A randomized study comparing two hypofractioned 3-D conformal radiotherapy for stage IIIb-IV non small cell lung cancer.

We compared the safety and efficacy of two hypofractionated irradiation schedules for elderly and low performance status patients with inoperable symptomatic non-small cell lung cancer (NSCLC). Patients that entered the study were either unfit or without response concerning chemotherapy. We randomized 14 patients (group A) vs 15 patients (group B) who underwent two different hypofractionated radiotherapy schedules. Group Α patients underwent a scheme of 13x3 Gy, while group B patients received 2x8.5 Gy and one fraction of 6 Gy one week apart. Efficacy was assessed in terms of disease-free survival (DFS), tumor response and overall survival (OS).Toxicity according to RTOG/EORTC criteria and duration of symptoms were also evaluated. Median follow up was 3 years. Median age was 64.5 years (group A) and 73 years (group B). Mean values for symptom palliation were higher for group B vs group A (3.20±1.21 vs 2.21±0.97, p=0.037), respectively. EORTC/RTOG toxicity was significantly higher (p=0.046) for group A (1.57±0.51) vs group B (1.13±0.35). Duration of toxicity was significantly lower in group B compared to group A (p=0.001). Median OS was similar between groups, while DFS was better in group B than group A (p=0.023). Although safe conclusions are difficult to be ascertained, hypofractionated schedule B might be an alternative scheme in elderly and low performance status patients offering adequate palliation, good tumor control and acceptable toxicity.