Becoming the paradigm for clinical trial enrollment

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The previous issue of The Sarcoma Journal focused on findings from numerous clinical trials in sarcomas of various histologies presented at ASCO’s annual meeting. This issue features a study on enrollment issues that surround clinical trials in sarcoma and sheds light on patient perceptions on clinical trial enrollment.

Clinical trials and their investigators are frequently impacted by enrollment issues, such as the limited number of eligible patients and the wide variations in time it can take to reach complete enrollment. For example, the phase 3 ANNOUNCE trial of olaratumab in soft tissue sarcoma completed its accrual of 509 patients in a record 10 months, while the trial of temozolomide by the European Pediatric Soft Tissue Sarcoma Study Group took 6 years to enroll 120 patients. Recruitment difficulties may even hamper the investigators’ and sponsors’ ability to bring a trial to a meaningful conclusion.

An interesting finding from the study published in this issue is the correlation between knowledge about trials and the positive attitude towards participating in them. People who had participated in clinical trials had higher levels of knowledge and developed more favorable attitudes towards clinical trials. One of the goals of the Sarcoma Foundation of America (curesarcoma.org) is to increase awareness of the numbers and types of ongoing clinical trials in sarcoma, benefitting patients and investigators alike. The SFA operates the Clinical Trial Navigating Service, which offers patients, caregivers, and health care professionals up-to-date information about sarcoma clinical trials throughout the United States and Canada. The service, provided in collaboration with EmergingMed, helps patients search for clinical trial options that match their specific diagnosis and treatment history.

The paper published in this issue suggests that, through patient education and careful trial design, sarcoma could become a paradigm for trial enrollment in other therapeutic areas. Together—as physicians, investigators, patients, trial sponsors, and anyone interested in curing sarcoma—we may be able to accomplish this. It’s certainly worth a try.

William D. Tap, MD
Editor-in-Chief

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The previous issue of The Sarcoma Journal focused on findings from numerous clinical trials in sarcomas of various histologies presented at ASCO’s annual meeting. This issue features a study on enrollment issues that surround clinical trials in sarcoma and sheds light on patient perceptions on clinical trial enrollment.

Clinical trials and their investigators are frequently impacted by enrollment issues, such as the limited number of eligible patients and the wide variations in time it can take to reach complete enrollment. For example, the phase 3 ANNOUNCE trial of olaratumab in soft tissue sarcoma completed its accrual of 509 patients in a record 10 months, while the trial of temozolomide by the European Pediatric Soft Tissue Sarcoma Study Group took 6 years to enroll 120 patients. Recruitment difficulties may even hamper the investigators’ and sponsors’ ability to bring a trial to a meaningful conclusion.

An interesting finding from the study published in this issue is the correlation between knowledge about trials and the positive attitude towards participating in them. People who had participated in clinical trials had higher levels of knowledge and developed more favorable attitudes towards clinical trials. One of the goals of the Sarcoma Foundation of America (curesarcoma.org) is to increase awareness of the numbers and types of ongoing clinical trials in sarcoma, benefitting patients and investigators alike. The SFA operates the Clinical Trial Navigating Service, which offers patients, caregivers, and health care professionals up-to-date information about sarcoma clinical trials throughout the United States and Canada. The service, provided in collaboration with EmergingMed, helps patients search for clinical trial options that match their specific diagnosis and treatment history.

The paper published in this issue suggests that, through patient education and careful trial design, sarcoma could become a paradigm for trial enrollment in other therapeutic areas. Together—as physicians, investigators, patients, trial sponsors, and anyone interested in curing sarcoma—we may be able to accomplish this. It’s certainly worth a try.

William D. Tap, MD
Editor-in-Chief

The previous issue of The Sarcoma Journal focused on findings from numerous clinical trials in sarcomas of various histologies presented at ASCO’s annual meeting. This issue features a study on enrollment issues that surround clinical trials in sarcoma and sheds light on patient perceptions on clinical trial enrollment.

Clinical trials and their investigators are frequently impacted by enrollment issues, such as the limited number of eligible patients and the wide variations in time it can take to reach complete enrollment. For example, the phase 3 ANNOUNCE trial of olaratumab in soft tissue sarcoma completed its accrual of 509 patients in a record 10 months, while the trial of temozolomide by the European Pediatric Soft Tissue Sarcoma Study Group took 6 years to enroll 120 patients. Recruitment difficulties may even hamper the investigators’ and sponsors’ ability to bring a trial to a meaningful conclusion.

