Postoperative Adjuvant Randomised Trial Comparing Chemoendocrine Therapy, Chemotherapy and Immunotherapy for Patients with Stage II Breast Cancer: 5-year Results

Authors: The Nishinihon Cooperative Study Group of Adjuvant Chemoendocrine Therapy for Breast Cancer (ACETBC) of Japan: T. Morimoto, M. Ogawa, K. Orita, K. Sugimachi, T. Toge, K. Dohi, Y. Nomura, Y. Monden, and N. Ogawa

Journal: European Journal of Cancer

Study Design: Randomized trial

Participants: 916 patients with Stage II breast cancer (540 ER+, 376 ER-)

Trial Length: The study was conducted between 1985 and 1988, with 5-year follow-up results presented.

Intervention:

• ER-positive patients:
  • Regimen A: Mitomycin C (MMC) + tamoxifen (TAM)
  • Regimen B: MMC + TAM + ftorafur (FT)
  • Regimen C: MMC + TAM + PSK (immunotherapy)
• ER-negative patients:
  • Regimen D: MMC + FT
  • Regimen E: MMC + PSK

Primary Outcomes: 5-year overall survival and relapse-free survival ratesSummary: The study evaluated the effects of adding FT or PSK to the conventional postoperative adjuvant therapy (MMC + TAM) in ER+ breast cancer patients and compared the effects of FT and PSK in ER- patients. The results showed that in ER+ patients, the combination of TAM + FT (regimen B) led to a higher 5-year overall survival rate (94.2%) and a significantly higher 5-year relapse-free survival rate (88.9%) compared to TAM alone (regimen A) or TAM + PSK (regimen C). In ER- patients, there was no significant difference in 5-year overall or relapse-free survival between FT (regimen D) and PSK (regimen E). The study concludes that FT in combination with TAM is effective for ER+ breast cancer patients, particularly those who are premenopausal or have lymph node metastasis.