up of 19 months, the unadjusted 5-year overall survival rate was 15.2% with radiation therapy alone and 30.3% with concurrent chemoradiation (hazard ratio, 0.59; P less than .001). Benefit fell only slightly after multivariate adjustment (HR, 0.63; P less than .001).

Findings were similar in a propensity-matched analysis, which showed an 18.1% survival with radiation therapy alone versus 26.4% with concurrent chemoradiation (HR, 0.73; P less than .001).

On recursive partitioning analysis, chemoradiation was associated with better survival among patients 81 years of age or younger who had low comorbidity based on Charlson-Deyo score and either T1-2,N2-3 disease or T3-4,N0-3 disease.

There was no survival benefit in patients older than age 81. And among patients aged 71-80, there was no benefit for those having less advanced disease (stage T1-2,N1) and low comorbidity, or having more advanced disease (T3-4,N1+ disease) and high comorbidity.

SCOTTSDALE, ARIZ. – Most patients who are treated for human papillomavirus (HPV)–positive oropharyngeal cancer can safely skip routine imaging after a negative 3-month posttreatment scan, suggest results of a retrospective cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

Investigators led by Dr. Jessica M. Frakes of the H. Lee Moffitt Cancer Center in Tampa, Fla., studied 246 patients treated nonsurgically between 2006 and 2014 for nonmetastatic HPV-positive disease.

With a median follow-up of 36 months, all local recurrences and the large majority of regional and distant recurrences were detected from symptoms, physical exam, and the 3-month posttreatment PET-CT imaging, according to data reported in a session and related press briefing.

“Routine imaging is not recommended after posttreatment imaging shows a complete response to treatment, unless the patient presents with symptoms or something else that would warrant imaging,” Dr. Frakes commented. “Follow-up should include history and physical examination with direct visualization.”

Currently, the National Comprehensive Cancer Network advises a one-size-fits-all approach to follow-up that does not consider tumor HPV status, she noted. But reducing surveillance imaging for HPV-positive patients would likely have considerable benefit in terms of less stress and anxiety (provided patients are educated about the safety of clinical follow-up) and lower financial burden for both the patient and the health care system as a whole.

Results additionally showed that the majority of recurrences occurred within the first 6 months, a pattern that was consistent whether or not patients had risk factors for recurrence. The 3-year rate of freedom from local failure exceeded 97%, and only 2% of patients had grade 3 or worse toxicity at their last follow-up.

“Our outcomes are excellent with low rates of permanent toxicity, and we think that this partly is due to the fact that they are treated by specialized multidisciplinary team,” Dr. Frakes commented at the meeting.

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University in Baltimore, commented, “This study is one that’s dear to my heart because I think that we probably do too much posttreatment surveillance, and they are exactly right that the NCCN is fairly vague about when to perform imaging.”

“I can tell you that we have stopped routinely imaging patients after 3 months if the PET is negative, and it’s true that we do pick up recurrences more clinically than we do radiologically,” she added. “And of course the false positives are causing much morbidity.”

Introducing the study, Dr. Frakes commented, “Several retrospective and prospective trials have shown increased survivals and decreased toxicity in patients with HPV-associated oropharynx cancer. As the number of patients and survivors grows, so does the need to determine general time to recurrence and the most effective modes of recurrence detection, thereby guiding our standards for optimal follow-up care.”

All patients studied received definitive radiation therapy, and 85% of them also received concurrent chemotherapy.

The patients had a 3-month posttreatment PET-CT scan, plus physical exams every 3 months in the first year post treatment, every 4 months in the second year, every 6 months in the third through fifth years, and annually thereafter.

Results showed that the 3-year rate of local control was 97.8%, and 100% of the local failures were detected by physical exam, including direct visualization or flexible laryngoscopy.

The rate of regional control was 95.3%, and 89% of cases of regional failure were detected through symptoms or the 3-month posttreatment imaging. Risk factors for regional recurrence included involvement of five or more lymph nodes in the neck and involvement of level 4 (low neck) lymph nodes (P less than .05 for each).

The rate of freedom from distant metastases was 91%, and 71% of cases of distant metastases were detected through symptoms or the 3-month posttreatment imaging. Risk factors for distant metastases included tumor in the lymph nodes measuring greater than 6 cm, involvement of bilateral lymph nodes, involvement of five or more lymph nodes in the neck, and involvement of level 4 lymph nodes (P less than .05 for each).

