NEW YORK (Reuters Health) – For women with advanced breast cancer, capecitabine provides similar overall survival with less toxicity compared with classical cyclophosphamide, methotrexate, and fluorouracil (CMF) first-line therapy, researchers report in the October 24th online Journal of Clinical Oncology.

“Single agent capecitabine is a good option as first line chemotherapy for the many women with advanced breast cancer unsuited to more intensive therapy, including the silent majority of women not often included in clinical trials,” Dr. Martin R. Stockler from University of Sydney, Camperdown, New South Wales, Australia told Reuters Health in an email.

Dr. Stockler and colleagues investigated whether treatment with capecitabine was preferable to that with classical CMF and whether capecitabine administered 21/21 days was preferable to the same dose administered 14/21 days in 323 women with advanced breast cancer unsuited to more intensive first-line chemotherapy.

Sixty-three women achieved complete or partial responses, and 151 women had disease control (confirmed response or stable disease) at 6 months. Objective tumor responses occurred with similar frequency in all 3 treatment groups.

Progression-free survival was similar in those assigned continuous or intermittent capecitabine (median, 6 months) and in those assigned CMF (median, 6 months), as was quality-adjusted progression-free survival (mean, 8.8 months for capecitabine versus 7.6 months for CMF).

Overall survival was significantly longer among patients assigned capecitabine (median, 22 months) than among those assigned CMF (median, 18 months)(P=0.02).

As for adverse events, hand-foot syndrome occurred more frequently with capecitabine, whereas uncomplicated neutropenia, febrile neutropenia, stomatitis, miscellaneous other grade 3 or 4 adverse events, and serious adverse events occurred more frequently with CMF.

Women assigned capecitabine received more cycles of chemotherapy, were more likely to continue chemotherapy beyond 6 and 12 months, and were more likely to continue chemotherapy until progression, compared with women assigned CMF.

In a post hoc exploratory analysis, progression-free survival during the first 6 months was similar for women assigned capecitabine or CMF, whereas progression-free survival beyond 6 months was significantly longer for women assigned capecitabine.

Dr. Stockler said that capecitabine is “a good option for those unsuited to more intensive first line therapy.”

“More intensive regimens may be preferable for women with extensive, rapidly progressing, or life-threatening visceral disease,” the investigators note. “However, these regimens are also more toxic and may be less suitable for women with advanced breast cancer who have significant comorbidities, have had bad experiences with adjuvant chemotherapy, or have breast cancer that is indolent or of low volume and are considering a less intense first-line regimen.”


Capecitabine Versus Classical Cyclophosphamide, Methotrexate, and Fluorouracil As First-Line Chemotherapy for Advanced Breast Cancer

J Clin Oncol 24 October 2011.