Clinical activity of nivolumab in patients with non-clear cell renal cell carcinoma

Journal for ImmunoTherapy of Cancer

Jorge A. Garcia¹  Moshe C. Ornstein¹  Timothy Gilligan¹  Brian I. Rini¹  Vadim S. Koshkin¹  Pedro C. Barata¹  Sumanta K. Pal²  JoAnn Hsu²  Daniel J. George³  Tian Zhang³  Leonard J. Appleman⁴  Petros Grivas⁵  Michael B. Atkins⁶  William J. Kelly⁶  Nicholas J. Vogelzang⁷ 

[1] Department of Hematology & Medical Oncology, Taussig Cancer Institute, Cleveland Clinic;Department of Medical Oncology & Therapeutics Research, City of Hope Comprehensive Cancer Center;Department of Medicine, Division of Medical Oncology, Duke University Medical Center;Division of Hematology/Oncology, University of Pittsburgh;Fred Hutchinson Cancer Research Center, University of Washington;Georgetown Lombardi Comprehensive Cancer Center;US Oncology Research/Comprehensive Cancer Centers of Nevada;

关键词: Non-clear cell renal cell carcinoma;    mRCC;    Nivolumab;    Immunotherapy;    PD1/PDL1 pathway;    Checkpoint inhibitor;   

DOI  :  10.1186/s40425-018-0319-9

来源: DOAJ

【 摘 要 】

Abstract Background Nivolumab is approved for patients with metastatic renal cell carcinoma (mRCC) refractory to prior antiangiogenic therapy. The clinical activity of nivolumab in patients with non-clear cell RCC subtypes remains unknown as these patients were excluded from the original nivolumab trials. Methods Patients from 6 centers in the United States who received at least one dose of nivolumab for non-clear cell mRCC between 12/2015 and 06/2017 were identified. A retrospective analysis including patient characteristics, objective response rate according to RECIST v1.1 and treatment-related adverse events (TRAEs) was undertaken. Results Forty-one patients were identified. Median age was 58 years (33–82), 71% were male, and majority had ECOG PS 0 (40%) or 1 (47%). Histology included 16 papillary, 14 unclassified, 5 chromophobe, 4 collecting duct, 1 Xp11 translocation and 1 MTSCC (mucinous tubular and spindle cell carcinoma). Among 35 patients who were evaluable for best response, 7 (20%) had PR and 10 (29%) had SD. Responses were observed in unclassified, papillary and collecting duct subtypes. In the entire cohort, median follow-up was 8.5 months and median treatment duration was 3.0 months. Median PFS was 3.5 months and median OS was not reached. Among responders, median time to best response was 5.1 months, and median duration of response was not reached as only 2 out of 7 responders had disease progression during follow-up. TRAEs of any grade were noted in 37% and most commonly included fatigue (12%), fever (10%) and rash (10%). Nivolumab treatments were postponed in 34% and discontinued in 15% of patients due to intolerance. No treatment-related deaths were observed. Conclusions Nivolumab monotherapy demonstrated objective responses and was well tolerated in a heterogeneous population of patients with non-clear cell mRCC. In the absence of other data in this treatment setting, this study lends support to the use of nivolumab for patients with metastatic non-clear cell renal cell carcinoma.

【 授权许可】

Unknown