Phase II study of docetaxel and cisplatin chemotherapy in 5-fluorouracil/cisplatin pretreated esophageal cancer.
BACKGROUND
This study was performed to determine the feasibility and safety of salvage chemotherapy, using docetaxel and cisplatin in 5-fluorouracil (5-FU) and cisplatin-pretreated esophageal cancer.


METHODS
Patients with metastatic or recurrent esophageal squamous cell carcinoma that had previously been treated with 5-FU and cisplatin chemotherapy or chemoradiotherapy were eligible for this study. Docetaxel (70 mg/m²) and cisplatin (75 mg/m²) were given as a 1-hour intravenous infusion on day 1, and the treatment was repeated every 3 weeks.


RESULTS
Thirty-eight male patients were enrolled, and 35 patients were available for evaluation. The median age was 64.5 years; Eastern Cooperative Oncology Group performance status was 0/1/2 = 2/18/18. The median and total numbers of cycles delivered were 3.5 (range, 1-9 cycles) and 162, respectively. One patient (2.6%) achieved complete response, 12 (31.6%) achieved partial response, 12 (31.6%) had stable disease, and 10 (26.3%) had progressive disease. The overall response rate was 34.2% (95% confidence interval, 19.6-51.3). The median progression-free survival and overall survival times were 4.5 ± 1.3 months (95% CI, 4.1-4.9) and 7.4 ± 0.4 months (95% CI, 7.3-7.5), respectively. The main hematological toxicities greater than grade 3 were neutropenia and leucopenia in 20 (52.6%) and 18 patients (47.3%), respectively. Nonhematological toxicities greater than grade 3 included asthenia in 12 patients (31.6%), nausea in 7 patients (18.4%), and peripheral neuropathy in 6 patients (15.8%).


CONCLUSIONS
Chemotherapy with docetaxel and cisplatin was an effective and feasible treatment following treatment with 5-FU and cisplatin, and would be considered as a salvage option for patients with refractory esophageal cancer.
Department of Internal medicine, Center for Biomedical Human Resources, Chonnam National University Medical School, Gwangju, Korea.
Hyun-Jeong
HJ
Shim
Sang-Hee
SH
Cho
Jun-Eul
JE
Hwang
Woo-Kyun
WK
Bae
Sang-Yun
SY
Song
Sung-Bum
SB
Cho
Wan-Sik
WS
Lee
Young-Eun
YE
Joo
Kook-Joo
KJ
Na
Ik-Joo
IJ
Chung
D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D016001:Confidence Intervals; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009367:Neoplasm Staging; D018570:Risk Assessment; D016879:Salvage Therapy; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil