Real-world bevacizumab utilization and outcomes among women with ovarian cancer in Europe and the United States
1Merck, Sharp, and Dohme, Kenilworth, NJ 0703, USA
2Adelphi Real World, SK10 5JB Bollington, UK
DOI: 10.31083/j.ejgo4206181 Vol.42,Issue 6,December 2021 pp.1252-1261
Submitted: 04 June 2021 Accepted: 21 July 2021
Published: 15 December 2021
*Corresponding Author(s): Matthew J. Monberg E-mail: firstname.lastname@example.org
Objective: To investigate real-world utilization of bevacizumab and treatment outcomes in patients with advanced ovarian cancer (OC) in Europe (EU5 - France, Germany, Italy, Spain, United Kingdom) and the United States (US). Methods: Data were derived from the Advanced Ovarian Cancer Disease Specific Programme™ - a point-in-time, independent survey conducted between November 2017–March 2018. Physicians provided data for 8 consecutive eligible patients; patients were included if their first-line (1L) treatment consisted of chemotherapy with no maintenance (chemotherapy only) or chemotherapy plus bevacizumab and bevacizumab maintenance (chemotherapy + bevacizumab). All analyses were descriptive. Results: Data on 1498 patients were analysed. At 1L, 82% received chemotherapy only and 18% received chemotherapy + bevacizumab; 63% had completed 1L, of which 38% were BReast CAncer (BRCA) gene wildtype. Bevacizumab was used by 20% of US patients and 11% of EU5 patients. Patients who received 1L chemotherapy + bevacizumab were more likely to have tumour response (96% vs 79%), be platinum sensitive (58% vs 35%) and initiate platinum chemotherapy at second-line (2L) (72% vs 58%) compared with patients who received chemotherapy only. Treatment response (85% vs 83%) and platinum sensitivity (51% vs 40%) were similar in patients with BRCA wildtype compared with the total study population. Benefits observed with chemotherapy + bevacizumab compared to chemotherapy alone were consistent, regardless of BRCA status. Conclusion: Despite the benefits observed with 1L chemotherapy + bevacizumab, relatively low proportions of patients received this regimen and treatment patterns between the US and EU5 were not uniform, in part due to differences in timings of approvals and reimbursement across territories.
Bevacizumab; Chemotherapy; First-line; Maintenance; Ovarian cancer; Realworld
Matthew J. Monberg,Jennifer P. Hall,Rebecca Moon,Keerun Khela. Real-world bevacizumab utilization and outcomes among women with ovarian cancer in Europe and the United States. European Journal of Gynaecological Oncology. 2021. 42(6);1252-1261.
 Colombo N, Sessa C, Bois AD, Ledermann J, McCluggage W, Mc- Neish I, et al. ESMO-ESGO consensus conference recommendations on ovarian cancer: pathology and molecular biology, early and advanced stages, borderline tumours and recurrent disease†. Annals of Oncology. 2019; 30: 672–705.
 Reid BM, Permuth JB, Sellers TA. Epidemiology of ovarian cancer: a review. Cancer Biology & Medicine. 2017; 14: 9–32.
 Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: A Cancer Journal for Clinicians. 2019; 68: 394–424.
 American Cancer Society. Key Statistics for Ovarian Cancer. 2020. Available at: https://www.cancer.org/cancer/ovarian-cancer/ab out/key-statistics.html (Accessed: 20 August 2021).
 Armstrong DK, Alvarez RD, Bakkum-Gamez JN, Barroilhet L, Behbakht K, Berchuck A, et al. NCCN Guidelines Insights: Ovar- ian Cancer, Version 1.2019. Journal of the National Comprehen- sive Cancer Network. 2019; 17: 896–909.
 Mirza MR, Monk BJ, Herrstedt J, Oza AM, Mahner S, Redondo A, et al. Niraparib Maintenance Therapy in Platinum-Sensitive, Re- current Ovarian Cancer. New England Journal of Medicine. 2016; 375: 2154–2164.
 González-Martín A, Pothuri B, Vergote I, DePont Christensen R, Graybill W, Mirza MR, et al. Niraparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. New England Journal of Medicine. 2019; 381: 2391–2402.
 Moore KN, Secord AA, Geller MA, Miller DS, Cloven N, Fleming GF, et al. Niraparib monotherapy for late-line treatment of ovarian cancer (QUADRA): a multicentre, open-label, single-arm, phase 2 trial. Lancet Oncology. 2019; 20: 636–648.
 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.
 Moore K, Colombo N, Scambia G, Kim B, Oaknin A, Friedlander M, et al. Maintenance Olaparib in Patients with Newly Diagnosed Advanced Ovarian Cancer. New England Journal of Medicine. 2018; 379: 2495–2505.
 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 Oncology. 2017; 18: 1274–1284.
