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Randomized adjuvant trial to evaluate the addition of tamoxifen and PSK to chemotherapy in patients with primary breast cancer: 5‐year results from the nishi‐nippon group of the adjuvant chemoendocrine therapy for breast cancer organization
Author(s) -
Toil Masakazu,
Hattori Takao,
Akagi Masanobu,
Lnokuchi Kiyoshi,
Orita Kunzo,
Sugimachi Keizo,
Dohi Kiyohiko,
Nomura Yasuo,
Monden Yasumasa,
Hamada Yuzo,
Morimoto Tadaoki,
Ogawa Nobuya
Publication year - 1992
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19921115)70:10<2475::aid-cncr2820701014>3.0.co;2-p
Subject(s) - medicine , tamoxifen , breast cancer , cancer , oncology , chemotherapy , stage (stratigraphy) , estrogen receptor , randomized controlled trial , adjuvant , gynecology , paleontology , biology
Background. A randomized adjuvant trial was conducted from October 1982 to January 1985 to evaluate the addition of tamoxifen (TAM) to combination chemotherapy with perioperative mitomycin C (MMC) and ftorafur (FT) for patients with estrogen receptor (ER)‐positive tumors and the addition of PSK, a biologic response modifier, to MMC + FT chemotherapy for patients with ER‐negative tumors in operable Stage IIA, IIB, and IIIA cancer. The doses used were 20 mg of oral TAM daily, 600 mg of oral FT daily, and 3 g of oral PSK daily for 2 years. Intravenous MMC (13 mg/m 2 ) was given on the day of operation. Methods. A total of 967 patients were entered and randomized by stratification based on ER status and staging (1978 International Union Against Cancer [UICC] criteria at the time of trial execution). Of 967 patients, 914 (94.5%) were evaluable. At 5‐year follow‐up, significant prolonged overall survival (0s) and relapse‐free survival (RFS) times were seen with the addition of TAM in patients with ER‐positive and Stage IIIA T3NO cancer (1987 UICC‐American Joint Committee on Cancer [AJCC] criteria); however, no significant survival benefit from TAM was seen in patients with ER‐positive and Stage IIA T2N1 cancer. There was no significant difference between regimens, with or without PSK, in patients with ER‐negative disease. Results. Results of subset analyses suggested a benefit from TAM in postmenopausal patients with ER‐positive and Stage IIA T2N1 cancer and a benefit from PSK in patients with node‐negative, ER‐negative, and Stage IIA T2N1 cancer. Conclusions. The 5‐year results of the current trial showed a survival advantage by the addition of TAM to chemotherapy in patients with ER‐positive and Stage IIIA T3NO cancer.