Raadpleeg ook literatuurlijst niet-toxische stoffen en behandelingen bij specifiek eierstokkanker van arts-bioloog drs. Engelbert Valstar

27 december 2019: Bron: NEJM december 2019

Olaparib samen met bevacizumab - Avastin geeft ook betere ziektevrije tijd en betere progressievrije ziekte als de BRCA status niet bekend is. Blijkt uit nieuwe grote placebo gecontroleerde gerandomiseerde studie. 

Zie hier het abstract met de resultaten die voor zichzelf spreken en hoef ik niet te vertalen denk ik:

.

Kernpunten uit de studie:

Born: NEJM december 2019 

December 19, 2019
N Engl J Med 2019; 381:2416-2428
DOI: 10.1056/NEJMoa191136

Olaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer

List of authors.

  • Isabelle Ray-Coquard, M.D., Ph.D., 
  • Patricia Pautier, M.D., 
  • Sandro Pignata, M.D., Ph.D., 
  • David Pérol, M.D., 
  • Antonio González-Martín, M.D., Ph.D., 
  • Regina Berger, Ph.D., 
  • Keiichi Fujiwara, M.D., Ph.D., 
  • Ignace Vergote, M.D., Ph.D., 
  • Nicoletta Colombo, M.D., 
  • Johanna Mäenpää, M.D., Ph.D., 
  • Frédéric Selle, M.D., 
  • Jalid Sehouli, M.D., 
  •  for the PAOLA-1 Investigators*

Abstract

BACKGROUND

Olaparib has shown significant clinical benefit as maintenance therapy in women with newly diagnosed advanced ovarian cancer with a BRCA mutation. The effect of combining maintenance olaparib and bevacizumab in patients regardless of BRCA mutation status is unknown.

METHODS

We conducted a randomized, double-blind, international phase 3 trial. Eligible patients had newly diagnosed, advanced, high-grade ovarian cancer and were having a response after first-line platinum–taxane chemotherapy plus bevacizumab. Patients were eligible regardless of surgical outcome or BRCA mutation status. Patients were randomly assigned in a 2:1 ratio to receive olaparib tablets (300 mg twice daily) or placebo for up to 24 months; all the patients received bevacizumab at a dose of 15 mg per kilogram of body weight every 3 weeks for up to 15 months in total. The primary end point was the time from randomization until investigator-assessed disease progression or death.

RESULTS

Of the 806 patients who underwent randomization, 537 were assigned to receive olaparib and 269 to receive placebo. After a median follow-up of 22.9 months, the median progression-free survival was 22.1 months with olaparib plus bevacizumab and 16.6 months with placebo plus bevacizumab (hazard ratio for disease progression or death, 0.59; 95% confidence interval , 0.49 to 0.72; P<0.001). The hazard ratio (olaparib group vs. placebo group) for disease progression or death was 0.33 (95% CI, 0.25 to 0.45) in patients with tumors positive for homologous-recombination deficiency (HRD), including tumors that had BRCAmutations (median progression-free survival, 37.2 vs. 17.7 months), and 0.43 (95% CI, 0.28 to 0.66) in patients with HRD-positive tumors that did not have BRCA mutations (median progression-free survival, 28.1 vs. 16.6 months). Adverse events were consistent with the established safety profiles of olaparib and bevacizumab.

CONCLUSIONS

In patients with advanced ovarian cancer receiving first-line standard therapy including bevacizumab, the addition of maintenance olaparib provided a significant progression-free survival benefit, which was substantial in patients with HRD-positive tumors, including those without a BRCA mutation. (Funded by ARCAGY Research and others; PAOLA-1 ClinicalTrials.gov number, NCT02477644. opens in new tab.)


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