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Lymphoma

HD-MT With/Without IT-MT and WBRT for Primary CNS Lymphoma

KEY TAKEAWAYS The study aimed to evaluate the efficacy and safety of HD-MT with or without IT-MT and WBRT for PCNSL. The results showed no significant difference in efficacy between HD-MT alone or with IT-MT plus radiotherapy, with manageable side effects. Primary...

Sep 19, 2024

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DARO Enhances Survival and Efficacy in Metastatic Prostate Cancer

KEY TAKEAWAYS

  • The ARANOTE phase III trial compared the effectiveness of DARO plus ADT vs ADT alone in patients with mHSPC.
  • The primary endpoint was to determine rPFS.
  • The DARO showed significant efficacy and good tolerability in mHSPC.

In the ARASENS trial, combining darolutamide (DARO) with androgen deprivation therapy (ADT) and docetaxel significantly improved overall survival (OS) compared to ADT plus docetaxel alone for patients with metastatic hormone-sensitive prostate cancer (mHSPC). The incidence of treatment-emergent adverse events (TEAEs) was similar across both treatment groups.

Fred Saad and the team aimed to compare the efficacy of DARO plus ADT versus ADT alone in patients with mHSPC.

The inclusion criteria for eligible patients was mHSPC, confirmed by imaging, with an ECOG performance status of 0-2 and had started ADT within the past 12 weeks.

The selected patients were randomly assigned in a 2:1 ratio to receive either DARO 600 mg twice daily or a placebo, both along with ADT. The primary goal was to measure radiological progression-free survival (rPFS), while secondary goals included OS, time to further therapy, and safety.

The results showed that 669 patients were enrolled (DARO: 446; placebo: 223), with a median age of 70 years. Of all, 31% were Asian, 9.7% were Black, the median PSA at baseline was 21.3 ng/mL, and 71% had high-volume HSBC. The DARO + ADT combination significantly improved rPFS compared to placebo + ADT (HR 0.54; 95% CI: 0.41-0.71, P<0.0001), showing consistent benefits across different patient subgroups.

DARO also demonstrated a positive trend in OS (HR 0.81; 95% CI: 0.59-1.12) and showed benefits in secondary endpoints like time to CRPC (HR 0.40; 95% CI: 0.32–0.51), PSA progression (HR 0.31; 95% CI 0.23–0.41), subsequent therapy (HR 0.40; 95% CI, 0.29–0.56) and pain progression (HR 0.72, 95% CI: 0.54-0.96). The TEAE was similar between groups, with fewer discontinuations due to adverse events (AEs) in the DARO group (6.1% vs. 9.0%).

The study concluded that DARO demonstrates strong efficacy and favorable tolerability in mHSPC, as confirmed by ARANOTE. ARASENS and ARANOTE show DARO’s benefits with and without chemotherapy, offering personalized treatment options with minimal progression and treatment burden.

The trial was sponsored by Bayer.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/18

Clinical Trials: https://clinicaltrials.gov/study/NCT04736199

Saad F, Vjaters E, Shore ND, et al. (2024). “Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial.” Presented at ESMO-2024 (Abstract LBA68)

Impact of Metformin on OS in mHSPC: STAMPEDE

KEY TAKEAWAYS

  • The study aimed to assess the effect of metformin on OS and metabolic outcomes in mHSPC with ADT.
  • Metformin did not improve survival in all metastatic patients but enhanced outcomes and metabolic parameters in high-volume cases.

Metformin is a commonly used and well-tolerated anti-diabetic medication. Previous research indicates that metformin may possess anti-cancer properties across various malignancies, including prostate cancer. This study hypothesized that metformin could mitigate the metabolic adverse effects associated with androgen deprivation therapy (ADT) and potentially enhance overall survival through these effects.

Silke Gillessen and the team aimed to assess the impact of combining metformin with ADT on overall survival and metabolic parameters in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

They performed an inclusive analysis of non-diabetic patients with metastatic hormone-sensitive prostate cancer who were randomly allocated 1:1 to receive either standard of care (SOC) or SOC plus metformin within the STAMPEDE trial. SOC included ADT with or without radiotherapy, docetaxel, or an androgen receptor pathway inhibitor (ARPI).

The primary outcome was overall survival (OS), with a target hazard ratio (HR) of 0.8, providing 92% power and a 2.5% one-sided significance level. Seven pre-specified subgroup analyses were conducted but were not pre-powered.

