Study: Niraparib increases progression-free survival in patients with newly diagnosed ovarian cancer
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|Questions for your doctor|
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.
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.
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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.
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This article is relevant for:
Women newly-diagnosed with ovarian cancer
This article is also relevant for:
Ovarian cancer survivors
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IN-DEPTH REVIEW OF RESEARCH
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:
- In 2017 was approved as a maintenance treatment for women with recurrent ovarian cancer who responded to platinum-based chemotherapy, even in the absence of a germline or somatic mutation.
- In 2019, was approved as fourth-line therapy for women with advanced ovarian cancer with a type of repair deficiency called ().
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.
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.
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).
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.
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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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 .
- 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 ?
The following are studies looking at PARP inhibitors and similar agents for treating people with ovarian cancer.
- NCT03462342 Combination ATR inhibitor and in Recurrent Ovarian Cancer (CAPRI). This study will look at how well patients with recurrent ovarian cancer respond to treatment with a known as an ATR inhibitor when combined with a .
- NCT04586335: Study of CYH33 in Combination With Olaparib an Oral in Patients With Advanced . The purpose of this study is to assess the safety, tolerability and preliminary efficacy of the CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior , and in patients with recurrent high grade serous ovarian, , or primary peritoneal cancer who are platinum resistant or refractory.
- NCT03579316: Adavosertib With or Without Olaparib in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Cancer. This studies how well adavosertib with or without olaparib work in patients with ovarian cancer that has come back (recurrent).
- NCT04267939: ATR Inhibitor Plus Study in Advanced and Ovarian Cancer. This study will look at how well how well people with advanced ovarian cancer or other respond to treatment with the BAY1895344 in combination with the . This study is open to people whose ovarian cancer progressed on a .
A number of other clinical trials for people with ovarian cancer can be found here.
The following organizations offer peer support services for people with or at high risk for ovarian cancer:
- FORCE peer support
- Our Message Boards allow people to connect with others who share their situation. Once you register, you can post on the Diagnosed With Cancer board to connect with others who have been diagnosed.
- Peer Navigation Program will match you with a volunteer who shares your mutation and situation.
- Private Facebook Group
- Virtual and in-person support meetings
- Join a Zoom community group meeting.
- American Sign Language
- People of Color
- National Ovarian Cancer Coalition
- Ovarian Cancer Research Alliance
- Clearity Foundation
Who covered this study?
Niraparib shows “impressive” survival improvements in advanced ovarian cancer This article rates 4.5 out of 5 stars
New treatment improves survival in women newly diagnosed with advanced ovarian cancer This article rates 4.0 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