Premium
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
Author(s) -
Rivkin Saul E.,
Green Stephanie J.,
Lew Danika,
Costanzi John J.,
Athens John W.,
Osborne C. Kent,
Vaughn Clarence B.,
Martino Silvana
Publication year - 2002
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.10982
Subject(s) - medicine , vincristine , cyclophosphamide , axillary lymph nodes , chemotherapy , methotrexate , fluorouracil , gastroenterology , surgery , prednisone , nitrogen mustard , breast carcinoma , breast cancer , urology , cancer
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/m 2 orally every day for 1 year), fluorouracil (300 mg/m 2 intravenously [IV] weekly for 1 year), methotrexate (15 mg/m 2 IV weekly for 1 year), vincristine (0.625 mg/m 2 IV for 10 weeks), prednisone (30 mg/m 2 orally on Days 1–14, 20 mg/m 2 on Days 15–28, and 10 mg/m 2 on Days 29–42), or single‐agent chemotherapy with L‐PAM (5 mg/m 2 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