About 1,874 patients with metastatic hormone-sensitive prostate cancer were randomized from September 2016 to March 2023. The arms were well balanced: median age 69 years (IQR 63-73); median PSA 84 ng/ml (IQR 24-352); 1,758 patients (94%) had de novo disease, and 116 (6%) had relapsed disease. Planned SOC included 82% receiving docetaxel and 3% receiving an ARPI. After a median follow-up of 60 months, the HR for OS between the arms was 0.91 (P=0.148; 95% CI 0.80-1.03).

The median OS was 63 months (95% CI 58-69) in the SOC arm and 69 months (95% CI 63-73) in the SOC plus metformin arm. In patients with high versus low volume disease (CHAARTED definition), the HR was 0.79 (P=0.006; 95% CI 0.66-0.93) and 1.0 (P=0.992; 95% CI 0.79-1.26), respectively, with an interaction P-value of 0.086.

For progression-free survival (PFS), the overall HR was 0.92 (P=0.164; 95% CI 0.81-1.04), with HRs of 0.76 (P=0.001; 95% CI 0.64-0.89) and 1.10 (P=0.401; 95% CI 0.88-1.37) in the high and low volume subgroups, respectively, with an interaction P-value of 0.006.

Metabolic parameters that improved significantly with metformin included reduced weight gain, fasting glucose, HbA1c, and total and LDL cholesterol. Fewer patients developed metabolic syndrome. Adverse events (AE) of grade 3 or higher were reported in 52% of the SOC arm and 57% of the SOC plus metformin arm, with gastrointestinal AEs increasing with metformin.

The study concluded that metformin does not improve survival in unselected metastatic patients but may enhance cancer outcomes and survival in patients with high-volume disease. Additionally, metabolic parameters were significantly improved overall.

The trial was sponsored by the Medical Research Council.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/18

Clinical Trial: https://clinicaltrials.gov/study/NCT00268476

Gillessen S, Murphy L.R, James N.D, et al. (2024). “LBA70 – Adding metformin to androgen deprivation therapy (ADT) for patients (pts) with metastatic hormone sensitive prostate cancer (mHSPC): Overall survival (OS) results from the multi-arm, multi-stage randomised platform trial STAMPEDE.” Presented at ESMO 2024 (Abstract LBA70).

Belzutifan Shows PFS Benefits Over Everolimus in ccRCC

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy of belzutifan vs everolimus in improving PFS and ORR in patients with ccRCC.
  • The primary endpoints were to determine PFS and OS.
  • Researchers noted that belzutifan showed PFS and ORR benefits over everolimus but did not significantly improve OS.

Compared to everolimus, Belzutifan significantly improved progression-free survival (PFS) and objective response rate (ORR) in patients with advanced clear cell renal cell carcinoma (ccRCC), who had previously received immune checkpoint and antiangiogenic agents.

Brian I. Rini and the team aimed to assess the comparative efficacy of belzutifan versus everolimus in this patient population.

They conducted a comprehensive analysis of adults with advanced ccRCC who had undergone 1–3 prior systemic treatments, including at least 1 PD-(L)1 inhibitor and one VEGFR-TKI. Participants were randomized 1:1 to receive either belzutifan 120 mg or everolimus 10 mg daily until disease progression or unacceptable adverse events occurred.

The dual primary endpoints were PFS and overall survival (OS), evaluated per RECIST 1.1 by central review. The key secondary endpoint was the ORR, also assessed per RECIST 1.1 by central review. Duration of response (DOR) and safety were additional secondary endpoints. Formal statistical testing for PFS and ORR was not performed at the final analysis, as positive results for these endpoints had already been established at the first interim analysis.

About 746 patients were allocated to belzutifan (n=374) or everolimus (n=372). At the final analysis (data cutoff: April 15, 2024), the median follow-up was 35.8 months (range 26.9–49.2); 14.5% of patients remained on treatment with belzutifan compared to 1.4% with everolimus. Belzutifan maintained a PFS benefit over everolimus (median 5.6 months vs 5.6 months; HR 0.75; 95% CI 0.63–0.88), with estimated PFS rates at 12 months (33.7% vs 17.6%) and at 24 months (17.5% vs 4.1%) favoring belzutifan.

The median OS was 21.4 months with belzutifan compared to 18.2 months with everolimus (HR 0.92; 95% CI 0.77–1.10; P=0.18). Estimated OS rates were 67.9% vs 65.8% at 12 months and 45.2% vs 41.2% at 24 months. The ORR was consistent with prior reports (22.7% vs 3.5%). Median (range) DOR was 19.3 months (1.9+–40.1+) vs 13.7 months (3.8–29.5+).

