Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421

Guru Sonpavde, Gregory R. Pond, Melissa Plets, Catherine M. Tangen, Maha H.A. Hussain, Primo N. Lara, Amir Goldkorn, Mark G. Garzotto, Philip C. Mack, Celestia S. Higano, Nicholas J. Vogelzang, Ian M. Thompson, Przemyslaw W. Twardowski, Peter J. Van Veldhuizen, Neeraj Agarwal, Michael A. Carducci, J. Paul Monk, David I. Quinn

Research output: Contribution to journalArticle

2 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
JournalClinical Genitourinary Cancer
DOIs
StateAccepted/In press - Mar 18 2017

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bis(2,3,3,3-tetrachloropropyl) ether
Castration
Prostatic Neoplasms
docetaxel
Survival
Prostate-Specific Antigen
Confidence Intervals
Response Evaluation Criteria in Solid Tumors
Bone and Bones
Prednisone

Keywords

  • Castration-resistant
  • Metastatic
  • Prostate
  • RECIST 1.0
  • Response
  • Survival

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421. / Sonpavde, Guru; Pond, Gregory R.; Plets, Melissa; Tangen, Catherine M.; Hussain, Maha H.A.; Lara, Primo N.; Goldkorn, Amir; Garzotto, Mark G.; Mack, Philip C.; Higano, Celestia S.; Vogelzang, Nicholas J.; Thompson, Ian M.; Twardowski, Przemyslaw W.; Van Veldhuizen, Peter J.; Agarwal, Neeraj; Carducci, Michael A.; Monk, J. Paul; Quinn, David I.

In: Clinical Genitourinary Cancer, 18.03.2017.

Research output: Contribution to journalArticle

Sonpavde, G, Pond, GR, Plets, M, Tangen, CM, Hussain, MHA, Lara, PN, Goldkorn, A, Garzotto, MG, Mack, PC, Higano, CS, Vogelzang, NJ, Thompson, IM, Twardowski, PW, Van Veldhuizen, PJ, Agarwal, N, Carducci, MA, Monk, JP & Quinn, DI 2017, 'Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421', Clinical Genitourinary Cancer. https://doi.org/10.1016/j.clgc.2017.05.014
Sonpavde, Guru ; Pond, Gregory R. ; Plets, Melissa ; Tangen, Catherine M. ; Hussain, Maha H.A. ; Lara, Primo N. ; Goldkorn, Amir ; Garzotto, Mark G. ; Mack, Philip C. ; Higano, Celestia S. ; Vogelzang, Nicholas J. ; Thompson, Ian M. ; Twardowski, Przemyslaw W. ; Van Veldhuizen, Peter J. ; Agarwal, Neeraj ; Carducci, Michael A. ; Monk, J. Paul ; Quinn, David I. / Validation of the Association of RECIST Changes With Survival in Men With Metastatic Castration-Resistant Prostate Cancer Treated on SWOG Study S0421. In: Clinical Genitourinary Cancer. 2017.
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abstract = "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.",
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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.

PY - 2017/3/18

Y1 - 2017/3/18

N2 - 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 - 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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