Oncology Decoded

• 12: Beyond the BEP: A Deep Dive into Testicular Cancer Management

  In this episode of Oncology Decoded, hosts Manojkumar Bupathi, MD, MS, and Benjamin Garmezy, MD, spoke with Nabil Adra, MD, about testicular cancer care. The discussion gave a comprehensive overview of managing germ cell tumors, offering practical pearls for community oncologists. The conversation opened with the initial approach to a patient presenting with a testicular mass. The doctors emphasize the importance of a thorough workup, including a CT scan of the chest, abdomen, and pelvis, and the use of tumor markers: AFP and hCG. Adra noted that while AFP and hCG are elevated in about 60% of cases, it’s crucial to understand their half-lives—about 5 to 7 days for AFP and 1 to 2 days for hCG—to properly assess their decline post-orchiectomy. He clarified that an AFP level under 25 ng/mL is considered normal and that mild elevations in hCG can be linked to marijuana use or cross-reactivity with luteinizing hormone, which should be investigated before initiating chemotherapy. The panel also touches on the use of lactate dehydrogenase as a prognostic marker, cautioning against using it as the sole basis for starting treatment. A central part of the discussion revolves around the bleomycin, etoposide, cisplatin (BEP) vs etoposide and cisplatin chemotherapy regimens for good-risk disease. Adra explained the rationale behind the preference for BEP for 3 cycles at his institution, arguing that it avoids the long-term toxicities of neuropathy and ototoxicity associated with a fourth cycle of platinum therapy, a concern with the EP for 4 cycles. He stressed that with careful patient selection—avoiding bleomycin in patients over 50, with renal dysfunction, or pre-existing lung disease—the risk of pulmonary toxicity is minimal. He also influenced Garmezy’s practice by highlighting the importance of monitoring tumor markers with every cycle of chemotherapy, noting that a rising marker could signal a need to pivot to second-line therapy. The conversation shifted to the role of surgery in stage II disease. For patients with non-bulky (less than 3 cm) stage II seminoma or non-seminoma, the panel discusses the preference for a retroperitoneal lymph node dissection (RPLND) over upfront chemotherapy or radiation to spare patients from long-term side effects. Adra highlighted that a proper RPLND at an experienced center can be curative in 80% of cases. The doctors stressed the importance of referring patients to surgeons with extensive experience in these complex procedures. Finally, the hosts and guest tackled the management of relapsed/refractory disease. They discussed the 3 main options: salvage surgery, standard-dose chemotherapy, or high-dose chemotherapy with stem cell transplant. Adra shared that his institutional preference is for high-dose chemotherapy due to published data showing high cure rates, mentioning the ongoing phase 3 TIGER trial (NCT02375204), which is directly comparing standard-dose paclitaxel, ifosfamide, and cisplatin with high-dose chemotherapy. The episode concluded with a key pearl on managing patients with a high burden of pulmonary metastases, where a "cycle 0" of EP is sometimes used before starting a full course of vinblastine, ifosfamide, and cisplatin to mitigate the risk of hemoptysis. Bupathi, is executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers; Garmezy, is associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, and Adra is associate professor of Clinical Medicine and Clinical Urology, service line leader in medical oncology, medical director of Indiana University Health Simon Cancer Center, and program leader-genitourinary. 

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• 11: Navigating the Evolving Second-Line Landscape of Metastatic Urothelial Carcinoma