An interesting finding from the study published in this issue is the correlation between knowledge about trials and the positive attitude towards participating in them. People who had participated in clinical trials had higher levels of knowledge and developed more favorable attitudes towards clinical trials. One of the goals of the Sarcoma Foundation of America (curesarcoma.org) is to increase awareness of the numbers and types of ongoing clinical trials in sarcoma, benefitting patients and investigators alike. The SFA operates the Clinical Trial Navigating Service, which offers patients, caregivers, and health care professionals up-to-date information about sarcoma clinical trials throughout the United States and Canada. The service, provided in collaboration with EmergingMed, helps patients search for clinical trial options that match their specific diagnosis and treatment history.

The paper published in this issue suggests that, through patient education and careful trial design, sarcoma could become a paradigm for trial enrollment in other therapeutic areas. Together—as physicians, investigators, patients, trial sponsors, and anyone interested in curing sarcoma—we may be able to accomplish this. It’s certainly worth a try.

William D. Tap, MD
Editor-in-Chief

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Clinical trials in sarcoma bring hope and promise

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In this issue of The Sarcoma Journal, we highlight research and developments presented at the 2019 ASCO annual meeting. Despite the rarity of sarcoma, it was not lost among the thousands of abstracts, posters, and talks presented during the four-and-a-half days of the meeting.

In the past 5 years, there has been a resurgence of phase 3 clinical trials in sarcoma, including several large first-line studies comparing combination therapies to doxorubicin—the gold standard since the mid-1970s. None have shown superiority. Despite this, there has been a gradual improvement in overall survival. This is attributed to advances in the multidisciplinary management of sarcomas and available supportive care services as well as a better understanding of and emergent therapies for individual sarcoma subtypes.

In the United States, we have seen the approval of several agents in sarcoma: pazopanib, with a 3-month improvement in progression-free survival (PFS) over placebo; trabectedin in liposarcoma and leiomyosarcoma, with a 2.7-month improvement in PFS over dacarbazine; and eribulin, based on a liposarcoma subgroup analysis that showed a 7-month improvement in overall survival over dacarbazine.None of these therapies are approved in the US in the front-line setting; rather, all after a patient generally receives a doxorubicin- based therapy.

We have learned a great deal from these studies. They highlight some of the challenges in designing clinical trials in a rare and heterogeneous group of malignancies. The sarcoma community is very much focused on overcoming these challenges by designing clinical trials appropriate to the disease and the therapy that is being studied. This includes the incorporation of novel endpoints, imaging modalities, patient-reported outcome measures, and statistical methodologies to best serve the patient and to determine whether and how the therapy is helping them.

There is tremendous hope and promise in sarcoma due to significant advancements in our understanding of mesenchymal biology and of the genetic diversity in these diseases. This has led to an influx of promising agents and trials, many of which have transformed treatment paradigms on specific sarcoma subtypes. This issue provides a glimpse into the progress being made.

From Dr. Tap’s plenary presentation at ASCO 2019

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The Sarcoma Journal - 3(3)
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In this issue of The Sarcoma Journal, we highlight research and developments presented at the 2019 ASCO annual meeting. Despite the rarity of sarcoma, it was not lost among the thousands of abstracts, posters, and talks presented during the four-and-a-half days of the meeting.

In the past 5 years, there has been a resurgence of phase 3 clinical trials in sarcoma, including several large first-line studies comparing combination therapies to doxorubicin—the gold standard since the mid-1970s. None have shown superiority. Despite this, there has been a gradual improvement in overall survival. This is attributed to advances in the multidisciplinary management of sarcomas and available supportive care services as well as a better understanding of and emergent therapies for individual sarcoma subtypes.

In the United States, we have seen the approval of several agents in sarcoma: pazopanib, with a 3-month improvement in progression-free survival (PFS) over placebo; trabectedin in liposarcoma and leiomyosarcoma, with a 2.7-month improvement in PFS over dacarbazine; and eribulin, based on a liposarcoma subgroup analysis that showed a 7-month improvement in overall survival over dacarbazine.None of these therapies are approved in the US in the front-line setting; rather, all after a patient generally receives a doxorubicin- based therapy.

We have learned a great deal from these studies. They highlight some of the challenges in designing clinical trials in a rare and heterogeneous group of malignancies. The sarcoma community is very much focused on overcoming these challenges by designing clinical trials appropriate to the disease and the therapy that is being studied. This includes the incorporation of novel endpoints, imaging modalities, patient-reported outcome measures, and statistical methodologies to best serve the patient and to determine whether and how the therapy is helping them.

There is tremendous hope and promise in sarcoma due to significant advancements in our understanding of mesenchymal biology and of the genetic diversity in these diseases. This has led to an influx of promising agents and trials, many of which have transformed treatment paradigms on specific sarcoma subtypes. This issue provides a glimpse into the progress being made.

From Dr. Tap’s plenary presentation at ASCO 2019

In this issue of The Sarcoma Journal, we highlight research and developments presented at the 2019 ASCO annual meeting. Despite the rarity of sarcoma, it was not lost among the thousands of abstracts, posters, and talks presented during the four-and-a-half days of the meeting.