Overall, 9% of patients experienced grade 3 or worse late toxicity (occurring at 3 months or thereafter), consisting of feeding/gastrostomy tube (G-tube) placement, necrosis or ulcer, and tracheostomy. However, these toxicities had resolved as of the last follow-up in most cases, with a final rate of toxicity of only 2%.

The center follows an aggressive approach to preventing and managing toxicity, noted Dr. Frakes.

“Even when the patients have their G-tube in place, we really do encourage p.o. [oral] intake as much as possible with pain medication. And I think that really does make a big difference for our patients,” she said. “They do meet with a speech pathologist and our nutritionist weekly when they are on treatment.” Patients are also allowed to have the G-tube removed by last follow-up, she added.

SCOTTSDALE, ARIZ. – Most patients who are treated for human papillomavirus (HPV)–positive oropharyngeal cancer can safely skip routine imaging after a negative 3-month posttreatment scan, suggest results of a retrospective cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

Investigators led by Dr. Jessica M. Frakes of the H. Lee Moffitt Cancer Center in Tampa, Fla., studied 246 patients treated nonsurgically between 2006 and 2014 for nonmetastatic HPV-positive disease.

With a median follow-up of 36 months, all local recurrences and the large majority of regional and distant recurrences were detected from symptoms, physical exam, and the 3-month posttreatment PET-CT imaging, according to data reported in a session and related press briefing.

“Routine imaging is not recommended after posttreatment imaging shows a complete response to treatment, unless the patient presents with symptoms or something else that would warrant imaging,” Dr. Frakes commented. “Follow-up should include history and physical examination with direct visualization.”

Currently, the National Comprehensive Cancer Network advises a one-size-fits-all approach to follow-up that does not consider tumor HPV status, she noted. But reducing surveillance imaging for HPV-positive patients would likely have considerable benefit in terms of less stress and anxiety (provided patients are educated about the safety of clinical follow-up) and lower financial burden for both the patient and the health care system as a whole.

Results additionally showed that the majority of recurrences occurred within the first 6 months, a pattern that was consistent whether or not patients had risk factors for recurrence. The 3-year rate of freedom from local failure exceeded 97%, and only 2% of patients had grade 3 or worse toxicity at their last follow-up.

“Our outcomes are excellent with low rates of permanent toxicity, and we think that this partly is due to the fact that they are treated by specialized multidisciplinary team,” Dr. Frakes commented at the meeting.

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University in Baltimore, commented, “This study is one that’s dear to my heart because I think that we probably do too much posttreatment surveillance, and they are exactly right that the NCCN is fairly vague about when to perform imaging.”

“I can tell you that we have stopped routinely imaging patients after 3 months if the PET is negative, and it’s true that we do pick up recurrences more clinically than we do radiologically,” she added. “And of course the false positives are causing much morbidity.”

Introducing the study, Dr. Frakes commented, “Several retrospective and prospective trials have shown increased survivals and decreased toxicity in patients with HPV-associated oropharynx cancer. As the number of patients and survivors grows, so does the need to determine general time to recurrence and the most effective modes of recurrence detection, thereby guiding our standards for optimal follow-up care.”

All patients studied received definitive radiation therapy, and 85% of them also received concurrent chemotherapy.

The patients had a 3-month posttreatment PET-CT scan, plus physical exams every 3 months in the first year post treatment, every 4 months in the second year, every 6 months in the third through fifth years, and annually thereafter.

Results showed that the 3-year rate of local control was 97.8%, and 100% of the local failures were detected by physical exam, including direct visualization or flexible laryngoscopy.

The rate of regional control was 95.3%, and 89% of cases of regional failure were detected through symptoms or the 3-month posttreatment imaging. Risk factors for regional recurrence included involvement of five or more lymph nodes in the neck and involvement of level 4 (low neck) lymph nodes (P less than .05 for each).

The rate of freedom from distant metastases was 91%, and 71% of cases of distant metastases were detected through symptoms or the 3-month posttreatment imaging. Risk factors for distant metastases included tumor in the lymph nodes measuring greater than 6 cm, involvement of bilateral lymph nodes, involvement of five or more lymph nodes in the neck, and involvement of level 4 lymph nodes (P less than .05 for each).

Overall, 9% of patients experienced grade 3 or worse late toxicity (occurring at 3 months or thereafter), consisting of feeding/gastrostomy tube (G-tube) placement, necrosis or ulcer, and tracheostomy. However, these toxicities had resolved as of the last follow-up in most cases, with a final rate of toxicity of only 2%.

The center follows an aggressive approach to preventing and managing toxicity, noted Dr. Frakes.

