Elsevier

European Urology

Volume 69, Issue 6, June 2016, Pages 980-983
European Urology

Brief Correspondence
Association Between RECIST Changes and Survival in Patients with Metastatic Castration-resistant Prostate Cancer Receiving Docetaxel

https://doi.org/10.1016/j.eururo.2015.10.008Get rights and content

Abstract

We explored the association between Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and 1.1 changes and overall survival (OS) in patients with metastatic castration-resistant prostate cancer (mCRPC) from the control arms of the VENICE and MAINSAIL phase 3 trials, respectively, receiving docetaxel, prednisone, and placebo. We used Cox proportional hazards regression to evaluate the OS prognostic ability of RECIST changes after adjusting for prognostic factors. In the VENICE trial, the OS hazard ratio (HR) was 0.64 (95% confidence interval [CI] 0.42–0.99; p = 0.045) for patients with a partial response (PR) compared to those without PR, and 1.78 (95% CI 1.07–2.95; p = 0.026) for those with progressive disease (PD) compared to those without PD. After adjusting for prostate-specific antigen (PSA) changes, PD remained significant (HR 1.85, 95% CI 1.10–3.12; p = 0.020). Data from the MAINSAIL trial corroborated the association of PR (HR 0.51, 95% CI 0.22–1.18; p = 0.12) and PD (HR 3.51, 95% CI 1.92–6.43; p < 0.001) with OS. After adjusting for PSA changes, PD was associated with poor OS (HR 2.36, 95% CI 1.11–5.04; p = 0.026). Given the association between RECIST changes and OS, more frequent detection of measurable disease with current imaging techniques, and the poor reliability of bone scan and PSA changes, assessment of RECIST changes on treatment with novel agents in patients with measurable tumors may provide an objective signal of efficacy.

Patient summary

In this study, we found an association between changes in objectively measurable tumors according to Response Evaluation Criteria in Solid Tumors (RECIST) and survival in patients with metastatic prostate cancer receiving docetaxel chemotherapy. Since bone scan and prostate-specific antigen changes are unreliable and measurable tumors are more frequently detected now because of better radiographic technology, a focus on RECIST changes should be considered during drug development to provide an objective signal of efficacy.

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    Objective changes by RECIST may warrant serious consideration even in mCRPC because body imaging with computed tomography (CT) or magnetic resonance imaging (MRI) is required more frequently and hence is detecting measurable tumors in mCRPC.9 Recent studies have discovered the association of measurable disease changes by World Health Organization criteria and RECIST 1.0 and 1.1 changes with overall survival (OS) in men with mCRPC receiving docetaxel-based chemotherapy.10,11 This study was undertaken to validate the association of RECIST 1.0 changes with OS in men with mCRPC receiving docetaxel-based chemotherapy in the Southwest Oncology Group (SWOG) S0421 trial.12

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    If our hypothesis is proven, measurable changes might need to be reconsidered as major end points in phase II trials of mCRPC seeking a signal of activity. Moreover, recent studies have shown the association of changes in measurable disease with survival in men receiving chemotherapy for mCRPC.5,6 To substantiate our hypothesis, we analyzed phase III trials of mCRPC to systematically quantitate the proportion of mCRPC with measurable disease.

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    In a review of a cohort of patients who received AR axis targeted drugs for CRPC at two major French cancer centers, the previous duration of response to ADT was found to be a predictor of sensitivity to next generation AR axis targeted drugs in patients with metastatic CRPC (Loriot et al., 2015). The association between Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 and 1.1 changes and OS in patients with metastatic CRPC from the control arms of the VENICE and MAINSAIL phase 3 trials, respectively, receiving docetaxel, prednisone, and placebo was examined (Sonpavde et al., 2016b). Based on the finding of an association between changes in objectively measurable tumors according to RECIST and survival, a focus on RECIST changes should be considered during drug development to provide an objective signal of efficacy.

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These authors contributed equally to this work.

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