dc.contributor.author | DiSilvestro, P | |
dc.contributor.author | Banerjee, S | |
dc.contributor.author | Colombo, N | |
dc.contributor.author | Scambia, G | |
dc.contributor.author | Kim, B-G | |
dc.contributor.author | Oaknin, A | |
dc.contributor.author | Friedlander, M | |
dc.contributor.author | Lisyanskaya, A | |
dc.contributor.author | Floquet, A | |
dc.contributor.author | Leary, A | |
dc.contributor.author | Sonke, GS | |
dc.contributor.author | Gourley, C | |
dc.contributor.author | Oza, A | |
dc.contributor.author | González-Martín, A | |
dc.contributor.author | Aghajanian, C | |
dc.contributor.author | Bradley, W | |
dc.contributor.author | Mathews, C | |
dc.contributor.author | Liu, J | |
dc.contributor.author | McNamara, J | |
dc.contributor.author | Lowe, ES | |
dc.contributor.author | Ah-See, M-L | |
dc.contributor.author | Moore, KN | |
dc.contributor.author | SOLO1 Investigators | |
dc.coverage.spatial | United States | |
dc.date.accessioned | 2022-12-07T13:31:52Z | |
dc.date.available | 2022-12-07T13:31:52Z | |
dc.date.issued | 2022-09-09 | |
dc.identifier.citation | Journal of Clinical Oncology, 2022, pp. JCO2201549 - | en_US |
dc.identifier.issn | 0732-183X | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5598 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.eissn | 1527-7755 | |
dc.identifier.doi | 10.1200/JCO.22.01549 | |
dc.description.abstract | PURPOSE: In SOLO1/GOG 3004 (ClinicalTrials.gov identifier: NCT01844986), maintenance therapy with the poly(ADP-ribose) polymerase inhibitor olaparib provided a sustained progression-free survival benefit in patients with newly diagnosed advanced ovarian cancer and a BRCA1 and/or BRCA2 (BRCA) mutation. We report overall survival (OS) after a 7-year follow-up, a clinically relevant time point and the longest follow-up for any poly(ADP-ribose) polymerase inhibitor in the first-line setting. METHODS: This double-blind phase III trial randomly assigned patients with newly diagnosed advanced ovarian cancer and a BRCA mutation in clinical response to platinum-based chemotherapy to maintenance olaparib (n = 260) or placebo (n = 131) for up to 2 years. A prespecified descriptive analysis of OS, a secondary end point, was conducted after a 7-year follow-up. RESULTS: The median duration of treatment was 24.6 months with olaparib and 13.9 months with placebo, and the median follow-up was 88.9 and 87.4 months, respectively. The hazard ratio for OS was 0.55 (95% CI, 0.40 to 0.76; P = .0004 [P < .0001 required to declare statistical significance]). At 7 years, 67.0% of olaparib patients versus 46.5% of placebo patients were alive, and 45.3% versus 20.6%, respectively, were alive and had not received a first subsequent treatment (Kaplan-Meier estimates). The incidence of myelodysplastic syndrome and acute myeloid leukemia remained low, and new primary malignancies remained balanced between treatment groups. CONCLUSION: Results indicate a clinically meaningful, albeit not statistically significant according to prespecified criteria, improvement in OS with maintenance olaparib in patients with newly diagnosed advanced ovarian cancer and a BRCA mutation and support the use of maintenance olaparib to achieve long-term remission in this setting; the potential for cure may also be enhanced. No new safety signals were observed during long-term follow-up. | |
dc.format | Print-Electronic | |
dc.format.extent | JCO2201549 - | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | American Society of Clinical Oncology (ASCO) | en_US |
dc.relation.ispartof | Journal of Clinical Oncology | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | SOLO1 Investigators | |
dc.title | Overall Survival With Maintenance Olaparib at a 7-Year Follow-Up in Patients With Newly Diagnosed Advanced Ovarian Cancer and a BRCA Mutation: The SOLO1/GOG 3004 Trial. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-08-12 | |
dc.date.updated | 2022-12-07T13:31:11Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1200/JCO.22.01549 | en_US |
rioxxterms.licenseref.startdate | 2022-09-09 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/36082969 | |
pubs.organisational-group | /ICR | |
pubs.organisational-group | /ICR/Primary Group | |
pubs.organisational-group | /ICR/Primary Group/Royal Marsden Clinical Units | |
pubs.publication-status | Published online | |
pubs.publisher-url | http://dx.doi.org/10.1200/jco.22.01549 | |
dc.contributor.icrauthor | Banerjee, Susana | |
icr.provenance | Deposited by Mr Arek Surman on 2022-12-07. Deposit type is initial. No. of files: 1. Files: jco.22.01549.pdf | |