Adjuvant chemotherapy with cyclophosphamide, methotrexate, and 5‐fluorouracil, vincristine, and prednisone compared with single‐agent L‐phenylalanine mustard for patients with operable breast carcinoma and positive axillary lymph nodes

Abstract

BACKGROUND Adjuvant combination chemotherapy with cyclophosphamide, methotrexate, and 5‐fluorouracil plus vincristine and prednisone (CMFVP) was compared with single‐agent L‐phenylalanine mustard (L‐PAM) for the treatment of patients with axillary lymph node positive primary breast carcinoma over 20‐years of follow‐up. METHODS Four hundred forty‐one women with axillary lymph node positive breast carcinoma were randomized to receive either combination chemotherapy with cyclophosphamide (60 mg/m2 orally every day for 1 year), fluorouracil (300 mg/m2 intravenously [IV] weekly for 1 year), methotrexate (15 mg/m2 IV weekly for 1 year), vincristine (0.625 mg/m2 IV for 10 weeks), prednisone (30 mg/m2 orally on Days 1–14, 20 mg/m2 on Days 15–28, and 10 mg/m2 on Days 29–42), or single‐agent chemotherapy with L‐PAM (5 mg/m2 orally every day for 5 days every 6 weeks for 2 years) after undergoing surgery. Patients were stratified according to menopausal status and number of positive lymph nodes (1–3 positive lymph nodes or > 3 positive lymph nodes). Seventy‐seven patients were ineligible. RESULTS The maximum follow‐up is 24 years, with a median follow‐up of 21.5 years. Disease free survival and overall survival were superior with CMFVP (two‐sided log‐rank test; P = 0.0008 and P = 0.007, respectively). For all patients, the estimated 20‐year survival rate of patients who received CMFVP was 40% compared with 27% for patients who received L‐PAM. There was a substantial survival benefit for CMFVP compared with L‐PAM in the subsets of premenopausal patients and patients with four or more positive lymph nodes. The estimated 20‐year survival rate for premenopausal women who received CMFVP was 49% compared with 33% for premenopausal women who received L‐PAM. Among women with ≥ 4 positive lymph nodes, the estimated survival rate for patients who received CMFVP was 31% compared with 15% for patients who received L‐PAM. Both regimens were tolerated well. Toxicity was more severe and frequent among patients who received CMFVP. CONCLUSIONS The authors conclude that, after 20 years of follow‐up, adjuvant chemotherapy with CMFVP remains superior to L‐PAM for the treatment of patients with lymph node positive breast carcinoma. Cancer 2003;97:21–9. © 2003 American Cancer Society. DOI 10.1002/cncr.10982

Cost-Effectiveness Analysis of Trastuzumab in the Adjuvant Treatment for Early Breast Cancer

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Do Estimates of Long-Term Survival Tell Us Whether Patients Diagnosed With Breast Cancer Before Age 50 Years Are Ever Cured?

“…The observation of decreased relative conditional survival in the last decade reported in this article seems particularly difficult to interpret, because rates of relapse generally decrease over time. Rate estimates from a Southwest Oncology Group study [3] with more than 20 years of follow-up are 0.16 per person years of follow-up for 0 to 2 years, 0.10 for 2 to 5 years, 0.04 for 5 to 10 years, and 0.02 for 10 to 20 years. Although there are late relapses reported on this study, after a median follow-up of 22 years, the majority of events are deaths without relapse.…”