A phase 1/11 study of second-line chemotherapy with fractionated docetaxel and nedaplatin for 5-FU/cisplatin-resistant esophageal squamous cell carcinoma.
OBJECTIVE
There are few second-line regimens available for esophageal cancer. The use of fractionated docetaxel and nedaplatin as second-line chemotherapy was examined in this study.


METHODS
Eligibility criteria were follows: histologically-proven squamous cell carcinoma, surgically unresectable disease, failure to respond to chemotherapy with 5-FU and cisplatin and no more than 2 prior chemotherapy regimens. A total of 12 patients were enrolled in this study. To reduce toxicities, fractionated docetaxel (50 mg/m² in day 1 and 8) and nedaplatin (50 mg/m² in day 8) were administered as second-line chemotherapy.


RESULTS
Stable disease (SD) was observed in 4 cases (33%) and the disease control rate was 33%. Regarding toxicities, leukopenia was the most frequently observed (8 cases, 67%); however, there were no cases of grade 4 nonhematological toxicity. The 1-year overall survival was 26.7% and the median survival time was 7.8 months (95% CI=3.328-12.272 months). The 1-year progression-free survival was 0% and the median progression-free time was 2.0 months (95% CI=1.319-2.681).


CONCLUSIONS
Combination chemotherapy using fractionated docetaxel and nedaplatin is safe and effective and appears to be a feasible regimen to use as second-line chemotherapy for FP-resistant advanced esophageal squamous cell carcinoma.
Department of Frontier Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. yakutsu@faculty.chiba-u.jp
Yasunori
Y
Akutsu
Kiyohiko
K
Shuto
Tsuguaki
T
Kono
Masaya
M
Uesato
Isamu
I
Hoshino
Toru
T
Shiratori
Yukimasa
Y
Miyazawa
Yuka
Y
Isozaki
Naoki
N
Akanuma
Hisahiro
H
Matsubara
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 / Q000627:therapeutic use*; D018572:Disease-Free Survival; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; D043823:Taxoids; D000077143:Docetaxel; C053989:nedaplatin; D002945:Cisplatin; D005472:Fluorouracil