Prospective study of vinorelbine and capecitabine combination therapy in Chinese patients with metastatic breast cancer pretreated with anthracyclines and taxanes.
OBJECTIVE
This phase II study prospectively evaluated the feasibility of vinorelbine in combination with capecitabine in Chinese patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes.


METHODS
Vinorelbine (25 mg/m(2) intravenous infusion on days 1 and 8) and capecitabine (1,000 mg/m(2) b.i.d., days 1-14) were administered to eligible MBC patients previously treated with anthracyclines and taxanes every 3 weeks for up to 6 cycles, until disease progression or unacceptable toxicity. The primary endpoint was objective response.


RESULTS
Seventy-two patients were enrolled. In total, 297 cycles were given (median 4 cycles, range 2-6). The overall response rate was 45.8% (95% CI 34.2-57.4%), including 5 complete (6.9%) and 28 partial responses (38.9%). With median follow-up of 22 months, median time to progression was 7.7 months (95% CI 5.5-10.0) and median survival was 26.1 months (95% CI 19.6-32.6). The response rate was 53.8% in patients resistant to anthracyclines and taxanes combination. The most common hematologic adverse events were leukopenia (81.9%) with grade 3/4 incidence of 41.7%; nausea was the most frequent non-hematologic toxicity (62.5%). Hand-foot syndrome occurred in 12.5% of patients, and diarrhea was rare.


CONCLUSIONS
Capecitabine 1,000 mg/m(2) b.i.d. combined with vinorelbine 25 mg/m(2) is an effective and safe treatment for MBC patients, no matter if anthracycline and taxane pretreated or resistant.
Fan
Ying
Y
Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Xu
Binghe
B
Yuan
Peng
P
Wang
Jiayu
J
Ma
Fei
F
Li
Qing
Q
Zhang
Pin
P
Li
Qiao
Q
Cai
Ruigang
R
D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000627:therapeutic use*; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018450:Disease Progression; D019008:Drug Resistance, Neoplasm; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D009362:Neoplasm Metastasis; D012074:Remission Induction; D043823:Taxoids / Q000627:therapeutic use*; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D055815:Young Adult
D018943:Anthracyclines; D000903:Antibiotics, Antineoplastic; D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine; D005472:Fluorouracil