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- Title
Tumor infiltrating lymphocytes as adjuvant treatment in stage III melanoma patients with only one invaded lymph node after complete resection: results from a multicentre, randomized clinical phase III trial.
- Authors
Khammari, Amir; Nguyen, Jean-Michel; Leccia, Marie-Thérèse; Guillot, Bernard; Saiagh, Soraya; Pandolfino, Marie-Christine; Knol, Anne-Chantal; Quéreux, Gaëlle; Chiffolettau, Anne; Labarrière, Nathalie; Dréno, Brigitte
- Abstract
Background: Adoptive tumor-infiltrating lymphocytes (TIL) therapy and interleukin-2 (IL-2) have been investigated in melanoma. Aim: To confirm previously observed preventive effects of TIL + IL2 in a subgroup of patients with relapsing metastatic stage III melanoma. Methodology: Open-label, randomized two-group, multicenter five-year trial in adult stage III melanoma patients with only one invaded lymph node after complete resection. Patients received TIL + IL2 or abstention. TIL + IL2 was administered within 8 weeks after lymph node resection and 4 weeks after. Disease-free survival was assessed every 2 months up to month 18, every 3 months up to month 36 and every 4 months up to 5 years. A once-a-year follow-up was scheduled beyond the five-year follow-up. Safety was assessed throughout the trial. Results: Overall, 49 patients accounted for the modified intent-to-treat and 47 for the PP. Slightly more male than female patients participated; mean age was 57.7 ± 11.4 years in the TIL + IL2 group and 53.5 ± 13.0 years in the abstention group. After 5 years of follow-up, 11/26 patients in the TIL + IL2 group and 13/23 in the abstention group had relapsed. There was no statistical difference between the groups (HR: 0.63 CI 95% [0.28–1.41], p = 0.258), nine patients in the TIL + IL2 and 11 in the abstention group died with no significant difference between the two groups (HR: 0.65 CI95% [0.27 − 1.59], p = 0.34). Safety was good. Conclusion: We did not confirm results of a previous trial. However, ulceration of the primary melanoma may be considered predictive of the efficacy of TIL in melanoma in adjuvant setting, in a manner similar to interferon α.
- Subjects
LYMPH nodes; LYMPHOCYTES; MELANOMA; PROGRESSION-free survival; INTERLEUKIN-2; WOMEN patients; COMPLETE dentures
- Publication
Cancer Immunology, Immunotherapy, 2020, Vol 69, Issue 8, p1663
- ISSN
0340-7004
- Publication type
Article
- DOI
10.1007/s00262-020-02572-1