“Even when the patients have their G-tube in place, we really do encourage p.o. [oral] intake as much as possible with pain medication. And I think that really does make a big difference for our patients,” she said. “They do meet with a speech pathologist and our nutritionist weekly when they are on treatment.” Patients are also allowed to have the G-tube removed by last follow-up, she added.

SCOTTSDALE, ARIZ. – Most patients who are treated for human papillomavirus (HPV)–positive oropharyngeal cancer can safely skip routine imaging after a negative 3-month posttreatment scan, suggest results of a retrospective cohort study reported at the Multidisciplinary Head and Neck Cancer Symposium.

Investigators led by Dr. Jessica M. Frakes of the H. Lee Moffitt Cancer Center in Tampa, Fla., studied 246 patients treated nonsurgically between 2006 and 2014 for nonmetastatic HPV-positive disease.

With a median follow-up of 36 months, all local recurrences and the large majority of regional and distant recurrences were detected from symptoms, physical exam, and the 3-month posttreatment PET-CT imaging, according to data reported in a session and related press briefing.

“Routine imaging is not recommended after posttreatment imaging shows a complete response to treatment, unless the patient presents with symptoms or something else that would warrant imaging,” Dr. Frakes commented. “Follow-up should include history and physical examination with direct visualization.”

Currently, the National Comprehensive Cancer Network advises a one-size-fits-all approach to follow-up that does not consider tumor HPV status, she noted. But reducing surveillance imaging for HPV-positive patients would likely have considerable benefit in terms of less stress and anxiety (provided patients are educated about the safety of clinical follow-up) and lower financial burden for both the patient and the health care system as a whole.

Results additionally showed that the majority of recurrences occurred within the first 6 months, a pattern that was consistent whether or not patients had risk factors for recurrence. The 3-year rate of freedom from local failure exceeded 97%, and only 2% of patients had grade 3 or worse toxicity at their last follow-up.

“Our outcomes are excellent with low rates of permanent toxicity, and we think that this partly is due to the fact that they are treated by specialized multidisciplinary team,” Dr. Frakes commented at the meeting.

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University in Baltimore, commented, “This study is one that’s dear to my heart because I think that we probably do too much posttreatment surveillance, and they are exactly right that the NCCN is fairly vague about when to perform imaging.”

“I can tell you that we have stopped routinely imaging patients after 3 months if the PET is negative, and it’s true that we do pick up recurrences more clinically than we do radiologically,” she added. “And of course the false positives are causing much morbidity.”

Introducing the study, Dr. Frakes commented, “Several retrospective and prospective trials have shown increased survivals and decreased toxicity in patients with HPV-associated oropharynx cancer. As the number of patients and survivors grows, so does the need to determine general time to recurrence and the most effective modes of recurrence detection, thereby guiding our standards for optimal follow-up care.”

All patients studied received definitive radiation therapy, and 85% of them also received concurrent chemotherapy.

The patients had a 3-month posttreatment PET-CT scan, plus physical exams every 3 months in the first year post treatment, every 4 months in the second year, every 6 months in the third through fifth years, and annually thereafter.

Results showed that the 3-year rate of local control was 97.8%, and 100% of the local failures were detected by physical exam, including direct visualization or flexible laryngoscopy.

The rate of regional control was 95.3%, and 89% of cases of regional failure were detected through symptoms or the 3-month posttreatment imaging. Risk factors for regional recurrence included involvement of five or more lymph nodes in the neck and involvement of level 4 (low neck) lymph nodes (P less than .05 for each).

The rate of freedom from distant metastases was 91%, and 71% of cases of distant metastases were detected through symptoms or the 3-month posttreatment imaging. Risk factors for distant metastases included tumor in the lymph nodes measuring greater than 6 cm, involvement of bilateral lymph nodes, involvement of five or more lymph nodes in the neck, and involvement of level 4 lymph nodes (P less than .05 for each).

Overall, 9% of patients experienced grade 3 or worse late toxicity (occurring at 3 months or thereafter), consisting of feeding/gastrostomy tube (G-tube) placement, necrosis or ulcer, and tracheostomy. However, these toxicities had resolved as of the last follow-up in most cases, with a final rate of toxicity of only 2%.

The center follows an aggressive approach to preventing and managing toxicity, noted Dr. Frakes.

“Even when the patients have their G-tube in place, we really do encourage p.o. [oral] intake as much as possible with pain medication. And I think that really does make a big difference for our patients,” she said. “They do meet with a speech pathologist and our nutritionist weekly when they are on treatment.” Patients are also allowed to have the G-tube removed by last follow-up, she added.

