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Real-world comparative assessment of tofacitinib and baricitinib in RA
Key clinical point: In real medical practice, tofacitinib and baricitinib demonstrated comparable efficacies and similar safety profiles in patients with rheumatoid arthritis (RA); however, predictive factors contributing to their treatment responses were different.
Major finding: At 24 weeks, clinical response (adjusted mean difference, −0.04; 95% confidence interval, −0.35 to 0.28) and adverse events (P = .866) were not significantly different between the 2 groups. Factors independently associated with the achievement of disease activity score-low disease activity were concomitant oral steroid use (odds ratio [OR], 0.470) in the tofacitinib group and the number of previous use of biological and/or targeted synthetic disease-modifying antirheumatic drugs (OR, 0.700) in the baricitinib group (both P < .05).
Study details: Findings are from the analysis of a real-world cohort of 242 patients with RA who were treated with tofacitinib (n=161) between August 2013 and October 2019 or baricitinib (n=81) between January 2018 and February 2020.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Iwamoto N et al. Arthritis Res Ther. 2021 Jul 23. doi: 10.1186/s13075-021-02582-z.
Key clinical point: In real medical practice, tofacitinib and baricitinib demonstrated comparable efficacies and similar safety profiles in patients with rheumatoid arthritis (RA); however, predictive factors contributing to their treatment responses were different.
Major finding: At 24 weeks, clinical response (adjusted mean difference, −0.04; 95% confidence interval, −0.35 to 0.28) and adverse events (P = .866) were not significantly different between the 2 groups. Factors independently associated with the achievement of disease activity score-low disease activity were concomitant oral steroid use (odds ratio [OR], 0.470) in the tofacitinib group and the number of previous use of biological and/or targeted synthetic disease-modifying antirheumatic drugs (OR, 0.700) in the baricitinib group (both P < .05).
Study details: Findings are from the analysis of a real-world cohort of 242 patients with RA who were treated with tofacitinib (n=161) between August 2013 and October 2019 or baricitinib (n=81) between January 2018 and February 2020.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Iwamoto N et al. Arthritis Res Ther. 2021 Jul 23. doi: 10.1186/s13075-021-02582-z.
Key clinical point: In real medical practice, tofacitinib and baricitinib demonstrated comparable efficacies and similar safety profiles in patients with rheumatoid arthritis (RA); however, predictive factors contributing to their treatment responses were different.
Major finding: At 24 weeks, clinical response (adjusted mean difference, −0.04; 95% confidence interval, −0.35 to 0.28) and adverse events (P = .866) were not significantly different between the 2 groups. Factors independently associated with the achievement of disease activity score-low disease activity were concomitant oral steroid use (odds ratio [OR], 0.470) in the tofacitinib group and the number of previous use of biological and/or targeted synthetic disease-modifying antirheumatic drugs (OR, 0.700) in the baricitinib group (both P < .05).
Study details: Findings are from the analysis of a real-world cohort of 242 patients with RA who were treated with tofacitinib (n=161) between August 2013 and October 2019 or baricitinib (n=81) between January 2018 and February 2020.
Disclosures: This study did not receive any funding. The authors declared no conflict of interests.
Source: Iwamoto N et al. Arthritis Res Ther. 2021 Jul 23. doi: 10.1186/s13075-021-02582-z.
Increased risk for vertebral fractures persists even with low-dose oral glucocorticoids for RA
Key clinical point: Patients with rheumatoid arthritis (RA) currently using low-dose oral glucocorticoid (7.5 mg or lower of prednisolone equivalent dose/day) were at a 59% increased risk of sustaining clinical vertebral fracture compared with past users.
Major finding: Although the overall risk for osteoporotic fractures was not different between past and current users of low-dose oral glucocorticoids (adjusted hazard ratio [aHR], 1.14; 95% confidence interval [CI], 0.98-1.33), the risk for clinical vertebral fracture was significantly higher with current use (aHR, 1.59; 95% CI, 1.11-2.29).
