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.
Keywords
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Article info
Publication history
Published online: May 10, 2017
Accepted:
May 3,
2017
Received in revised form:
April 17,
2017
Received:
March 18,
2017
Footnotes
G.S. and G.R.P. contributed equally to this work as first authors.
Presented in part at the American Society of Clinical Oncology annual conference, June 2016, Chicago, IL.
Identification
Copyright
© 2017 Elsevier Inc. All rights reserved.