SCOTTSDALE, ARIZ. – The human papillomavirus (HPV)–positive oropharyngeal cancers of heavy smokers and light smokers have distinctly different molecular profiles, which may have implications for treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium.

The population-based cohort study of 66 patients found that mutations in certain genes associated with tobacco exposure and poorer survival – for example, NOTCH1, TP53, CDKN2A, and KRAS – were found almost exclusively in heavy smokers, investigators reported in a session and related press briefing. Also, the number of HPV reads detected in tumors was lower for heavy smokers as compared with light smokers.

Taken together, the findings suggest that although HPV-positive cancers in heavy smokers may be initiated through virus-related mutations, they go on to acquire tobacco-related mutations and become less dependent on the E6/E7 carcinogenesis mechanisms typically associated with the virus, said first author Dr. Jose P. Zevallos of the University of North Carolina, Chapel Hill.

“We think that this study and future studies based on this work will have important implications for personalizing treatment and decision making in HPV-positive oropharynx cancer, particularly in the era of less aggressive treatments for HPV-positive tumors because of their excellent prognosis,” he said. “As opposed to arbitrarily deciding that 10 pack-years [of smoking] is a number that we use to define more aggressive disease, we are trying to provide a molecular basis for more aggressive disease in order to decide who will benefit from less-aggressive versus more-aggressive treatment.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, said “This study is so important because we know that the molecular fingerprint of HPV-related oropharyngeal cancer is really different from anything that we have seen before – different patient population, different outcomes than when I was in training.”

“We don’t really understand fully why this fingerprint is so different and why tobacco affects the fingerprint,” she added. “The finding of differences in the molecular phenotypes of light smokers versus heavy smokers is something that we all appreciate clinically and we need to understand better to tailor treatment.”

Introducing the study, Dr. Zevallos noted that the HPV-positive cancers of smokers are known to have prognosis intermediate between those of the more favorable HPV-positive cancers of never smokers and the less favorable HPV-negative cancers. What remains unclear is the molecular basis for these differences.

Patients came from the population-based CHANCE (Carolina Head and Neck Cancer Epidemiology) study conducted during 2001-2006. The investigators performed targeted next-generation DNA sequencing in tumors with an assay for more than 700 genes associated with human cancers.

“We focused our attention on genes that overlap with those in COSMIC [the Catalogue of Somatic Mutations in Cancer] as well as on TCGA [The Cancer Genome Atlas] genes that were demonstrated to be significant in head and neck cancer,” Dr. Zevallos explained.

All 66 patients studied had HPV-positive tumors according to p16 expression or HPV polymerase chain reaction findings. Overall, 61% were heavy smokers, defined as having a greater than 10 pack-year history of smoking.

In terms of clinical outcome, the 5-year overall survival rate was 82% among the heavy smokers and 60% among the light or never smokers.

Mutations associated with tobacco use were found almost exclusively in the heavy smokers, Dr. Zevallos reported. For example, they had higher prevalences of mutations in NOTCH1 (18% vs. 0%), FAT1 (14% vs. 6%), and FGFR3 (10% vs. 0%), among others. On the other hand, the light and never smokers had a higher prevalence of mutations in PIK3CA (50% vs. 34%). Additionally, KRAS mutations were found only in the heavy smokers (4% vs. 0%), whereas HRAS mutations were found in the light and never smokers only (6% vs. 0%).

A pathway analysis incorporating the new information for HPV-positive heavy smokers confirmed that despite persistence of the HPV-related signature, these tumors also had signaling in several of the pathways typically associated with HPV-negative cancers, according to Dr. Zevallos.

HPV DNA was detected in all of the tumors, and in 95% of cases, the viral type was type 16. However, PCR for HPV was falsely negative in 9%. “This is a very important number as we rely on this as a surrogate for HPV status,” he commented. “p16 was the main inclusion criterion for this particular study, but this should be noted.”

Heavy smokers and patients who had died had a lower number of HPV reads per tumor. “This tells us that there are potentially subclones developing in these patients that are driven by tobacco-associated mutations, and this may explain worse outcomes in this patient population and warrants further exploration,” Dr. Zevallos elaborated.

SCOTTSDALE, ARIZ. – The human papillomavirus (HPV)–positive oropharyngeal cancers of heavy smokers and light smokers have distinctly different molecular profiles, which may have implications for treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium.

