Induction chemotherapy before surgery for early-stage lung cancer: A novelapproach

Objective: This phase II. trial assessed the feasibility, as measured by re sponse rate, toxicity, resectability rate, and surgical morbidity and morta lity rates, of perioperative paclitaxel and carboplatin chemotherapy in pat ients with early-stage non-small cell lung carcinoma. Methods: till patient s required negative mediastinoscopy results and adequate medical parameters to undergo induction chemotherapy and an operation. Superior sulcus patien ts were excluded. Chemotherapy consisted of paclitaxel 225 mg/m(2) over 3 h ours and carboplatin (area under the curve = 6) every 21 days for 2 cycles preoperatively. Three postoperative cycles of chemotherapy were planned for patients undergoing complete resection. Results: Between June 1996 and Jul y 1998, 94 patients were entered into the study. Sixty-five (69%) were men, and the median age was 64 years (range, 34-79 gears),After induction chemo therapy, 53 of 94 (56%; 95% confidence interval, 46%-67%) had a major objec tive response, 88 (94%) underwent surgical exploration, and 81 (86%; 95% co nfidence interval, 78%-92%) underwent complete resection, Reasons for not u ndergoing an operation included disease progression (n = 3), clinically unr esectable status (n = 1), death (n = 1), and patient lost to follow-up (n = 1), Two postoperative deaths occurred. Six (6%; 95% confidence interval, 0 %-13%) pathologic complete responses were observed. Ninety (96%) patients r eceived the planned preoperative chemotherapy versus 45% receiving postoper ative chemotherapy, No unexpected chemotherapy or surgical morbidity occurr ed. The 1-year survival is currently estimated at 85%, and the median survi val has not yet been reached. Conclusions: Induction chemotherapy with pacl itaxel and carboplatin is feasible and produces a high response rate with a cceptable morbidity and mortality rates in early-stage non-small cell lung carcinoma. A prospective randomized trial comparing 3 cycles of induction c hemotherapy and surgery with surgery alone in early-stage non-small cell lu ng carcinoma is planned.