A modified Phase I trial of radiation dose escalation in 3D conformal radiation therapy with concurrent vinorelbine and carboplatin chemotherapy for non-small-cell lung cancer

The radiation therapy oncology group reported a maximum tolerated dose of 74 gy for patients with non-small cell lung cancer (nsclc); however,it was unclear whether this dose could be safely administered to asian patients due to differences in their physique compared to western patients. we therefore conducted a modified phase i trial to determine whether 70 gy could be safely delivered to chinese patients with nsclc undergoing 3d-conformal radiation therapy (3d-crt) with concurrent chemotherapy. previously untreated nsclc patients received 3d-crt (2 gy/day,5 fractions per week). three dose levels were examined: 62,66 and 70 gy. two cycles of concurrent chemotherapy (vinorelbine and carboplatin) were started on the first day of radiation therapy. dose-limiting toxicity (dlt) was defined as severe or life-threatening side effects that altered the continued implementation of chemoradiotherapy. among the 19 patients recruited in this study,most of the haematologic and non-haematologic toxicities were mild to moderate and clinically manageable. only one patient,in the 70 gy cohort,experienced a dlt of grade 3 radiation-induced pneumonia. the overall response rate was 77.8% (14/18). the median progression-free survival (pfs) was 12 months,and the 1-year pfs was 37.6%. our results support both the feasibility of incorporating 3d-crt with concurrent vinorelbine and carboplatin and a dose escalation to 70 gy for chinese patients with nsclc,based on the acceptable toxicity and encouraging overall response and survival rates. a further evaluation of this regimen in a prospective phase ii trial is ongoing. © the author 2012. published by oxford university press on behalf of the japan radiation research society and japanese society for therapeutic radiology and oncology.