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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2018-01-29

AUTHORS

Vadim S. Koshkin, Pedro C. Barata, Tian Zhang, Daniel J. George, Michael B. Atkins, William J. Kelly, Nicholas J. Vogelzang, Sumanta K. Pal, JoAnn Hsu, Leonard J. Appleman, Moshe C. Ornstein, Timothy Gilligan, Petros Grivas, Jorge A. Garcia, Brian I. Rini

ABSTRACT

BackgroundNivolumab 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.MethodsPatients 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.ResultsForty-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.ConclusionsNivolumab 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. More... »

PAGES

9

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s40425-018-0319-9

DOI

http://dx.doi.org/10.1186/s40425-018-0319-9

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1100689551

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/29378660


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19 schema:description BackgroundNivolumab 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.MethodsPatients 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.ResultsForty-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.ConclusionsNivolumab 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.
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25 schema:keywords BackgroundNivolumab
26 ECOG PS 0
27 MTSCC
28 MethodsPatients
29 OS
30 PFS
31 PR
32 PS 0
33 RCC subtypes
34 RECIST v1.1
35 ResultsForty-one patients
36 SD
37 United States
38 Xp11 translocation
39 absence
40 activity
41 adverse events
42 age
43 analysis
44 antiangiogenic therapy
45 carcinoma
46 cell carcinoma
47 cell renal cell carcinoma
48 center
49 characteristics
50 chromophobe
51 clinical activity
52 cohort
53 data
54 death
55 disease progression
56 dose
57 dose of nivolumab
58 duct
59 duration
60 entire cohort
61 events
62 fatigue
63 fever
64 good response
65 grade
66 heterogeneous population
67 histology
68 intolerance
69 majority
70 median OS
71 median PFS
72 median age
73 median duration
74 median time
75 median treatment duration
76 metastatic non-clear cell renal cell carcinoma
77 metastatic renal cell carcinoma
78 monotherapy
79 months
80 nivolumab
81 nivolumab treatment
82 non-clear cell metastatic renal cell carcinoma
83 non-clear cell renal cell carcinoma
84 objective response
85 objective response rate
86 patient characteristics
87 patients
88 population
89 prior antiangiogenic therapy
90 progression
91 rate
92 renal cell carcinoma
93 responders
94 response
95 response rate
96 retrospective analysis
97 state
98 study
99 subtypes
100 therapy
101 time
102 translocation
103 treatment
104 treatment duration
105 treatment-related adverse events
106 treatment-related deaths
107 trials
108 use
109 use of nivolumab
110 v1.1
111 years
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