The population-based cohort study of 66 patients found that mutations in certain genes associated with tobacco exposure and poorer survival – for example, NOTCH1, TP53, CDKN2A, and KRAS – were found almost exclusively in heavy smokers, investigators reported in a session and related press briefing. Also, the number of HPV reads detected in tumors was lower for heavy smokers as compared with light smokers.

Taken together, the findings suggest that although HPV-positive cancers in heavy smokers may be initiated through virus-related mutations, they go on to acquire tobacco-related mutations and become less dependent on the E6/E7 carcinogenesis mechanisms typically associated with the virus, said first author Dr. Jose P. Zevallos of the University of North Carolina, Chapel Hill.

“We think that this study and future studies based on this work will have important implications for personalizing treatment and decision making in HPV-positive oropharynx cancer, particularly in the era of less aggressive treatments for HPV-positive tumors because of their excellent prognosis,” he said. “As opposed to arbitrarily deciding that 10 pack-years [of smoking] is a number that we use to define more aggressive disease, we are trying to provide a molecular basis for more aggressive disease in order to decide who will benefit from less-aggressive versus more-aggressive treatment.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, said “This study is so important because we know that the molecular fingerprint of HPV-related oropharyngeal cancer is really different from anything that we have seen before – different patient population, different outcomes than when I was in training.”

“We don’t really understand fully why this fingerprint is so different and why tobacco affects the fingerprint,” she added. “The finding of differences in the molecular phenotypes of light smokers versus heavy smokers is something that we all appreciate clinically and we need to understand better to tailor treatment.”

Introducing the study, Dr. Zevallos noted that the HPV-positive cancers of smokers are known to have prognosis intermediate between those of the more favorable HPV-positive cancers of never smokers and the less favorable HPV-negative cancers. What remains unclear is the molecular basis for these differences.

Patients came from the population-based CHANCE (Carolina Head and Neck Cancer Epidemiology) study conducted during 2001-2006. The investigators performed targeted next-generation DNA sequencing in tumors with an assay for more than 700 genes associated with human cancers.

“We focused our attention on genes that overlap with those in COSMIC [the Catalogue of Somatic Mutations in Cancer] as well as on TCGA [The Cancer Genome Atlas] genes that were demonstrated to be significant in head and neck cancer,” Dr. Zevallos explained.

All 66 patients studied had HPV-positive tumors according to p16 expression or HPV polymerase chain reaction findings. Overall, 61% were heavy smokers, defined as having a greater than 10 pack-year history of smoking.

In terms of clinical outcome, the 5-year overall survival rate was 82% among the heavy smokers and 60% among the light or never smokers.

Mutations associated with tobacco use were found almost exclusively in the heavy smokers, Dr. Zevallos reported. For example, they had higher prevalences of mutations in NOTCH1 (18% vs. 0%), FAT1 (14% vs. 6%), and FGFR3 (10% vs. 0%), among others. On the other hand, the light and never smokers had a higher prevalence of mutations in PIK3CA (50% vs. 34%). Additionally, KRAS mutations were found only in the heavy smokers (4% vs. 0%), whereas HRAS mutations were found in the light and never smokers only (6% vs. 0%).

A pathway analysis incorporating the new information for HPV-positive heavy smokers confirmed that despite persistence of the HPV-related signature, these tumors also had signaling in several of the pathways typically associated with HPV-negative cancers, according to Dr. Zevallos.

HPV DNA was detected in all of the tumors, and in 95% of cases, the viral type was type 16. However, PCR for HPV was falsely negative in 9%. “This is a very important number as we rely on this as a surrogate for HPV status,” he commented. “p16 was the main inclusion criterion for this particular study, but this should be noted.”

Heavy smokers and patients who had died had a lower number of HPV reads per tumor. “This tells us that there are potentially subclones developing in these patients that are driven by tobacco-associated mutations, and this may explain worse outcomes in this patient population and warrants further exploration,” Dr. Zevallos elaborated.

SCOTTSDALE, ARIZ. – The human papillomavirus (HPV)–positive oropharyngeal cancers of heavy smokers and light smokers have distinctly different molecular profiles, which may have implications for treatment, according to a study presented at the Multidisciplinary Head and Neck Cancer Symposium.

The population-based cohort study of 66 patients found that mutations in certain genes associated with tobacco exposure and poorer survival – for example, NOTCH1, TP53, CDKN2A, and KRAS – were found almost exclusively in heavy smokers, investigators reported in a session and related press briefing. Also, the number of HPV reads detected in tumors was lower for heavy smokers as compared with light smokers.

