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

18050 Background: Concurrent chemoradiotherapy treatment is standard of care for patients with stage III NSCLC in good performance. Optimal chemotherapy have yet to be defined and the role of surgery is still unclear. This prospective phase II study analysed the feasibility and efficacy of weekly docetaxel/cisplatin (DC) and concurrent involved-field thoracic radiotherapy (CRT) followed by surgery in good performance status patients with stage IIIA/B NSCLC. Primary endpoint is radiological 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. CT-based planning was used to minimise radiation to the contralateral lung. Invasive and non-invasive investigations were performed after induction treatment 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 43 patients were evaluable. Stage IIIB disease was present in 18 patients (cT4N2=9, cT4N0/N1=5 and cN3=4) and 25 had stage IIIA-N2 disease. Radiologic response was seen in 20 patients (47%) and 8 (19%) showed progressive disease. Toxicity was mild. Explorative thoracotomy was performed in 24 (56%) patients. Of these, 14 were initially staged as IIIA and ten as stage IIIB (4 of whom had N3 metastases). Twenty patients (47%) underwent a radical resection without residual mediastinal malignant disease, and ten pneumonectomies (8 left sided) were performed. Three patients showed complete pathological response. The 30 days mortality after operation was 4% (one patient) due to ARDS. Conclusions: Weekly DC and CRT is possible in stage III NSCLC, with limited toxicity and nearly half of the treated patients (47%) could undergo a radical surgical resection (R0) without residual mediastinal malignant disease. This promising tri-modality regimen should be tested in future phase II or III trials. No significant financial relationships to disclose.