Surgery plus adjuvant chemotherapy for T1-3N0M0 small-cell lung cancer. Rationale for current approach.

Between January 1980 and December 1986, 42 patients with histological confirmed small-cell lung cancer (SCLC) staged pathologically as T1-3N0M0 disease entered a prospective study of surgery plus adjuvant chemotherapy including six courses of i.v. cyclophosphamide (1 g/m2, day 1), epirubicin (60 mg/m2, day 1), and etoposide (120 mg/m2, days 1, 3, and 5), at 3-week intervals. No thoracic or prophylactic cranial irradiation was given. With a 52.5-month median follow-up, estimated 5-year survival was 36% and median survival was 32.7 months (range, 5-100+) for all patients. Seven patients (17%) are currently alive and disease-free at 63 to 100 months. In univariate analysis, baseline characteristics significantly influencing survival and disease-free interval (DFI) were the tumor stage (T1 and T2 versus T3), tumor histology (oat and intermediate versus combined cell type), and type of resection (lobectomy versus pneumonectomy). However, in multivariate analysis, only the tumor stage (T1-2 versus T3) maintained its level of significance. There was a significant correlation (p less than 0.0001) between the pathological tumor size (maximum tumor diameter [(MTD) cm] and survival and DFI; once the MTD (less than versus greater than median value, 3.9 cm) was included in univariate and multivariate analysis, the tumor stage no longer appeared to maintain its level of significance. Treatment was generally well-tolerated and toxicity was acceptable. This study demonstrates the effectiveness of surgery and adjuvant chemotherapy in yielding impressive long-term survival for T1 and T2N0M0 SCLC and provides evidence that the MTD can be used as a powerful and independent prognostic factor for stratification of patients in further trials.