Fewer patients discontinued belzutifan (6.2%) compared to everolimus (15.3%) due to any-cause adverse events. The median duration of therapy was longer with belzutifan (7.6 months vs 3.9 months). The rate of grade ≥3 treatment-related adverse events (TRAEs) was similar between the 2 arms (39.5% vs 40.0%).

The study concluded that belzutifan continued to demonstrate benefits in PFS and ORR compared to everolimus, although a significant improvement in OS was not observed. With over 2 years of minimum follow-up, the safety profile of belzutifan remained consistent with prior reports. The final analysis results of LITESPARK-005 support belzutifan as a viable treatment option for advanced ccRCC following PD-(L)1 inhibitor and VEGFR-TKI therapy.

The study was sponsored by the Merck Sharp & Dohme LLC.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/14

Clinical Trial: https://clinicaltrials.gov/study/NCT04195750

Rini B.I, Rodriguez C.S, Albiges L, et al. (2024). “Final analysis of the phase III LITESPARK-005 study of belzutifan versus everolimus in participants (pts) with previously treated advanced clear cell renal cell carcinoma (ccRCC).” Presented at ESMO 2024 (Abstract LBA74).

Impact of Metformin on OS in mHSPC: STAMPEDE

Impact of Metformin on OS in mHSPC: STAMPEDE

KEY TAKEAWAYS

  • The study aimed to assess the effect of metformin on OS and metabolic outcomes in mHSPC with ADT.
  • Metformin did not improve survival in all metastatic patients but enhanced outcomes and metabolic parameters in high-volume cases.

Metformin is a commonly used and well-tolerated anti-diabetic medication. Previous research indicates that metformin may possess anti-cancer properties across various malignancies, including prostate cancer. This study hypothesized that metformin could mitigate the metabolic adverse effects associated with androgen deprivation therapy (ADT) and potentially enhance overall survival through these effects.

Silke Gillessen and the team aimed to assess the impact of combining metformin with ADT on overall survival and metabolic parameters in patients with metastatic hormone-sensitive prostate cancer (mHSPC).

They performed an inclusive analysis of non-diabetic patients with metastatic hormone-sensitive prostate cancer who were randomly allocated 1:1 to receive either standard of care (SOC) or SOC plus metformin within the STAMPEDE trial. SOC included ADT with or without radiotherapy, docetaxel, or an androgen receptor pathway inhibitor (ARPI).

The primary outcome was overall survival (OS), with a target hazard ratio (HR) of 0.8, providing 92% power and a 2.5% one-sided significance level. Seven pre-specified subgroup analyses were conducted but were not pre-powered.

About 1,874 patients with metastatic hormone-sensitive prostate cancer were randomized from September 2016 to March 2023. The arms were well balanced: median age 69 years (IQR 63-73); median PSA 84 ng/ml (IQR 24-352); 1,758 patients (94%) had de novo disease, and 116 (6%) had relapsed disease. Planned SOC included 82% receiving docetaxel and 3% receiving an ARPI. After a median follow-up of 60 months, the HR for OS between the arms was 0.91 (P=0.148; 95% CI 0.80-1.03).

The median OS was 63 months (95% CI 58-69) in the SOC arm and 69 months (95% CI 63-73) in the SOC plus metformin arm. In patients with high versus low volume disease (CHAARTED definition), the HR was 0.79 (P=0.006; 95% CI 0.66-0.93) and 1.0 (P=0.992; 95% CI 0.79-1.26), respectively, with an interaction P-value of 0.086.

For progression-free survival (PFS), the overall HR was 0.92 (P=0.164; 95% CI 0.81-1.04), with HRs of 0.76 (P=0.001; 95% CI 0.64-0.89) and 1.10 (P=0.401; 95% CI 0.88-1.37) in the high and low volume subgroups, respectively, with an interaction P-value of 0.006.

Metabolic parameters that improved significantly with metformin included reduced weight gain, fasting glucose, HbA1c, and total and LDL cholesterol. Fewer patients developed metabolic syndrome. Adverse events (AE) of grade 3 or higher were reported in 52% of the SOC arm and 57% of the SOC plus metformin arm, with gastrointestinal AEs increasing with metformin.

The study concluded that metformin does not improve survival in unselected metastatic patients but may enhance cancer outcomes and survival in patients with high-volume disease. Additionally, metabolic parameters were significantly improved overall.

The trial was sponsored by the Medical Research Council.

