Concomitant Chemoradiation gives Significant Survival and Hrqol Benefits in Patients with Locally Advanced Stage III Non Small Cell Lung Cancer (NSCLC) Not Eligible for Radical Treatment: A Randomized Trial by the Norwegian Lung Cancer Study Group

ABSTRACT Background In patients with locally advanced, inoperable NSCLC and negative prognostic factors, treatment will be of palliative intent. Platinum-based chemotherapy and thoracic radiation are both well documented, but the role of chemoradiation has not been established. Objective: Will concomitant radio- and chemotherapy (chemoradiation), when compared to chemotherapy alone, be superior with respect to survival and health-related quality of life (HRQOL) in patients with incurable NSCLC stage III (negative prognostic factors)? Methods Stage III NSCLC patients, not eligible for curative radiotherapy due to tumor size ≥ 8 cm or performance status 2 or weight loss ≥ 10 % during the last 6 months, were randomized to receive either chemoradiation or chemotherapy alone. Chemotherapy consisted of 4 cycles of carboplatin iv day 1 and vinorelbine po day 1 and 8, with 3-week intervals. Patients in the chemoradiation arm also received radiotherapy with fractionation 42 Gy/2.8 Gy, starting at the 2nd chemo course. The primary endpoint was overall survival. Secondary endpoints were HRQOL and toxicity. Results 191 patients from 25 Norwegian hospitals were randomized from Nov 2006 until Nov 2011, when enrollment was terminated due to slow accrual. Median age was 67 years and 20% had PS 2. In the chemotherapy versus the concomitant arm, the median overall survival was 9.7 and 13.3 months, respectively (p  Conclusions Of the 2 investigated treatment regimens; chemoradiation was superior to chemotherapy alone with respect to both survival and global HRQOL, at the expense of more hospital admissions due to toxicity. Disclosure All authors have declared no conflicts of interest.