Phase II study of neoadjuvant chemotherapy in patients with surgically-proven, unresectable stage III non-small cell lung cancer.

Background: The aim of this study was to assess whether patients with truly unresectable (bulky extracapsular N2, T4 for tracheobronchial angle or mediastinal organ invasion) stage III non-small cell lung cancer (NSCLC), as proven by cervical mediastinoscopy supplemented or not by left anterior mediastinoscopy and fiberoptic bronchoscopy or thoracotomy, could become resectable after induction cisplatin-containing chemotherapy. In addition, we studied the value of preoperatory magnetic resonance imaging (MRI), in evaluating the probability of achieving a radical resection after neoadjuvant chemotherapy. Patients and Methods: Sixteen consecutive untreated stage III NSCLC patients were enrolled in the study. All the patients received two cycles of combination chemotherapy including cisplatin 100-120 mg/m(2) intravenously (i.v.) days 1 and 22 and vinorelbine 30 mg/m(2) i.v. days 1, 8, 15, 22 and 28 or vinblastine 5 mg/m(2) i. v. days 1, 8, 15, 22 and 28. Thoracotomy was planned, after chemotherapy, for all non-progressive patients. No other treatment after surgery was devised following radical resection and patients with residual disease after surgery received standard post-operative radiotherapy. Response to treatment was evaluated by thorax CT and MRI two weeks after the last administration of chemotherapy. Results: The overall complete resection rate was 38% (6 out of 16 patients). MRI was predictive of complete resectability in 80% of cases. In fact, 6 patients judged resectable were completely resected, 3 patients judged unresectable underwent only explorative thoracotomy or incomplete resection while MRI was unpredictive only in one case. The most important chemotherapy-related toxicity was hematological: eight patients (50%) had grades III-IV leukopenia. Conclusion: These results indicate that preoperative second generation cisplatin-based chemotherapy can make resectable truly unresectable stage Iff NSCLC patients in only 38% of cases and that MRI is a reliable tool for assessment of radical resection probability after neoadjuvant chemotherapy.