PEAX: Men with metastatic castrate-resistant prostate cancer (mCRPC) treated with either sipuleucel-T (SIP-T), enzalutamide (ENZA) or abiraterone acetate (ABI) undergoing cardiopulmonary exercise testing (CPET).
Harrison, MR; Khouri, M; Armstrong, AJ; Zhang, T; McNamara, MA; Anand, M; Bratt, E; Hood, H; Coyne, B; Wu, Y; Healy, P; George, DJ
Published in: Journal of Clinical Oncology
281 Background: Both ENZA and ABI are associated with significant toxicity to the cardiovascular-musculoskeletal system and physical side effects. However whether they cause a decline in cardiorespiratory fitness (CRF), as conventional ADT does, has not been studied. We hypothesized that men treated with ENZA or ABI would have a significant decline in CRF, whereas those treated with SIP-T would not. Methods: Men starting standard of care (SOC) ENZA or ABI for asymptomatic or minimally symptomatic mCRPC were treated per institutional standards. SIP-T (SOC) is the control arm. Primary endpoint is change in VOpeak from baseline to week 21 by CPET. Secondary endpoints include measurement of functional status by patient reported outcomes (FACT-P, FACIT-Fatigue) and physician reported outcomes (ECOG PS, AEs). Results: In this single-site, prospective, parallel group, observational study, 28 pts completed the baseline and week 21 CPET and secondary assessments. Median age was 68 years; 86% were white. Two-thirds of pts had ECOG PS 0; the rest had PS 1. 93% were nonsmokers. Intention to treat analyses for mean 21-week change from baseline with a 95% confidence interval (CI) for each assessment by arm are presented in the Table. Conclusions: Unexpectedly, there was great heterogeneity in 21-week ΔVOpeak within each therapy group. Reasons for heterogeneity will be explored and correlated with baseline variables, clinical status, and questionnaire data. A low percentage of patients exercised regularly. Larger trials of exercise training interventions in this setting are warranted. Clinical trial information: NCT02353715. [Table: see text]
