59 research outputs found
Determining Front-Line Therapeutic Strategy for Metastatic Clear Cell Renal Cell Carcinoma
The therapeutic landscape for metastatic renal cell carcinoma has rapidly evolved over the years, and we are now in an era of combination therapy strategies employing immune checkpoint blockade and anti-angiogenesis targeted therapy. Since 2018, we have gained regulatory approval for four distinct combination therapies, all with survival benefits, and with guideline recommendation for use in the front-line setting. As such, treatment selection has become increasingly complex with a myriad of treatment choices but little high-level head-to-head data to guide treatment selection. Heterogeneity in tumor biology further complicates treatment selection as tumors vary in behavior and treatment responsiveness. Ongoing development of biomarkers will certainly assist in this setting, and validation of predictive markers represents an unmet need. In their absence, we highlight features of disease and nuances to datasets from landmark prospective clinical trials to help inform treatment selection. There is growing evidence to support deferring upfront systemic therapy in some patients, with opportunities for active surveillance or metastasis-directed therapy. In others, upfront systemic therapy is warranted and necessitates thoughtful consideration of multiple clinicopathologic parameters to inform optimal patient-centered decision making
Temporal Trends in Grade 3/4 Adverse Events and Associated Costs of Nivolumab Plus Cabozantinib Versus Sunitinib for Previously Untreated Advanced Renal Cell Carcinoma
Advanced Renal Cell Carcinoma; Adverse Events; NivolumabCarcinoma de células renales avanzado; Eventos adversos; NivolumabCarcinoma de cÚl·lules renals avançat; Esdeveniments adversos; NivolumabBackground and Objectives
Novel immunotherapy-based combination treatments have drastically improved clinical outcomes for previously untreated patients with advanced/metastatic renal cell carcinoma (aRCC). This study aimed to assess the temporal trends in grade 3/4 adverse event (AE) rates and associated costs of nivolumab plus cabozantinib combination therapy versus sunitinib monotherapy in previously untreated patients with aRCC.
Methods
Individual patient data from the CheckMate 9ER trial (nivolumab plus cabozantinib: N = 320; sunitinib: N = 320) were used to calculate the proportion of patients experiencing grade 3/4 AEs. AE unit costs were obtained from the United States (US) 2017 Healthcare Cost and Utilization Project (HCUP) and inflated to 2020 US dollars. Per-patient-per-month (PPPM) all-cause and treatment-related grade 3/4 AE costs over 18-months, temporal trends, and top drivers of AE costs were evaluated in both treatment arms.
Results
Overall, the proportion of patients experiencing grade 3/4 AEs decreased over time, with the highest rates observed in the first 3 months for the nivolumab plus cabozantinib and sunitinib arms. Compared with sunitinib, nivolumab plus cabozantinib was associated with consistently lower average all-cause AE costs PPPM [month 3: 3097 (p 0.05); month 18: 1755 (p > 0.05)]. Over 18 months, metabolism and nutrition disorders (182), and general disorders and administration site conditions (443), blood and lymphatic system disorders (177) were the costliest in the sunitinib arm. Trends of treatment-related AE costs were consistent with all-cause AE costs.
Conclusions
Nivolumab plus cabozantinib was associated with lower costs of grade 3/4 AE management PPPM than sunitinib, which accumulated over the 18-month study period
Grade 3/4 Adverse Event Costs of Immuno-oncology Combination Therapies for Previously Untreated Advanced Renal Cell Carcinoma
Advanced renal cell carcinoma; Adverse event cost; Nivolumab plus cabozantinibCarcinoma de células renales avanzado; Coste de eventos adversos; Nivolumab mås cabozantinibCarcinoma de cÚl·lules renals avançat; Cost d'esdeveniments adversos; Nivolumab més cabozantinibBackground
Despite 4 approved combination regimens in the first-line setting for advanced renal cell carcinoma (aRCC), adverse event (AE) costs data are lacking.
