Oncology Department. Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain
Manuel Domine , Cristina Carames Sanchez , Francisco Lobo , Tatiana Carolina Hernandez Guerrero , Ana Leon , Victoria Casado , Gustavo Rubio , Jose Ignacio Martin-Valades , Yann Izarzugaza , Juan Luis Arranz , Irene Moreno , Andrea Correa Noguera , Victor Zenzola , Miriam Dorta , Susana Casado , Ana Ruperez , Roberto Hernandez Lopez , Victor Moreno , Jesus Garcia-Foncillas
Background: Concurrent chemo- and radiotherapy (CT+RT) is standard of care for inoperable stage IIIA/B NSCLC. Optimal CT + concurrent RT regimen and schedule remain undefined. This trial evaluated carboplatin –gemcitabine + concurrent RT followed by consolidation carboplatin – gemcitabine. Methods: Treatment schedule during CT-RT phase: weekly carboplatin (AUC 2) + gemcitabine (200mg/m2) for 6 weeks + concurrent RT (60 Gy). CT consolidation phase: carboplatin (AUC 3) gemcitabine (2500 mg/m2) every two weeks for 3 cycles. Primary endpoint was security and secondary response rate, time to progression (TTP) and overall survival (OS). Results: 24 patients were enrolled: Sex 18 male, 6 female. Histology: 12 adenocarcinoma, 8 squamous, 4 undifferentiated large cell carcinoma. Stage: IIIB: 20, IIIA: 4. ECOG 0-1: 23, ECOG 2: 1. All the patients completed concurrent CT-RT and 22 consolidation CT. Toxicity: CT- RT phase: No grade 4 toxicity was observed. Grade 3: Neutropenia 0, anemia 4.1%, thrombocytopenia 12.5%, esophagitis 16.6%. CT consolidation phase: Grade 3-4 toxicity: Neutropenia 16.6%, Anemia 21%, Thrombocytopenia 16.6% of the patients.. 3 patients required red blood cell transfusion and 1 patient died for febrile neutropenia grade 4 during consolidation. Efficacy: Response Rate: 75% (Partial: 50% Complete: 22%), Stable disease 21% Progression 4%. Median TTP: 11 months (95% CI 7-17) and median OS: 18 months (95% CI 16.2- 20.5) Conclusions: Concurrent carboplatin – gemcitabine with thoracic RT is feasible with a favorable profile showing less hematologic toxicity and esophagitis than other CT-RT regimens. CT consolidation showed severe hematological toxicity. This regimen is active and could be a good option to combine with concurrent RT.
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