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Outstanding Ovarian Cancer PFS With Olaparib Maintenance.

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A first-of-its kind phase 3 study found that patients with advanced ovarian cancer who carry a BRCA mutation have a marked increase in progression-free survival (PFS) if they are given maintenance therapy with the poly(ADP)-ribose polymerase (PARP) inhibitor olaparib (Lynparza, AstraZeneca) following successful first-line chemotherapy.

Kathleen Moore, MD

The finding comes from the SOLO1 study, presented here at the European Society of Medical Oncology 2018 annual meeting, and simultaneously published in the New England Journal of Medicine.

Kathleen Moore, MD, associate professor at the Stephenson Cancer Center, University of Oklahoma, and colleagues found that, after more than 3 years of follow-up, olaparib was associated with a 70% increase in PFS compared with placebo, while causing few toxicities and having no impact on quality of life.

Noting that the “outstanding” improvement in PFS was maintained even after stopping treatment at 2 years, Moore said that the findings “herald a new era in treatment for women diagnosed with advanced ovarian cancer who carry a BRCA mutation.”

“While it is too early to say whether we have impacted the fraction of women who could be cured with their front-line therapy, the fact that it is estimated that over 50% of women in the olaparib arm were still progression free at 4 years as compared to only 11% for placebo speaks to this hope,” she said in a statement.

At a press briefing, Moore said, “We believe that the SOLO1 data really promise a change in the standard of care for women with advanced ovarian cancer who harbor a BRCA mutation, and we hope that this will be available to patients relatively soon.”

Jonathan A. Ledermann, MD, director of Cancer Research UK and the University College London Cancer Trials Centre, UK, commented for ESMO: “Comparing that with all the trials we’ve done with other cytotoxic chemotherapy and drugs like bevacizumab, we’ve just not seen median progression-free survivals that good at that period of time out to 3 years.”

There’s a real, real hope that this treatment will perhaps lead to an increase in the cure rate- Jonathan A. Ledermann, MD

“So I think there’s a real, real hope that this treatment will perhaps lead to an increase in the cure rate, which will be reflected by a reduction in the first relapse rate. We’ll need to wait longer for that, but there’s no doubt that this is a big step forward for the patients with BRCA-mutated ovarian cancer.”

Ledermann noted that there nevertheless remain many challenges “not least access to the drug and the cost of the drug, but also the testing of patients for BRCA mutations.”

He explained that testing will need to be “done earlier in patients, at diagnosis, to know whether they will be able to qualify for olaparib maintenance after their first chemotherapy, and that produces some logistical challenges in many countries and many regions.”

GDMeds, an India Pharmacy Service company

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