Phase II study of paclitaxel combined with capecitabine as second-line treatment for advanced gastric carcinoma after failure of cisplatin-based regimens.
OBJECTIVE
To determine the safety and the efficacy of paclitaxel and capecitabine as second-line combination chemotherapy after failure of platinum regimens in advanced gastric cancer.


METHODS
Patients with histologically proven gastric cancer and measurable metastatic disease received capecitabine 825 mg/m(2) twice daily (1,650 mg/m(2) per day) on days 1-14 and paclitaxel 175 mg/m(2) by intravenous infusion on day 1 every 3 weeks until disease progression or unacceptable toxicities.


RESULTS
Between June 2003 and October 2005, 26 patients, of median age 59 years (range 41-84 years) were included in the study and were treated by paclitaxel/capecitabine combination. Overall response rate was 34.6% (95%CI = 17.2-55.7%) with one complete response and 42.3% (95%CI = 17.2-55.7%) of patients achieved a stable disease. Median progression-free survival was 4.5 months (95%CI = 4-4.5 months). Median overall survival was 7.5 months (95%CI = 6-10 months). Cumulated overall survival including cisplatin regimens was 15.5 months (95%CI = 11-18 months). Grade 3/4 adverse events included alopecia (30.8%), neutropenia (11.5%), hand foot skin reaction (11.5%), neuropathy (11.5%), arthralgias (7.5%), and anemia (3.8%).


CONCLUSIONS
Paclitaxel and capecitabine combination was safe and effective in advanced gastric cancer after failure of cisplatin regimens. The cumulated overall survival of 15.5 months suggests a particular interest of taxanes in second-line treatment after failure of platinum salts.
Baize
N
N
Medical Department of Oncology, University of Nice, Nice, France.
Abakar-Mahamat
A
A
Mounier
N
N
Berthier
F
F
Caroli-Bosc
F X
FX
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D017211:Treatment Failure; D016896:Treatment Outcome
D003841:Deoxycytidine; D000069287:Capecitabine; D017239:Paclitaxel; D005472:Fluorouracil