Vinorelbine and cisplatin (CIVIC regimen) for the treatment of metastatic breast carcinoma after failure of anthracycline- and/or paclitaxel-containing regimens
✍ Scribed by Isabelle Ray-Coquard; Pierre Biron; Thomas Bachelot; Jean-Paul Guastalla; Gilles Catimel; Yacine Merrouche; Jean-Pierre Droz; Franck Chauvin; Jean-Yves Blay
- Publisher
- John Wiley and Sons
- Year
- 1998
- Tongue
- English
- Weight
- 82 KB
- Volume
- 82
- Category
- Article
- ISSN
- 0008-543X
No coin nor oath required. For personal study only.
✦ Synopsis
Background:
A pilot study of a new chemotherapy, the civic regimen, was performed in 58 patients with metastatic breast carcinoma previously treated with chemotherapy with or without hormonal therapy (n = 41). cisplatin, 20 mg/m2/day, was given (days 1-5) every 21 days during a 1-hour intravenous (i.v.) infusion, and vinorelbine (vnb) was delivered at a dose of 6 mg i.v. bolus followed by vnb, 6 mg/m2/day, in continuous i.v. infusion (days 1-5) every 21 days.
Methods:
Fifty-eight patients were included in this trial between june 1992 and march 1994 (median age, 46.5 years; range, 28-69 years). the number of previous chemotherapy in the adjuvant or metastatic phase were: 1 in 9 patients, 2 in 33 patients, and > or = 3 in 16 patients. forty-four and 12 patients, respectively, were previously treated in metastatic phase with regimens containing anthracyclines and paclitaxel. overall, 210 cycles were given (median, 3 cycles; range, 1-6 cycles).
Results:
Among the 58 patients assessable for tumor response to the civic regimen, 24 patients (41%) (95% confidence interval, 28-54) achieved an objective response (complete response or partial response) with 2 complete response (3%) and 22 partial response (38%). the median time to response was 11 weeks (range, 4-16 weeks). the median survival time from the initiation of the civic regimen was 9.2 months (range, 0-45 months). the response rate was 43% (19 of 44 patients) in patients refractory to anthracyclines and 58% (7 of 12 patients) in patients with disease progression after treatment with anthracyclines and paclitaxel. myelosuppression was the most frequent side effect. world health organization grade 3 neutropenia occurred in 8 of 58 patients (14%) and in 41 of 210 cycles (20%), grade 4 neutropenia occurred in 37 of 58 patients (64%) and in 63 of 210 cycles (30%), and grade 3 and 4 thrombopenia occurred in 7 of 58 patients (12%) and in 9 of 210 cycles (4%). grade 2 peripheral neuropathy was observed in 6 of 58 patients (10%) and in 12 of 210 cycles (6%), and grade 3 peripheral neuropathy was observed in 3 of 58 patients (5%) and in 4 of 210 cycles (2%). the risk of grade 2-3 neuropathy was significantly higher after the fourth chemotherapy cycle (14 of 23 patients vs. 3 of 35 patients: p = 0.00002).
Conclusions:
The civic regimen is effective and has acceptable tolerance in patients with metastatic breast carcinoma refractory to previous anthracycline- and/or paclitaxel-containing chemotherapy. four cycles were found to provide the best toxicity-efficacy ratio.