PURPOSE: We prospectively conducted a multi-center, open-label, randomized phase II trial to compare the efficacy and safety of docetaxel plus cisplatin (DC) and etoposide plus cisplatin (EC) for treating advanced stage non-small cell lung cancer (NSCLC). MATERIALS AND METHODS:Seventy-eight previously untreated patients with locally advanced, recurrent or metastatic NSCLC were enrolled in this study. The patients received cisplatin 75 mg/m(2) on day 1 and either docetaxel 75 mg/m(2) on day 1 or etoposide 100 mg/m(2) on days 1 to 3 in the DC or EC arm, respectively, every 3 weeks. RESULTS: The objective response rate was 39.4% (15/38) and 18.4% (7/38) (p=0.023) in the DC and EC arms, respectively. The median time to progression (TTP) was 5.9 and 2.7 months (p=0.119), and the overall survival was 12.1 and 8.7 months (p=0.168) in the DC and EC arms, respectively. The prognostic factors for longer survival were an earlier disease stage (stage III, p=0.0095), the responders to DC (p=0.0174) and the adenocarcinoma histology (p=0.0454). The grades 3 and 4 toxicities were similar in both arms, with more febrile neutropenia (7.9% vs. 0%) and fatigue (7.9% vs. 0%) being noted in the DC arm. CONCLUSION: DC offered a superior overall response rate than does EC, along with tolerable toxicity profiles, although the DC drug combination did not show significantly improved survival and TTP.
RCT Entities:
PURPOSE: We prospectively conducted a multi-center, open-label, randomized phase II trial to compare the efficacy and safety of docetaxel plus cisplatin (DC) and etoposide plus cisplatin (EC) for treating advanced stage non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: Seventy-eight previously untreated patients with locally advanced, recurrent or metastatic NSCLC were enrolled in this study. The patients received cisplatin 75 mg/m(2) on day 1 and either docetaxel 75 mg/m(2) on day 1 or etoposide 100 mg/m(2) on days 1 to 3 in the DC or EC arm, respectively, every 3 weeks. RESULTS: The objective response rate was 39.4% (15/38) and 18.4% (7/38) (p=0.023) in the DC and EC arms, respectively. The median time to progression (TTP) was 5.9 and 2.7 months (p=0.119), and the overall survival was 12.1 and 8.7 months (p=0.168) in the DC and EC arms, respectively. The prognostic factors for longer survival were an earlier disease stage (stage III, p=0.0095), the responders to DC (p=0.0174) and the adenocarcinoma histology (p=0.0454). The grades 3 and 4 toxicities were similar in both arms, with more febrile neutropenia (7.9% vs. 0%) and fatigue (7.9% vs. 0%) being noted in the DC arm. CONCLUSION:DC offered a superior overall response rate than does EC, along with tolerable toxicity profiles, although the DC drug combination did not show significantly improved survival and TTP.
Authors: K Kelly; J Crowley; P A Bunn; C A Presant; P K Grevstad; C M Moinpour; S D Ramsey; A J Wozniak; G R Weiss; D F Moore; V K Israel; R B Livingston; D R Gandara Journal: J Clin Oncol Date: 2001-07-01 Impact factor: 44.544
Authors: V Georgoulias; N Androulakis; A M Dimopoulos; C Kourousis; S Kakolyris; E Papadakis; F Apostolopoulou; C Papadimitriou; A Vossos; M Agelidou; P Heras; S Tzannes; J Vlachonicolis; E Mavromanolakis; D Hatzidaki Journal: Ann Oncol Date: 1998-03 Impact factor: 32.976
Authors: M H Cullen; L J Billingham; C M Woodroffe; A D Chetiyawardana; N H Gower; R Joshi; D R Ferry; R M Rudd; S G Spiro; J E Cook; C Trask; E Bessell; C K Connolly; J Tobias; R L Souhami Journal: J Clin Oncol Date: 1999-10 Impact factor: 44.544
Authors: F A Shepherd; J Dancey; R Ramlau; K Mattson; R Gralla; M O'Rourke; N Levitan; L Gressot; M Vincent; R Burkes; S Coughlin; Y Kim; J Berille Journal: J Clin Oncol Date: 2000-05 Impact factor: 44.544
Authors: Frank Fossella; Jose R Pereira; Joachim von Pawel; Anna Pluzanska; Vera Gorbounova; Eckhard Kaukel; Karin V Mattson; Rodryg Ramlau; Aleksandra Szczesna; Panagiotis Fidias; Michael Millward; Chandra P Belani Journal: J Clin Oncol Date: 2003-07-01 Impact factor: 44.544