Source: https://cslide.ctimeetingtech.com/esmo2024/attendee/confcal/show/session/18

Clinical Trial: https://clinicaltrials.gov/study/NCT00268476

Gillessen S, Murphy L.R, James N.D, et al. (2024). “LBA70 – Adding metformin to androgen deprivation therapy (ADT) for patients (pts) with metastatic hormone sensitive prostate cancer (mHSPC): Overall survival (OS) results from the multi-arm, multi-stage randomised platform trial STAMPEDE.” Presented at ESMO 2024 (Abstract LBA70).

Safety & Efficacy of Imidafenacin for Post-RARP Incontinence

KEY TAKEAWAYS

  • The study aimed to investigate the efficacy and safety of imidafenacin for managing detrusor overactivity following RARP.
  • Researchers noticed that imidafenacin improves urinary incontinence after RARP, even with preserved sphincter function.

Jun Hee Lee and the team aimed to prospectively analyze the effects of anticholinergic therapy with imidafenacin on detrusor overactivity following robot-assisted radical prostatectomy (RARP) also known as prostate cancer surgery. The investigation focuses on evaluating how imidafenacin, an anticholinergic agent, influences urinary symptoms resulting from bladder changes after RARP, specifically targeting the management of persistent urinary incontinence.

They performed an inclusive analysis by following up with patients at outpatient visits 2-4 weeks post-surgery (visit 2) to confirm the presence of urinary incontinence. Those diagnosed with urinary incontinence were then randomly assigned in a 1:1 ratio to receive either the anticholinergic medication (imidafenacin 0.1 mg twice daily) or standard care.

Subsequent follow-up visits at 1, 3, and 6 months post-surgery included observational assessments using the International Prostate Symptom Score (IPSS) and Overactive Bladder Symptom Score (OABSS) to evaluate the efficacy and safety of the treatment.

About 49 patients (25 in the treatment group and 24 in the control group) were randomized for the study. No significant differences were observed between the groups in terms of age, comorbidities, prostate size, or pathological staging. According to the IPSS questionnaire results, there was no statistically significant difference between the medication and control groups (P = 0.161).

However, when comparing storage and voiding symptoms separately, there was a statistically significant improvement in storage symptom scores (P = 0.012). OABSS also revealed a statistically significant improvement in symptoms starting from 3 months post-surgery (P = 0.005), which persisted until 6 months post-surgery (IPSS storage: P = 0.023, OABSS: P = 0.013).

The study concluded that in cases of urinary incontinence occurring after RARP, even with preserved intrinsic sphincter function, pharmacological therapy using imidafenacin can be beneficial in managing urinary incontinence when persistent due to changes in the bladder.

The study was funded by the Chong Kun Dang Pharmaceutical Corporation.

Source: https://pubmed.ncbi.nlm.nih.gov/39249919/

Lee JH, Goh HJ, Lee K, et al. (2024). “Efficacy and safety evaluation of imidafenacin administered twice daily for continency recovery following radical prostatectomy in prostate cancer patients: Prospective open-label case-controlled randomized trial.” Investig Clin Urol. 2024;65(5):466-472. doi:10.4111/icu.20240129

Impact of QoL and Optimism on Prognostic Views in mRCC and mBC

KEY TAKEAWAYS

  • The study aimed to evaluate perceptions of treatment outcomes in patients with mRCC and mBC, focusing on the role of optimism and QoL.
  • Most patients with mRCC and mBC had inaccurate views on treatment outcomes, linked to higher QoL and optimism.

Durable complete response rates for metastatic renal cell carcinoma (mRCC) and metastatic bladder cancer (mBC) remain low despite advancements in therapy. Palliative care prioritizes life extension and improving quality of life (QoL) rather than a cure.

Hatice Bolek and the team aimed to examine how patients with mRCC and mBC perceive treatment outcomes and how QoL and optimism impact these perceptions.

Between March 15, 2023, and January 15, 2024, researchers conducted a multicenter, cross-sectional online survey targeting patients diagnosed with mRCC and mBC. The survey included structured questions assessing perceptions of disease cure, symptom improvement, daily activity performance, and life extension from treatment.

To measure optimism and QoL, the European Organization for Research and Treatment of Cancer 30.3 QoL questionnaire and the Life Orientation Test were used. The study revealed high optimism and inaccurate beliefs about cure among patients.

About 169 patients participated in the survey, with the majority rating their general health as good (72.2%) and excellent (13.6%). Patients who rated their health as good-excellent had higher median general QoL and optimism scores than those who rated it fair-poor. Overall, 85.2% of patients believed the possibility of a cure was very likely or likely.

