TY - JOUR
T1 - Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421
AU - Sonpavde, Guru
AU - Pond, Gregory R.
AU - Plets, Melissa
AU - Tangen, Catherine M.
AU - Hussain, Maha H.A.
AU - Lara, Primo N.
AU - Goldkorn, Amir
AU - Garzotto, Mark G.
AU - Mack, Philip C.
AU - Higano, Celestia S.
AU - Vogelzang, Nicholas J.
AU - Thompson, Ian M.
AU - Twardowski, Przemyslaw W.
AU - Van Veldhuizen, Peter J.
AU - Agarwal, Neeraj
AU - Carducci, Michael A.
AU - Monk, J. Paul
AU - Quinn, David I.
N1 - Publisher Copyright:
© 2017 Elsevier Inc.
PY - 2017/12
Y1 - 2017/12
N2 - Micro-Abstract The association of Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 changes within 120 days with survival in men with metastatic castration-resistant prostate cancer receiving docetaxel was validated from a phase 3 trial. Given the limitations of prostate-specific antigen and bone scan alterations to translate to improved survival, improved RECIST changes in phase 2 trials may be important before launching phase 3 trials. Background Phase 2 trials evaluating new agents for metastatic castration-resistant prostate cancer (mCRPC) have relied on bone scan and prostate-specific antigen changes to assess activity. Given the increasing detection of measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) changes warrant consideration to evaluate activity. We validated the association of RECIST 1.0 changes with survival in men with mCRPC receiving docetaxel. Patients and Methods Data for men with measurable disease from the Southwest Oncology Group (SWOG) S0421, a phase 3 trial in men with mCRPC receiving docetaxel and prednisone plus placebo or atrasentan, were used. Cox proportional hazards regression was used to evaluate the association of RECIST 1.0 outcomes within 120 days, ie, unconfirmed partial response (uPR), stable disease, and progressive disease (PD), with overall survival (OS) from day 120, adjusted for prognostic factors. Results Overall, 326 men were evaluable for landmark analysis, of whom 23 had PD, 230 stable disease, and 73 uPR. OS beyond day 120 was significantly different (P =.004) among these subgroups, with median (95% confidence interval) OS of 7.1 (3.5-8.8), 13.4 (11.4-15.6), and 16.3 (10.0-19.6) months for those with PD, stable disease, and uPR, respectively. In a multivariable model, the hazard ratio (95% confidence interval) for patients with PD was 2.47 (1.42-4.29) compared to patients with an uPR (P =.002). Conclusion The association of RECIST 1.0 changes with OS in men with mCRPC receiving docetaxel was validated. Given limitations of bone scan and prostate-specific antigen alterations, improvements in objective RECIST 1.0 changes should be reported in phase 2 trials before launching phase 3 trials.
AB - Micro-Abstract The association of Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 changes within 120 days with survival in men with metastatic castration-resistant prostate cancer receiving docetaxel was validated from a phase 3 trial. Given the limitations of prostate-specific antigen and bone scan alterations to translate to improved survival, improved RECIST changes in phase 2 trials may be important before launching phase 3 trials. Background Phase 2 trials evaluating new agents for metastatic castration-resistant prostate cancer (mCRPC) have relied on bone scan and prostate-specific antigen changes to assess activity. Given the increasing detection of measurable disease, Response Evaluation Criteria in Solid Tumors (RECIST) changes warrant consideration to evaluate activity. We validated the association of RECIST 1.0 changes with survival in men with mCRPC receiving docetaxel. Patients and Methods Data for men with measurable disease from the Southwest Oncology Group (SWOG) S0421, a phase 3 trial in men with mCRPC receiving docetaxel and prednisone plus placebo or atrasentan, were used. Cox proportional hazards regression was used to evaluate the association of RECIST 1.0 outcomes within 120 days, ie, unconfirmed partial response (uPR), stable disease, and progressive disease (PD), with overall survival (OS) from day 120, adjusted for prognostic factors. Results Overall, 326 men were evaluable for landmark analysis, of whom 23 had PD, 230 stable disease, and 73 uPR. OS beyond day 120 was significantly different (P =.004) among these subgroups, with median (95% confidence interval) OS of 7.1 (3.5-8.8), 13.4 (11.4-15.6), and 16.3 (10.0-19.6) months for those with PD, stable disease, and uPR, respectively. In a multivariable model, the hazard ratio (95% confidence interval) for patients with PD was 2.47 (1.42-4.29) compared to patients with an uPR (P =.002). Conclusion The association of RECIST 1.0 changes with OS in men with mCRPC receiving docetaxel was validated. Given limitations of bone scan and prostate-specific antigen alterations, improvements in objective RECIST 1.0 changes should be reported in phase 2 trials before launching phase 3 trials.
KW - Castration-resistant
KW - Metastatic
KW - Prostate
KW - RECIST 1.0
KW - Response
KW - Survival
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UR - http://www.scopus.com/inward/citedby.url?scp=85020079558&partnerID=8YFLogxK
U2 - 10.1016/j.clgc.2017.05.014
DO - 10.1016/j.clgc.2017.05.014
M3 - Article
C2 - 28579151
AN - SCOPUS:85020079558
SN - 1558-7673
VL - 15
SP - 635
EP - 641
JO - Clinical Genitourinary Cancer
JF - Clinical Genitourinary Cancer
IS - 6
ER -