Taken together, the findings suggest that although HPV-positive cancers in heavy smokers may be initiated through virus-related mutations, they go on to acquire tobacco-related mutations and become less dependent on the E6/E7 carcinogenesis mechanisms typically associated with the virus, said first author Dr. Jose P. Zevallos of the University of North Carolina, Chapel Hill.

“We think that this study and future studies based on this work will have important implications for personalizing treatment and decision making in HPV-positive oropharynx cancer, particularly in the era of less aggressive treatments for HPV-positive tumors because of their excellent prognosis,” he said. “As opposed to arbitrarily deciding that 10 pack-years [of smoking] is a number that we use to define more aggressive disease, we are trying to provide a molecular basis for more aggressive disease in order to decide who will benefit from less-aggressive versus more-aggressive treatment.”

Press briefing moderator Dr. Christine Gourin of Johns Hopkins University, Baltimore, said “This study is so important because we know that the molecular fingerprint of HPV-related oropharyngeal cancer is really different from anything that we have seen before – different patient population, different outcomes than when I was in training.”

“We don’t really understand fully why this fingerprint is so different and why tobacco affects the fingerprint,” she added. “The finding of differences in the molecular phenotypes of light smokers versus heavy smokers is something that we all appreciate clinically and we need to understand better to tailor treatment.”

Introducing the study, Dr. Zevallos noted that the HPV-positive cancers of smokers are known to have prognosis intermediate between those of the more favorable HPV-positive cancers of never smokers and the less favorable HPV-negative cancers. What remains unclear is the molecular basis for these differences.

Patients came from the population-based CHANCE (Carolina Head and Neck Cancer Epidemiology) study conducted during 2001-2006. The investigators performed targeted next-generation DNA sequencing in tumors with an assay for more than 700 genes associated with human cancers.

“We focused our attention on genes that overlap with those in COSMIC [the Catalogue of Somatic Mutations in Cancer] as well as on TCGA [The Cancer Genome Atlas] genes that were demonstrated to be significant in head and neck cancer,” Dr. Zevallos explained.

All 66 patients studied had HPV-positive tumors according to p16 expression or HPV polymerase chain reaction findings. Overall, 61% were heavy smokers, defined as having a greater than 10 pack-year history of smoking.

In terms of clinical outcome, the 5-year overall survival rate was 82% among the heavy smokers and 60% among the light or never smokers.

Mutations associated with tobacco use were found almost exclusively in the heavy smokers, Dr. Zevallos reported. For example, they had higher prevalences of mutations in NOTCH1 (18% vs. 0%), FAT1 (14% vs. 6%), and FGFR3 (10% vs. 0%), among others. On the other hand, the light and never smokers had a higher prevalence of mutations in PIK3CA (50% vs. 34%). Additionally, KRAS mutations were found only in the heavy smokers (4% vs. 0%), whereas HRAS mutations were found in the light and never smokers only (6% vs. 0%).

A pathway analysis incorporating the new information for HPV-positive heavy smokers confirmed that despite persistence of the HPV-related signature, these tumors also had signaling in several of the pathways typically associated with HPV-negative cancers, according to Dr. Zevallos.

HPV DNA was detected in all of the tumors, and in 95% of cases, the viral type was type 16. However, PCR for HPV was falsely negative in 9%. “This is a very important number as we rely on this as a surrogate for HPV status,” he commented. “p16 was the main inclusion criterion for this particular study, but this should be noted.”

Heavy smokers and patients who had died had a lower number of HPV reads per tumor. “This tells us that there are potentially subclones developing in these patients that are driven by tobacco-associated mutations, and this may explain worse outcomes in this patient population and warrants further exploration,” Dr. Zevallos elaborated.

SCOTTSDALE, ARIZ. – Costs of care are a major burden in patients undergoing treatment for head and neck cancer, especially those who are socially isolated, finds a study reported at the Multidisciplinary Head and Neck Cancer Symposium.

More than two-thirds of the 73 patients with locally advanced disease had adopted life-altering strategies, such as tapping their savings or using credit to help pay for treatment, according to data presented in a poster session and related press briefing.

Patients who had a high perceived level of social isolation were more than 10 times as likely to have taken such actions than counterparts who had a medium or low level of isolation.

“Based on our study, a majority of patients rely on lifestyle-altering, cost-coping strategies to manage the financial side effects of head and neck cancer care. Financial side effects should be considered a morbidity of head and neck cancer,” commented lead author Sunny Kung, a second-year medical student at the University of Chicago and lead author on the study. “A lack of social support, coupled with increased loneliness is a risk factor for suboptimal medication adherence, missed appointments, and longer length of hospital stay.”

