RESULTS OF CANCER AND LEUKEMIA GROUP-B PROTOCOL-8935 - A MULTIINSTITUTIONAL PHASE-II TRIMODALITY TRIAL FOR STAGE-IIIA (N2) NON-SMALL-CELL LUNG-CANCER

From October 1989 to February 1992, 74 patients with mediastinoscopica lly staged IIIA (N2) non-small-cell lung cancer from 30 CALGB-affiliat ed hospitals received two cycles of preresectional cisplatin and vinbl astine chemotherapy. Patients with responsive or stable disease underw ent standardized surgical resection and radical lymphadenectomy. Patie nts who underwent resection received sequential adjuvant therapy with two cycles of cisplatin and vinblastine, followed by thoracic irradiat ion (54 Gy after complete resection and 59.4 Gy after incomplete resec tion or no resection at 1.8 Gy per fraction). There were no radiograph ic complete responses to the neoadjuvant chemotherapy, although 65 (88 %) patients had either a response or no disease progression. During in duction chemotherapy, disease progressed in seven patients (9%). Sixty -three patients (86%) had exploratory thoracotomy, and 46 of those (75 %) had resectable lesions. A complete surgical resection was accomplis hed in 23 patients, and 23 patients had an incomplete resection with e ither a diseased margin or diseased highest node resected. Operative m ortality was 3.2% (2/63), In 10 patients (22% of the 46 having resecti on) the disease was pathologically downstaged. There was no correlatio n between radiographic response to the induction chemotherapy and down staging at surgical resection. The full protocol was completed by 33 p atients (45% of original cohort). Overall survival at 3 years was 23%. Patients undergoing resection had significantly improved survival at 3 years compared with patients not having resection: 46% for complete resection (median 20.9 months), 25% for incomplete resection (median 1 7.8 months), and 0% for no resection (median 8.5 months). Five deaths occurred during the treatment period. A total of 18 of the 46 (39%) pa tients who underwent resection are either alive and disease-free or ha ve died without recurrence.