Similar Outcomes Reported With Surgery vs Definitive Concurrent Chemoradiotherapy in Resectable Stage III NSCLC
- overall survival or progression-free survival between chemoradiotherapy boost and surgery in patients with resectable disease following induction therapy WERE SIMILAR
- The study was statistically underpowered.
Findings in an early-terminated German phase III trial (ESPATUE), reported in the Journal of Clinical Oncology by Eberhardt et al, indicate similar outcomes with surgery vs definitive concurrent chemoradiotherapy after induction chemotherapy and chemoradiotherapy in patients with resectable stage III non–small cell lung cancer (NSCLC). The study was stopped early due to slow enrollment and an end to funding.
In the trial, with accrual between January 2004 and January 2013, 246 (of a planned 500) patients with stage IIIA (N2) or select stage IIIB disease received induction chemotherapy with three cycles of cisplatin/paclitaxel and concurrent chemoradiotherapy, consisting of 45 Gy with cisplatin/vinorelbine. A total of 161 patients (65%) had tumors considered resectable in the last week of radiotherapy and were randomly assigned to receive a chemoradiotherapy boost risk adapted to between 65 and 71 Gy (n = 80) or surgery (n = 81). The primary endpoint was overall survival.
The trial was closed after the second scheduled interim analysis and was underpowered for analysis of the primary study endpoint. R0 resection was performed in 81% of the surgery group.
After a median follow-up of 78 months, 5-year overall survival was 40% in the chemoradiotherapy group and 44% in the surgery group (P = .34). In addition, 5-year progression-free survival was 35% and 32% (P = .75). Among all 246 patients, 5-year overall survival was 34%, with 88% receiving definitive local treatment.
The investigators concluded: “The 5-year [overall survival and progression-free survival] rates in randomly assigned patients with resectable stage III non–small cell lung cancer were excellent with both treatments. Both are acceptable strategies for this good-prognosis group.”
The study was supported by German Cancer Aid, Deutsche Krebshilfe, and Pierre Fabre.
Wilfried Ernst Erich Eberhardt, MD, of the Essen University Hospital, Essen, Germany, is the corresponding author of the Journal of Clinical Oncology article.