  The latest Oncology Decoded discussion with Manojkumar Bupathi, MD, MS, executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers, and Benjamin Garmezy, MD, associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, dissects the current management of metastatic urothelial carcinoma, with a focus on treatment strategies beyond standard first-line therapies. The conversation highlights the recent paradigm shift with the approval of enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda). This combination’s efficacy, as demonstrated in the phase 3 EV-302 trial (NCT04223856), has positioned it as a new standard of care for many patients. The alternative, gemcitabine plus cisplatin with nivolumab (Opdivo), supported by the phase 3 CheckMate 901 trial (NCT03036098), remains a crucial first-line option, particularly for patients who are cisplatin-eligible. The hosts delve into the nuances of second-line therapy, which has become a more complex and critical area. For patients who progress on enfortumab vedotin/pembrolizumab, the discussion covers options such as platinum-based chemotherapy with gemcitabine/cisplatin or carboplatin. The importance of biomarker-driven therapy is also emphasized, particularly the role of molecular testing for FGFR gene alterations. The FDA-approved FGFR inhibitor erdafitinib (Balversa) is highlighted as a viable option for patients with susceptible genetic alterations. Furthermore, the discussion touches on the evolving role of HER2-targeted agents and other novel early-phase assets that are being developed to address the unmet need in this patient population. Management of toxicities is also a significant theme. The clinicians share insights on mitigating adverse effects such as peripheral neuropathy from enfortumab vedotin, and the challenges of managing hyperglycemia and skin toxicities. The need for more data-driven guidance on treatment duration and maintenance therapy is also underscored, with the observation that treatment discontinuation is a common clinical challenge lacking clear guidelines. Reference FDA approves enfortumab vedotin-ejfv with pembrolizumab for locally advanced or metastatic urothelial cancer. News release. FDA. December 15, 2023. Accessed August 13, 2025. https://tinyurl.com/45wkm3bd

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• 10: Navigating Second-Line Treatment Options in Urothelial Carcinoma

  This episode of Oncology Decoded focuses on a discussion between hosts Manojkumar Bupathi, MD, MS, executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers, and Benjamin Garmezy, MD, associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, in a recent live session with US Oncology Network and the Pathways Task Force, discussing the evolving landscape of second-line and beyond therapy for urothelial carcinoma, particularly in the context of recent advancements in first-line treatment. First Line Strategies The current standard of care for frontline metastatic urothelial carcinoma is enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda). Recent data from the phase EV-302 trial (NCT04223856) presented at the 2025 American Society of Clinical Oncology (ASCO) highlighted the remarkable durability of responses with this combination, showing a 2-year durability in a significant proportion of responders, including 75% of complete responders.1 While this combination is favored for most patients, the hosts acknowledged a subgroup for whom it may not be suitable due to unique toxicities such as neuropathy, skin toxicity, and hyperglycemia.  The phase 3 Checkmate901 trial (NCT03036098), evaluating cisplatin/gemcitabine with nivolumab (Opdivo), is also mentioned as a prior standard of care, though generally superseded by enfortumab vedotin/pembrolizumab. For patients with lymph-node-only disease, both cisplatin/gemcitabine and nivolumab or enfortumab vedotin/pembrolizumab show comparable high response rates, necessitating shared decision-making. Second Line Strategies For patients progressing on enfortumab vedotin/pembrolizumab, the subsequent treatment landscape becomes more complex. Platinum-based chemotherapy doublets (cisplatin/gemcitabine or carboplatin/gemcitabine) are considered, though their efficacy in this heavily pretreated setting is limited and associated with significant toxicity. Molecular testing for FGFR alterations is crucial, as erdafitinib (Balversa) offers a targeted option with a 40% response rate in patients who are FGFR-positive. Managing erdafitinib toxicities, including nail changes, skin reactions, and phosphate level elevations, requires close monitoring and patient education. The potential role of HER2-targeted antibody-drug conjugates is also discussed, particularly for HER2 3+ expression, though data in urothelial carcinoma are limited. For patients without actionable biomarkers, single-agent taxanes (docetaxel, paclitaxel) have historically shown dismal response rates (~15-17%). Sacituzumab govitecan-hziy (Trodelvy), despite its accelerated approval withdrawal due to the confirmatory phase 2 TROPHY-U-01 trial (NCT03547973) not meeting statistical significance against single-agent chemotherapy, is still utilized by the speakers. They emphasize that with appropriate growth factor support, sacituzumab govitecan can be less toxic and equally efficacious as carboplatin/gemcitabine in select patients. References 1.        Bedke J, Powles TB, Valderrama BP, et al. EV-302: long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab (EV+P) vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC). J Clin Oncol. 2025;43(suppl 16):4571. doi:10.1200/JCO.2025.43.16_suppl.4571 2.        Van der Heijden M, Galsky M, Powles T, et al. Nivolumab plus ipilimumab (NIVO+IPI) vs gemcitabine-carboplatin (gem-carbo) chemotherapy for previously untreated unresectable or metastatic urothelial carcinoma (mUC): Final results for cisplatin-ineligible patients from the CheckMate 901 trial. J Clin Oncol. 2025;43(suppl 17):4500. doi:10.1200/JCO.2025.43.16_suppl.4500 3.        Gilead provides update on U.S. Indication for Trodelvy in metastatic urothelial cancer. News release. Gilead Sciences, Inc. October 18, 2024. Accessed July 30, 2025. https://tinyurl.com/2aku377j

