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Significance of Relapse after Adjuvant Treatment with Combination Chemotherapy or 5-Fluorouracil Alone in High-Risk Breast Cancer¹

A Western Cancer Study Group Project

Harbor-University of California Los Angeles Medical Center, Torrance, California 90509 [R. T. C.]; Los Angeles County/University of Southern California Medical Center, Los Angeles, California 90033 [J. M. W., V. M. J. R., J. R. B.]; Kaiser Permanente, Oakland, California 94611 [R. H.]; Navy Regional Medical Center, San Diego, California [J. E. L.]; David Grant Medical Center, Travis Air Force Base, California 94535 [R. R.]; University Medical Center, Loma Linda, California 92350[T. G.]; and Mountain States Tumor Institute, Boise, Idaho [J. L.]

Beginning in 1974, patients undergoing mastectomy at high risk for recurrence (4 nodes positive; median, 9.4 positive; range, 4 to 28) were randomized after stratification for menopausal status and radiotherapy to receive either 5-fluorouracil (5-FU, 500 mg/sq m i.v. every week) or cyclophosphamide, 400 mg/sq m; methotrexate, 30 mg/sq m; and 5-FU, 500 mg/sq m (CMF; all given i.v. every 2 weeks) in a 12-month program. All 62 patients remain evaluable with median follow-up now exceeding 70 months (range, 60 to 80 months). CMF significantly prevented early disease recurrence (97% relapse free on CMF versus 75% on 5-FU at 12 months; p < 0.05) and demonstrated survival advantage during the initial 40-month follow-up. This significance was subsequently lost, and the percentages of relapse free and overall survival after 70 months are: The apparently paradoxical relationship between relapse and survival on the 5-FU arm was related to survival after recurrence. Survival after recurrence was significantly longer on the 5-FU compared to the CMF arm (median of >38 versus 10 months, respectively; p < 0.01). These results suggest (a) long-term survival in adjuvant trials cannot be accurately predicted by short-term differences in relapse frequency, (b) survival after relapse may be influenced by the antecedent adjuvant therapy received, and (c) disease relapse does not necessarily preclude long-term survival.

¹ This study was supported by Grant 3R10CA 05186-15 to the Western Cancer Study Group and Grant CA 08099-12 to CCTG. A Western Cancer Study Group Project. Presented and published in abstract form (8). The following members of the Western Cancer Study Group participated in this study: J. Bateman, V. Ryden, J. Weiner, Los Angeles County/University of Southern California Medical Center, Los Angeles, Calif.; R. Chlebowski, Harbor-UCLA Medical Center, Torrance, Calif.; T. Godfrey, University Medical Center, Loma Linda, Calif.; C. Hendrickson, Kaiser Permanente, San Francisco, Calif.; R. Hestorff, Kaiser Permanente, Oakland, Calif.; J. E. Lang, Navy Regional Medical Center, San Diego, Calif.; J. Linman, University of Oregon, Portland, Oreg.; J. Luce, Mountain States Tumor Institute, Boise, Idaho; R. Pugh, Allegheny General Hospital, Pittsburg, Penn.; R. Reynolds, David Grant Medical Center, Travis Air Force Base, Calif.; I. Silverberg, Mount Zion Hospital, San Francisco, Calif.; L. Sadoff, Kaiser Permanente, Los Angeles, Calif.; R. Weisberg, Beaumont Army Medical Center, El Paso, Texas.

² To whom requests for reprints should be addressed, at Division of Medical Oncology, Department of Medicine, UCLA School of Medicine, Harbor-UCLA Medical Center, 1000 West Carson Street, Torrance, Calif. 90509.

Received 6/ 8/81. Accepted 7/30/81.