A randomized trial comparing ftorafur alone with ftorafur plus tamoxifen in postoperative adjuvant therapy for breast cancer

1996 ◽  
Vol 37 (6) ◽  
pp. 587-592
Author(s):  
K. Sakai ◽  
Goro Kosaki ◽  
Tsuneaki Seno ◽  
Tetsuo Taguchi ◽  
Toshio Terasawa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Randomized Trial ◽  
Postoperative Adjuvant Therapy

Randomized trial of chemoendocrine therapy started before or after surgery for treatment of primary breast cancer.

1995 ◽  
Vol 13 (3) ◽  
pp. 547-552 ◽  
Author(s):  
T J Powles ◽  
T F Hickish ◽  
A Makris ◽  
S E Ashley ◽  
M E O'Brien ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Adjuvant Therapy ◽  
Randomized Trial ◽  
Response Rate ◽  
Neoadjuvant Treatment ◽  
Operable Breast Cancer ◽  
Chemoendocrine Therapy ◽  
Primary Operable Breast Cancer

PURPOSE To evaluate in a randomized clinical trial systemic chemoendocrine therapy used as primary (neo-adjuvant) treatment before surgery in women with primary operable breast cancer. PATIENTS AND METHODS Patients aged less than 70 years with clinically palpable, primary operable breast cancer diagnostically confirmed by fine-needle aspiration cytology (FNAC) and suitable for treatment with surgery, radiotherapy, cytotoxic chemotherapy, and tamoxifen were considered eligible. Patients randomized to neoadjuvant treatment received four cycles of chemo-therapy for 3 months before surgery followed by another four cycles after surgery, and were compared with patients randomized to adjuvant therapy who received eight cycles of chemotherapy over 6 months after surgery. RESULTS Of 212 patients who were randomized to receive either adjuvant (n = 107) or neoadjuvant (n = 105) chemoendocrine therapy, 200 are now assessable for response. The two groups are comparable for age, menopausal status, disease stage, and surgical requirements. The overall clinical response rate was 85%, with a complete histologic response rate of 10%. There was a significant reduction in the requirement for mastectomy in patients who received neoadjuvant treatment (13%) as compared with those who received adjuvant therapy (28%) (P < .005). Symptomatic and hematologic acute toxicity was low and similar for adjuvant and neoadjuvant therapy. The median follow-up period for patients in this trial is 28 months, during which time four patients have relapsed locally and 20, including one of the local relapses, have developed metastatic disease, 19 of whom have died. The follow-up period is too brief to evaluate relapse rate or survival duration. CONCLUSION This trial confirms previous reports of a high rate of response to neoadjuvant therapy, but is the first to include small primary cancers and to show, in the context of a randomized trial, a reduction in the requirement for mastectomy. Until disease-free and overall survival data are available from the larger National Surgical Adjuvant Breast and Bowel Project (NSABP)-18 trial, such neoadjuvant treatment cannot be recommended outside of a clinical trial.

Randomized Trial of Observation Versus Adjuvant Therapy With Cyclophosphamide, Fluorouracil, Prednisone With or Without Tamoxifen Following Mastectomy in Postmenopausal Women With Node-Positive Breast Cancer

1989 ◽  
Vol 7 (1) ◽  
pp. 145-145
Author(s):  
James N. Ingle ◽  
Lloyd K. Everson ◽  
H. Sam Wieand ◽  
J. Kirk Martin ◽  
Henry J. Votava ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Adjuvant Therapy ◽  
Randomized Trial ◽  
Clin Oncol ◽  
Postmenopausal Women ◽  
Median Dose ◽  
The Mean ◽  
Made In ◽  
September Issue ◽  
Positive Breast Cancer

In Table 4 of the manuscript by Ingle et al published in the September issue (J Clin Oncol 6:1388–1396, 1988) an error was made in the dosage of tamoxifen. The planned dose should have read 140 mg/wk; the mean dose, 125 mg/wk; and the median dose, 140 mg/wk.

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