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• 9: Unveiling Advances in GU Cancers: Insights from Oncology Decoded

  The Oncology Decoded podcast, co-hosted by Manojkumar Bupathi, MD, MS, executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers, and Benjamin Garmezy, MD, associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners specializing in genitourinary cancers, in a recent live session with US Oncology Network and the Pathways Task Force, delved into significant updates that were set to happen at the 2025 American Society of Clinical Oncology (ASCO), focusing on the genitourinary cancer landscape. Bupathi and Garmezy were joined by John M. Burke, MD, a hematologist and medical oncologist at Rocky Mountain Cancer Centers, and Dhaval R. Shah, MBBS, a medical oncologist from Christiana Care.  A primary focus of the discussion was the phase 3 KEYNOTE-564 trial (NCT03142334), a pivotal trial for patients with renal cell carcinoma (RCC). This study investigated pembrolizumab (Keytruda) as adjuvant therapy for patients with clear cell RCC who had undergone surgical resection and presented with intermediate-high or high-risk features.  Garmezy highlighted the "clear separation of the curves" in disease-free survival (DFS), with an HR of 0.68, and a compelling 5% difference in long-term overall survival, signifying a benefit for "about 1 in 20 patients". Despite about 20% of patients discontinuing treatment due to toxicity, the overall safety profile of pembrolizumab was considered well-tolerated, with no statistically significant difference in quality of life compared with placebo. Burke provided the panel with his perspective on evaluating such trials. He emphasized the importance of scrutinizing study design flaws, even in "randomized, double-blind, placebo-controlled, phase 3 clinical trials," which are often seen as the "epitome of great science". Key questions for consideration include the appropriateness of the control arm (placebo in KEYNOTE-564 was deemed appropriate), the validity of surrogate end points like DFS, and the presence of "informative censoring"—a form of bias that can skew results. Burke noted that informative censoring can occur if patients drop out of a trial due to disappointment with their randomized arm or due to drug toxicity, which can make the treatment arm's progression-free survival look better than it truly is. The discussion also touched upon the consistency of KEYNOTE-564’s findings with other trials. Garmezy noted that while pembrolizumab showed positive results, other adjuvant studies involving atezolizumab (Tecentriq), nivolumab (Opdivo), and nivolumab plus ipilimumab (Yervoy) had no significant difference, potentially due to differences in drug type or duration of therapy (6 vs 12 months). Shah affirmed that despite these nuances, the overall survival benefit seen in KEYNOTE-564 justifies the use of adjuvant pembrolizumab for eligible patients, emphasizing adherence to the exact trial criteria. Beyond kidney cancer, the podcast previewed discussions on the phase 3 NIAGARA trial (NCT03732677) for perioperative bladder cancer and the phase 3 TALAPRO-2 trial (NCT03395197) for first-line metastatic castrate-resistant prostate cancer (mCRPC). Bupathi highlighted the ongoing debate within the Pathways Committees regarding the integration of new data vs established practices, particularly concerning the timeline for new drugs to be incorporated into pathways. Burke clarified that while Pathways guides value-driven decisions, physicians retain the autonomy to prescribe off-pathway regimens, though financial implications might arise. The episode concluded with a look ahead to more data releases, underscoring the dynamic nature of oncology practice and the continuous evaluation of therapies for optimal patient care. Reference Choueiri TK, Tomczak P, Park SH, et al; KEYNOTE-564 Investigators. Overall survival with adjuvant pembrolizumab in renal-cell carcinoma. N Engl J Med. 2024;390(15):1359-1371. doi:10.1056/NEJMoa2312695

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• 8: ASCO 2025 Debrief: Key Updates in Genitourinary Cancer Management

