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Phase II trial of tamoxifen, etoposide, mitoxantrone, and cisplatin in patients with metastatic breast carcinoma.

Abstract：

BACKGROUND:Based on previous data demonstrating a potentially synergistic interaction between tamoxifen and cisplatin in metastatic melanoma therapy, a Phase II study was performed to assess the activity of tamoxifen, etoposide, mitoxantrone, and cisplatin (TEMP) in patients with metastatic breast carcinoma. METHODS:Forty-six patients with metastatic breast carcinoma were treated with tamoxifen, 10 mg orally, twice a day for 28 days; etoposide, 100 mg/m2, on Days 1-3; mitoxantrone, 10 mg/m2, on Day 1; and cisplatin, 30 mg/m2, on Days 1 and 2. Forty-four patients (7 with bone only disease) were evaluable for response and toxicity after at least 1 cycle of therapy. All patients had previously received doxorubicin-containing regimens in either the adjuvant or metastatic setting. RESULTS:The overall objective response rate for the 37 patients with visceral and/ or soft tissue disease was 41% (95% confidence interval, 25-58%). The objective response rate among women previously treated with doxorubicin in the adjuvant setting was 56% (14 of 24). Only 1 of 13 patients with metastatic carcinoma who had failed doxorubicin responded. Five of seven patients with bone-only disease had subjective improvement of bone pain without worsening of bone scans. Approximately 59% of patients had Grade 3 or 4 neutropenia at some time in their therapy and 1 patient died of neuropenic sepsis. Logistic regression analysis (n = 37) revealed that response was not related to estrogen receptor (ER) status or to the presence of visceral metastases. CONCLUSIONS:TEMP appears to be an active regimen for patients with either ER positive (tamoxifen-resistant) or ER negative metastatic breast carcinoma that progresses after adjuvant doxorubicin therapy. Moreover, among patients who developed metastatic disease either during or < 12 months after adjuvant doxorubicin therapy, TEMP had a higher response rate than would have been predicted from previous studies. Although the mechanism remains to be elucidated, these results suggest a potentially synergistic role for tamoxifen in etoposide/cisplatin-based chemotherapy of breast carcinoma.

journal_name

Cancer

journal_title

Cancer

authors

Conzen SD,Kaufman PA,Arvizu C,LeMarbre P,Maurer LH,Mott LA,Mills LE

doi

10.1002/(sici)1097-0142(19961101)78:9<1906::aid-cn

subject

Has Abstract

pub_date

1996-11-01 00:00:00

pages

1906-11

issue

eissn

0008-543X

issn

1097-0142

pii

10.1002/(SICI)1097-0142(19961101)78:9<1906::AID-CN

journal_volume

pub_type

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Phase II trial of tamoxifen, etoposide, mitoxantrone, and cisplatin in patients with metastatic breast carcinoma.