Phase II trial of induction gemcitabine and carboplatin followed by conformal thoracic radiation to 74 Gy with weekly paclitaxel and carboplatin in unresectable stage III non-small cell lung cancer.

INTRODUCTION: The survival for patients with locally advanced, unresectable non-small cell lung cancer receiving standard of care concomitant chemoradiation remains disappointingly low. A reduction in both local and distant recurrence is needed to improve patients' outcome. Performing molecular studies on serially collected tumor specimens may result in a better selection of therapeutic options.
METHODS: We conducted a phase II single-institution trial of two cycles of induction chemotherapy with gemcitabine and carboplatin followed by high-dose conformal radiation concomitant with weekly paclitaxel and carboplatin in 39 patients. The trial required a dedicated tumor biopsy before treatment initiation. In addition, tumor biopsies were requested, if safely feasible, before initiation of chemoradiation and 2 months after completion all therapy.
RESULTS: Induction chemotherapy was well tolerated, and 38 patients proceeded with chemoradiation. The mean delivered radiation dose was 70.2 Gy, 23 patients received the full dose of 74 Gy, and 19 patients completed all treatment on schedule without dose reductions or delays. Median overall and progression-free survivals were 22.7 and 14.3 months, respectively. A total of 82 procedures, including 46 transthoracic core needle biopsies, were performed. Thirteen patients had all three serial tumor biopsies. Three of these procedures resulted in complications that required an intervention; all for the treatment of a biopsy-induced pneumothorax.
CONCLUSIONS: We conclude that induction gemcitabine/carboplatin followed by concurrent paclitaxel/carboplatin with conformal radiation to 74 Gy is safe and tolerable with promising efficacy. We demonstrated that dedicated and serial tumor collections are safe, feasible, and acceptable for patients with non-small cell lung cancer.