  As part of the latest Oncology Decoded discussion, Manojkumar Bupathi, MD, MS, met with Benjamin Garmezy, MD, after the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to review data from the late-breaking abstracts, poster sessions, and other presentations of interest that may shift the paradigm across different genitourinary malignancies. Bupathi is the executive cochair of the Genitourinary Cancer Research Executive Committee at Sarah Cannon Research Institute (SCRI) and medical oncologist with Rocky Mountain Cancer Centers specializing in solid tumors and genitourinary cancers. Garmezy is the associate director of genitourinary research and executive cochair of the Genitourinary Cancer Research Executive Committee at SCRI and medical oncologist at SCRI Oncology Partners, also specializing in genitourinary cancers.  These experts highlighted their top abstracts and presentations from this year’s ASCO Annual Meeting, breaking down the results and clinical implications of key research in prostate cancer, bladder cancer, and other patient populations. Noteworthy studies and analyses included the following: ·      Phase 3 AMPLITUDE Trial (NCT04497844) o   Niraparib (Zejula) plus abiraterone acetate (Zytiga) with prednisone (AAP) reached the primary end point of radiographic progression-free survival (rPFS), reducing the risk of radiographic progression or death by 48% (HR, 0.52; 95% CI, 0.37-0.72; P <.0001) in the BRCA-mutated metastatic castration-sensitive prostate cancer (CSPC) population and 37% (HR, 0.63; 95% CI, 0.49-0.80; P = .0001) in the homologous recombination repair (HRR)–mutated subgroup vs AAP alone. o   The niraparib combination also improved time to symptomatic progression across the BRCA-mutant population (HR, 0.44; 95% CI, 0.29-0.68; P = .0001) and the HRR-mutant subgroup (HR, 0.50; 95% CI, 0.36-0.69; P <.0001). o   Overall, data from AMPLITUDE appear to support early genomic testing and reinforce niraparib plus AAP as a new therapeutic option for patients with metastatic CSPC harboring HRR alterations. ·      Phase 3 NIAGARA Trial (NCT03732677) o   Investigators found circulating tumor DNA (ctDNA) status to be highly prognostic for outcomes among patients who received perioperative durvalumab (Imfinzi) plus neoadjuvant chemotherapy for muscle-invasive bladder cancer (MIBC). o   Across the treatment arms in the NIAGARA trial, ctDNA-negative status conferred improvements in event-free survival (EFS) vs ctDNA positivity (HR, 0.42; 95% CI, 0.30-0.60). o   Adding nivolumab to neoadjuvant chemotherapy increased the rate of ctDNA clearance by 13% vs the use of chemotherapy alone. ·      Phase 2 SURE-02 Trial (NCT05535218) o   Combining perioperative sacituzumab govitecan-hziy (Trodelvy) with pembrolizumab (Keytruda) produced clinical complete responses in 44.4% (95% CI, 27.9%-61.9%) of patients with MIBC. o   The study treatment allowed for bladder preservation without chemoradiotherapy in 74% of patients who refused radical cystectomy. o   The data demonstrated a potentially safe and effective approach for patients with no standard-of-care options at the time of refusing radical cystectomy. References 1. Attard G, Agarwal N, Graff J, et al. Phase 3 AMPLITUDE trial: niraparib (NIRA) and abiraterone acetate plus prednisone (AAP) for metastatic castration-sensitive prostate cancer (mCSPC) patients (pts) with alterations in homologous recombination repair (HRR) genes. J Clin Oncol. 2025;43(suppl 17):LBA5006. doi:10.1200/JCO.2025.43.17_suppl.LBA5006 2. Powles T, Van Der Heijden M, Wang Y, et al. Circulating tumor DNA (ctDNA) in patients with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. J Clin Oncol. 2025;43(suppl 16):4503.doi:10.1200/JCO.2025.43.16_suppl.4503 3. Necchi A, de Jong J, Proudfoot J, et al. First results of SURE-02: A phase 2 study of neoadjuvant sacituzumab govitecan (SG) plus pembrolizumab (pembro), followed by response-adapted bladder sparing and adjuvant pembro, in patients with muscle-invasive bladder cancer (MIBC). J Clin Oncol. 2025;43(suppl 16):4518. doi:10.1200/JCO.2025.43.16_suppl.4518

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