When All Else Fails, Consider Capecitabine for SCC

VANCOUVER, B.C. — Capecitabine, an oral prodrug of 5-fluorouracil, can be used to control advanced squamous cell carcinoma of the skin when conventional treatment options have run out, according to the results of two studies involving a total of five patients.

Capecitabine (Xeloda) "was designed to improve upon existing 5-fluorouracil by having increased efficacy, an improved side-effect profile, and increased ease of administration," Dr. Mariah R. Brown, lead investigator of one study, explained at the annual meeting of the American College of Mohs Surgery.

Although capecitabine is currently approved only for treatment of colorectal cancer and breast cancer, research suggests a possible role for the drug in managing several other malignancies, including skin cancer, she noted.

Dr. Brown and her colleagues at the University of Colorado, Denver, studied three patients (two women and one man) aged 60-73 years who had locally advanced squamous cell carcinoma (SCC) of the head and neck. In each case, the cancer was inoperable because of tumor size or limitations imposed by prior surgery or radiation therapy; patients also wanted to avoid aggressive therapy. None of the patients had evidence of metastases.

The patients were treated with multiple courses of capecitabine (1,500 mg twice daily), with each course consisting of 2 weeks on the drug and 1 week off. The total duration of treatment ranged from 2 to 6 months.

All patients had a clinical response, with visible shrinkage of tumors by more than 50% and response beginning within the first course of therapy, Dr. Brown reported.

One patient was clinically disease-free after four courses of therapy. She continued taking capecitabine, albeit at a lower dose, because she experienced severe hand-foot syndrome, and was stable 6 months after starting the lower-dose therapy. Another patient had to discontinue the drug after 21/2 courses because of adverse effects (neutropenia and diarrhea) and experienced rapid regrowth of her tumor. The remaining patient was free of disease after four courses but was then lost to follow-up.

"Capecitabine demonstrates some initial positive results in advanced cutaneous squamous cell carcinoma," Dr. Brown said. "The medication was relatively well tolerated, but side effects may necessitate dose reduction or discontinuation."

The second study, presented as a poster by Dr. Jeffrey E. Petersen of Wright State University in Dayton, Ohio, described use of capecitabine in two patients with SCC.

The first patient was an 87-year-old man who had multiple recurrent SCCs of the scalp and had undergone previous cryotherapy, topical 5-fluorouracil treatment, and multiple excisions including a Mohs procedure. The cancer progressed, despite treatment with a maximum dose of radiation therapy. The patient declined extensive surgery.

The second patient was an 84-year-old man who had previously undergone Mohs surgery down to bone for SCC of the scalp but experienced a recurrence. He had already received radiation to that area. The patient had severe Alzheimer's disease, and his family declined further surgery.

Both patients were treated with capecitabine at 50% of the standard dose of 1,250 mg/m

Although the patients experienced mild nausea and reduced taste while on treatment, the drug was otherwise well tolerated, he noted.

In addition to improving visible disease, capecitabine may be acting on disease that is not yet clinically evident. "Because it's a systemic drug, … in the large tumors where there is a high risk of metastatic disease you may be also treating that microscopic metastatic disease," he explained.

"Capecitabine gives you an option sometimes when you are looking at a patient and thinking, 'I don't have any more options, I don't have anything more to offer these people.' And [now] we do," Dr. Petersen said.

Dr. Brown and Dr. Petersen reported that they had no conflicts of interest in association with their studies.

This 87-year-old patient's recurrent SCC had progressed despite treatment with a maximum dose of radiation.

There is marked improvement of the scalp after four courses of capecitabine, although some ulcers are still present. Photos courtesy Dr. Jeffrey E. Petersen

VANCOUVER, B.C. — Capecitabine, an oral prodrug of 5-fluorouracil, can be used to control advanced squamous cell carcinoma of the skin when conventional treatment options have run out, according to the results of two studies involving a total of five patients.

Capecitabine (Xeloda) "was designed to improve upon existing 5-fluorouracil by having increased efficacy, an improved side-effect profile, and increased ease of administration," Dr. Mariah R. Brown, lead investigator of one study, explained at the annual meeting of the American College of Mohs Surgery.

Although capecitabine is currently approved only for treatment of colorectal cancer and breast cancer, research suggests a possible role for the drug in managing several other malignancies, including skin cancer, she noted.

Dr. Brown and her colleagues at the University of Colorado, Denver, studied three patients (two women and one man) aged 60-73 years who had locally advanced squamous cell carcinoma (SCC) of the head and neck. In each case, the cancer was inoperable because of tumor size or limitations imposed by prior surgery or radiation therapy; patients also wanted to avoid aggressive therapy. None of the patients had evidence of metastases.

The patients were treated with multiple courses of capecitabine (1,500 mg twice daily), with each course consisting of 2 weeks on the drug and 1 week off. The total duration of treatment ranged from 2 to 6 months.

All patients had a clinical response, with visible shrinkage of tumors by more than 50% and response beginning within the first course of therapy, Dr. Brown reported.

One patient was clinically disease-free after four courses of therapy. She continued taking capecitabine, albeit at a lower dose, because she experienced severe hand-foot syndrome, and was stable 6 months after starting the lower-dose therapy. Another patient had to discontinue the drug after 21/2 courses because of adverse effects (neutropenia and diarrhea) and experienced rapid regrowth of her tumor. The remaining patient was free of disease after four courses but was then lost to follow-up.