Most participants thought treatment would relieve symptoms (30.2% very likely, 49.1% likely), improve daily activity performance (28.4% very likely, 55.6% likely), and extend life (32.5% very likely, 53.3% likely). Patients who responded very likely and likely to these questions had higher QoL and optimism scores than those who responded a little likely or not possible.

The study concluded that most patients with mRCC and mBC held inaccurate beliefs about treatment outcomes. Higher QoL and optimism were linked to greater inaccuracies in these perceptions.

Funding is provided by Roche, Novartis, BMS, Merck, AstraZeneca, Nektar, Johnson &Johnson, Lilly, Amgen, Incyte, Bayer, Yuhan, Henlius, Pfizer, Biontech, Genmab, Beigene, GSK.

Source: https://pubmed.ncbi.nlm.nih.gov/39208383/

Bolek H, Arslan C, Basaran M, et al. (2024). “Perceptions and Expectations: A Study on Prognostic Perception and Quality of Life in Patients With Metastatic Renal and Bladder Cancer.” JCO Glob Oncol. 2024;10:e2400201. doi:10.1200/GO.24.00201

ScRNA-seq Identifies M2 Macrophage Markers for PCa Prognosis

KEY TAKEAWAYS

  • The study aimed to investigate the prognostic value of M2 macrophages and their associated markers in PCa.
  • Researchers noticed that M2 macrophages and their associated genes are crucial predictors of PCa progression and metastasis.

Prostate cancer (PCa) is the highest malignant tumor among men globally, with the tumor microenvironment (TME) playing a critical role in tumor growth. M2 macrophages are implicated in the progression of various solid tumors, including PCa.

Yitian Ou and the team aimed to assess the role of M2 macrophages and their associated genes in predicting the occurrence, development, and metastasis of PCa.

They performed an inclusive analysis using Single-cell RNA-seq (scRNA-seq) and mRNA expression data from the Gene Expression Omnibus (GEO) and The Cancer Genome Atlas (TCGA). Quality control, normalization, reduction, clustering, and cell annotation of scRNA-seq data were conducted using the Seurat package.

Tumor-associated macrophages (TAMs) were analyzed to identify sub-populations and marker genes specific to M2 macrophages. Differentially expressed genes (DEGs) in PCa were determined with limma, and immune infiltration was assessed using CIBERSORTx.

A weighted correlation network analysis (WGCNA) was performed to identify M2 macrophage-related modules and genes. Marker genes from scRNA-seq data and hub genes from WGCNA were integrated to develop a prognostic gene signature using Univariate and LASSO regression analyses.

The risk score was calculated, and DEGs, biological functions, and immune characteristics related to the risk score were explored. Additionally, a predictive nomogram was constructed, and CCK8, Transwell, and wound healing assays were employed to validate cell phenotype changes in co-cultured patients.

About 2,431 marker genes of M2 macrophages and 650 hub M2 macrophage-related genes were identified through scRNA-seq data and WGCNA. An overlap of scRNA-seq data and WGCNA results yielded 113 M2 macrophage-related genes. Nine M2 macrophage-related genes (SMOC2, PLPP1, HES1, STMN1, GPR160, ABCG1, MAZ, MYC, and EPCAM) were selected as prognostic gene signatures.

The M2 risk score was calculated, and DEGs, immune scores, stromal scores, ESTIMATE scores, tumor purity, immune cell infiltration, immune checkpoint expression, and responses to immunotherapy and chemotherapy were assessed. Additionally, a predictive nomogram was constructed. CCK8, Transwell invasion, and wound healing assays further confirmed that M2 macrophages promoted the proliferation, invasion, and migration of PCa (P < 0.05).

The study concluded that M2 macrophages and their associated genes are crucial in promoting the occurrence, development, and metastasis of PCa, serving as reliable predictors for the disease.

The study was funded by the Natural Science Foundation of China (No. 81860453), the Yunnan Provincial Major Science and Technology Projects (No. 2018ZF009), and the Top Physician Project of Yunnan 2019. The Scientific Research Foundation Project of Yunnan Provincial Department of Education (2022Y195), and the Project of Yunnan Provincial Science and Technology (202301AT070321, 202201AY070001-119).

Source: https://pubmed.ncbi.nlm.nih.gov/39221762/

Ou Y, Xia C, Ye C, et al. (2024). “Comprehensive scRNA-seq analysis to identify new markers of M2 macrophages for predicting the prognosis of prostate cancer.” Ann Med. 2024;56(1):2398195. doi:10.1080/07853890.2024.2398195

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