Study details: This was a retrospective cohort study of 15,123 adults aged 50 years or older from the Clinical Practice Research Datalink who were diagnosed with RA between 1997 and 2017.
Disclosures: No specific funding was received for this study. AM Burden and JP van den Bergh reported receiving grants and lectures/advisory board meetings fees from various sources. FD Vries supervised 3 PhD students who were employed with F. Hoffmann La Roche Ltd. All the other authors declared no conflict of interests.
Source: Abtahi S et al. Rheumatology (Oxford). 2021 Jul 13. doi: 10.1093/rheumatology/keab548.
Key clinical point: Patients with rheumatoid arthritis (RA) currently using low-dose oral glucocorticoid (7.5 mg or lower of prednisolone equivalent dose/day) were at a 59% increased risk of sustaining clinical vertebral fracture compared with past users.
Major finding: Although the overall risk for osteoporotic fractures was not different between past and current users of low-dose oral glucocorticoids (adjusted hazard ratio [aHR], 1.14; 95% confidence interval [CI], 0.98-1.33), the risk for clinical vertebral fracture was significantly higher with current use (aHR, 1.59; 95% CI, 1.11-2.29).
Study details: This was a retrospective cohort study of 15,123 adults aged 50 years or older from the Clinical Practice Research Datalink who were diagnosed with RA between 1997 and 2017.
Disclosures: No specific funding was received for this study. AM Burden and JP van den Bergh reported receiving grants and lectures/advisory board meetings fees from various sources. FD Vries supervised 3 PhD students who were employed with F. Hoffmann La Roche Ltd. All the other authors declared no conflict of interests.
Source: Abtahi S et al. Rheumatology (Oxford). 2021 Jul 13. doi: 10.1093/rheumatology/keab548.
Key clinical point: Patients with rheumatoid arthritis (RA) currently using low-dose oral glucocorticoid (7.5 mg or lower of prednisolone equivalent dose/day) were at a 59% increased risk of sustaining clinical vertebral fracture compared with past users.
Major finding: Although the overall risk for osteoporotic fractures was not different between past and current users of low-dose oral glucocorticoids (adjusted hazard ratio [aHR], 1.14; 95% confidence interval [CI], 0.98-1.33), the risk for clinical vertebral fracture was significantly higher with current use (aHR, 1.59; 95% CI, 1.11-2.29).
Study details: This was a retrospective cohort study of 15,123 adults aged 50 years or older from the Clinical Practice Research Datalink who were diagnosed with RA between 1997 and 2017.
Disclosures: No specific funding was received for this study. AM Burden and JP van den Bergh reported receiving grants and lectures/advisory board meetings fees from various sources. FD Vries supervised 3 PhD students who were employed with F. Hoffmann La Roche Ltd. All the other authors declared no conflict of interests.
Source: Abtahi S et al. Rheumatology (Oxford). 2021 Jul 13. doi: 10.1093/rheumatology/keab548.
Rheumatoid arthritis: Olokizumab shows promise in phase 3
Key clinical point: Olokizumab significantly improved signs and symptoms of rheumatoid arthritis (RA) in patients with inadequate response to methotrexate and was reasonably well tolerated over a period of 24 weeks.
Major finding: At 12 weeks, the proportion of patients who achieved American College of Rheumatology 20% response was significantly higher with olokizumab every 2 (63.6%) and 4 (70.4%) weeks vs placebo (25.9%; both P < .0001). Most treatment-emergent adverse events were mild to moderate.
Study details: Findings are from CREDO 1, a phase 3 trial of 428 patients with active RA despite treatment with methotrexate who were randomly assigned to receive subcutaneous olokizumab 64 mg once every 2 or 4 weeks or placebo with continuation of background methotrexate.
Disclosures: This study was funded by CJSC R-Pharm. E Korneva and M Samsonov reported being employees of R-Pharm. Some of the authors declared receiving consulting fees and/or research grants from, being on speakers’ bureau for, being consultant and/or employee of, and/or holding stocks for various sources.
Source: Nasonov E et al. Ann Rheum Dis. 2021 Aug 3. doi: 10.1136/annrheumdis-2021-219876.
