In:
Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 4667-4667
Abstract:
4667 Background: Small retrospective reviews have suggested the possibility of a decreased benefit of docetaxel in mCRPC patients (pts) previously treated with abiraterone acetate, a novel androgen synthesis inhibitor (ASI). CALGB 90401 was an intergroup (CALGB, ECOG) randomized phase 3 trial in which 1050 mCRPC pts were treated with docetaxel, which offered the opportunity to evaluate the effect of prior treatment with keto, an earlier generation ASI, on clinical outcomes following docetaxel treatment in mCRPC pts. Methods: Data from 1,050 men randomized on CALGB 90401 to treatment with docetaxel and prednisone with either bevacizumab or placebo were used. Pts were chemotherapy naïve, had evidence of progressive mCRPC, an ECOG performance status ≤ 2, and adequate bone marrow, hepatic and renal function. Randomization was stratified by age, prior history of a thromboembolic event, and 24-month predicted survival using the CALGB nomogram. The effect of prior keto use on overall survival (OS), progression-free survival (PFS), PSA decline, and objective response rate (RR) was estimated using proportional hazards and logistic regression models. Results: 277/1050 pts (26%) had received prior keto. Baseline characteristics including the 3 stratification factors, race, performance status, measurable disease, and baseline alkaline phosphatase and Hgb were balanced between prior keto treated pts and keto untreated pts. LDH and PSA were higher in the keto treated patients (211 vs. 201, p = 0.01; and 121 vs. 73, p 〈 .0001; respectively.) There were no statistically significant differences in keto vs. non-keto treated patients with regards to OS (21.1 vs. 22.3 m, p = 0.643); PFS (8.1 vs. 8.6m p = 0.394 ); 〉 50% decline in PSA (61% vs. 66% p=.112); or objective response (39% vs. 43% p = 0.34). Conclusions: As measured by OS, PFS, PSA and RR, prior treatment with the ASI ketoconazole has no impact on the subsequent clinical impact of docetaxel in mCRPC pts.
Type of Medium:
Online Resource
ISSN:
0732-183X
,
1527-7755
DOI:
10.1200/jco.2012.30.15_suppl.4667
Language:
English
Publisher:
American Society of Clinical Oncology (ASCO)
Publication Date:
2012
detail.hit.zdb_id:
2005181-5
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