Paclitaxel versus docetaxel for advanced gastric cancer: a randomized phase II trial in combination with infusional 5-fluorouracil.
Taxanes have clearly demonstrated activities against gastric cancer. We compared the combination of paclitaxel plus 5-fluorouracil (5-FU) (PF) with docetaxel plus 5-FU (DF) as first-line chemotherapy in patients with measurable metastatic gastric cancer. Seventy-seven patients were randomly assigned to receive paclitaxel 175 mg/m2 or docetaxel 75 mg/m2 on day 1, in combination with 5-FU 500 mg/m2 continuous infusion on days 1-5. Treatment was repeated every 3 weeks. Of 314 chemotherapy cycles delivered (median 5 in both groups), dose reduction was required more frequently in the DF group, being 9 and 19%, respectively (P<0.01). PF was associated with, although statistically insignificant, substantially less grade 3 or 4 toxicities than DF (68 versus 85%; P=0.09). Global quality of life was similar in both groups, but substantive differences in many symptom scores including pain, dyspnea, constipation and diarrhea favored PF. There were no significant differences in therapeutic efficacy between PF and DF with respect to response rate (42 versus 33%, respectively; P=0.53), and failure-free (3.6 versus 4.2 months; P=0.92) and overall survival (9.9 versus 9.3 months; P=0.42). Both PF and DF appear to have efficacy against metastatic gastric cancer, with different, but acceptable, safety profiles.
Park
Se Hoon
SH
Division of Hematology and Oncology, Department of Internal Medicine, Gachon Medical School Gil Medical Center, Incheon, South Korea.
Lee
Woon Kee
WK
Chung
Min
M
Lee
Yuna
Y
Han
Sang Hoon
SH
Bang
Soo-Mee
SM
Cho
Eun Kyung
EK
Shin
Dong Bok
DB
Lee
Jae Hoon
JH
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D011788:Quality of Life; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel; D005472:Fluorouracil