Key clinical point: Olokizumab significantly improved signs and symptoms of rheumatoid arthritis (RA) in patients with inadequate response to methotrexate and was reasonably well tolerated over a period of 24 weeks.
Major finding: At 12 weeks, the proportion of patients who achieved American College of Rheumatology 20% response was significantly higher with olokizumab every 2 (63.6%) and 4 (70.4%) weeks vs placebo (25.9%; both P < .0001). Most treatment-emergent adverse events were mild to moderate.
Study details: Findings are from CREDO 1, a phase 3 trial of 428 patients with active RA despite treatment with methotrexate who were randomly assigned to receive subcutaneous olokizumab 64 mg once every 2 or 4 weeks or placebo with continuation of background methotrexate.
Disclosures: This study was funded by CJSC R-Pharm. E Korneva and M Samsonov reported being employees of R-Pharm. Some of the authors declared receiving consulting fees and/or research grants from, being on speakers’ bureau for, being consultant and/or employee of, and/or holding stocks for various sources.
Source: Nasonov E et al. Ann Rheum Dis. 2021 Aug 3. doi: 10.1136/annrheumdis-2021-219876.
Key clinical point: Olokizumab significantly improved signs and symptoms of rheumatoid arthritis (RA) in patients with inadequate response to methotrexate and was reasonably well tolerated over a period of 24 weeks.
Major finding: At 12 weeks, the proportion of patients who achieved American College of Rheumatology 20% response was significantly higher with olokizumab every 2 (63.6%) and 4 (70.4%) weeks vs placebo (25.9%; both P < .0001). Most treatment-emergent adverse events were mild to moderate.
Study details: Findings are from CREDO 1, a phase 3 trial of 428 patients with active RA despite treatment with methotrexate who were randomly assigned to receive subcutaneous olokizumab 64 mg once every 2 or 4 weeks or placebo with continuation of background methotrexate.
Disclosures: This study was funded by CJSC R-Pharm. E Korneva and M Samsonov reported being employees of R-Pharm. Some of the authors declared receiving consulting fees and/or research grants from, being on speakers’ bureau for, being consultant and/or employee of, and/or holding stocks for various sources.
Source: Nasonov E et al. Ann Rheum Dis. 2021 Aug 3. doi: 10.1136/annrheumdis-2021-219876.
Bone resorption inhibitors extend OS in castration-resistant prostate cancer
Key clinical point: The addition of bone resorption inhibitors (BRIs) to abiraterone acetate with prednisone prolongs overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases. The OS was similar regardless of the BRI type used.
Major finding: The median follow-up was 23.5 months. Concomitant use of BRIs was reported in 29.0% of patients. BRI use was associated with OS improvement (31.8 months vs 23.0 months; hazard ratio [HR], 0.65; P less than .001) and shorter time to the first skeletal-related event (32.4 months vs 42.7 months; HR, 1.27; P = .04). Both denosumab and zoledronic acid were associated with similar OS (P = .79).
Study details: A retrospective study of 745 consecutive patients with metastatic CRPC and bone metastases who received abiraterone acetate plus prednisone between 2013 and 2016.
Disclosures: No funding source was reported. The authors received grants, personal fees, travel expenses, and research funding from and/or owned stocks in pharmaceutical companies outside the submitted work.
Source: Francini E et al. JAMA Netw Open. 2021 Jul 22. doi: 10.1001/jamanetworkopen.2021.16536.
Key clinical point: The addition of bone resorption inhibitors (BRIs) to abiraterone acetate with prednisone prolongs overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases. The OS was similar regardless of the BRI type used.
Major finding: The median follow-up was 23.5 months. Concomitant use of BRIs was reported in 29.0% of patients. BRI use was associated with OS improvement (31.8 months vs 23.0 months; hazard ratio [HR], 0.65; P less than .001) and shorter time to the first skeletal-related event (32.4 months vs 42.7 months; HR, 1.27; P = .04). Both denosumab and zoledronic acid were associated with similar OS (P = .79).
