Adjuvant chemotherapy for stage IB non-small cell lung cancer

Objective. At present time surgical resection is still considered the most adequate treatment for stage IB non-small-cell lung cancer. Nevertheless the long-term survival is not satisfactory and the recurrence rate is quite high. A randomised trial has been carried out in order to verify, in terms of disease free and overall survival, the validity of postoperative chemotherapy in patients affected with lung cancer staged as IB. Methods. This is a prospective, phase III, randomised clinical trial postoperative adjuvant chemotherapy versus surgery alone as control group The main eligibility criteria is stage IB disease (pT2N0) assessed after a radical surgical procedure. Chemotherapy consisting of cisplatin (100mg/m2 d.1) and etoposide (120mg/m2 d.l,2,3) has been administrated every 21 days for a total of 6 cycles. Results. Between January 1988 and December 1994, 66 patients entered into the study: 33 of them belonged to the adjuvant chemotherapy group and 33 to the control group. Conventional risk factors were homogeneous to both groups. No clinical significant morbidity associated to chemotherapy was found. Minimum follow-up period has been 5 years. Loco-regional recurrence and distant metastases rates were 18% (6733) and 30% (10/33) in the adjuvant chemotherapy group and 24% (9/33) and 43% (14/33) in the control group. The 5-year disease free survival rates were 59% in the adjuvant group and 30% in the control group (p<0 02) The Kaplan-Meier survival difference between the groups showed significance at log-rank test (p<0 04). The 5-year survival rates were 63% in the adjuvant group and 45% in the control, respectively. The difference of the Kaplan-Meyer survival between the groups was significant at log-rank test (p<0.04). No other prognostic factor resulted to be significant. At Cox's model the absence of chemotherapy resulted a significant negative prognosticator (p