Chemotherapy plus RT with or without resection acceptable in stage III NSCLC

According to data from a phase-3 trial, chemotherapy plus radiotherapy — with or without resection — are feasible treatment options for patients with stage IIIa (N2) non–small cell lung cancer.

“On the basis of the findings of our study, patients should be counseled about the risks and potential benefits of definitive chemotherapy plus radiotherapy with and without a surgical resection (preferably by lobectomy),” the researchers wrote.

The study was based on results of several phase-2 trials conducted in patients with stage IIIa (N2) NSCLC. The studies demonstrated the possibility of resection after concurrent chemotherapy and radiotherapy with promising survival rates.

The phase-3 trial included patients with stage T1-3pN2M0 NSCLC; patients were assigned concurrent induction chemotherapy plus radiotherapy at 45 Gy. If their disease did not progress, patients either underwent resection (group one, n=202) or continued with uninterrupted radiotherapy up to 61 Gy (group two, n=194). Both groups were assigned to two additional cycles of cisplatin and etoposide. The primary endpoint was OS.

Median OS was 23.6 months in group one and 22.2 months in group two (HR=0.87; 95% CI, 0.70-1.10). At five years, 37 patients from group one and 24 patients from group two were still alive (OR=0.63; 95% CI, 0.36-1.10). Median OS among patients with N0 status at thoracotomy was 34.4 months.

Patients in group one had superior median PFS (12.8 months) compared with patients in group two (10.5 months; HR=0.77; 95% CI, 0.62-0.96). At five years, 32 patients in group one had no disease progression compared with 13 in group two.

The most common grade-3 or -4 toxicities associated with chemotherapy plus radiotherapy were neutropenia (38% in group one vs. 41% in group two) and oesophagitis (10% vs. 23%). Sixteen deaths in group one were treatment related vs. four deaths in group two.

Albain K. Lancet. 2009;doi:10.1016/S0140-6736(09)60737-6