Study details: A retrospective study of 745 consecutive patients with metastatic CRPC and bone metastases who received abiraterone acetate plus prednisone between 2013 and 2016.
Disclosures: No funding source was reported. The authors received grants, personal fees, travel expenses, and research funding from and/or owned stocks in pharmaceutical companies outside the submitted work.
Source: Francini E et al. JAMA Netw Open. 2021 Jul 22. doi: 10.1001/jamanetworkopen.2021.16536.
Key clinical point: The addition of bone resorption inhibitors (BRIs) to abiraterone acetate with prednisone prolongs overall survival (OS) in patients with metastatic castration-resistant prostate cancer (CRPC) and bone metastases. The OS was similar regardless of the BRI type used.
Major finding: The median follow-up was 23.5 months. Concomitant use of BRIs was reported in 29.0% of patients. BRI use was associated with OS improvement (31.8 months vs 23.0 months; hazard ratio [HR], 0.65; P less than .001) and shorter time to the first skeletal-related event (32.4 months vs 42.7 months; HR, 1.27; P = .04). Both denosumab and zoledronic acid were associated with similar OS (P = .79).
Study details: A retrospective study of 745 consecutive patients with metastatic CRPC and bone metastases who received abiraterone acetate plus prednisone between 2013 and 2016.
Disclosures: No funding source was reported. The authors received grants, personal fees, travel expenses, and research funding from and/or owned stocks in pharmaceutical companies outside the submitted work.
Source: Francini E et al. JAMA Netw Open. 2021 Jul 22. doi: 10.1001/jamanetworkopen.2021.16536.
Prostate cancer: PDE-5 inhibitor use linked to survival benefit
Key clinical point: In patients with localized prostate cancer, the use of phosphodiesterase (PDE)-5 inhibitors improve survival.
Major finding: The patients who received PDE-5 inhibitors vs those who did not showed a significant improvement in biochemical recurrence-free (BCRF) survival (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.34-0.56) and overall survival (OS; HR, 0.65; 95% CI, 0.45-0.94) at 10 years. In PDE-5 inhibitors users vs nonusers, BCRF survival was 93.2% vs 85.3% and OS was 95.8% vs 94.5%.
Study details: A retrospective cohort study of 3,100 patients with prostate cancer who underwent radical prostatectomy between 2003 and 2015; 1,372 patients received PDE-5 inhibitors.
Disclosures: The study was supported by National Cancer Institute. The authors declared no conflict of interests.
Source: Danley KT et al. Urol Oncol. 2021 Jul 18. doi: 10.1016/j.urolonc.2021.05.031.
Key clinical point: In patients with localized prostate cancer, the use of phosphodiesterase (PDE)-5 inhibitors improve survival.
Major finding: The patients who received PDE-5 inhibitors vs those who did not showed a significant improvement in biochemical recurrence-free (BCRF) survival (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.34-0.56) and overall survival (OS; HR, 0.65; 95% CI, 0.45-0.94) at 10 years. In PDE-5 inhibitors users vs nonusers, BCRF survival was 93.2% vs 85.3% and OS was 95.8% vs 94.5%.
Study details: A retrospective cohort study of 3,100 patients with prostate cancer who underwent radical prostatectomy between 2003 and 2015; 1,372 patients received PDE-5 inhibitors.
Disclosures: The study was supported by National Cancer Institute. The authors declared no conflict of interests.
Source: Danley KT et al. Urol Oncol. 2021 Jul 18. doi: 10.1016/j.urolonc.2021.05.031.
Key clinical point: In patients with localized prostate cancer, the use of phosphodiesterase (PDE)-5 inhibitors improve survival.
Major finding: The patients who received PDE-5 inhibitors vs those who did not showed a significant improvement in biochemical recurrence-free (BCRF) survival (hazard ratio [HR], 0.44; 95% confidence interval [CI], 0.34-0.56) and overall survival (OS; HR, 0.65; 95% CI, 0.45-0.94) at 10 years. In PDE-5 inhibitors users vs nonusers, BCRF survival was 93.2% vs 85.3% and OS was 95.8% vs 94.5%.
