scholarly journals Mortality in men with castration‐resistant prostate cancer—A long‐term follow‐up of a population‐based real‐world cohort

BJUI Compass ◽  
2021 ◽  
Author(s):  
Yashar Khoshkar ◽  
Marcus Westerberg ◽  
Jan Adolfsson ◽  
Anna Bill‐Axelson ◽  
Henrik Olsson ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Population Based ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Long Term Follow Up

Long-term follow-up from STAMP, a phase II trial, evaluating sipuleucel-T and concurrent (CON) vs sequential (SEQ) abiraterone acetate + prednisone in metastatic castration-resistant prostate cancer patients (pts).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 190-190 ◽  
Author(s):  
Eric Jay Small ◽  
Raymond S. Lance ◽  
Charles H. Redfern ◽  
Frederick E. Millard ◽  
Thomas A. Gardner ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Outcomes ◽  
Median Time ◽  
Abiraterone Acetate ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Long Term Follow Up ◽  
Safety Signals

190 Background: The optimal sequence and combination of life-extending anticancer therapies in mCRPC pts remains unknown. Sipuleucel-T (sip-T), an autologous cellular immunotherapy approved for the therapy of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC) pts, was evaluated in combination with abiraterone acetate and prednisone (abi) in the phase II STAMP trial (NCT01487863), with pts randomly assigned to receive CON sip-T + abi or SEQ sip-T followed by abi. The combination was well-tolerated and did not alter the immune response parameters that correlate with overall survival (OS) (Small Clin Can Res 2015). Here, we present long-term follow-up of clinical outcomes, including OS. Methods: mCRPC pts were randomized 1:1 to CON or SEQ therapy with sip-T and abi. Abi began 1 day after (CON) or at wk 10 (SEQ) after the first sip-T infusion and continued for 26 wk of therapy, after which continued abi therapy was permitted. Long-term clinical outcomes included OS, disease-specific death (DSS), progressive disease (PD), time to first anticancer intervention (tACI), and safety. Results: 69 pts were enrolled (35 CON; 34 SEQ). Median OS was 34.0 mo (95% CI, 24.4-not estimable [NE]; 30.0 mo CON; 34.2 mo SEQ; p = 0.921), and median time to DSS was not reached (CON vs SEQ; p = 0.733). Median time to PD was 17.3 mo (95% CI, 9.7–NE; 17.7 mo CON vs 13.9 mo SEQ; p = 0.914; consistent with higher rates of abi discontinuation due to PD in SEQ [26.5% vs 14.3% in CON]). tACI was similar between arms at 15.4 mo (95% CI, 11.0–19.9). No new safety signals were observed with the combination, and no discernable difference in clinical outcomes was observed with CON or SEQ treatments. Conclusions: Long-term follow-up data confirm that sip-T + CON or SEQ abi is well-tolerated, with no new safety signals. No clear differences were observed in clinical outcomes between arms, although the study was not powered to detect these differences. Future and more appropriately powered studies on the effect of sip-T + continuous abi for responding pts may provide further insights on the benefit of combination therapy. Clinical trial information: NCT01487863.

Predictors for survival with cabazitaxel (CBZ) in metastatic, castration-resistant prostate cancer (mCRPC): Long term follow-up of the Spanish registry.

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. e602-e602
Author(s):  
Iria González-Maeso ◽  
Nuria Lainez ◽  
Daniel Castellano ◽  
Iciar Garcia Carbonero ◽  
Pablo Borrega ◽  
...  
Keyword(s):  
Progression Free Survival ◽  
Therapeutic Benefit ◽  
Castration Resistant Prostate Cancer ◽  
First Line ◽  
Castration Resistant ◽  
Long Term Follow Up ◽  
Baseline Characteristics ◽  
Grade 3