"Capecitabine demonstrates some initial positive results in advanced cutaneous squamous cell carcinoma," Dr. Brown said. "The medication was relatively well tolerated, but side effects may necessitate dose reduction or discontinuation."

The second study, presented as a poster by Dr. Jeffrey E. Petersen of Wright State University in Dayton, Ohio, described use of capecitabine in two patients with SCC.

The first patient was an 87-year-old man who had multiple recurrent SCCs of the scalp and had undergone previous cryotherapy, topical 5-fluorouracil treatment, and multiple excisions including a Mohs procedure. The cancer progressed, despite treatment with a maximum dose of radiation therapy. The patient declined extensive surgery.

The second patient was an 84-year-old man who had previously undergone Mohs surgery down to bone for SCC of the scalp but experienced a recurrence. He had already received radiation to that area. The patient had severe Alzheimer's disease, and his family declined further surgery.

Both patients were treated with capecitabine at 50% of the standard dose of 1,250 mg/m

Although the patients experienced mild nausea and reduced taste while on treatment, the drug was otherwise well tolerated, he noted.

In addition to improving visible disease, capecitabine may be acting on disease that is not yet clinically evident. "Because it's a systemic drug, … in the large tumors where there is a high risk of metastatic disease you may be also treating that microscopic metastatic disease," he explained.

"Capecitabine gives you an option sometimes when you are looking at a patient and thinking, 'I don't have any more options, I don't have anything more to offer these people.' And [now] we do," Dr. Petersen said.

Dr. Brown and Dr. Petersen reported that they had no conflicts of interest in association with their studies.

This 87-year-old patient's recurrent SCC had progressed despite treatment with a maximum dose of radiation.

There is marked improvement of the scalp after four courses of capecitabine, although some ulcers are still present. Photos courtesy Dr. Jeffrey E. Petersen

VANCOUVER, B.C. — Capecitabine, an oral prodrug of 5-fluorouracil, can be used to control advanced squamous cell carcinoma of the skin when conventional treatment options have run out, according to the results of two studies involving a total of five patients.

Capecitabine (Xeloda) "was designed to improve upon existing 5-fluorouracil by having increased efficacy, an improved side-effect profile, and increased ease of administration," Dr. Mariah R. Brown, lead investigator of one study, explained at the annual meeting of the American College of Mohs Surgery.

Although capecitabine is currently approved only for treatment of colorectal cancer and breast cancer, research suggests a possible role for the drug in managing several other malignancies, including skin cancer, she noted.

Dr. Brown and her colleagues at the University of Colorado, Denver, studied three patients (two women and one man) aged 60-73 years who had locally advanced squamous cell carcinoma (SCC) of the head and neck. In each case, the cancer was inoperable because of tumor size or limitations imposed by prior surgery or radiation therapy; patients also wanted to avoid aggressive therapy. None of the patients had evidence of metastases.

The patients were treated with multiple courses of capecitabine (1,500 mg twice daily), with each course consisting of 2 weeks on the drug and 1 week off. The total duration of treatment ranged from 2 to 6 months.

All patients had a clinical response, with visible shrinkage of tumors by more than 50% and response beginning within the first course of therapy, Dr. Brown reported.

One patient was clinically disease-free after four courses of therapy. She continued taking capecitabine, albeit at a lower dose, because she experienced severe hand-foot syndrome, and was stable 6 months after starting the lower-dose therapy. Another patient had to discontinue the drug after 21/2 courses because of adverse effects (neutropenia and diarrhea) and experienced rapid regrowth of her tumor. The remaining patient was free of disease after four courses but was then lost to follow-up.

"Capecitabine demonstrates some initial positive results in advanced cutaneous squamous cell carcinoma," Dr. Brown said. "The medication was relatively well tolerated, but side effects may necessitate dose reduction or discontinuation."

The second study, presented as a poster by Dr. Jeffrey E. Petersen of Wright State University in Dayton, Ohio, described use of capecitabine in two patients with SCC.

The first patient was an 87-year-old man who had multiple recurrent SCCs of the scalp and had undergone previous cryotherapy, topical 5-fluorouracil treatment, and multiple excisions including a Mohs procedure. The cancer progressed, despite treatment with a maximum dose of radiation therapy. The patient declined extensive surgery.

The second patient was an 84-year-old man who had previously undergone Mohs surgery down to bone for SCC of the scalp but experienced a recurrence. He had already received radiation to that area. The patient had severe Alzheimer's disease, and his family declined further surgery.

Both patients were treated with capecitabine at 50% of the standard dose of 1,250 mg/m

Although the patients experienced mild nausea and reduced taste while on treatment, the drug was otherwise well tolerated, he noted.

In addition to improving visible disease, capecitabine may be acting on disease that is not yet clinically evident. "Because it's a systemic drug, … in the large tumors where there is a high risk of metastatic disease you may be also treating that microscopic metastatic disease," he explained.

"Capecitabine gives you an option sometimes when you are looking at a patient and thinking, 'I don't have any more options, I don't have anything more to offer these people.' And [now] we do," Dr. Petersen said.

Dr. Brown and Dr. Petersen reported that they had no conflicts of interest in association with their studies.

This 87-year-old patient's recurrent SCC had progressed despite treatment with a maximum dose of radiation.

There is marked improvement of the scalp after four courses of capecitabine, although some ulcers are still present. Photos courtesy Dr. Jeffrey E. Petersen