Multicenter phase II study of combination chemotherapy with capecitabine and intravenous vinorelbine in patients with pretreated metastatic breast cancer

Abstract

Background: Capecitabine and i.v. vinorelbine are both active in metastatic breast cancer with nonoverlapping toxicities. This study examined the efficacy and safety of the combination of these agents in patients with pretreated metastatic breast cancer. Methods: Patients previously treated for breast cancer, maximum of one prior metastatic regimen, received capecitabine 1000 mg/m 2 b.d. for days 1-14 and vinorelbine 25 mg/m 2 i.v. days 1 and 8 every 21 days. All patients had measurable disease and adequate baseline organ function. The primary endpoint was response and secondary endpoints time to progression, duration of response, survival and safety. Results: Twenty-two patients (median age 56 years) received a median of six cycles. All patients had received anthracyclines and 64% taxanes. Objective responses were seen in 7/21 (33%, 95% confidence interval [CI] 18-57%), with two complete responses; stable disease was seen in 5/21 (24%, 95% CI 8-42%). Median duration of response was 6.9 months (95% CI 4.7-13.1), time to progression was 5.8 months (95% CI 2.8-6.8) and survival was 13.5 months (95% CI 6.9-19.9). The median dose intensity of vinorelbine was 75% of the intended dose and of capecitabine 85% of intended dose. The main toxicity was myelosuppression including 16 episodes of G3-4 neutropenia in 11 patients (50%). Other toxicities were generally mild to moderate. Conclusion: The combination of capecitabine and i.v. vinorelbine is active and well tolerated in patients with pretreated metastatic breast cancer. The recent availability of oral vinorelbine provides an opportunity to explore a fully oral combination.

Metronomic Capecitabine and Vinorelbine as Second Line Therapy in Advanced Breast Cancer

“…In our study the response rate was 57% which is higher than that reported in some other trials, in which capecitabine-vinorelbine combination was used in pretreated MBC patients, and ranged from 33% to 50% 14,17,18 .…”

“…On the other hand, the PFS in the present study (4.2 months) was lower than that reported in other studies. In studies that assessed the efficacy of capecitabine-vinorelbine combination as a second line in MBC, the time to progression ranged from 5.3 to 6 months 14,17,18 .…”

A Phase II Study of Combination Chemotherapy with Capecitabine and Intravenous Vinorelbine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines and Taxanes: Efficacy and Tolerance

“…In other phase II trials [25][26][27][28][29][30][31] , the treatment was also safe and well tolerated. The most common severe hematologic toxicity was G3/4 neutropenia, probably a result of vinorelbine administration (6.6%-68.2%).…”

“…In other phase II trials in which the combination of capecitabine and vinorelbine was administered to patients with breast cancer pretreated with anthracyclines and taxanes Table (4) [25][26][27][28][29][30][31] , the RRs obtained ranged between 33% and 70%. In these studies, the median time to progression (TTP) ranged from 4.5 months to 10 months and the median OS was within 10 months and 30.4 months.…”

Oral vinorelbine: its role in advanced breast cancer pre-treated with anthracycline and taxane chemotherapies

“…For all phase II combination studies (including trastuzumab combination in HER2-neu positive setting), the overall tumour RRs ranged from 33 to 75%, median OS from 13 to 35.8 months, median response duration from 2.6 to 17.5 months, median TTP (reported in two studies) from 6.6 to 8.6 months and median PFS (reported in two studies) from 9.6 to 9.9 months. The most commonly reported adverse events attributed to VI were neutropoenia, nausea, vomiting and alopecia [12][13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28].…”