“Our study demonstrates that it is important for physicians to assess risk factors such as financial burden, loneliness, and [lack of] social support in order to provide optimal care for our patients,” she added. “Additional studies should be done to identify patient-specific interventions in order to help these patients optimize their care.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, noted, “One of the questions that our patients often ask and one of the things that we often spend time talking to our patients about is how long can they continue working after treatment. Was your dataset able to provide any insight into that?”

“Our study confirms that many of our patients are actually unable to continue working,” Ms. Kung replied. “I think head and neck cancer has some of the highest rates of disability of all the cancers – it’s something above 50% or 60%. I’m not sure about the exact number, but it’s quite high.”

In the study, the investigators followed patients starting treatment at the University of Chicago, surveying them monthly for 6 months about out-of-pocket costs, coping strategies, medication compliance, health care use, and perceived social isolation (loneliness and lack of social support).

During that 6-month period, 69% of patients overall used one or more lifestyle-altering strategies to cope with the costs of treatment. Specifically, 62% used part or all of their savings, 42% borrowed money or used credit, 25% sold possessions or property, and 23% had family members work more hours.

“We only assessed whether or not they used their savings, not how much of their savings they used,” Ms. Kung noted. “So this is a limitation of our study.”

The patients’ mean total monthly out-of-pocket costs totaled to $1,589. This was mainly driven by direct medical costs such as deductibles and hospital bills ($1,286), but insurance premiums also contributed ($303). Median values were lower but still substantial.

In multivariate analyses that controlled for potential confounders including factors such as marital status, patients were significantly and markedly more likely to resort to cost-coping strategies if they had Medicaid as compared with private insurance (odds ratio, 42.3). The likelihood rose with each $1,000 increment in total out-of-pocket costs (OR, 1.07) and fell with each $10,000 increment in wealth status (OR, 0.95). Patients who had a high perceived level of social isolation before starting treatment were also dramatically more likely to use these strategies (OR, 11.5).

Furthermore, on average, patients with a high level of social isolation skipped medication on more days (21.4 vs. 5.5; P = .03) and missed more appointments (7 vs. 3; P = .008).

“I believe it’s important for physicians to start screening patients – just as we do for depression – and identifying patients who have high perceived social isolation so that we can intervene earlier on, before they experience these negative financial side effects of their care,” concluded Ms. Kung.

SCOTTSDALE, ARIZ. – Costs of care are a major burden in patients undergoing treatment for head and neck cancer, especially those who are socially isolated, finds a study reported at the Multidisciplinary Head and Neck Cancer Symposium.

More than two-thirds of the 73 patients with locally advanced disease had adopted life-altering strategies, such as tapping their savings or using credit to help pay for treatment, according to data presented in a poster session and related press briefing.

Patients who had a high perceived level of social isolation were more than 10 times as likely to have taken such actions than counterparts who had a medium or low level of isolation.

“Based on our study, a majority of patients rely on lifestyle-altering, cost-coping strategies to manage the financial side effects of head and neck cancer care. Financial side effects should be considered a morbidity of head and neck cancer,” commented lead author Sunny Kung, a second-year medical student at the University of Chicago and lead author on the study. “A lack of social support, coupled with increased loneliness is a risk factor for suboptimal medication adherence, missed appointments, and longer length of hospital stay.”

“Our study demonstrates that it is important for physicians to assess risk factors such as financial burden, loneliness, and [lack of] social support in order to provide optimal care for our patients,” she added. “Additional studies should be done to identify patient-specific interventions in order to help these patients optimize their care.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, noted, “One of the questions that our patients often ask and one of the things that we often spend time talking to our patients about is how long can they continue working after treatment. Was your dataset able to provide any insight into that?”

“Our study confirms that many of our patients are actually unable to continue working,” Ms. Kung replied. “I think head and neck cancer has some of the highest rates of disability of all the cancers – it’s something above 50% or 60%. I’m not sure about the exact number, but it’s quite high.”

In the study, the investigators followed patients starting treatment at the University of Chicago, surveying them monthly for 6 months about out-of-pocket costs, coping strategies, medication compliance, health care use, and perceived social isolation (loneliness and lack of social support).

During that 6-month period, 69% of patients overall used one or more lifestyle-altering strategies to cope with the costs of treatment. Specifically, 62% used part or all of their savings, 42% borrowed money or used credit, 25% sold possessions or property, and 23% had family members work more hours.

“We only assessed whether or not they used their savings, not how much of their savings they used,” Ms. Kung noted. “So this is a limitation of our study.”