Study details: A retrospective cohort study of 3,100 patients with prostate cancer who underwent radical prostatectomy between 2003 and 2015; 1,372 patients received PDE-5 inhibitors.
Disclosures: The study was supported by National Cancer Institute. The authors declared no conflict of interests.
Source: Danley KT et al. Urol Oncol. 2021 Jul 18. doi: 10.1016/j.urolonc.2021.05.031.
Positive PSMA PET indicates worse metastasis-free survival in recurrent prostate cancer
Key clinical point: Positive prostate-specific membrane antigen positron emission tomography (PSMA PET) findings prior to salvage radiotherapy (SRT) are associated with worse metastasis-free survival (MFS) in patients with recurrent prostate cancer.
Major finding: In 155 patients who underwent PSMA PET prior to SRT, 31.6% had positive PSMA PET. After propensity score matching, 5-year MFS was significantly lower in patients with “positive PSMA PET” vs those who did not undergo PSMA PET (48.5% vs 92.3%; P < .001). Positive PSMA PET imaging was associated with worse MFS compared with “no PSMA PET” (hazard ratio, 13.8; P < .001).
Study design: A retrospective study of 1,599 patients with recurrent prostate cancer who received salvage radiotherapy after biochemical recurrence.
Disclosures: The study received no funding. The authors declared no conflict of interests.
Source: Wenzel M et al. Urol Oncol. 2021 Jul 31. doi: 10.1016/j.urolonc.2021.06.008.
Key clinical point: Positive prostate-specific membrane antigen positron emission tomography (PSMA PET) findings prior to salvage radiotherapy (SRT) are associated with worse metastasis-free survival (MFS) in patients with recurrent prostate cancer.
Major finding: In 155 patients who underwent PSMA PET prior to SRT, 31.6% had positive PSMA PET. After propensity score matching, 5-year MFS was significantly lower in patients with “positive PSMA PET” vs those who did not undergo PSMA PET (48.5% vs 92.3%; P < .001). Positive PSMA PET imaging was associated with worse MFS compared with “no PSMA PET” (hazard ratio, 13.8; P < .001).
Study design: A retrospective study of 1,599 patients with recurrent prostate cancer who received salvage radiotherapy after biochemical recurrence.
Disclosures: The study received no funding. The authors declared no conflict of interests.
Source: Wenzel M et al. Urol Oncol. 2021 Jul 31. doi: 10.1016/j.urolonc.2021.06.008.
Key clinical point: Positive prostate-specific membrane antigen positron emission tomography (PSMA PET) findings prior to salvage radiotherapy (SRT) are associated with worse metastasis-free survival (MFS) in patients with recurrent prostate cancer.
Major finding: In 155 patients who underwent PSMA PET prior to SRT, 31.6% had positive PSMA PET. After propensity score matching, 5-year MFS was significantly lower in patients with “positive PSMA PET” vs those who did not undergo PSMA PET (48.5% vs 92.3%; P < .001). Positive PSMA PET imaging was associated with worse MFS compared with “no PSMA PET” (hazard ratio, 13.8; P < .001).
Study design: A retrospective study of 1,599 patients with recurrent prostate cancer who received salvage radiotherapy after biochemical recurrence.
Disclosures: The study received no funding. The authors declared no conflict of interests.
Source: Wenzel M et al. Urol Oncol. 2021 Jul 31. doi: 10.1016/j.urolonc.2021.06.008.
High-grade prostate cancer: Elevated PSA is linked to high mortality risk
Key clinical point: In patients with Gleason grade 3+4 prostate cancer treated with brachytherapy, high prostate-specific antigen (PSA) levels are associated with an elevated risk for prostate cancer-specific mortality (PCSM).
Major finding: The median follow-up was 7.8 years. The PSA levels of 10.1-20.0 ng/mL vs 4.0-10.0 ng/mL were associated with higher PCSM in patients who received brachytherapy alone (adjusted hazard ratio [aHR], 5.55; P < .001) and those who received brachytherapy with androgen deprivation treatment (ADT; aHR, 4.17; P = .02).
