M Costa Rivas1, G Huidobro Vence1, J L Fírvida Pérez2, B Campos Balea3, J García Gonzalez4, M Lázaro Quintela1, M Caeiro Muñoz5, B Taboada Valladares6, J E Castro Gómez7, S Vázquez Estevez3, F J Afonso Afonso8, C Azpitarte Raposeiras9, M Amenedo Gancedo10, J Casal Rubio11. 1. Department of Medical Oncology, Complexo Hospitalario Universitario de Vigo, Clara Campoamor 341, 36312, Vigo, Spain. 2. Department of Medical Oncology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain. 3. Department of Medical Oncology, Hospital Universitario Lucus Augusti de Lugo, Lugo, Spain. 4. Department of Medical Oncology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain. 5. Department of Radiation Oncology, Complexo Hospitalario Universitario de Vigo, Vigo, Spain. 6. Department of Radiation Oncology, Complexo Hospitalario Universitario de Santiago de Compostela, Santiago de Compostela, Spain. 7. Department of Radiation Oncology, Complexo Hospitalario Universitario de Ourense, Ourense, Spain. 8. Department of Medical Oncology, Complexo Hospitalario Universitario de Ferrol, Ferrol, Spain. 9. Department of Medical Oncology, Complexo Hospitalario de Pontevedra, Pontevedra, Spain. 10. Department of Medical Oncology, Centro Oncológico de Galicia, A Coruña, Spain. 11. Department of Medical Oncology, Complexo Hospitalario Universitario de Vigo, Clara Campoamor 341, 36312, Vigo, Spain. joaquin.casal.rubio@sergas.es.
Abstract
PURPOSE: The aim of this phase II study was to evaluate the activity and safety of the combination of cisplatin and vinorelbine with thoracic radiotherapy in unresectable locally advanced stage III non-small cell lung cancer (NSCLC). The primary endpoint was the objective response rate (ORR). Secondary objectives included toxicity profile, progression-free survival (PFS), and overall survival (OS). MATERIALS AND METHODS: A total of 48 NSCLC patients were enrolled (median age 60 years, 52% stage IIIA and 48% stage IIIB, 52% adenocarcinoma). Patients received three cycles of chemotherapy every 21 days [intravenous cisplatin 80 mg/m2 and intravenous vinorelbine 25 mg/m2 on day 1 and oral vinorelbine on day 8 (60 mg/m2)] concurrent with radiotherapy (66 Gy, administered at 1.8 Gy per day, five consecutive days per week). RESULTS: ORR was 79.2% (72.9% showing partial response and 6.3% showing complete response). With a median follow-up of 20.7 months, median PFS was 12 months and median OS was 36 months. Grade 3/4 toxicities were: neutropenia (14.5%), anaemia (6.2%), vomiting (2%), and oesophagitis (4.2%). No toxic deaths were reported. CONCLUSION: This combined regimen shows efficacy and a manageable safety profile. PFS and OS outcomes are encouraging and warrant further research.
PURPOSE: The aim of this phase II study was to evaluate the activity and safety of the combination of cisplatin and vinorelbine with thoracic radiotherapy in unresectable locally advanced stage III non-small cell lung cancer (NSCLC). The primary endpoint was the objective response rate (ORR). Secondary objectives included toxicity profile, progression-free survival (PFS), and overall survival (OS). MATERIALS AND METHODS: A total of 48 NSCLCpatients were enrolled (median age 60 years, 52% stage IIIA and 48% stage IIIB, 52% adenocarcinoma). Patients received three cycles of chemotherapy every 21 days [intravenous cisplatin 80 mg/m2 and intravenous vinorelbine 25 mg/m2 on day 1 and oral vinorelbine on day 8 (60 mg/m2)] concurrent with radiotherapy (66 Gy, administered at 1.8 Gy per day, five consecutive days per week). RESULTS: ORR was 79.2% (72.9% showing partial response and 6.3% showing complete response). With a median follow-up of 20.7 months, median PFS was 12 months and median OS was 36 months. Grade 3/4 toxicities were: neutropenia (14.5%), anaemia (6.2%), vomiting (2%), and oesophagitis (4.2%). No toxic deaths were reported. CONCLUSION: This combined regimen shows efficacy and a manageable safety profile. PFS and OS outcomes are encouraging and warrant further research.
Authors: M De Lena; R Ramlau; O Hansen; V Lorusso; L Wagner; S Barni; M M Cristovao; R Huber; V Alberola; M Mitrovic; C Colin; J Gasmi Journal: Lung Cancer Date: 2004-12-21 Impact factor: 5.705
Authors: K Furuse; M Fukuoka; M Kawahara; H Nishikawa; Y Takada; S Kudoh; N Katagami; Y Ariyoshi Journal: J Clin Oncol Date: 1999-09 Impact factor: 44.544
Authors: Walter J Curran; Rebecca Paulus; Corey J Langer; Ritsuko Komaki; Jin S Lee; Stephen Hauser; Benjamin Movsas; Todd Wasserman; Seth A Rosenthal; Elizabeth Gore; Mitchell Machtay; William Sause; James D Cox Journal: J Natl Cancer Inst Date: 2011-09-08 Impact factor: 13.506
Authors: J Jassem; R Ramlau; H Karnicka-Młodkowska; K Krawczyk; M Krzakowski; P Zatloukal; E Lemarié; W Hartmann; L Novakova; M O'Brien; A Depierr Journal: Ann Oncol Date: 2001-10 Impact factor: 32.976
Authors: J Jassem; P Kosmidis; R Ramlau; K Zarogoulidis; L Novakova; J Breton; P-L Etienne; C Seebacher; M Grivaux; A Ojala; D Aubert; F Lefresne Journal: Ann Oncol Date: 2003-11 Impact factor: 32.976