Radical radiotherapy with or without gemcitabine in patients with early stage medically inoperable non-small cell lung cancer

Background: Preclinical and phase I data suggest gemcitabine to be a potent radiosensitiser. This multi-centre study addressed whether the addition of low dose gemcitabine to radical radiotherapy improved 2 year event-free survival in patients with medically inoperable stages I-II non-small cell lung cancer. Aim: To determine whether low dose gemcitabine increased event-free survival in patients with T1-2 N0-1 M0 NSCLC deemed unfit for surgery. Methods: Patients with T1-2 N0-1 M0 NSCLC deemed unfit for surgery were randomised to 3D conformal radiotherapy delivering 55 Gy in 20 fractions over 4 weeks to known sites of cancer with (Arm B) or without (Arm A) 100 mg/m(2) weekly gemcitabine. Results: Study entry was terminated early because of slow accrual. 111 patients were randomised between March 2003 and December 2005, of whom 4 withdrew consent and 2 were lost to follow-up. Median age was 75 (range 49-88) years and 67(63%) were male. 86(81%) were PS 0-1 and 31(30%) Charlson index 2 or greater. Event-free survival in arm A and B, respectively, was 42% and 46% at 2 years and 20% and 31% at 5 years (p = 0.72), while overall survival was 56% and 52% at 2 years and 20% and 33% at 5 years (p = 0.87). Two deaths from accelerated interstitial lung disease were seen in arm B. but toxicity was otherwise mild. Conclusion: No evidence of an improvement in event-free survival was seen with the addition of weekly gemcitabine at this dose for patients with early stage NSCLC unfit for surgery, although the power of the study was low. (c) 2012 Elsevier Ireland Ltd. All rights reserved.