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17 mei 2019: Lees ook dit artikel: 

https://kanker-actueel.nl/immuuntherapie-met-atezolizumab-plus-avestin-bevacizumab-geeft-betere-progressievrije-ziekte-en-overall-overleving-dan-sunitinib-bij-patienten-met-gevorderde-uitgezaaide-nierkanker.html

4 maart 2019: lees ook dit artikel: 

https://kanker-actueel.nl/immuuntherapie-met-axitinib-inlyta-en-pembrolizumab-keytruda-bij-gevorderde-nog-onbehandelde-nierkanker-verdubbelt-progressievrije-ziekte-10-vs-20-maanden.html

4 maart 2019. Bron: NEJM februari 2019

Ik plaats dit artikel vanuit een internetcafe in Santo Domingo dus vertaal deze niet want is heel lastig op een oude computer om artikelen te plaatsen, maar wil jullie er wel attent opmaken. 

Pembrolizumb plus Axitinib geeft als eerstelijns behandeling betere resultaten op overall overleving op 1-jaars meting (89,9 procent versus 78,3 procent) dan sunitinib bij gevorderde nierkanker. En ook betere progressievrije ziekte (15.1 vs 11.1 months; 59.3% vs 35.7%) 

Dit zijn de conclusies uit de fase III studie: NCT02853331

  • In this open-label, phase III study, 861 patients with untreated advanced ccRCC were randomized to receive pembrolizumab plus axitinib or pembrolizumab plus sunitinib to investigate survival outcomes. The estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab plus axitinib group and 78.3% in the pembrolizumab plus sunitinib group (median follow-up, 12.8 months). Median progression-free survival and objective response rate were significantly better in patients receiving pembrolizumab plus axitinib compared with those receiving pembrolizumab plus sunitinib (15.1 vs 11.1 months; 59.3% vs 35.7%). Adverse events of grade 3 or higher were reported in 75.8% of patients receiving pembrolizumab plus axitinib and in 70.6% of patients receiving pembrolizumab plus sunitinib.
  • These findings demonstrate improved progression-free survival and a higher objective response rate in patients with advanced ccRCC treated with pembrolizumab plus axitinib.

het studierapport: Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma is tegen betaling in te zien.

Hier het abstract van de studie:

Pembrolizumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma

  • Brian I. Rini, M.D., 
  • Elizabeth R. Plimack, M.D., 
  • Viktor Stus, M.D., Ph.D., 
  • Rustem Gafanov, M.D., 
  • Robert Hawkins, M.B., B.S., Ph.D., 
  • Dmitry Nosov, M.D., D.Sci., 
  • Frédéric Pouliot, M.D., Ph.D., 
  • Boris Alekseev, M.D., 
  • Denis Soulières, M.D., 
  • Bohuslav Melichar, M.D., Ph.D., 
  • Ihor Vynnychenko, M.D., Ph.D., 
  • Anna Kryzhanivska, M.D., 
  •  for the KEYNOTE-426 Investigators*

Abstract

BACKGROUND

The combination of pembrolizumab and axitinib showed antitumor activity in a phase 1b trial involving patients with previously untreated advanced renal-cell carcinoma. Whether pembrolizumab plus axitinib would result in better outcomes than sunitinib in such patients was unclear.

METHODS

In an open-label, phase 3 trial, we randomly assigned 861 patients with previously untreated advanced clear-cell renal-cell carcinoma to receive pembrolizumab (200 mg) intravenously once every 3 weeks plus axitinib (5 mg) orally twice daily (432 patients) or sunitinib (50 mg) orally once daily for the first 4 weeks of each 6-week cycle (429 patients). The primary end points were overall survival and progression-free survival in the intention-to-treat population. The key secondary end point was the objective response rate. All reported results are from the protocol-specified first interim analysis.

RESULTS

After a median follow-up of 12.8 months, the estimated percentage of patients who were alive at 12 months was 89.9% in the pembrolizumab–axitinib group and 78.3% in the sunitinib group (hazard ratio for death, 0.53; 95% confidence interval , 0.38 to 0.74; P<0.0001). Median progression-free survival was 15.1 months in the pembrolizumab–axitinib group and 11.1 months in the sunitinib group (hazard ratio for disease progression or death, 0.69; 95% CI, 0.57 to 0.84; P<0.001). The objective response rate was 59.3% (95% CI, 54.5 to 63.9) in the pembrolizumab–axitinib group and 35.7% (95% CI, 31.1 to 40.4) in the sunitinib group (P<0.001). The benefit of pembrolizumab plus axitinib was observed across the International Metastatic Renal Cell Carcinoma Database Consortium risk groups (i.e., favorable, intermediate, and poor risk) and regardless of programmed death ligand 1 expression. Grade 3 or higher adverse events of any cause occurred in 75.8% of patients in the pembrolizumab–axitinib group and in 70.6% in the sunitinib group.

CONCLUSIONS

Among patients with previously untreated advanced renal-cell carcinoma, treatment with pembrolizumab plus axitinib resulted in significantly longer overall survival and progression-free survival, as well as a higher objective response rate, than treatment with sunitinib. (Funded by Merck Sharp & Dohme; KEYNOTE-426 ClinicalTrials.gov number, NCT02853331.)


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