e602 Background: The clinical experience with CBZ in mCRPC patients (pts) has enriched notably since its approval for clinical use, but there is still a lack of well-defined prognostic/predictive factors to better characterize the profile of pts that could achieve the best therapeutic benefit. Analysis of the final expanded cohort and mature long-term follow-up are presented. Methods: Medical records from mCRPC pts progressing during or after docetaxel and treated with CBZ at 21 centres in Spain were reviewed retrospectively. Baseline characteristics, overall survival (OS), radiographic progression-free survival (rPFS), and toxicity were collected. Univariate and multivariate analysis of a variety of factors predicting OS were conducted. Results: 187 consecutive pts (median age 69) with intermediate-poor prognostic baseline characteristics (Table 1) received a median of 6 cycles (range 2-59) of CBZ. Median OS from first CBZ cycle was 15.3 [CI: 11.7; 18.0] months (mo) and median clinical and/or rPFS was 7.9 mo [CI: 6.8; 10.3]. Gleason score (GS) < 8 (vs ≥ 8), time under first-line androgen deprivation therapy (ADT) ( > 16.1 (median) vs < 16.1 mo) and the number of chemotherapy lines before CBZ did not significantly influence OS. Median follow-up was 9.5 mo. Febrile neutropenia occurred in 4 pts and 1 pt had neutropenic infection. Main nonhematologic grade ≥ 3 toxicities were asthenia (2.7%) and diarrhea (1.6%). Alopecia, nails disorders and peripheral neuropathy were uncommon. Conclusions: CBZ administered in the daily clinical practice is associated with consistent OS, similar to that observed in pivotal clinical trials. GS, median time under first-line ADT and number of chemotherapy lines before CBZ did not influence clinical benefit. CBZ has an acceptable safety profile. Funding: Sanofi [Table: see text]

Overall survival and immune responses with sipuleucel-T and enzalutamide: STRIDE study.

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 246-246 ◽  
Author(s):  
Daniel Peter Petrylak ◽  
Charles G. Drake ◽  
Christopher Michael Pieczonka ◽  
John M. Corman ◽  
Jorge A. Garcia ◽  
...  
Keyword(s):  
Immune Responses ◽  
Clinical Impact ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Kaplan Meier ◽  
Long Term Follow Up ◽  
Baseline Characteristics ◽  
Clinical Trial Information

246 Background: STRIDE (NCT01981122) is the first study comparing concurrent (con) vs sequential (seq) enzalutamide (enz) with sipuleucel-T (sip-T) in patients (pts) with metastatic castration-resistant prostate cancer. Pts were followed until death or for 3 years. Methods: Fifty-two pts were randomized 1:1 to 3 sip-T infusions and enz started 2 wks before (n = 25, con) or 10 wks after (n = 27, seq) sip-T. Enz was continued for 52 wks or until disease progression (DP)/toxicity. Time to clinical outcomes was estimated by Kaplan-Meier analysis. Results: Median age (years): con 66; seq 72 (p = 0.01). Baseline characteristics and laboratory values were similar between arms. K-M estimated median follow up: 40.2 months. Clinical trial information: NCT01981122. Conclusions: Long-term follow-up suggests sip-T+enz is well-tolerated with no new safety concerns. Though not powered for such, con vs seq rx did not result in differences in OS or DP; differences in PSA responses cannot be excluded. Larger studies could better evaluate the clinical impact of combining immunotherapy with hormonal agents.[Table: see text]

Real-world outcomes in second-line treatment of metastatic castration-resistant prostate cancer (mCRPC): The Prostate Cancer Registry.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 5028-5028 ◽  
Author(s):  
Simon Chowdhury ◽  
Alison J. Birtle ◽  
Anders Bjartell ◽  
Luis Costa ◽  
Susan Feyerabend ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Cancer Registry ◽  
Real World ◽  
Abiraterone Acetate ◽  
Second Line ◽  
Castration Resistant Prostate Cancer ◽  
Castration Resistant ◽  
Baseline Characteristics ◽  
Clinical Trial Information

5028 Background: The Prostate Cancer Registry is a prospective, international observational study that began in June 2013 and will assess the characteristics and management of > 3000 mCRPC patients (pts) in routine clinical practice for ≤ 3 years. Methods: Data were collected from men with mCRPC irrespective of treatment (tx). This interim analysis reports baseline characteristics, txs and outcomes in pts with ≥ 12-month follow-up receiving second-line mCRPC tx following docetaxel as the only prior mCRPC tx. Results: The most commonly initiated second-line mCPRC txs (n ≥ 50) were abiraterone acetate + prednisone (AAP, n = 177), enzalutamide (ENZ, n = 94), or cabazitaxel (CAB, n = 70). Characteristics and outcomes are shown in the table below. TTP was not significantly different for AAP vs ENZ, AAP vs CAB or ENZ vs CAB (propensity score adjusted p = 0.5954, p = 0.5888 and p= 0.4808, respectively). Conclusions: In this real-world study, clinical outcomes reveal that, in pts receiving second-line mCRPC tx after docetaxel, TTP was similar across tx groups; QoL improved most in AAP and ENZ groups and no deterioration was observed most in AAP and CAB groups. Clinical trial information: NCT02236637. [Table: see text]

Sign in / Sign up

Export Citation Format

Share Document