Olaparib is the first poly(ADP-ribose) polymerase inhibitor approved as maintenance therapy of recurrent ovarian cancer (OC) patients with a BRCA mutation. To achieve the maximum clinical benefit, adherence to olaparib must be persistent. However, in clinical practice, this is challenged by the frequent suboptimal management of toxicities. In view of the expanding use of olaparib also in Italy, physicians must learn how to adequately and promptly manage drug toxicities not to unnecessarily interrupt or reduce the dose. The experts agreed that nausea,vomiting, anemia, and fatigue are the most frequent events experienced by OC patients on olaparib, and that these toxicities usually develop early during treatment, are mainly of grade 1–2 and transient and can be managed with simple non-pharmacological interventions. By sharing their real-world experiences, the panel prepared, for each toxicity, an algorithm organized by grade and besides the procedures indicated in the local label, included supportive care interventions based also on nutritional and lifestyle modifications and psycho-oncology consultation. Moreover, in view of the tablet entry into the Italian market, the full and reduced dosages of capsules and tablets were compared. This practical guidance is intended to be a tool to support especially less-experienced physicians in the management of these complex patients, with the aim to help preventing the worsening of patients’ conditions and the unnecessary interruption/reduction of olaparib dosage, which may jeopardize treatment efficacy.
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Faraoni I, Graziani G (2018) Role of BRCA mutations in Cancer treatment with poly(ADP-ribose) polymerase (PARP) inhibitors. Cancers (Basel) 10. https://doi.org/10.3390/cancers10120487
Bryant HE, Schultz N, Thomas HD et al (2005) Specific killing of BRCA2-deficient tumours with inhibitors of poly(ADP-ribose) polymerase. Nature 434:913–917. https://doi.org/10.1038/nature03443
Farmer H, McCabe N, Lord CJ et al (2005) Targeting the DNA repair defect in BRCA mutant cells as a therapeutic strategy. Nature 434:917–921. https://doi.org/10.1038/nature03445
Kaufman B, Shapira-Frommer R, Schmutzler RK et al (2015) Olaparib monotherapy in patients with advanced cancer and a germline BRCA1/2 mutation. J Clin Oncol 33:244–250. https://doi.org/10.1200/JCO.2014.56.2728
Franzese E, Centonze S, Diana A et al (2019) PARP inhibitors in ovarian cancer. Cancer Treat Rev 73:1–9. https://doi.org/10.1016/j.ctrv.2018.12.002
Hollis RL, Gourley C (2016) Genetic and molecular changes in ovarian cancer. Cancer Biol Med 13:236–247. https://doi.org/10.20892/j.issn.2095-3941.2016.0024
Ledermann J, Harter P, Gourley C et al (2012) Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. N Engl J Med 366:1382–1392. https://doi.org/10.1056/NEJMoa1105535
Ledermann J, Harter P, Gourley C et al (2014) Olaparib maintenance therapy in patients with platinum-sensitive relapsed serous ovarian cancer: a preplanned retrospective analysis of outcomes by BRCA status in a randomised phase 2 trial. Lancet Oncol 15:852–861. https://doi.org/10.1016/S1470-2045(14)70228-1
Pujade-Lauraine E, Ledermann JA, Selle F et al (2017) 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 18:1274–1284. https://doi.org/10.1016/S1470-2045(17)30469-2
Moore K, Colombo N, Scambia G et al (2018) Maintenance Olaparib in patients with newly diagnosed advanced ovarian Cancer. N Engl J Med. https://doi.org/10.1056/NEJMoa1810858
Friedlander M, Matulonis U, Gourley C et al (2018) Long-term efficacy, tolerability and overall survival in patients with platinum-sensitive, recurrent high-grade serous ovarian cancer treated with maintenance olaparib capsules following response to chemotherapy. Br J Cancer 119:1075–1085. https://doi.org/10.1038/s41416-018-0271-y
Exhibition Hall Break and Poster Session II. In: SGO - SGO 50th Annual Meeting on Women’s Cancer. https://sgo.confex.com/sgo/2019/meetingapp.cgi/Session/1813. Accessed 9 Jul 2019
Common Terminology Criteria for Adverse Events (CTCAE) (2017). 155
Gourley C, Friedlander M, Matulonis UA et al (2017) Clinically significant long-term maintenance treatment with olaparib in patients (pts) with platinum-sensitive relapsed serous ovarian cancer (PSR SOC). JCO 35:5533–5533. https://doi.org/10.1200/JCO.2017.35.15_suppl.5533
Friedlander M, Gebski V, Gibbs E et al (2018) Health-related quality of life and patient-centred outcomes with olaparib maintenance after chemotherapy in patients with platinum-sensitive, relapsed ovarian cancer and a BRCA1/2 mutation (SOLO2/ENGOT Ov-21): a placebo-controlled, phase 3 randomised trial. Lancet Oncol 19:1126–1134. https://doi.org/10.1016/S1470-2045(18)30343-7
Ledermann JA, Harter P, Gourley C et al (2016) Quality of life during olaparib maintenance therapy in platinum-sensitive relapsed serous ovarian cancer. Br J Cancer 115:1313–1320. https://doi.org/10.1038/bjc.2016.348
