A phase 3 study of induction treatment with concurrent chemoradiotherapy versus chemotherapy before surgery in patients with pathologically confirmed N2 stage IIIA nonsmall cell lung cancer (WJTOG9903)
Katakamia M et al. – The addition of radiotherapy to induction chemotherapy conferred better local control without significant adverse events. Tumor downstaging is important for prolonging the OS in patients with stage IIIA (N2) NSCLC.Methods
- Patients with pathologically proven N2 disease were randomized to receive either induction chemotherapy (docetaxel 60 mg/m2 and carboplatin AUC [area under the receiver operating characteristic curve] = 5 for 2 cycles) plus concurrent radiation therapy (40 Gy) followed by surgery (CRS arm) or induction chemotherapy followed by surgery (CS arm).
- They subsequently underwent pulmonary resection when possible.
- Sixty patients were randomly assigned between December 2000 and August 2005.
- The study was prematurely terminated in January 2006 because of slow accrual.
- The most common toxicity was grade 3 or 4 leukopenia in 92.9% of patients in the CRS arm and 46.4% in the CS arm.
- Induction therapy was generally well tolerated, and there were no treatment-related deaths in either arm.
- Downstaging in the CS arm and CRS arm was 21% and 40%, respectively.
- The progression-free survival (PFS) and overall survival (OS) in the CS arm were 9.7 months and 29.9 months (PFS, hazard ratio [HR] = 0.68, P = .187), and those in the CRS arm were 12.4 months and 39.6 months (OS, HR = 0.77, P = .397), respectively.
- The PFS with and without downstaging was 55.0 and 9.4 months, respectively (HR = 3.39, P = .001).
- The OS with and without downstaging was 63.3 and 29.5 months, respectively (HR = 2.62, P = .021).