A phase II study of paclitaxel and nedaplatin as first-line chemotherapy in patients with advanced esophageal cancer.
OBJECTIVE
The aim of this study was to assess the efficacy and toxicity of the combination of paclitaxel and nedaplatin as a first-line chemotherapy for patients with advanced esophageal cancer.


METHODS
Patients with advanced esophageal cancer received 175 mg/m(2) of paclitaxel over a 3 h infusion, followed by nedaplatin 80 mg/m(2) in a 1 h infusion on day 1 every 3 weeks until the documented disease progression, unacceptable toxicity or patient's refusal.


RESULTS
Between March 2005 and December 2007, 48 patients entered in the study. Forty-six (95.8%) of the 48 patients were assessable for response. The overall response rate was 41.7% (95% CI, 27.8-55.7%) with 2 complete responses and 18 partial responses. The median follow-up period was 20.5 months (range, 12.5-27.2 months). The median overall time to progression and overall survival (OS) were 6.1 months (95% CI, 4.8-7.4 months) and 11.5 months (95% CI, 9.1-13.9 months), respectively. The estimate of OS at 12 and 24 months was 43.8% (95% CI, 29.7-77.8%) and 10.4% (95% CI, 1.8-19.1%), respectively. Most patients experienced anemia, during their course of therapy with 6 (13.0%) patients for grade 3/4 anemia, and grade 1 or 2 anemia was detected in 23 (50%) patients. Grade 3 leucopenia, neutropenia and thrombocytopenia were documented in 8 (17.4%), 9 (17.4%) and 2 (4.3%) patients, respectively. Grade 3 nausea and vomiting were detected in 3 (6.5%) and 2 (4.3%) patients, respectively. Two patients (4.3%) were hospitalized because of treatment-related complications. The treatment was well tolerated and no toxic death occurred.


CONCLUSIONS
Combination of paclitaxel and nedaplatin is a tolerated treatment modality with promising activity in previously untreated advanced esophageal cancer.
Cao
Weiguo
W
Department of Oncology, Shanghai Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, No. 197, Rui Jin Er Lu, Shanghai 200025, PR China.
Xu
Chun
C
Lou
Guying
G
Jiang
Jinsong
J
Zhao
Shunguang
S
Geng
Mei
M
Xi
Wenqi
W
Li
Hao
H
Jin
Yening
Y
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D017239:Paclitaxel / Q000008:administration & dosage; D011379:Prognosis; D015996:Survival Rate; D016896:Treatment Outcome
D009944:Organoplatinum Compounds; C053989:nedaplatin; D017239:Paclitaxel