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Quality-of-Life-Adjusted Evaluation of Adjuvant Therapies for Operable Breast Cancer

Richard D. Gelber, PhD; Aron Goldhirsch, MD; and Franco Cavalli, MD
[+] Article, Author, and Disclosure Information

Grant Support: By the Swiss Cancer League, Cancer League of Ticino, Swiss Group for Clinical Cancer Research, Swedish Cancer Society, Australia-New Zealand Breast Cancer Study Group, Frontier Science and Technology Research Foundation, Ludwig Institute for Cancer Research and Grant PBR-53 from the American Cancer Society.

Requests for Reprints: Richard D. Gelber, PhD, Division of Biostatistics and Epidemiology, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115.

Current Author Addresses: Dr. Gelber: Division of Biostatistics and Epidemiology, Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115.

Dr. Goldhirsch: Ospedale Civico, Servizio Oncologico, 6900 Lugano, Switzerland.

Dr. Cavalli: Servizio Oncologico, Ospedale San Giovanni, 6500 Bellinzona, Switzerland.

for the International Breast Cancer Study Group*

©1991 American College of PhysiciansAmerican College of Physicians

Ann Intern Med. 1991;114(8):621-628. doi:10.7326/0003-4819-114-8-621
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Objective: To evaluate a single cycle of adjuvant chemotherapy compared with longer duration chemotherapy for premenopausal women or chemoendocrine therapy for postmenopausal women with operable breast cancer using a quality-of-life-oriented end point, Q-TWiST (quality-adjusted analysis of TWiST: Time Without Symptoms and Toxicity).

Design: Multicenter randomized clinical trial—International Breast Cancer Study Group (IBCSG: formerly Ludwig Group) Trial V.

Setting: IBCSG participating centers in Sweden, Switzerland, Australia, Yugoslavia, Spain, New Zealand, Italy, Germany, and South Africa.

Patients: Data were available for 1229 eligible patients with node-positive breast cancer who were randomized to receive one of three adjuvant treatments after at least a total mastectomy and axillary clearance.

Interventions: Patients received either a single cycle of perioperative chemotherapy consisting of cyclophosphamide, methotrexate, fluorouracil, and leucovorin; or six cycles (6 months) of a conventionally timed chemotherapy consisting of cyclophosphamide, methotrexate, fluorouracil, and prednisone for premenopausal women or this combination plus tamoxifen for postmenopausal women; or both perioperative and conventionally timed chemotherapy for a 7-month course of adjuvant therapy.

Results: At 5 years of median follow-up, patients who received the longer duration therapies had an improved 5-year disease-free survival percentage (53% compared with 36%; P < 0. 001) and 5-year overall survival percentage (73% compared with 63%; P = 0.001) compared with those who received the single perioperative cycle alone. By 3.5 years, the greater burden of toxic effects associated with the longer duration treatments was balanced by their superior control of disease. Within 5 years of follow-up, even after subtracting time with adjuvant treatment toxicity, patients gained an average of 2.2 months of Q-TWiST if treated with the longer duration therapies compared with the single cycle (P = 0.03). The gain for premenopausal patients was 2.8 months (P = 0.05), whereas the gain for postmenopausal women was 1.5 months (P > 0.2).

Conclusions: Six or seven months of adjuvant chemotherapy or chemoendocrine therapy improve both the quantity and quality of life for patients with node-positive breast cancer compared with a single short course of perioperative combination chemotherapy.





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