Abstract 2243
Background
Early analyses revealed significant increase in overall survival (OS) for patients with a higher burden of disease with early docetaxel (D) plus androgen deprivation therapy (ADT) over ADT alone. Patients with low volume disease have a more favorable natural history with ADT alone and the benefit of early D for this distinct subset requires longer follow-up
Methods
790 men were accrued from 7/28/06 to 11/21/2012 and randomized to ADT alone or ADT + D at 75mg/m2 every 3 weeks for 6 cycles within 4 mos of ADT. Patients were prospectively stratified into high volume (HV) vs. low volume (LV) disease (HV: visceral metastases and/or 4 or more bone metastases with at least one outside of the vertebral column and pelvis).
Results
As of April 23, 2016, the median follow-up was 53.7 months and there were 299 deaths of 513 HV pts and 100 deaths of the 277 LV pts. The overall median OS was 57.6 mos for ADT + D [95% CI: (52.0, 63.9)] and 47.2 (41.8, 52.8) for ADT alone HR: 0.73 (0.59, 0.89), p = 0.0018 (stratified log rank). Deaths and distribution of OS by arm and volume of disease are in Table 1. The evaluation of outcome by disease volume interaction with treatments revealed a p-value of 0.029 indicating the impact of early docetaxel differed between the HV and LV pts. The burden of cancer and therapy was assessed by FACT-P score and notable findings were (i) HV pts had lower baseline QOL than LV pts, (ii) there was a decline in QOL from baseline to 3 months in ADT + D LV ps and (iii) the lowest FACT-P score at 12 months was in ADT alone HV pts (see Table).
| Survival | ADT + D | ADT | p-value | HR (95%CI*) |
|---|---|---|---|---|
| LV Deaths / N (%) | 51/134 (38.1%) | 49/143 (34.3%) | ||
| LV Median OS mos* | 63.5 (58.3, 78.5) | NR (59.8, - ) | 0.86 | 1.04 (0.70, 1.55) |
| HV Deaths/ N (%) | 137/263 (52.1%) | 162/250 (64.8%) | ||
| HV Median OS mos* | 51.2 (45.2, 58.1) | 34.4 (30.1, 42.1) | ConclusionsThe clinical benefit of ADT + D is limited to pts with a higher burden of metastatic prostate. Partial Support and drug supply by Sanofi. Clinical trial identificationNCT00309985 Legal entity responsible for the studyNCI FundingNCI DisclosureC. Sweeney: Grant support from the NCI, personal fees from Sanofi, Janssen, Astellas, Bayer, and Genentech. G. Liu: Dr. Liu reports grant support from the University of Wisconsin Carbone Cancer Center during the conduct of the study. M. Carducci: Dr. Carducci reports personal fees from Sanofi, Amgen, Astellas, and Medivation outside the submitted work. M. Eisenberger: Dr. Eisenberger reports personal fees from Sanofi outside the submitted work. Y-N. Wong: Dr. Wong reports other support from Sanofi during the conduct of the study; grant support from Pfizer, Medivation, Millennium, and other support from eviti outside the submitted work. N. Hahn: Grant support from Sanofi-Aventis and from Dendreon, grant support and personal fees from OncoGeneX, grant and non-financial support from Millennium, and personal fees from Medivation and Sanofi-Aventis outside the submitted work. R. Dreicer: Dr. Dreicer reports personal fees from Millennium, Medivation, Astellas, Bind Pharmaceuticals, Genentech, Roche, and Dendreon outside the submitted work. J. Picus: Dr. Picus reports grant support from the National Cancer Institute during the conduct of the study. M. Hussain: Dr. Hussain reports grant support from the SWOG during the conduct of the study J. Garcia: Dr. Garcia reports grant support and personal fees from Astellas and Bayer, and personal fees from Sanofi outside the submitted work. R. Dipaola: Dr. DiPaola reports other support from Sanofi-Aventis during the conduct of the study All other authors have declared no conflicts of interest. Resources from the same session3202 - PTEN loss as a predictive biomarker for the Akt inhibitor ipatasertib combined with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC)Presenter: Johann de Bono Session: Genitourinary tumours, prostate Resources: Abstract Slides Invited discussant abstracts 717O and 718OPresenter: Felix Feng Session: Genitourinary tumours, prostate Resources: Slides Invited discussant abstracts LBA29 and 719OPresenter: Winald Gerritsen Session: Genitourinary tumours, prostate Resources: Slides 2636 - Metastasis free survival (MFS) is a surrogate for overall survival (OS) in localized prostate cancer (CaP)Presenter: Wanling Xie Session: Genitourinary tumours, prostate Resources: Abstract 1863 - A phase 2 study of the aurora kinase A inhibitor alisertib for patients with neuroendocrine prostate cancer (NEPC)Presenter: Himisha Beltran Session: Genitourinary tumours, prostate Resources: Abstract Slides 1905 - First evidence of significant clinical activity of PD-1 inhibitors in metastatic, castration resistant prostate cancer (mCRPC)Presenter: Julie Graff Session: Genitourinary tumours, prostate Resources: Abstract 3045 - FIRSTANA: Health-related quality of life (HRQL) and post-hoc analyses for the phase III study assessing cabazitaxel (C) vs docetaxel (D) in chemotherapy-naïve patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)Presenter: Stephane Oudard Session: Genitourinary tumours, prostate Resources: Abstract 2907 - PROSELICA: Health-related quality of life (HRQL) and post-hoc analyses for the phase 3 study assessing cabazitaxel 20 (C20) vs 25 (C25) mg/m2 post-docetaxel (D) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)Presenter: Johann de Bono Session: Genitourinary tumours, prostate Resources: Abstract 2161 - Modelling relapse in patients with high-risk localised prostate cancer treated randomly in the GETUG 12 phase III trial reveals two populations of relapsing patientsPresenter: Cécile Vicier Session: Genitourinary tumours, prostate Resources: Abstract 1354 - Risk of prostate cancer mortality in men with an initial benign needle core biopsy set: a population based analysis with up to 20 years of follow-upPresenter: Nina Klemann Session: Genitourinary tumours, prostate Resources: Abstract This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used. For more detailed information on the cookies we use, please check our Privacy Policy.
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