A RANDOMIZED TRIAL OF ADOPTIVE IMMUNOTHERAPY WITH TUMOR-INFILTRATING LYMPHOCYTES AND INTERLEUKIN-2 VERSUS STANDARD THERAPY IN THE POSTOPERATIVE TREATMENT OF RESECTED NONSMALL CELL LUNG-CARCINOMA

BAGKGROUND. A previous pilot study from our group suggested that: (1) adoptive immunotherapy (Al) with tumor-infiltrating lymphocytes (TIL) and recombinant interleukin-2 (rIL-2) may be applied with safety to mo re than 80% of the patients who had surgery for Stage TIT nonsmall cel l lung carcinoma (NSCLC); and (2) AI could be useful in patients with locally advanced disease. The present randomized study was planned to assess the efficacy of AI in the postoperative treatment of Stage II, IIIa, or mb NSCLC. METHODS. TIL were expanded in vitro from tissue sam ples obtained from the surgically removed specimens of 131 patients. E ighteen cultures yielded no growth of TIL. The remaining 113 patients were stratified according to disease stage and randomized to receive A l or standard chemoradiotherapy. TIL were infused intravenously 6 to 8 weeks after surgery. rIL-2 was administered subcutaneously at escalat ing doses for 2 weeks, and then at reduced doses for 2 weeks and then for 2 to 3 months. RESULTS. Three-year survival was significantly bett er (P < 0.05) for patients who underwent AI than for controls. Al was of no benefit to patients with Stage II NSCLC, potentially useful to p atients with Stage IIIa NSCLC (P = 0.06), and significantly advantageo us to patients with Stage mb (T4) NSCLC (P < 0.01). For patients with Stage III NSCLC, local relapse (but not distant relapse) was significa ntly reduced following Al (P < 0.05). CONCLUSIONS. AI should be consid ered when designing future adjuvant therapy protocols for the treatmen t of NSCLC. (C) 1996 American Cancer Society.