Effects of cabozantinib on pain and narcotic use in patients with castration-resistant prostate cancer: Results from a phase 2 nonrandomized expansion cohort Journal Article
| Authors: | Basch, E.; Autio, K. A.; Smith, M. R.; Bennett, A. V.; Weitzman, A. L.; Scheffold, C.; Sweeney, C.; Rathkopf, D. E.; Smith, D. C.; George, D. J.; Higano, C. S.; Harzstark, A. L.; Sartor, A. O.; Gordon, M. S.; Vogelzang, N. J.; de Bono, J. S.; Haas, N. B.; Corn, P. G.; Schimmoller, F.; Scher, H. I. |
| Article Title: | Effects of cabozantinib on pain and narcotic use in patients with castration-resistant prostate cancer: Results from a phase 2 nonrandomized expansion cohort |
| Abstract: | Background Pain negatively affects quality of life for cancer patients. Preliminary data in metastatic castration-resistant prostate cancer (mCRPC) suggested a benefit of the oral tyrosine kinase inhibitor cabozantinib to pain palliation. Objective Prospective evaluation of cabozantinib's benefits on pain and narcotic use in mCRPC. Design, setting, and participants This was a nonrandomized expansion (NRE) cohort (n = 144) of a phase 2 randomized discontinuation trial in docetaxel-refractory mCRPC patients. Pain and interference of symptoms with sleep and general activity were electronically self-reported daily for 7-d intervals at baseline and regularly scheduled throughout the study. Mean per-patient scores were calculated for each interval. Narcotic use was recorded daily during the same intervals. Intervention Open-label cabozantinib (100 mg or 40 mg). Outcome measurements and statistical analysis The following stringent response definition was used: clinically meaningful pain reduction (≥30% improvement in mean scores from baseline) confirmed at a later interval without concomitant increases in narcotics. Only patients with moderate or severe baseline pain were analyzed. Results and limitations Sixty-five patients with moderate or severe baseline pain were evaluable. Of these, 27 (42%) experienced pain palliation according to the stringent response definition. Thirty-seven patients (57%) had clinically meaningful pain relief at two consecutive intervals, reported ≥6 wk apart in the majority. Forty-four patients (68%) had palliation at one or more intervals; 36 (55%) decreased narcotics use during one or more intervals. Clinically meaningful pain reduction was associated with significant (p ≤ 0.001) improvements in sleep quality and general activity. A limitation of this study was its open-label design. Conclusions Cabozantinib demonstrated clinically meaningful pain palliation, reduced or eliminated patients' narcotic use, and improved patient functioning, thus meriting prospective validation in phase 3 studies. Patient summary We evaluated the potential of cabozantinib to improve symptoms in patients with metastatic prostate cancer that no longer responds to standard therapies. We saw a promising reduction in pain and reduced need for narcotic painkillers. Larger, well-controlled trials are necessary to confirm these findings. |
| Keywords: | quality of life; patient-reported outcomes; tyrosine kinase inhibitor; pain control; mcrpc; phase 2 trial |
| Journal Title: | European Urology |
| Volume: | 67 |
| Issue: | 2 |
| ISSN: | 0302-2838 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2015-02-01 |
| Start Page: | 310 |
| End Page: | 318 |
| Language: | English |
| DOI: | 10.1016/j.eururo.2014.02.013 |
| PROVIDER: | scopus |
| PUBMED: | 24631409 |
| DOI/URL: | |
| Notes: | Export Date: 2 February 2015 -- Source: Scopus |
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