Materials and Methods
A descriptive analysis on 2 AE cost comparisons was conducted using patient-level data for the nivolumab-based therapies and published data for the pembrolizumab-based therapies. First, grade 3/4 AE costs were compared between nivolumabâ
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ipilimumab vs. nivolumabâ
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cabozantinib vs. pembrolizumabâ
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axitinib using data from the CheckMate 214 (median follow-up [mFU]: 13.1 months), CheckMate 9ER (mFU: 12.8 months), and KEYNOTE-426 (mFU: 12.8 months) trials, respectively. Second, grade 3/4 AE costs were compared between nivolumabâ
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ipilimumab vs. nivolumabâ
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cabozantinib vs. pembrolizumabâ
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lenvatinib using data from the CheckMate 214 (mFU: 26.7 months), CheckMate 9ER (mFU: 23.5 months), and KEYNOTE-581 (mFU: 26.6 months) trials, respectively. Per-patient costs for all-cause and treatment-related grade 3/4 AEs with corresponding any-grade AE ratesâ
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20% were calculated based on the Healthcare Cost and Utilization Project database and inflated to 2020 US dollars.
Results
Per-patient all-cause grade 3/4 AE costs for nivolumabâ
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ipilimumab vs. nivolumabâ
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cabozantinib vs. pembrolizumabâ
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axitinib were 4508 vs. 741 vs. 4440 over ~12.8 months of FU. For nivolumabâ
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ipilimumab vs. nivolumabâ
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cabozantinib vs. pembrolizumabâ
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lenvatinib, per-patient all-cause grade 3/4 AE costs were 5800 vs. 863 vs. 5030 over ~26.6 months of FU.
Conclusion
Patients with aRCC treated with first-line nivolumab-based therapies had lower grade 3/4 all-cause and treatment-related AE costs than pembrolizumab-based therapies, suggesting a more favorable cost-benefit profile.This study was funded by Bristol Myers Squibb
Resolution of a Debilitating Paraneoplastic Parkinson-like Neurological Syndrome Following Tyrosine Inhibitor Therapy and Consolidative Nephrectomy in a Patient with Advanced Clear Cell Renal Cell Carcinoma
Paraneoplastic syndromes are commonly encountered in renal cell carcinoma, but neurological manifestations are rare. Herein we report a case of a patient with locally advanced renal cell carcinoma who presented with Parkinson-like symptoms which prohibited surgery due to poor performance status. However, a significant improvement was noted after tyrosine kinase inhibitor therapy, allowing the patient to proceed to curative surgery
Treatment (tx) patterns and drug (Rx) costs for patients (pts) with metastatic renal cell carcinoma (mRCC) in the United States.
Determining Front-Line Therapeutic Strategy for Metastatic Clear Cell Renal Cell Carcinoma
The therapeutic landscape for metastatic renal cell carcinoma has rapidly evolved over the years, and we are now in an era of combination therapy strategies employing immune checkpoint blockade and anti-angiogenesis targeted therapy. Since 2018, we have gained regulatory approval for four distinct combination therapies, all with survival benefits, and with guideline recommendation for use in the front-line setting. As such, treatment selection has become increasingly complex with a myriad of treatment choices but little high-level head-to-head data to guide treatment selection. Heterogeneity in tumor biology further complicates treatment selection as tumors vary in behavior and treatment responsiveness. Ongoing development of biomarkers will certainly assist in this setting, and validation of predictive markers represents an unmet need. In their absence, we highlight features of disease and nuances to datasets from landmark prospective clinical trials to help inform treatment selection. There is growing evidence to support deferring upfront systemic therapy in some patients, with opportunities for active surveillance or metastasis-directed therapy. In others, upfront systemic therapy is warranted and necessitates thoughtful consideration of multiple clinicopathologic parameters to inform optimal patient-centered decision making
Non-adherence and health outcomes in women treated with oral endocrine therapy for breast cancer.
Approved checkpoint inhibitors in bladder cancer: which drug should be used when?
The treatment of advanced metastatic urothelial carcinoma has recently evolved with the approval of five checkpoint inhibitors. In the second-line setting, in patients who have progressed on cisplatin-based chemotherapy, pembrolizumab, atezolizumab, durvalumab, nivolumab and avelumab are United States Food and Drug Administration (FDA) approved. In cisplatin-ineligible patients, atezolizumab and pembrolizumab are the FDA-approved checkpoint inhibitors. Here we describe the updated clinical efficacy of these checkpoint inhibitors in the treatment of advanced urothelial carcinoma and then suggest how they can be sequenced in the context of available chemotherapeutic options. For cisplatin-eligible patients, platinum-based chemotherapy remains the standard first-line treatment. For patients progressing on platinum-based therapy, phase III trials have been performed comparing pembrolizumab and atezolizumab separately with standard chemotherapy, and results favor the use of pembrolizumab
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