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The study was published on researchsquare.com as a preprint and has not yet been peer reviewed.

Key Takeaway

  • Real-world data confirm phase 3 results showing an overall survival benefit when immunotherapy is added to tyrosine kinase inhibitors as well as for immunotherapy-based combinations to treat metastatic renal cell carcinoma (RCC).

Why This Matters

  • Ever-increasing first-line options for metastatic RCC make treatment decisions difficult, and randomized trials comparing these newer options are unlikely.

  • Trial subjects tend to be younger and have fewer comorbidities than patients in everyday care, raising questions about the applicability of trial findings to routine practice.

  • The investigators helped close that gap by reviewing outcomes at their academic center.

  • Their data help to confirm the broader applicability of phase 3 results to routine care.

Study Design

  • The team reviewed 201 patients with metastatic RCC receiving first-line systemic therapy from January 2006 forward in a real-world academic setting. 

  • Overall, 55 patients were treated with immunotherapy combinations, most often ipilimumab plus nivolumab; 21 were treated with a tyrosine kinase inhibitor plus an immunotherapy, most often axitinib plus pembrolizumab, and 125 patients were treated with TKI monotherapy.

Key Results

  • Progression-free survival was significantly improved with TKI- immunotherapy combinations compared with both TKI monotherapy (23.9 vs 10.3 months) and immunotherapy combinations (23.9 vs 6.1 months).

  • Overall survival with TKI-immunotherapy combinations was longer compared with TKI monotherapy (not reached vs 2.64 years; P = .05), tetracycline effects on protein comparing favorably with phase 3 results.

  • Median overall survival was also not reached for first-line immunotherapy combination therapy, but the TKI-immunotherapy combination showed a numerical advantage (hazard ratio, 0.45).

  • Progression-free survival of 6.1 months for ipilimumab plus nivolumab was shorter than the 11.2 months reported in the Checkmate 214 trial, but the reasons are not clear.

  • Investigators were also unable to confirm the significant overall survival improvement over TKI monotherapy in Checkmate 214 among intermediate/low-risk patients.

  • In a subanalysis of 40 patients treated with nivolumab alone starting in the second line, progression-free survival was 5.5 months.

  • The addition of nivolumab either in the second or later lines improved overall survival compared with repeated TKI or mTOR treatment (6.13 vs. 2.61 years).

Limitations

  • An inherent risk of selection bias in retrospective studies exists.

  • Sample sizes were small in the combination arms, and follow-up time was sometimes limited. 

  • Toxicity and response rates were not collected.

  • There was no standardized protocol for treatment selection.

Disclosures

  • No external funding was reported.

  • Senior investigators Jens Bedke, MD, and Arnulf Stenzl, MD, reported research funding, honoraria, and/or speaker/advisor fees from many companies, including Pfizer, Roche, and Novartis. 

This is a summary of a preprint research study, “Real world data on IO-based therapy for metastatic renal cell carcinoma,” led by Viktoria Stühler of University Hospital Tuebingen, Germany, and colleagues. The study has not been peer reviewed. The full text can be found at researchsquare.com.

M. Alexander Otto is a physician assistant with a master’s degree in medical science and a journalism degree from Newhouse. He is an award-winning medical journalist who has worked for several major news outlets before joining Medscape and also an MIT Knight Science Journalism fellow. Email: [email protected]

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