Neoadjuvant Erlotinib Has Activity in Patients with Early-Stage Resectable NSCLC
The open-label phase 2 trial investigated the safety of preoperative erlotinib treatment and in vivo response in patients with early-stage NSCLC (n=15) from an enriched population (ie, never-smoker, female sex, nonsquamous histology, or Asian ethnicity) and in unselected patients to a total of 60 patients, Houke M. Klomp, MD, PhD, of the Netherlands Cancer Institute–Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands, and colleagues reported.
Preoperative erlotinib 150mg/day was administered for 3 weeks. Response was evaluated using [18F] PET and CT scans during treatment and histologic examination of the resection specimen. Primary end points were toxicity and pathologic response.
Seven patients (12%) stopped treatment prematurely. Skin toxicity was present in 37 patients (62%) and diarrhea 21 (35%). PET evaluation revealed metabolic response in 16 patients (27%); by CT, 3 patients (5%). No unexpected complications occurred during surgery. On pathologic examination, >50% necrosis was observed in 14 patients (23%); 3 (5%) had >95% tumor necrosis. Response rate in the enriched population was 34% (10 of 29 patients).