Colombo N, Lorusso D, Scollo P (2017) Impact of recurrence of ovarian Cancer on quality of life and outlook for the future. Int J Gynecol Cancer 27:1134–1140. https://doi.org/10.1097/IGC.0000000000001023
Mangone L, Mandato VD, Gandolfi R et al (2014) The impact of epithelial ovarian cancer diagnosis on women’s life: a qualitative study. Eur J Gynaecol Oncol 35:32–38
Watts S, Prescott P, Mason J et al (2015) Depression and anxiety in ovarian cancer: a systematic review and meta-analysis of prevalence rates. BMJ Open 5:e007618. https://doi.org/10.1136/bmjopen-2015-007618
Wen Q, Shao Z, Zhang P et al (2017) Mental distress, quality of life and social support in recurrent ovarian cancer patients during active chemotherapy. Eur J Obstet Gynecol Reprod Biol 216:85–91. https://doi.org/10.1016/j.ejogrb.2017.07.004
Friedlander M, Banerjee S, Mileshkin L et al (2016) Practical guidance on the use of olaparib capsules as maintenance therapy for women with BRCA mutations and platinum-sensitive recurrent ovarian cancer. Asia Pac J Clin Oncol 12:323–331. https://doi.org/10.1111/ajco.12636
Eriksson I, Wettermark B, Bergfeldt K (2018) Real-world use and outcomes of Olaparib: a population-based cohort study. Target Oncol 13:725–733. https://doi.org/10.1007/s11523-018-0604-z
De La Motte RT, Pautier P, Alexandre J et al (2015) 2755 first real life data on Olaparib in BRCA1/2 mutated platinum-sensitive relapsed (PSR) epithelial ovarian Cancer (EOC) in France: analysis of 52 patients (pts) enrolled in the French temporary authorization for use (ATU). Eur J Cancer 51:S548–S549. https://doi.org/10.1016/S0959-8049(16)31521-0
To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer - Tabular View - ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/record/NCT02476968. Accessed 25 Mar 2019
Olaparib in German routine clinical practice: Updated interim results of the non-interventional study C-PATROL. | J Clin Oncol. https://ascopubs.org/doi/abs/10.1200/JCO.2018.36.15_suppl.e17549. Accessed 24 Mar 2019
Sehouli J, Hilpert F, Welslau M et al (2018) Olaparib in German routine clinical practice: updated interim results of the non-interventional study c-patrol. Gynecol Oncol 149:120. https://doi.org/10.1016/j.ygyno.2018.04.278
Paik ES, Kim J, Kim T-J et al (2018) 274PReal-world experience of olaparib maintenance in high grade serous recurrent ovarian cancer patients with BRCA 1/2 mutation. Ann Oncol 29. https://doi.org/10.1093/annonc/mdy436.021
Moore KN, Monk BJ (2016) Patient counseling and Management of Symptoms during Olaparib Therapy for recurrent ovarian Cancer. Oncologist 21:954–963. https://doi.org/10.1634/theoncologist.2015-0268
Anonymous (2018) Lynparza. European Medicines Agency https://www.ema.europa.eu/en/medicines/human/EPAR/lynparza.
Liavaag AH, Dørum A, Fosså SD et al (2009) Morbidity associated with “self-rated health” in epithelial ovarian cancer survivors. BMC Cancer 9:2. https://doi.org/10.1186/1471-2407-9-2
Fighting Cancer Fatigue. https://www.nccn.org/patients/resources/life_with_cancer/fatigue.aspx. Accessed 28 Mar 2019
Nausea and Vomiting. In: National Cancer Institute (2015) https://www.cancer.gov/about-cancer/treatment/side-effects/nausea. Accessed 28 Mar 2019
Nota Informativa Importante su LYNPARZA (Olaparib) (28/09/2018) | AIFA Agenzia Italiana del Farmaco. http://www.agenziafarmaco.gov.it/content/nota-informativa-importante-su-lynparza-olaparib-28092018. Accessed 24 Mar 2019
This editorial project was supported by AstraZeneca SpA Italy. Medical writing support and editorial assistance was provided by Clara Ricci, PhD (Edra SpA, Milan, Italy), and unconditionally funded by AstraZeneca SpA Italy.
Conflict of interest
DL reports grants and personal fees from Immunogen, Genmab, Pharmamar, Clovis, Tesaro and Merck; personal fees from Astra Zeneca outside the submitted work; CZ reports personal fees from Takeda, Pierre Fabre, TEVA, Istituto Gentili, Roche, EISAI, Novartis, from AstraZeneca, Pfizer, PharmaMar, Celgene, Lilly, Amgen, Tesaro and QuintilesIMS outside the submitted work; RDV reports grant from AstraZeneca and Tesaro; GM reports personal fees from AstraZeneca and Tesaro, and non-financial support from Roche; VS reports fees for advisory boards and educational meetings from AstraZeneca; GT reports fees and non-financial support from Tesaro outside the submitted work; VG reports personal fees from Edra and travel grants from Tesaro.
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Lorusso, D., Bologna, A., Cecere, S.C. et al. Sharing real-world experiences to optimize the management of olaparib toxicities: a practical guidance from an Italian expert panel. Support Care Cancer (2020). https://doi.org/10.1007/s00520-020-05320-4
- Clinical practice
- Recurrent ovarian cancer