Postsurgical adjuvant chemotherapy of stage II breast carcinoma with or without crossover to a non-cross-resistant regimen: A Cancer and Leukemia Group B study Journal Article


Authors: Perloff, M.; Norton, L.; Korzun, A. H.; Wood, W. C.; Carey, R. W.; Gottlieb, A.; Aust, J. C.; Bank, A.; Silver, R. T.; Saleh, F.; Canellos, G. P.; Perry, M. C.; Weiss, R. B.; Holland, J. F.
Article Title: Postsurgical adjuvant chemotherapy of stage II breast carcinoma with or without crossover to a non-cross-resistant regimen: A Cancer and Leukemia Group B study
Abstract: Purpose: To compare two cyclophosphamide, methotrexate, fluorouracil, vincristine, and prednisone (CMFVP) regimens with a doxorubicin-based regimen-vinblastine, doxorubicin, thiotepa, and Halotestin (Upjohn, Kalamazoo, MI) (VATH)-in patients with stage II node-positive breast carcinoma. Methods: Nine hundred forty-five women were treated with a 6-week induction course of CMFVP. They were then randomized to receive one of two consolidation CMFVP regimens: 6-week courses or 2-week courses. Following completion of CMFVP consolidation, patients were again randomized to either continue the CMFVP regimen or to receive six escalating doses of VATH. Results: Among all patients, with a median follow-up time of 11.5 years, there is no statistically significant difference in disease-free survival (DFS) between the two consolidation CMFVP regimens, VATH intensification treatment is statistically significantly superior to CMFVP in terms of DFS (P = .0040), For patients with one to three involved nodes, there is currently no significant difference between VATH and CMFVP; however, among those with four or more positive lymph nodes, there is a significant difference in favor of VATH (P = .0037). There is also improved overall survival with VATH (P = .043; median, > 14 years v 10 years), This difference is also statistically significant in patients with four or more involved lymph nodes, among postmenopausal patients, and among postmenopausal estrogen receptor-positive patients. Conclusion: Chemotherapy with crossover to escalating dose of VATH following CMFVP was well tolerated and effective, Inauguration of VATH as a treatment intensification at the eighth month produced a major increase in relapse-free and overall survival, The observation that sensitivity to VATH is retained 50 long after mastectomy raises questions about the proper duration of adjuvant chemotherapy and lends support to further investigation of crossover designs in future trials of postoperative adjuvant chemotherapy regimens. (C) 1996 by American Society of Clinical Oncology.
Keywords: methotrexate; randomized trial; therapy; sensitivity; models; adriamycin
Journal Title: Journal of Clinical Oncology
Volume: 14
Issue: 5
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 1996-05-01
Start Page: 1589
End Page: 1598
Language: English
ACCESSION: WOS:A1996UJ40300025
DOI: 10.1200/jco.1996.14.5.1589
PROVIDER: wos
PUBMED: 8622076
Notes: Article -- Source: Wos
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  1. Larry Norton
    544 Norton