Heterogeneity in subgroup reporting across clinical trials assessing systemic therapies in metastatic castration resistant prostate cancer: A report from a living systematic review.

Author: Jajja, Salman Ayub ; Riaz, Irbaz Bin ; Parikh, Rahul Atul ; Anjum, Muhammad Umair ; Garje, Rohan ; Naqvi, Syed Arsalan Ahmed ; Khakwani, Kaneez Zahra Rubab ; Raina, Ammad ; Rumble, Bryan ; Khan, Muhammad Ali ; Bryce, Alan Haruo ; Singh, Parminder ; Zakharia, Yousef

10 Feb 2025·Journal of Clinical Oncology

Survival in advanced prostate cancer (PCa) patients with visceral metastasis: A population-based SEER study.

Author: Childs, Daniel S ; Bryce, Alan Haruo ; Naqvi, Syed Arsalan Ahmed ; Cobran, Ewan Kemar ; Khan, Muhammad Ali ; Jajja, Salman Ayub ; Zakharia, Yousef ; Swati, Fnu ; Riaz, Irbaz Bin ; Anjum, Muhammad Umair ; Raina, Ammad ; Afzal, Muhammad Umar ; Singh, Parminder ; Riaz, Zaryab Bin ; Jain, Prateek

134Background: Prostate cancer patients with visceral metastases at diagnosis are often treated using one-size-fits-all approach. For example, CHAARTED criteria treats any visceral metastasis as high volume. Therefore, we aimed to assess overall survival (OS) by site of visceral involvement in patients with metastatic PCa. Methods: Surveillance, Epidemiology, and End Results (SEER) database (2010-2021) was queried to obtain case listing data on metastatic PCa patients from 17 registries. The patients were categorized into three groups based on visceral metastasis at diagnosis: lung metastasis, liver metastasis, and others. Kaplan-Meier survival analysis was performed to estimate median OS with 95% confidence interval (CI). Log-rank test was conducted to assess if survival was significantly different among the groups. Cox proportional hazard regression analysis was performed to assess the magnitude of difference among the groups. P-value <0.05 established statistical significance. Results: This analysis included 21,007 metastatic PCa patients (lung: n=319; liver: n=123; brain: 107; bone: 20538). Metastatic PCa population with lung metastasis exhibited a median OS of 60 months (95% CI: 48-72) compared to 24 months (95% CI: 12-36) in population with liver metastases and to 36 months (95% CI: 36-36) in population with other metastases. The difference in OS among the groups was statistically significant (p < 0.001). Compared to population with lung metastasis, those with liver (HR: 1.91; 95% CI: 1.41-2.57) but not those with other metastases (1.16; 0.97-1.39) had significantly worse OS adjusting for Gleason score, PSA and race (Table). Conclusions: In metastatic PCa, patients with lung-only metastasis have significantly better overall survival and should be considered differently in prognostication to liver metastases. Consideration of site of visceral metastasis is critical for treatment intensification decisions. Limitations of this analysis include lack of accounting for confounding relationships at individual patient level. VariableHazard Ratio (95% CI)Metastases (Lung)REFERENCEMetastases (Liver)1.91 (1.41-2.57)Metastases (Other)1.16 (0.97-1.39)Gleason score≥8REFERENCEGleason score <80.68 (0.64 -0.72)PSA - ng/dL1.01 (1.00 – 1.01)Race (White)REFERENCERace (Black)0.99 (0.94 – 1.05)Race (Asian or Pacific Islander)0.70 (0.64 – 0.76)

01 Jun 2024·Journal of Clinical Oncology

First-line (1L) systemic therapy in locally advanced/metastatic urothelial cancer (Ia/mUC): A living interactive systematic review and network meta-analysis.

Author: Saxena, Akshat ; Bryce, Alan Haruo ; Khan, Muhammad Ali ; Raina, Ammad ; Channar, Aneeta ; Khakwani, Kaneez Zahra Rubab ; Singh, Parminder ; Bibi, Arifa ; Tripathi, Nikita ; Childs, Daniel S ; Riaz, Irbaz Bin ; Naqvi, Syed Arsalan Ahmed

e16579 Background: Recent results from EV 302 and CheckMate 901 have transformed the treatment landscape of untreated locally advanced/metastatic urothelial cancer (Ia/mUC). Here, we present the most up-to-date evidence of comparative efficacy and safety of first line (1L) treatment options in Ia/mUC with emphasis on Enfortumab vedotin (EV)-pembrolizumab (P) and gemcitabine (Gem)-cisplatin (Cis)-nivolumab (N). Methods: This living systematic review used the living interactive evidence (LIvE) synthesis framework. Full-text and abstract publications of phase II/III randomized clinical trials comparing 1L immunotherapy combined with chemotherapy (IO+C) or immunotherapy alone (IO) regimens with platinum-based chemotherapy (Plat) in Ia/mUC were included. Outcomes of interest included overall survival (OS), progression-free survival (PFS) and treatment-related grade 3 or greater adverse events (≥G3 TRAE). Mixed treatment comparisons were made using network meta-analysis. P-scores were computed to assess relative treatment rankings. Results: A total of 5 trials (8 references) with 4,749 patients and 9 unique treatments were included. EV-P and Gem-Cis-N were ranked first and second in terms of OS and PFS improvement. EV-P improved OS compared to Gem-Cis-N (HR: 0.60; 0.45-0.81), Gem-Plat-atezolizumab(A) (0.55; 0.42-0.72), durvalumab(D)- tremelimumab(T) (0.55; 0.42-0.72), Gem-Plat-P (0.55; 0.42-0.72), P (0.51; 0.39-0.68), D (0.47; 0.36-0.63), A (0.48; 0.36-0.63) and Gem-Plat (0.47; 0.38-0.58). EV-P also improved PFS compared to Gem-Cis-N (0.63; 0.48-0.82), Gem-Plat-A (0.55; 0.43-0.69), D-T (0.42; 0.33-0.53), Gem-Plat-P (0.58; 0.45-0.74), P (0.34; 0.26-0.44), D (0.35; 0.27-0.44) and Gem-Plat (0.45; 0.38- 0.54). For ≥G3 TRAE, A was ranked first with the lowest adverse events compared to others. EV-P (rank 5) had significantly fewer events compared to Gem-Plat, Gem-Plat-A, Gem-Cis-N and Gem-Plat-P. Gem-Cis-N was ranked last with significantly greater events compared to A, P, D, D-T, Gem-Plat, EV-P, and Gem-Plat-A (Table with ranks [p-scores]). Conclusions: Current evidence suggests that patients with untreated la/mUC experience improved survival and slower disease progression with EV-P when compared to other contemporary options. Gem-Cis-N may be a reasonable alternative in patients who are cisplatin-eligible. Cost and access to these treatments are crucial and should be considered to facilitate shared decision making. [Table: see text]

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