AIM: To evaluate the efficacy and safety of paclitaxel-nedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma (ESCC). METHODS: A two-center, open-label, single-arm phase II study was designed. Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Patients received 175 mg/m² of paclitaxel over a 3 h infusion on 1 d, followed by nedaplatin 80 mg/m² in a 1 h infusion on 2 d every 3 wk until the documented disease progression, unacceptable toxicity or patient's refusal. RESULTS: Of the 36 patients assessable for efficacy, there were 2 patients (5.1%) with complete response and 16 patients (41.0%) with partial response, giving an overall response rate of 46.1%. The median progression-free survival and median overall survival for all patients were 7.1 mo (95%CI: 4.6-9.7) and 12.4 mo (95%CI: 9.5-15.3), respectively. Toxicities were moderate and manageable. Grade 3/4 toxicities included neutropenia (15.4%), nausea (10.3%), anemia (7.7%), thrombocytopenia (5.1%), vomiting (5.1%) and neutropenia fever (2.6%). CONCLUSION: The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.
AIM: To evaluate the efficacy and safety of paclitaxel-nedaplatin combination as a front-line regimen in Chinese patients with metastatic esophageal squamous cell carcinoma (ESCC). METHODS: A two-center, open-label, single-arm phase II study was designed. Thirty-nine patients were enrolled and included in the intention-to-treat analysis of efficacy and adverse events. Patients received 175 mg/m² of paclitaxel over a 3 h infusion on 1 d, followed by nedaplatin 80 mg/m² in a 1 h infusion on 2 d every 3 wk until the documented disease progression, unacceptable toxicity or patient's refusal. RESULTS: Of the 36 patients assessable for efficacy, there were 2 patients (5.1%) with complete response and 16 patients (41.0%) with partial response, giving an overall response rate of 46.1%. The median progression-free survival and median overall survival for all patients were 7.1 mo (95%CI: 4.6-9.7) and 12.4 mo (95%CI: 9.5-15.3), respectively. Toxicities were moderate and manageable. Grade 3/4 toxicities included neutropenia (15.4%), nausea (10.3%), anemia (7.7%), thrombocytopenia (5.1%), vomiting (5.1%) and neutropenia fever (2.6%). CONCLUSION: The combination of paclitaxel and nedaplatin is active and well tolerated as a first-line therapy for patients with metastatic ESCC.
Authors: K Noda; M Ikeda; M Yakushiji; H Nishimura; Y Terashima; H Sasaki; T Hata; H Kuramoto; K Tanaka; T Takahashi Journal: Gan To Kagaku Ryoho Date: 1992-06
Authors: Susan G Urba; Kari Chansky; Peter J VanVeldhuizen; Robert E Pluenneke; Jacqueline K Benedetti; John S Macdonald; James L Abbruzzese Journal: Invest New Drugs Date: 2004-01 Impact factor: 3.850
Authors: B F El-Rayes; A Shields; M Zalupski; L K Heilbrun; V Jain; D Terry; A Ferris; P A Philip Journal: Ann Oncol Date: 2004-06 Impact factor: 32.976
Authors: Wayne Hofstetter; Stephen G Swisher; Arlene M Correa; Kenneth Hess; Joe B Putnam; Jaffer A Ajani; Marcelo Dolormente; Rhodette Francisco; Ritsuko R Komaki; Axbal Lara; Faye Martin; David C Rice; Arcenio J Sarabia; W Roy Smythe; Ara A Vaporciyan; Garrett L Walsh; Jack A Roth Journal: Ann Surg Date: 2002-09 Impact factor: 12.969
Authors: M B Polee; F A L M Eskens; M E L van der Burg; T A W Splinter; P D Siersema; H W Tilanus; J Verweij; G Stoter; A van der Gaast Journal: Br J Cancer Date: 2002-03-04 Impact factor: 7.640
Authors: I Sekine; H Nokihara; A Horiike; N Yamamoto; H Kunitoh; Y Ohe; T Tamura; T Kodama; N Saijo Journal: Br J Cancer Date: 2004-03-22 Impact factor: 7.640