In the past 5 years, there has been a resurgence of phase 3 clinical trials in sarcoma, including several large first-line studies comparing combination therapies to doxorubicin—the gold standard since the mid-1970s. None have shown superiority. Despite this, there has been a gradual improvement in overall survival. This is attributed to advances in the multidisciplinary management of sarcomas and available supportive care services as well as a better understanding of and emergent therapies for individual sarcoma subtypes.

In the United States, we have seen the approval of several agents in sarcoma: pazopanib, with a 3-month improvement in progression-free survival (PFS) over placebo; trabectedin in liposarcoma and leiomyosarcoma, with a 2.7-month improvement in PFS over dacarbazine; and eribulin, based on a liposarcoma subgroup analysis that showed a 7-month improvement in overall survival over dacarbazine.None of these therapies are approved in the US in the front-line setting; rather, all after a patient generally receives a doxorubicin- based therapy.

We have learned a great deal from these studies. They highlight some of the challenges in designing clinical trials in a rare and heterogeneous group of malignancies. The sarcoma community is very much focused on overcoming these challenges by designing clinical trials appropriate to the disease and the therapy that is being studied. This includes the incorporation of novel endpoints, imaging modalities, patient-reported outcome measures, and statistical methodologies to best serve the patient and to determine whether and how the therapy is helping them.

There is tremendous hope and promise in sarcoma due to significant advancements in our understanding of mesenchymal biology and of the genetic diversity in these diseases. This has led to an influx of promising agents and trials, many of which have transformed treatment paradigms on specific sarcoma subtypes. This issue provides a glimpse into the progress being made.

From Dr. Tap’s plenary presentation at ASCO 2019

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The Sarcoma Journal enters its second full year with renewed commitment and energy

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The Sarcoma Journal enters its second full year with renewed commitment and energy

We begin this second full year publishing The Sarcoma Journal—Official Journal of the Sarcoma Foundation of AmericaTMwith renewed energy and dedication to its founding principle of communicating authoritative and comprehensive scientific information on the diagnosis and treatment of sarcomas and sarcoma subtypes.

Despite advances in treatment and management options for our patients, the need still exists for more effective treatment strategies, new treatment paradigms, and improved understanding of disease biology. This journal, along with its online platform, plays an important role in the dissemination of reliable, peer-reviewed content to the sarcoma community and aims to bridge the gap between bench and bedside.

To this end, we have again recruited an outstanding advisory board, many of whom have long-standing affiliations with the Sarcoma Foundation of America. With their help, the editorial staff and I will continue to build the journal and make it the number one academic and practice resource for the sarcoma community.

We invite you and your colleagues to submit original research, review articles, case reports, opinion pieces, and meeting summaries for publication. In this way we will create the robust forum we all desire.

eea.jpg

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We begin this second full year publishing The Sarcoma Journal—Official Journal of the Sarcoma Foundation of AmericaTMwith renewed energy and dedication to its founding principle of communicating authoritative and comprehensive scientific information on the diagnosis and treatment of sarcomas and sarcoma subtypes.

Despite advances in treatment and management options for our patients, the need still exists for more effective treatment strategies, new treatment paradigms, and improved understanding of disease biology. This journal, along with its online platform, plays an important role in the dissemination of reliable, peer-reviewed content to the sarcoma community and aims to bridge the gap between bench and bedside.

To this end, we have again recruited an outstanding advisory board, many of whom have long-standing affiliations with the Sarcoma Foundation of America. With their help, the editorial staff and I will continue to build the journal and make it the number one academic and practice resource for the sarcoma community.

We invite you and your colleagues to submit original research, review articles, case reports, opinion pieces, and meeting summaries for publication. In this way we will create the robust forum we all desire.

eea.jpg

We begin this second full year publishing The Sarcoma Journal—Official Journal of the Sarcoma Foundation of AmericaTMwith renewed energy and dedication to its founding principle of communicating authoritative and comprehensive scientific information on the diagnosis and treatment of sarcomas and sarcoma subtypes.

Despite advances in treatment and management options for our patients, the need still exists for more effective treatment strategies, new treatment paradigms, and improved understanding of disease biology. This journal, along with its online platform, plays an important role in the dissemination of reliable, peer-reviewed content to the sarcoma community and aims to bridge the gap between bench and bedside.

To this end, we have again recruited an outstanding advisory board, many of whom have long-standing affiliations with the Sarcoma Foundation of America. With their help, the editorial staff and I will continue to build the journal and make it the number one academic and practice resource for the sarcoma community.

We invite you and your colleagues to submit original research, review articles, case reports, opinion pieces, and meeting summaries for publication. In this way we will create the robust forum we all desire.

eea.jpg

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The Sarcoma Journal enters its second full year with renewed commitment and energy
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