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Study: Niraparib increases progression-free survival in patients with newly diagnosed ovarian cancer

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Contents

At a glance                  In-depth
Findings              Limitations                
Clinical trials Resources                            
Questions for your doctor  


STUDY AT A GLANCE

This study is about:

The use of () as (a therapy that is designed to keep cancer from coming back after a successful first therapy) for newly diagnosed ovarian cancer patients.

Why is this study important?

The PRIMA trial looked at the effectiveness and safety of as after a response to chemotherapy (before recurrence) in women with newly diagnosed ovarian cancer. 

Study findings:

Women who received had a longer progression-free survival (amount of time until their cancer came back or got worse) than those who received a

  • For patients who received , the average progression-free survival was 13.8 months compared to 8.2 months for patients who received a .
  • After two years, the rate of overall survival was 84% for patients who received compared to 77% for patients who received a .
  • The most common side effects were anemia (decrease in red blood cells), thrombocytopenia (decrease in blood platelets which help healing), and neutropenia (decrease in neutrophils which help fight infection).

What does this mean for me?

The results of this study suggest that , when used as , may increase progression-free survival.

posted 11/5/19

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Reference

González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, McCormick C, Lorusso D, Hoskins P, Freyer G, Baumann K, Jardon K, Redondo A, Moore RG, Vulsteke C, O'Cearbhaill RE, Lund B, Backes F, Barretina-Ginesta P, Haggerty AF, Rubio-Pérez MJ, Shahin MS, Mangili G, Bradley WH, Bruchim I, Sun K, Malinowska IA, Li Y, Gupta D, Monk BJ; PRIMA/ENGOT-OV26/GOG-3012 Investigators. in Patients with Newly Diagnosed Advanced Ovarian Cancer. N Engl J Med. Published on line September 28, 2019.
 

Disclosure

FORCE receives funding from industry sponsors, including companies that manufacture cancer drugs, tests and devices. All XRAYS articles are written independently of any sponsor and are reviewed by members of our Scientific Advisory Board prior to publication to assure scientific integrity.

This article is relevant for:

Women newly-diagnosed with ovarian cancer

This article is also relevant for:

Ovarian cancer survivors

Newly diagnosed

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IN-DEPTH REVIEW OF RESEARCH

Study background:

Clinical benefit with PARP inhibitors has been observed for patients with mutations, in both the up-front setting and the recurrent setting.  Some recent trials have shown that is effective in some patients with normal genes in their tumors. These trials resulted in two approvals:

The researchers conducting the PRIMA trial wanted to know if the observed clinical benefit of could be extended to all patients with advanced ovarian cancer including those patients whose tumors had (with or without a mutation) and those patients whose tumors did not have .

Researchers of this study wanted to know:

How well works as a following front-line platinum-based chemotherapy in patients with III or IV ovarian cancer (including fallopian and peritoneal cancers).

  • The primary end-point was progression-free survival in both patients whose tumors had and in patients in the overall population.
  • The secondary end-point was overall survival.

Populations looked at in this study:

This study 733 newly diagnosed ovarian cancer patients to receive (487 patients) or a or sugar pill (246 patients) once daily following chemotherapy.

Of the patients who were and received either or a placebo:

  • 373/733 (51%) had tumors with with Myriad’s myChoice testing.
    • 223/373 (60%) had tumors with a mutation (either inherited or acquired).
    • 150/373 (40%) had tumors without a mutation.

Study design:

This phase III trial was conducted in 20 countries at 181 clinical sites from July 2016-June 2018. Within 12 weeks of completing the last dose of chemotherapy, patients were in a 2:1 ratio to receive oral or a once daily for 36 months or until their disease progressed. Computed tomography (a form of tomography in which a computer controls the X-ray source and detectors, processes the data and produces the image) or was used to assess disease every 12 weeks until the treatment ended or was discontinued.

Study findings:

Among the 373 patients whose tumors had HRD:

  • The median progression-free survival was longer in the group than in the group (21.9 months v. 10.4 months).
  • In the BRCA-mutated group (a subset of the group), median progression-free survival was longer in the group than in the group (19.6 months v 8.2 months).

In the overall population (all 733 patients):

  • The median progression-free survival was longer in the group than in the group (13.8 months vs. 8.2 months).
  • At 24 months, the rate of overall survival was 84% in the group and 77% in the group.

The most common adverse events were anemia (decrease in red blood cells), thrombocytopenia (decrease in blood platelets which help healing), and neutropenia (decrease in neutrophils which help fight infection).

Limitations:

While not a limitation of this study, it is important to note that among the 484 patients to receive , just over 18% discontinued due to adverse events (58) or for other reasons (31). Among the 244 patients to receive a , a little over 5% discontinued the trial due to adverse events (5) or for other reasons (8).  However, patient withdrawal from ovarian cancer trials is neither uncommon nor unique to this study. These patients all had advanced disease and had undergone multiple rounds of chemotherapy. Importantly, there were a total of 626 woman who remained on the trial for which there is data.

Conclusions:

The results of this trial showed that treatment with provides longer progression-free survival than for the overall patient population.  Clinical benefit was not limited to the subset of patients whose tumors were , however the largest benefit was seen in cancers.

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Posted 11/5/19

Expert Guidelines
Expert Guidelines

The following NCCN recommendations are for for women with ovarian cancer who have had a complete or partial response to first-line therapy:

  • Women who have a mutation may benefit from a as .
  • Women who have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or Lynparza and Avastin as .
  • Women who do not have a mutation and had Avastin as part of their first-line treatment may benefit from a alone or in combination with Avastin as , depending on their status.
  • Women who do not have a mutation and did not have Avastin as part of their first-line treatment may benefit from a as .

Updated: 12/07/2021

Questions To Ask Your Doctor
Questions To Ask Your Doctor

  • I have finished my first-line treatment. Should I consider ?
  • What are my options for after chemotherapy?
  • What type of side effects should I expect on a ?

Open Clinical Trials
Open Clinical Trials

The following are studies looking at PARP inhibitors and similar agents for treating people with ovarian cancer.  

A number of other clinical trials for people with ovarian cancer can be found here.

Updated: 03/13/2022

Peer Support
Peer Support

The following organizations offer peer support services for people with or at high risk for ovarian cancer:

Updated: 02/05/2022

Who covered this study?

Cancer Network

Niraparib shows “impressive” survival improvements in advanced ovarian cancer This article rates 4.5 out of 5 stars

The Health Site

Drug Niraparib may benefit women newly diagnosed with advanced ovarian cancer This article rates 3.5 out of 5 stars

How we rated the media

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