Olaparib maintenance therapy for platinum-sensitive relapsed ovarian cancer at a single institution: A retrospective study.

maintenance therapy olaparib platinum‐sensitive ovarian cancer recurrent retrospective study

Journal

The journal of obstetrics and gynaecology research
ISSN: 1447-0756
Titre abrégé: J Obstet Gynaecol Res
Pays: Australia
ID NLM: 9612761

Informations de publication

Date de publication:
14 May 2024
Historique:
received: 16 02 2024
accepted: 27 04 2024
medline: 15 5 2024
pubmed: 15 5 2024
entrez: 14 5 2024
Statut: aheadofprint

Résumé

In this study, we aimed to investigate patient characteristics, efficacy, prognostic factors, and safety of olaparib maintenance therapy for platinum-sensitive recurrent ovarian cancer at our institution. Patients responding to platinum-based therapy and starting olaparib maintenance therapy for recurrent epithelial ovarian, fallopian tube, or peritoneal cancer at Kurume University Hospital between January 2018 and November 2021 were enrolled in the study. Their data were extracted retrospectively from medical records. In all, 50 patients were included. The median (range) age of the patients, follow-up time, and duration of olaparib maintenance therapy were 62 (39-87) years, 21.6 (2.2-45.9) months, and 7.2 (2-45.9) months, respectively. Among the 29 patients tested for homologous recombination (HR) status, 22 (75.9%) were positive for HR deficiency (HRD), 12 (54.5%) of whom had BRCA-positive tumors. The median progression-free survival was 8.9 months (95% confidence interval: 6.2-12.6), and the median overall survival was 27.1 months (95% confidence interval: 22.5-40.3). Multivariate analysis of prognostic factors revealed that HRD was an independent prognostic factor for both progression-free survival and overall survival. The most common adverse event was nausea (any grade, n = 30, 60%), resulting in drug interruption (n = 23, 46%), dose reduction (n = 17, 34%), and discontinuation of treatment (n = 1, 2%). Olaparib maintenance therapy for recurrent platinum-sensitive ovarian cancer at our institution was effective, with acceptable adverse events. HRD was the most significant prognostic factor for patients with recurrent platinum-sensitive ovarian cancer.

Identifiants

pubmed: 38742699
doi: 10.1111/jog.15965
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2024 Japan Society of Obstetrics and Gynecology.

