Tamoxifen plus tegafur-uracil (TUFT) versus tamoxifen plus Adriamycin (doxorubicin) and cyclophosphamide (ACT) as adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC): results of Japan Clinical Oncology Group Study 9404.

Autor: Shien, Tadahiko, Iwata, Hiroji, Fukutomi, Takashi, Inoue, Kenichi, Aogi, Kenjiro, Kinoshita, Takayuki, Ando, Jiro, Takashima, Seiki, Nakamura, Kenichi, Shibata, Taro, Fukuda, Haruhiko
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Zdroj: Cancer Chemotherapy & Pharmacology; Sep2014, Vol. 74 Issue 3, p603-609, 7p
Abstrakt: Purpose: A prospective randomized clinical trial was conducted to evaluate the efficacy of tamoxifen plus doxorubicin and cyclophosphamide compared to tamoxifen plus tegafur-uracil as an adjuvant therapy to treat node-positive premenopausal breast cancer (PreMBC). Methods: Eligibility criteria included pathologically node-positive ( n = 1-9) preMBC with curative resection, in stages I-IIIA. Patients were randomized to receive either tamoxifen 20 mg/day plus tegafur-uracil 400 mg/day (TU) for 2 years or six courses of a 28-day cycle of doxorubicin 40 mg/m plus cyclophosphamide 500 mg/m on day 1 along with tamoxifen (ACT) given for 2 years as adjuvant therapy. Primary endpoint was overall survival (OS), and secondary endpoint was recurrence-free survival (RFS). Results: In total, 169 patients were recruited (TU arm 87, ACT arm 82) between October 1994 and September 1999. The HR for OS was 0.76 (95 % CI 0.35, 1.66, log-rank p = 0.49) and that for RFS was 0.77 (95 % CI 0.44, 1.36, log-rank p = 0.37), with ACT resulting in a better HR. The 5-year OS was 79.7 % for patients in the TU arm and 83 % for those in the ACT arm. The 5-year RFS was 66.1 % for patients in the TU arm and 70.6 % for those in the ACT arm. A higher proportion of patients in the ACT arm experienced grade 3 leucopenia (0 % in the TU arm, 4 % in the ACT arm). Conclusions: There were no significant differences in the efficacy of TU and ACT as adjuvant therapy. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index