Study details: A retrospective study of 1,920 patients with Gleason grade 3+4 prostate cancer who received brachytherapy with or without ADT.
Disclosures: No funding source was reported. The authors did not report any conflict of interests.
Source: Yang DD et al. Urol Oncol. 2021 Jul 24. doi: 10.1016/j.urolonc.2021.06.022.
Key clinical point: In patients with Gleason grade 3+4 prostate cancer treated with brachytherapy, high prostate-specific antigen (PSA) levels are associated with an elevated risk for prostate cancer-specific mortality (PCSM).
Major finding: The median follow-up was 7.8 years. The PSA levels of 10.1-20.0 ng/mL vs 4.0-10.0 ng/mL were associated with higher PCSM in patients who received brachytherapy alone (adjusted hazard ratio [aHR], 5.55; P < .001) and those who received brachytherapy with androgen deprivation treatment (ADT; aHR, 4.17; P = .02).
Study details: A retrospective study of 1,920 patients with Gleason grade 3+4 prostate cancer who received brachytherapy with or without ADT.
Disclosures: No funding source was reported. The authors did not report any conflict of interests.
Source: Yang DD et al. Urol Oncol. 2021 Jul 24. doi: 10.1016/j.urolonc.2021.06.022.
Key clinical point: In patients with Gleason grade 3+4 prostate cancer treated with brachytherapy, high prostate-specific antigen (PSA) levels are associated with an elevated risk for prostate cancer-specific mortality (PCSM).
Major finding: The median follow-up was 7.8 years. The PSA levels of 10.1-20.0 ng/mL vs 4.0-10.0 ng/mL were associated with higher PCSM in patients who received brachytherapy alone (adjusted hazard ratio [aHR], 5.55; P < .001) and those who received brachytherapy with androgen deprivation treatment (ADT; aHR, 4.17; P = .02).
Study details: A retrospective study of 1,920 patients with Gleason grade 3+4 prostate cancer who received brachytherapy with or without ADT.
Disclosures: No funding source was reported. The authors did not report any conflict of interests.
Source: Yang DD et al. Urol Oncol. 2021 Jul 24. doi: 10.1016/j.urolonc.2021.06.022.
CRPC: Nomograms predict outcomes with targeted radionuclide therapy
Key clinical point: Nomograms to predict survival and prostate-specific antigen (PSA) response in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving lutetium-177 prostate-specific membrane antigen (¹⁷⁷Lu-PSMA) radionuclide treatment have been developed and externally validated.
Major finding: The median follow-up was 21.5 months. The concordance index of the overall survival model was 0.71 and PSA-progression-free survival model was 0.70. The model for PSA decline of 50% or more had a sensitivity of 94%, negative predictive value of 89%, and specificity of 38%.
Study details: Nomograms for predicting outcomes after Lu-PSMA treatment were developed (n=196) and validated (n=74) using clinical trial and real-world data of patients with late-stage mCRPC.
Disclosures: The study was supported by Prostate Cancer Foundation. The authors declared consulting, personal fees, travel fees, grants, honoraria, nonfinancial support, and patents outside this work. Dr. J Czernin reported being a founder and board member of and holding equity in Sofie Biosciences and Trethera Therapeutics.
Source: Gafita A et al. Lancet Oncol. 2021 Jul 8. doi: 10.1016/S1470-2045(21)00274-6.
Key clinical point: Nomograms to predict survival and prostate-specific antigen (PSA) response in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving lutetium-177 prostate-specific membrane antigen (¹⁷⁷Lu-PSMA) radionuclide treatment have been developed and externally validated.
Major finding: The median follow-up was 21.5 months. The concordance index of the overall survival model was 0.71 and PSA-progression-free survival model was 0.70. The model for PSA decline of 50% or more had a sensitivity of 94%, negative predictive value of 89%, and specificity of 38%.
Study details: Nomograms for predicting outcomes after Lu-PSMA treatment were developed (n=196) and validated (n=74) using clinical trial and real-world data of patients with late-stage mCRPC.
