Progression-free survival and safety at 3.5 years of follow-up: Results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer – A plain language summary Journal Article
| Authors: | González-Martín, A.; Pothuri, B.; Vergote, I.; Graybill, W.; Lorusso, D.; McCormick, C. C.; Freyer, G.; Backes, F.; Heitz, F.; Redondo, A.; Moore, R. G.; Vulsteke, C.; O'Cearbhaill, R. E.; Malinowska, I. A.; Shtessel, L.; Compton, N.; Mirza, M. R.; Monk, B. J. |
| Article Title: | Progression-free survival and safety at 3.5 years of follow-up: Results from the randomized phase 3 PRIMA/ENGOT-OV26/GOG-3012 trial of niraparib maintenance treatment in patients with newly diagnosed ovarian cancer – A plain language summary |
| Abstract: | What is this summary about?: This PLSP provides a short summary of an original scientific article that presented results from the PRIMA study after 3.5 years of follow-up time. The original article was published in the European Journal of Cancer in 2023. The PRIMA study included adult patients with newly diagnosed advanced high-risk ovarian cancer whose tumors shrunk or became undetectable after treatment with chemotherapy with or without surgery. The PRIMA study evaluated how well the drug niraparib, also known as Zejula, worked at delaying or preventing ovarian cancer from coming back (recurring) or getting worse (progressing) compared with placebo (a substance with no effects that a doctor gives to a patient instead of a drug). The first results from the PRIMA study were published in 2019, when patients had participated in the PRIMA study for about 1.2 years. The article this PLSP is based on reports longer-term data from the PRIMA study, when patients had participated in the PRIMA study for about 3.5 years. Patients were monitored (or followed) for a longer time to understand how well niraparib continued to work and to evaluate whether the safety of niraparib changed with additional time being monitored. What were the results?: Patients who took niraparib had more time before their cancer came back or got worse than patients who took placebo. In terms of safety, no new types of side effects with niraparib treatment were observed with additional time being monitored as part of the PRIMA study. What do the results mean?: These results support that niraparib remains an important treatment option to help delay the cancer from coming back or getting worse in patients with newly diagnosed advanced ovarian cancer that responded to initial treatment. Clinical Trial Registration:NCT02655016 (PRIMA study) (ClinicalTrials.gov). © 2024 The Authors. |
| Keywords: | controlled study; middle aged; gene mutation; clinical trial; constipation; fatigue; mortality; placebo; diarrhea; drug safety; chemotherapy; follow up; follow-up studies; ovarian cancer; ovarian neoplasms; dna damage; progression free survival; ovary cancer; randomized controlled trial; vomiting; maintenance therapy; randomized controlled trials as topic; oncology; publication; insomnia; myelodysplastic syndrome; ovary tumor; health care personnel; nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor; caregiver; piperidines; headache; phase 3 clinical trial; piperazines; drug therapy; language; piperazine derivative; nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase; progression-free survival; randomized controlled trial (topic); indazoles; piperidine derivative; acute myeloid leukemia; parp inhibitor; procedures; stomach pain; maintenance chemotherapy; niraparib; humans; human; female; article; poly(adp-ribose) polymerase inhibitors; lay summary; plain language summary; indazole derivative; plain language summary of publication |
| Journal Title: | Future Oncology |
| Volume: | 20 |
| Issue: | 22 |
| ISSN: | 1479-6694 |
| Publisher: | Future Medicine |
| Date Published: | 2024-03-19 |
| Start Page: | 1531 |
| End Page: | 1544 |
| Language: | English |
| DOI: | 10.2217/fon-2023-0782 |
| PUBMED: | 38501262 |
| PROVIDER: | scopus |
| PMCID: | PMC11500825 |
| DOI/URL: | |
| Notes: | Article -- MSK Cancer Center Support Grant (P30 CA008748) acknowledged in PubMed (In Conflict of Interest statement) and PDF -- Source: Scopus |
