Phase II study of weekly carboplatin/gemcitabine + concurrent thoracic radiotherapy (RT) followed by consolidation carboplatin/gemcitabine for inoperable stage III non-small cell lung cancer (NSCLC).

Authors

null

Manuel Domine

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

Organizations

Oncology Department. Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain, Oncology Department Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain, Oncology Department. Hospital Universitario. Fundacion Jimenez Diaz, Madrid, Spain, Oncology Department, Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain, Oncology Department. Hospital Universitario Fundación Jiménez Díaz, Madrid, Spain, Oncology Department, Hospital Universitario Fundacion Jimenez Diaz, Madrid, Spain, Oncology Department, Hospital Universitario Fundacion Jimenez Diaz. Universidad Autonoma de Madrid, Madrid, Spain

Research Funding

No funding sources reported

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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Abstract Details

Meeting

2015 ASCO Annual Meeting

Session Type

Publication Only

Session Title

Publication Only: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Citation

J Clin Oncol 33, 2015 (suppl; abstr e18515)

DOI

10.1200/jco.2015.33.15_suppl.e18515

Abstract #

e18515

Abstract Disclosures