Target Oncol: Real-world evaluation of the efficacy and safety of abiraterone plus prednisone or prednisolone (AAP) in first- or second-line treatment of metastatic castration-resistant prostate cancer (mCRPC)

Prostate cancer mortality remains high despite standard androgen deprivation therapy and a growing number of treatment options
.

Metastatic castration - resistant prostate cancer (mCRPC) requires additional treatment after progression

Prostate cancer mortality remains high despite standard androgen deprivation therapy and a growing number of treatment options

Recently, Targeted Oncology published data from a real-world study evaluating the safety and efficacy of AAP as a first- and second-line [post-docetaxel (AAP-PD) only] treatment of patients with mCRPC

The PCR study was a prospective, international observational study of patients ≥ 18 years of age with diagnosed mCRPC .

The patients' baseline characteristics, safety of AAP treatment (treatment acute adverse events, treatment acute serious adverse events), efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed .

The PCR study was a prospective, international observational study of patients ≥ 18 years of age with diagnosed mCRPC .
The patients' baseline characteristics, safety of AAP treatment (treatment acute adverse events, treatment acute serious adverse events), efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed .
The PCR study was a prospective, international observational study of patients ≥ 18 years of age with diagnosed mCRPC .
The patients' baseline characteristics, safety of AAP treatment (treatment acute adverse events, treatment acute serious adverse events), efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed .

754 patients received AAP as first-line therapy and 394 patients received second-line (AAP-PD) therapy
.

Patients in the AAP and AAP-PD groups received corticosteroids almost simultaneously (98.
9% and 98.
2%, respectively)

754 patients received AAP as first-line therapy and 394 patients received second-line (AAP-PD) therapy

According to Kaplan-Meier analysis, the median duration of treatment [95% confidence interval (CI)] for AAP as first-line therapy was 11.

No unexpected AEs were observed in analyses of the entire patient population or cardiovascular comorbidity subgroups
.

TEAEs were more common in patients receiving first-line AAP than in patients receiving AAP-PD

No unexpected AEs were observed in analyses of the entire patient population or cardiovascular comorbidity subgroups

Efficacy outcomes for first-line AAP were similar between the overall population patient group and the baseline cardiovascular comorbidity subgroup of patients
.

According to Kaplan-Meier estimates, the median (95% CI) PFS was 8.

Efficacy outcomes for first-line AAP were similar between the overall population patient group and the baseline cardiovascular comorbidity subgroup of patients

Differences in PFS with first-line AAP therapy

First-line AAP treatment PFS difference                First-line AAP treatment PFS difference

            Differences in PFS in second-line AAP-PD therapy

            Second-line AAP-PD treatment PFS difference             Second-line AAP-PD treatment PFS difference

With first-line AAP therapy, the median (95% CI) OS was 27.
1 (25.
3-28.
9) months for all patients and 27.
4 (23.
0-30.
3) months for patients with cardiovascular disease
.

AAP-PD treatment, median (95% CI) OS was 23.
4 (20.
1-30.
6) months for all patients and 23.
1 (19.
4-30.
0) months for patients with cardiovascular disease
.

With first-line AAP therapy, the median (95% CI) OS was 27.
1 (25.
3-28.
9) months for all patients and 27.
4 (23.
0-30.
3) months for patients with cardiovascular disease
.
AAP-PD treatment, median (95% CI) OS was 23.
4 (20.
1-30.
6) months for all patients and 23.
1 (19.
4-30.
0) months for patients with cardiovascular disease
.
With first-line AAP therapy, the median (95% CI) OS was 27.
1 (25.
3-28.
9) months for all patients and 27.
4 (23.
0-30.
3) months for patients with cardiovascular disease
.
AAP-PD treatment, median (95% CI) OS was 23.
4 (20.
1-30.
6) months for all patients and 23.
1 (19.
4-30.
0) months for patients with cardiovascular disease
.

            Differences in OS with first-line AAP therapy

            First-line AAP treatment OS difference First-line AAP treatment OS difference First-line AAP treatment OS difference

              Differences in OS between second-line AAP-PD therapy

              Second-line AAP-PD treatment OS difference               Second-line AAP-PD treatment OS difference               Second-line AAP-PD treatment OS difference

 

Taken together, the study shows that these real-world data complement the results of randomized controlled trials showing that first- and second-line AAPs are well tolerated and effective in patients with mCRPC, including those with underlying cardiovascular comorbidities
.

Taken together, the study shows that these real-world data complement the results of randomized controlled trials showing that first- and second-line AAPs are well tolerated and effective in patients with mCRPC, including those with underlying cardiovascular comorbidities
.
CONCLUSIONS: These real-world data complement findings from randomized controlled trials showing that first- and second-line AAPs are well tolerated and effective in patients with mCRPC, including those with underlying cardiovascular comorbidities
.
CONCLUSIONS: These real-world data complement findings from randomized controlled trials showing that first- and second-line AAPs are well tolerated and effective in patients with mCRPC, including those with underlying cardiovascular comorbidities
.

 

Original source:

Original source:

Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaëth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S.
Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry.
Target Oncol.
2021 May;16(3):357 -367.
doi: 10.
1007/s11523-021-00807-4.
Epub 2021 Apr 7.
PMID: 33826036; PMCID: PMC8105236.

Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, Birtle A, Kramer G, Kalinka E, Spaëth D, Feyerabend S, Matveev V, Lefresne F, Lukac M, Wapenaar R, Costa L, Chowdhury S.
Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry.
Target Oncol.
2021 May;16(3):357 -367.
doi: 10.
1007/s11523-021-00807-4.
Epub 2021 Apr 7.
PMID: 33826036; PMCID: PMC8105236.
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