Disclosures: The study was supported by Prostate Cancer Foundation. The authors declared consulting, personal fees, travel fees, grants, honoraria, nonfinancial support, and patents outside this work. Dr. J Czernin reported being a founder and board member of and holding equity in Sofie Biosciences and Trethera Therapeutics.
Source: Gafita A et al. Lancet Oncol. 2021 Jul 8. doi: 10.1016/S1470-2045(21)00274-6.
Key clinical point: Nomograms to predict survival and prostate-specific antigen (PSA) response in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving lutetium-177 prostate-specific membrane antigen (¹⁷⁷Lu-PSMA) radionuclide treatment have been developed and externally validated.
Major finding: The median follow-up was 21.5 months. The concordance index of the overall survival model was 0.71 and PSA-progression-free survival model was 0.70. The model for PSA decline of 50% or more had a sensitivity of 94%, negative predictive value of 89%, and specificity of 38%.
Study details: Nomograms for predicting outcomes after Lu-PSMA treatment were developed (n=196) and validated (n=74) using clinical trial and real-world data of patients with late-stage mCRPC.
Disclosures: The study was supported by Prostate Cancer Foundation. The authors declared consulting, personal fees, travel fees, grants, honoraria, nonfinancial support, and patents outside this work. Dr. J Czernin reported being a founder and board member of and holding equity in Sofie Biosciences and Trethera Therapeutics.
Source: Gafita A et al. Lancet Oncol. 2021 Jul 8. doi: 10.1016/S1470-2045(21)00274-6.
CRPC: Talazoparib shows response in heavily pretreated patients
Key clinical point: Talazoparib shows antitumor response in heavily pretreated patients with metastatic, castration-resistant prostate cancer (CRPC) with alterations in DNA damage repair (DDR) genes.
Major finding: The median follow-up was 16.4 months. The confirmed objective response rate (ORR) was 29.8%. The ORR was 46% in patients with BRCA2 alterations and 50% in those with BRCA1 alterations. Grade 3-4 adverse event rate was 48%; anemia, thrombocytopenia, and neutropenia were most common.
Study details: A multicenter, phase 2 TALAPRO-1 trial of 127 heavily pretreated patients with metastatic, CRPC with alterations in DDR genes who received talazoparib; 104 patients had measurable soft tissue disease.
Disclosures: This study was funded by Pfizer. The authors received grants/funding, consulting fees, travel/accommodation expenses, and/or honoraria from and/or reported employment and/or stock ownership in companies. Dr. JS de Bono also reported patent ownership.
Source: de Bono JS et al. Lancet Oncol. 2021 Aug 10. doi: 10.1016/ S1470-2045(21)00376-4.
Key clinical point: Talazoparib shows antitumor response in heavily pretreated patients with metastatic, castration-resistant prostate cancer (CRPC) with alterations in DNA damage repair (DDR) genes.
Major finding: The median follow-up was 16.4 months. The confirmed objective response rate (ORR) was 29.8%. The ORR was 46% in patients with BRCA2 alterations and 50% in those with BRCA1 alterations. Grade 3-4 adverse event rate was 48%; anemia, thrombocytopenia, and neutropenia were most common.
Study details: A multicenter, phase 2 TALAPRO-1 trial of 127 heavily pretreated patients with metastatic, CRPC with alterations in DDR genes who received talazoparib; 104 patients had measurable soft tissue disease.
Disclosures: This study was funded by Pfizer. The authors received grants/funding, consulting fees, travel/accommodation expenses, and/or honoraria from and/or reported employment and/or stock ownership in companies. Dr. JS de Bono also reported patent ownership.
Source: de Bono JS et al. Lancet Oncol. 2021 Aug 10. doi: 10.1016/ S1470-2045(21)00376-4.
Key clinical point: Talazoparib shows antitumor response in heavily pretreated patients with metastatic, castration-resistant prostate cancer (CRPC) with alterations in DNA damage repair (DDR) genes.