Références

Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2021;71:209–249.
Cancer Registry and Statistics. Cancer Information Service, National Cancer Center, Japan (Vital Statistics of Japan). Available from: https://ganjoho.jp/en/professional/statistics/brochure/2019_en.html
Jayson GC, Kohn EC, Kitchener HC, Ledermann JA. Ovarian cancer. Lancet. 2014;384:1376–1388.
Pignata S, Cecere CSC, Du Bois A, Harter P, Heitz F. Treatment of recurrent ovarian cancer. Ann Oncol. 2017;28:viii51–viii56.
TCGA. Integrated genomic analyses of ovarian carcinoma. Nature. 2011;474:609–615.
Murai J, Huang SY, Das BB, Renaud A, Zhang Y, Doroshow JH, et al. Trapping of PARP1 and PARP2 by clinical PARP inhibitors. Cancer Res. 2012;72:5588–5599.
Kelland L. The resurgence of platinum‐based cancer chemotherapy. Nat Rev Cancer. 2007;7:573–584.
Sakai W, Swisher EM, Karlan BY, Agarwal MK, Higgins J, Friedman C, et al. Secondary mutations as a mechanism of cisplatin resistance in BRCA2‐mutated cancers. Nature. 2008;451:1116–1120.
Sakai W, Swisher EM, Jacquemont C, Chandramohan KV, Couch FJ, Langdon SP, et al. Functional restoration of BRCA2 protein by secondary BRCA2 mutations in BRCA2‐mutated ovarian carcinoma. Cancer Res. 2009;69:6381–6386.
Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, et al. Olaparib maintenance therapy in platinum‐sensitive relapsed ovarian cancer. N Engl J Med. 2012;366:1382–1392.
Pujade‐Lauraine E, Ledermann JA, Selle F, Gebski V, Penson RT, Oza AM, et al. Olaparib tablets as maintenance therapy in patients with platinum‐sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT‐Ov21): a double‐blind, randomised, placebo‐controlled, phase 3 trial. Lancet Oncol. 2017;18:1274–1284.
Yoshihama T, Kuroda Y, Chiyoda T, Takahashi M, Yoshimura T, Saotome K, et al. Efficacy and safety of olaparib maintenance monotherapy for Japanese patients with platinum‐sensitive relapsed ovarian, fallopian tube, and primary peritoneal cancer. Int J Clin Oncol. 2022;27:1644–1650.
Wildiers H, Reiser M. Relative dose intensity of chemotherapy and its impact on outcomes in patients with early breast cancer or aggressive lymphoma. Crit Rev Oncol Hematol. 2011;77:221–240.
Hryniuk W, Bush H. The importance of dose intensity in chemotherapy of metastatic breast cancer. J Clin Oncol. 1984;2:1281–1288.
Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Increasing the dose intensity of chemotherapy by more frequent administration or sequential scheduling: a patient‐level meta‐analysis of 37 298 women with early breast cancer in 26 randomised trials. Lancet. 2019;393:1440–1452.
Hanna RK, Poniewierski MS, Laskey RA, Lopez MA, Shafer A, Van le L, et al. Predictors of reduced relative dose intensity and its relationship to mortality in women receiving multi‐agent chemotherapy for epithelial ovarian cancer. Gynecol Oncol. 2013;129:74–80.
Fauci JM, Whitworth JM, Schneider KE, Subramaniam A, Zhang B, Frederick PJ, et al. Prognostic significance of the relative dose intensity of chemotherapy in primary treatment of epithelial ovarian cancer. Gynecol Oncol. 2011;122:532–535.
Au‐Yeung G, Webb PM, DeFazio A, Fereday S, Bressel M, Mileshkin L. Impact of obesity on chemotherapy dosing for women with advanced stage serous ovarian cancer in the Australian Ovarian Cancer Study (AOCS). Gynecol Oncol. 2014;133:16–22.
Francis KE, Kim SI, Friedlander M, Gebski V, Ray‐Coquard I, Clamp A, et al. The impact of olaparib dose reduction and treatment interruption on treatment outcome in the SOLO2/ENGOT‐ov21 platinum‐sensitive recurrent ovarian cancer. Ann Oncol. 2022;33:593–601.
Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228–247.
US Department of Health and Human Services. National Cancer Institute common terminology criteria for adverse events (CTCAE). Version 5.0, 2017. Available from: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_50
Sabrina CC, Gaia G, Vanda S, Arenare L, Lorusso D, Ronzino G, et al. Olaparib as maintenance therapy in patients with BRCA 1‐2 mutated recurrent platinum sensitive ovarian cancer: real world date and post progression outcome. Gynecol Oncol. 2020;156:38–44.
Labidi‐Galy SI, de La Motte RT, Derbel O, Wolfer A, Kalbacher E, Olivier T, et al. Clinical factors associated with prolonged response and survival under olaparib as maintenance therapy in BRCA mutated ovarian cancers. Gynecol Oncol. 2019;155:262–269.
Kanda Y. Investigation of the freely available easy‐to‐use software ‘EZR’ for medical statistics. Bone Marrow Transplant. 2013;48:452–458.
Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, et al. Niraparib maintenance therapy in platinum‐sensitive, recurrent ovarian cancer. N Engl J Med. 2016;375:2154–2164.
Coleman RL, Oza AM, Lorusso D, Aghajanian C, Oaknin A, Dean A, et al. Rucaparib maintenance treatment for recurrent ovarian carcinoma after response to platinum therapy (ARIEL3): a randomised, double‐blind, placebo‐controlled, phase 3 trial. Lancet. 2017;390:1949–1961.
Miller RE, Leary A, Scott CL, Serra V, Lord CJ, Bowtell D, et al. ESMO recommendations on predictive biomarker testing. For homologous recombination deficiency and PARP inhibitor benefit in ovarian cancer. Ann Oncol. 2020;31:1606–1622.
Sokolenko AP, Bizin IV, Preobrazhenskaya EV, Gorodnova TV, Ivantsov AO, Iyevleva AG, et al. Molecular profiles of BRCA1‐associated ovarian cancer treated by platinum‐based therapy: analysis of primary, residual and relapsed tumors. Int J Cancer. 2020;146:1879–1888.
Moore K, Colombo N, Scambia G, Kim BG, Oaknin A, Friedlander M, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379:2495–2505.
Poveda A, Floquet A, Ledermann JA, Asher R, Penson RT, Oza AM, et al. Olaparib tablets as maintenance therapy in patients with platinum‐sensitive relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT‐OV21): a final analysis of a double‐blind, randomised, placebo‐controlled, phase 3 trial. Lancet Oncol. 2021;22:620–631.
Short NJ, Rytting ME, Cortes JE. Acute myeloid leukaemia. Lancet. 2018;392:593–606.
Shenolikar R, Durden E, Meyer N, Lenhart G, Moore K. Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real‐world setting in the United States. Gynecol Oncol. 2018;151:190–195.
Lafargue CJ, Dal Molin GZ, Sood AK, Coleman RL. Exploring and comparing adverse events between PARP inhibitors. Lancet Oncol. 2019;20:e15–e28.
Morice PM, Leary A, Dolladille C, Chrétien B, Poulain L, González‐Martín A, et al. Myelodysplastic syndrome and acute myeloid leukaemia in patients treated with PARP inhibitors: a safety meta‐analysis of randomised controlled trials and a retrospective study of the WHO pharmacovigilance database. Lancet Haematol. 2021;8:e122–e134.

Auteurs

Takahiro Katsuda (T)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Shin Nishio (S)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Shingo Tasaki (S)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Jongmyung Park (J)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Kazuto Tasaki (K)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Naotake Tsuda (N)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Kimio Ushijima (K)

Department of Obstetrics and Gynecology, Kurume University School of Medicine, Fukuoka, Japan.

Classifications MeSH