A phase II study of weekly docetaxel/cisplatin and concurrent radiotherapy followed by surgery in patients with stage III non-small cell lung cancer (NSCLC)

Abstract

7586 Background: Concurrent chemoradiotherapy (CRT) is standard of care in stage III NSCLC. Optimal chemotherapy has yet to be defined and the role of surgery is still unclear. This prospective study analyzed the feasibility and efficacy of weekly docetaxel/cisplatin (DC) and concurrent involved-field thoracic radiotherapy (CRT) followed by surgery in patients with stage IIIA/B NSCLC. Primary endpoint is radiologic response of DC and CRT. Secondary endpoints included toxicity, efficacy of surgery, postoperative morbidity and mortality, time to progression and overall survival. Methods: DC consisted of IV docetaxel 20 mg/m2 and cisplatin 20mg/m2 at days 1, 8, 15, 22, 29 and 36. CRT was given in once-daily fractions of 1.8 Gy, 5 fractions a week to a total dose of 45 Gy during days 8 to 36. (Non-)invasive investigations were performed after CRT in order to restage the mediastinum. When mediastinal downstaging was achieved, surgery was performed in order to achieve radical resection. Results: Between January 2005 until August 2006, 45 patients were included, of whom 42 patients were evaluable. The median follow-up time was 26.2 months (95 % CI: 24.6–27.7). Stage IIIB disease was present in 17 patients (cT4N2=10, cT4N0/N1=4 and cN3=3) and 25 had stage IIIA-N2 disease. A radiologic response was seen in 20 patients (48%) and eight (19%) showed progressive disease. Toxicity was mild. Twenty patients (48%) of the twenty-three operated patients underwent a radical resection without residual mediastinal malignant disease, ten pneumonectomies (8 left sided) were performed. The mean survival time for this group was 20.3 months (95% CI: 16.5–24.1) vs 16 months (95% CI: 10.4–21.7) for the patients without operation (p=0.068, median was not reached). The 30 days mortality was 4%. Twenty-one patients of 42 showed progression (50%), of which 16 patients developed distant metastasis (38%). Conclusions: Weekly DC and involved-field CRT is possible in stage III NSCLC, with limited toxicity. Radiologic response was seen in 20 patients (48%) and 14 patients showed stable disease. Nearly half of the treated patients (48%) could undergo a radical surgical resection (R0) with a mean survival benefit of 4.3 months. No significant financial relationships to disclose.