Dose-escalation study of chemoradiotherapy of three-dimensional conformal radiotherapy (3D-CRT) with accelerated hyperfractionation (AHF) and concurrent chemotherapy (cisplatin and vinorelbine) for unresectable stage III non-small cell lung cancer (NSCLC).

Le résumé fourni par la source

e17518 Background: To determine a recommended dose (RD) of radiotherapy using AHF for unresectable NSCLC. Methods: Eligible patients had unresectable stage III NSCLC, age of less than 75 years, PS: 0 or 1, V20 of 35% or less. PET was used for staging. Cisplatin (80mg/m2) was administered on day 1 and vinorelbine (20mg/m2) was administered on days 1 and 8 for first cycle. Twice-daily 3D-CRT (1.5 Gy per fraction) without elective nodal irradiation started on day 1. Total doses were 60 Gy in 40 fractions and 66 Gy in 44 fractions at levels 1 and 2 respectively. After concurrent chemoradiotherapy, consolidation chemotherapy regimen was cisplatin (80mg/m2) on day 1 and vinorelbine (20mg/m2) on days 1 and 8 every 4 week for three cycles. The dose-limiting toxicity (DLT) was defined as grade ≥a3 esophagitis, grade 3 neutropenic fever, grade ≥a3 other non-hematologic toxicities and interruption of irradiation for more than 2 weeks. DLT was monitored for 90 days. Results: A total of 12 patients were enrolled (n=6,4 in the levels 1,2). DLTs were noted in 2 patients at Level 1,which were grade 3 esophagitis and the other grade 3 febrile neutropenia. Radiation dose was escalated up to 66 Gy in 44 fractions (Level 2), and there was no DLT in level 2. In principle, Sixty-six Gy in 44 fractions (Level 2) should be the RD. Major toxicities were leucopenia, neutropenia, and anemia. The response rate (RR) and 1-year survival rate was 83.3% and 91.7%, respectively. The progression free survival time was 11.3 months. Conclusions: The RD was 66 Gy in 44 fractions (Level 2). The toxicity of this chemoradiothrapy regimen was managiable and efficacy is promissing. Phase II study is warranted.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.