ABSTRACT
Recent studies have suggested the superiority of concurrent chemoradiotherapy and the efficacy of paclitaxel/carboplatin in adjuvant non-small-cell lung cancer [NSCLC]. In view of those results, we conducted this phase II trial to examine the safety and efficacy of administration of radiosensitizing paclitaxel/carboplatin weekly with concurrent thoracic radiation therapy [XRT] followed by consolidation paclitaxel/carboplatin for stage II and IIIA NSCLC. Patients with resected NSCLC, pathological stage II or IIIA, Nl-N2 with or without positive margin received paclitaxel/carboplatin weekly during thoracic radiotherapy. All patients received 50.4Gy in 28 fractions for 6 weeks [1.8Gy/d, 5 days/wk]. A boost of 10.8Gy in six fractions was given for extracapsular nodal extension or positive margin. Four weeks after radiotherapy, the patients received two courses of consolidation paclitaxel/carboplatin every 3 weeks. Treatment compliance was acceptable, with 96% compliance for radiation therapy and 92% for chemotherapy completion. The median duration of follow-up was 30 months. The 3-year actuarial survival and progression-free survival rates were 56% and 44%, respectively. Loco-regional failure was a component of first failure in 24% of patients. Toxicities were acceptable. The results of this study suggest that weekly paclitaxel/carboplatin concurrent with radiotherapy is safe and acceptable adjuvant treatment for stage II and IIIA resected NSCLC patients. A randomized phase III trial comparing this treatment regimen with standard therapy seems warranted