期刊
CANCER IMMUNOLOGY IMMUNOTHERAPY
卷 67, 期 10, 页码 1647-1658出版社
SPRINGER
DOI: 10.1007/s00262-018-2223-z
关键词
Immunotherapy; Immunocytokine; Melanoma; Anti-ganglioside antibody; Interleukin-2
资金
- NIH from the National Cancer Institute [R01 CA032685, R01 CA087025, R35 CA166105, P30 CA014520]
- William S. Middleton Memorial Veterans Hospital, Madison, WI
- Clinical and Translational Science Award (CTSA) program, through the NIH National Center for Advancing Translational Sciences (NCATS) [UL1TR000427]
- Midwest Athletes for Childhood Cancer Fund
- Crawdaddy Foundation
- Stand Up to Cancer Foundation
- St. Baldrick's Foundation
- Hyundai Hope on Wheels Program
- Ann's Hope Foundation
- Tim Eagle Memorial
- Jay Van Sloan Memorial from the Steve Leuthold Family
Phase I testing of the hu14.18-IL2 immunocytokine (IC) in melanoma patients showed immune activation, reversible toxicities, and a maximal tolerated dose of 7.5 mg/m(2)/day. Preclinical data in IC-treated tumor-bearing mice with low tumor burden documented striking antitumor effects. Patients with completely resectable recurrent stage III or stage IV melanoma were scheduled to receive 3 courses of IC at 6 mg/m(2)/day i.v. on days 1, 2 and 3 of each 28-day course. Patients were randomized to complete surgical resection either following neoadjuvant (Group A) or prior to adjuvant (Group B) IC course 1. Primary objectives were to: (1) evaluate histological evidence of anti-tumor activity and (2) evaluate recurrence-free survival (RFS) and OS. Twenty melanoma patients were randomized to Group A (11 patients) or B (9 patients). Two Group B patients did not receive IC due to persistent disease following surgery. Six of 18 IC-treated patients remained free of recurrence, with a median RFS of 5.7 months (95% confidence interval (CI) 1.8-not reached). The 24-month RFS rate was 38.9% (95% CI 17.5-60.0%). The median follow-up of surviving patients was 50.0 months (range: 31.8-70.4). The 24-month OS rate was 65.0% (95% CI 40.3-81.5%). Toxicities were similar to those previously reported. Exploratory tumor-infiltrating lymphocyte (TIL) analyses suggest prognostic value of TILs from Group A patients. Prolonged tumor-free survival was seen in some melanoma patients at high risk for recurrence who were treated with IC.
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