Major finding: The median follow-up was 16.4 months. The confirmed objective response rate (ORR) was 29.8%. The ORR was 46% in patients with BRCA2 alterations and 50% in those with BRCA1 alterations. Grade 3-4 adverse event rate was 48%; anemia, thrombocytopenia, and neutropenia were most common.
Study details: A multicenter, phase 2 TALAPRO-1 trial of 127 heavily pretreated patients with metastatic, CRPC with alterations in DDR genes who received talazoparib; 104 patients had measurable soft tissue disease.
Disclosures: This study was funded by Pfizer. The authors received grants/funding, consulting fees, travel/accommodation expenses, and/or honoraria from and/or reported employment and/or stock ownership in companies. Dr. JS de Bono also reported patent ownership.
Source: de Bono JS et al. Lancet Oncol. 2021 Aug 10. doi: 10.1016/ S1470-2045(21)00376-4.
Prostate cancer: Oral relugolix has efficacy and safety comparable with parenteral degarelix
Key clinical point: A network meta-analysis suggests that relugolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, had similar efficacy and safety to parenteral degarelix.
Major finding: Compared with GnRH agonists, there was no significant difference in castration rate at 12 months with relugolix (risk ratio [RR], 1.09; 95% credible interval [CrI], 0.95-1.23) and degarelix (RR, 0.98; 95% CrI, 0.91-1.06). Efficacy ranking analyses showed that relugolix was the most effective medical castration drug to induce sustained castration at 12 months. Compared with GnRH agonists, adverse events rates were similar with relugolix (RR, 0.99; 95% CrI, 0.6-1.6) and degarelix (RR, 1.1; 95% CrI, 0.75-1.35).
Study design: A network meta-analysis of 4 studies compared relugolix and degarelix with GnRH antagonists in 2,059 patients with advanced prostate cancer.
Disclosures: The study did not receive any funding. The authors declared no competing interest.
Source: Motlagh RS et al. Eur Urol Oncol. 2021 Jul 20. doi: 10.1016/j.euo.2021.07.002.
Key clinical point: A network meta-analysis suggests that relugolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, had similar efficacy and safety to parenteral degarelix.
Major finding: Compared with GnRH agonists, there was no significant difference in castration rate at 12 months with relugolix (risk ratio [RR], 1.09; 95% credible interval [CrI], 0.95-1.23) and degarelix (RR, 0.98; 95% CrI, 0.91-1.06). Efficacy ranking analyses showed that relugolix was the most effective medical castration drug to induce sustained castration at 12 months. Compared with GnRH agonists, adverse events rates were similar with relugolix (RR, 0.99; 95% CrI, 0.6-1.6) and degarelix (RR, 1.1; 95% CrI, 0.75-1.35).
Study design: A network meta-analysis of 4 studies compared relugolix and degarelix with GnRH antagonists in 2,059 patients with advanced prostate cancer.
Disclosures: The study did not receive any funding. The authors declared no competing interest.
Source: Motlagh RS et al. Eur Urol Oncol. 2021 Jul 20. doi: 10.1016/j.euo.2021.07.002.
Key clinical point: A network meta-analysis suggests that relugolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, had similar efficacy and safety to parenteral degarelix.
Major finding: Compared with GnRH agonists, there was no significant difference in castration rate at 12 months with relugolix (risk ratio [RR], 1.09; 95% credible interval [CrI], 0.95-1.23) and degarelix (RR, 0.98; 95% CrI, 0.91-1.06). Efficacy ranking analyses showed that relugolix was the most effective medical castration drug to induce sustained castration at 12 months. Compared with GnRH agonists, adverse events rates were similar with relugolix (RR, 0.99; 95% CrI, 0.6-1.6) and degarelix (RR, 1.1; 95% CrI, 0.75-1.35).
Study design: A network meta-analysis of 4 studies compared relugolix and degarelix with GnRH antagonists in 2,059 patients with advanced prostate cancer.
Disclosures: The study did not receive any funding. The authors declared no competing interest.
Source: Motlagh RS et al. Eur Urol Oncol. 2021 Jul 20. doi: 10.1016/j.euo.2021.07.002.