The patients’ mean total monthly out-of-pocket costs totaled to $1,589. This was mainly driven by direct medical costs such as deductibles and hospital bills ($1,286), but insurance premiums also contributed ($303). Median values were lower but still substantial.

In multivariate analyses that controlled for potential confounders including factors such as marital status, patients were significantly and markedly more likely to resort to cost-coping strategies if they had Medicaid as compared with private insurance (odds ratio, 42.3). The likelihood rose with each $1,000 increment in total out-of-pocket costs (OR, 1.07) and fell with each $10,000 increment in wealth status (OR, 0.95). Patients who had a high perceived level of social isolation before starting treatment were also dramatically more likely to use these strategies (OR, 11.5).

Furthermore, on average, patients with a high level of social isolation skipped medication on more days (21.4 vs. 5.5; P = .03) and missed more appointments (7 vs. 3; P = .008).

“I believe it’s important for physicians to start screening patients – just as we do for depression – and identifying patients who have high perceived social isolation so that we can intervene earlier on, before they experience these negative financial side effects of their care,” concluded Ms. Kung.

SCOTTSDALE, ARIZ. – Costs of care are a major burden in patients undergoing treatment for head and neck cancer, especially those who are socially isolated, finds a study reported at the Multidisciplinary Head and Neck Cancer Symposium.

More than two-thirds of the 73 patients with locally advanced disease had adopted life-altering strategies, such as tapping their savings or using credit to help pay for treatment, according to data presented in a poster session and related press briefing.

Patients who had a high perceived level of social isolation were more than 10 times as likely to have taken such actions than counterparts who had a medium or low level of isolation.

“Based on our study, a majority of patients rely on lifestyle-altering, cost-coping strategies to manage the financial side effects of head and neck cancer care. Financial side effects should be considered a morbidity of head and neck cancer,” commented lead author Sunny Kung, a second-year medical student at the University of Chicago and lead author on the study. “A lack of social support, coupled with increased loneliness is a risk factor for suboptimal medication adherence, missed appointments, and longer length of hospital stay.”

“Our study demonstrates that it is important for physicians to assess risk factors such as financial burden, loneliness, and [lack of] social support in order to provide optimal care for our patients,” she added. “Additional studies should be done to identify patient-specific interventions in order to help these patients optimize their care.”

Press briefing moderator Dr. Randall J. Kimple of the University of Wisconsin–Madison, noted, “One of the questions that our patients often ask and one of the things that we often spend time talking to our patients about is how long can they continue working after treatment. Was your dataset able to provide any insight into that?”

“Our study confirms that many of our patients are actually unable to continue working,” Ms. Kung replied. “I think head and neck cancer has some of the highest rates of disability of all the cancers – it’s something above 50% or 60%. I’m not sure about the exact number, but it’s quite high.”

In the study, the investigators followed patients starting treatment at the University of Chicago, surveying them monthly for 6 months about out-of-pocket costs, coping strategies, medication compliance, health care use, and perceived social isolation (loneliness and lack of social support).

During that 6-month period, 69% of patients overall used one or more lifestyle-altering strategies to cope with the costs of treatment. Specifically, 62% used part or all of their savings, 42% borrowed money or used credit, 25% sold possessions or property, and 23% had family members work more hours.

“We only assessed whether or not they used their savings, not how much of their savings they used,” Ms. Kung noted. “So this is a limitation of our study.”

The patients’ mean total monthly out-of-pocket costs totaled to $1,589. This was mainly driven by direct medical costs such as deductibles and hospital bills ($1,286), but insurance premiums also contributed ($303). Median values were lower but still substantial.

In multivariate analyses that controlled for potential confounders including factors such as marital status, patients were significantly and markedly more likely to resort to cost-coping strategies if they had Medicaid as compared with private insurance (odds ratio, 42.3). The likelihood rose with each $1,000 increment in total out-of-pocket costs (OR, 1.07) and fell with each $10,000 increment in wealth status (OR, 0.95). Patients who had a high perceived level of social isolation before starting treatment were also dramatically more likely to use these strategies (OR, 11.5).

Furthermore, on average, patients with a high level of social isolation skipped medication on more days (21.4 vs. 5.5; P = .03) and missed more appointments (7 vs. 3; P = .008).

“I believe it’s important for physicians to start screening patients – just as we do for depression – and identifying patients who have high perceived social isolation so that we can intervene earlier on, before they experience these negative financial side effects of their care,” concluded Ms. Kung.