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Phase 2 study of neoadjuvant docetaxel plus bevacizumab in patients with high‐risk localized prostate cancer
Author(s) -
Ross Robert W.,
Galsky Matthew D.,
Febbo Phil,
Barry Marc,
Richie Jerome P.,
Xie Wanling,
Fennessy Fiona M.,
Bhatt Rupal S.,
Hayes Julia,
Choueiri Toni K.,
Tempany Clare M.,
Kantoff Philip W.,
Taplin Mary E.,
Oh William K.
Publication year - 2012
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.27416
Subject(s) - medicine , docetaxel , prostate cancer , bevacizumab , prostatectomy , urology , prostate specific antigen , clinical endpoint , febrile neutropenia , biopsy , phases of clinical research , progressive disease , cancer , neutropenia , chemotherapy , clinical trial
BACKGROUND: Treatment of high‐risk localized prostate cancer remains inadequate. The authors performed a phase 2 multicenter trial of neoadjuvant docetaxel plus bevacizumab before radical prostatectomy. METHODS: Eligibility included any of the following: prostate‐specific antigen (PSA) >20 ng/mL or PSA velocity >2 ng/mL/y, cT3 disease, any biopsy Gleason score 8 to 10, and Gleason score 7 with T3 disease by endorectal magnetic resonance imaging (MRI) at 1.5 T. Also, those with ≥50% biopsy cores involved and either Gleason score 7, PSA >10, or cT2 disease were eligible. Patients were treated with docetaxel 70 mg/m 2 every 3 weeks for 6 cycles and bevacizumab 15 mg/m 2 every 3 weeks for 5 cycles. The primary endpoint was partial response by endorectal MRI. RESULTS: Forty‐one patients were treated. Median age was 55 years (range, 40‐66 years). Baseline characteristics included: median PSA, 10.1 ng/mL; cT2, 49%, cT3, 32%; and Gleason score 8 to 10, 73%. Thirty‐eight of 41 (93%) patients completed all 6 cycles. Grade ≥3 adverse events were rare, although 3 of 41 (7%) experienced febrile neutropenia. Twelve patients (29%; 95% confidence interval [CI], 16%‐45%) achieved a >50% reduction in tumor volume, and 9 patients (22%; 95% CI, 11%‐38%) achieved a >50% post‐treatment decline in PSA. Thirty‐seven of the 41 patients underwent radical prostatectomy; there were no complete pathologic responses. CONCLUSIONS: Neoadjuvant docetaxel and bevacizumab is safe, and results in reductions in both tumor volume and serum PSA, in men with high‐risk localized prostate cancer. The role of neoadjuvant chemotherapy in prostate cancer, and perioperative antiangiogenic therapy in general, requires further elucidation through ongoing and planned trials. Cancer 2012. © 2012 American Cancer Society.