Survival outcomes and risk group validation from SWOG S0925: a randomized phase II study of cixutumumab in new metastatic hormone-sensitive ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2020-02-13

AUTHORS

Risa L. Wong, Mai T. Duong, Catherine M. Tangen, Neeraj Agarwal, Heather H. Cheng, Nicholas J. Vogelzang, Maha Hussain, Ian M. Thompson, David I. Quinn, Evan Y. Yu

ABSTRACT

BackgroundCixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints.MethodsWe randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan–Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk.ResultsNo difference was seen between treatment arms in overall survival (HR 1.01 [0.70–1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85–1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75–1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29–2.80]; p = 0.001) and high-volume (HR 2.75 [1.84–4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99–6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24–11.9]; p < 0.0001).ConclusionsIn new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival. More... »

PAGES

486-493

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41391-020-0210-x

DOI

http://dx.doi.org/10.1038/s41391-020-0210-x

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1124843808

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/32055002


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23 schema:description BackgroundCixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints.MethodsWe randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan–Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk.ResultsNo difference was seen between treatment arms in overall survival (HR 1.01 [0.70–1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85–1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75–1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29–2.80]; p = 0.001) and high-volume (HR 2.75 [1.84–4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99–6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24–11.9]; p < 0.0001).ConclusionsIn new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival.
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29 schema:keywords Cox proportional hazards model
30 I receptor
31 II study
32 Kaplan-Meier curves
33 MethodsWe
34 PSA
35 ResultsNo differences
36 addition
37 analysis
38 androgen deprivation
39 antibodies
40 arm
41 baseline
42 baseline risk
43 best fit
44 cancer
45 castration resistance-free survival
46 categories
47 cixutumumab
48 classification
49 covariate-adjusted Cox proportional hazard models
50 curves
51 data
52 deprivation
53 differences
54 discordant classifications
55 disease
56 disease volume
57 endpoint
58 exploratory endpoints
59 features
60 fit
61 group
62 group validation
63 hazards model
64 high-risk features
65 high-volume disease
66 hormone-sensitive prostate cancer
67 inferior survival
68 information
69 insulin-like growth factor I receptor
70 intermediate endpoints
71 low category
72 metastatic hormone-sensitive prostate cancer
73 model
74 monoclonal antibodies
75 outcomes
76 overall survival
77 patients
78 phase II study
79 population
80 prognostic information
81 prognostic value
82 progression-free survival
83 proportional hazards model
84 prostate cancer
85 prostate-specific antigen rate
86 radiographic progression-free survival
87 randomized phase II study
88 rate
89 receptors
90 response
91 risk
92 risk groups
93 study
94 survival
95 survival analysis
96 survival data
97 survival outcomes
98 treatment arms
99 treatment response
100 trial population
101 trials
102 undetectable PSA
103 validation
104 values
105 volume
106 weeks
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