 Ray-Coquard I, Pautier P, Pignata S, Pérol D, González-Martín A, Berger R, et al. Olaparib plus Bevacizumab as first-Line Maintenance in Ovarian Cancer. New England Journal of Medicine. 2019; 381: 2416–2428.
 Jiang X, Li W, Li X, Bai H, Zhang Z. Current status and future prospects of PARP inhibitor clinical trials in ovarian cancer. Can- cer Management and Research. 2019; 11: 4371–4390.
 Haunschild CE, Tewari KS. Bevacizumab use in the frontline, maintenance and recurrent settings for ovarian cancer. Future Oncology. 2020; 16: 225–246.
 Perren TJ, Swart AM, Pfisterer J, Ledermann JA, Pujade-Lauraine E, Kristensen G, et al. A phase 3 trial of bevacizumab in ovarian cancer. New England Journal of Medicine. 2011; 365: 2484–2496.
 Oza AM, Cook AD, Pfisterer J, Embleton A, Ledermann JA, Pujade-Lauraine E, et al. Standard chemotherapy with or with- out bevacizumab for women with newly diagnosed ovarian cancer (ICON7): overall survival results of a phase 3 randomised trial. Lancet Oncology. 2015; 16: 928–936.
 Burger RA, Brady MF, Bookman MA, Fleming GF, Monk BJ, Huang H, et al. Incorporation of bevacizumab in the primary treat- ment of ovarian cancer. New England Journal of Medicine. 2011; 365: 2473–2483.
 Marchetti C, Muzii L, Romito A, Benedetti Panici P. First-line treatment of women with advanced ovarian cancer: focus on bevacizumab. OncoTargets and Therapy. 2019; 12: 1095–1103.
 Tewari KS, Burger RA, Enserro D, Norquist BM, Swisher EM, Brady MF, et al. Final Overall Survival of a Randomized Trial of Bevacizumab for Primary Treatment of Ovarian Cancer. Journal of Clinical Oncology. 2019; 37: 2317–2328.
 NHS England. National Cancer Drugs Fund List ver1. 2019. Avaialbe at: https://www.england.nhs.uk/wp-content/uploads/2017/04/national-cdf-list-ver1.165.pdf (Accessed: 20 August 2021).
 Miksad RA, Abernethy AP. Harnessing the Power of Real-World Evidence (RWE): a Checklist to Ensure Regulatory-Grade Data Quality. Clinical Pharmacology & Therapeutics. 2018; 103: 202– 205.
 Anderson P, Benford M, Harris N, Karavali M, Piercy J. Real- world physician and patient behaviour across countries: Disease-Specific Programmes - a means to understand. Current Medical Research and Opinion. 2008; 24: 3063–3072.
 Babineaux SM, Curtis B, Holbrook T, Milligan G, Piercy J. Evidence for validity of a national physician and patient-reported, cross-sectional survey in China and UK: the Disease Specific Pro- gramme. BMJ Open. 2016; 6: e010352.
 Higgins V, Piercy J, Roughley A, Milligan G, Leith A, Siddall J, et al. Trends in medication use in patients with type 2 diabetes mellitus: a long-term view of real-world treatment between 2000 and 2015. Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy. 2016; 9: 371–380.
 European Pharmaceutical Market Research Association (EphMRA). Code of Conduct. 2019. Available at: https://www.ephmra.org/standards/code-of-conduct-aer/ (Accessed: 20 August 2021).
 US Department of Health and Human Services. Summary of the HIPAA Privacy Rule. 2003. Available at: https://www.hhs.go v/sites/default/files/privacysummary.pdf (Accessed: 20 August 2021).
 US Department of Health and Human Services. Health Information Technology (HITECH). Act. 2009. available at: https://www.healthit.gov/sites/default/files/hitech_act_excerp t_from_arra_with_index.pdf (Accessed: 20 August 2021).
 StataCorp. Stata Statistical Software: Release 16. StataCorp LLC, College Station, TX. 2019.
 Bertelli G, Drews F, Lutchman-Singh K. Bevacizumab for Ovar- ian Cancer at High Risk of Progression: Reproducibility of Trial Results in ‘Real-world’ Patients. Anticancer Research. 2016; 36: 4947–4950.
 Komiyama S, Kato K, Inokuchi Y, Takano H, Matsumoto T, Hongo A, et al. Bevacizumab combined with platinum-taxane chemotherapy as first-line treatment for advanced ovarian cancer: a prospective observational study of safety and efficacy in Japanese patients (JGOG3022 trial). International Journal of Clinical Oncology. 2019; 24: 103–114.
 Monk BJ, Lammers PE, Cartwright T, Jacobs I. Barriers to the Access of Bevacizumab in Patients with Solid Tumors and the Potential Impact of Biosimilars: a Physician Survey. Pharmaceuticals. 2017; 10: 19.
 European Medicines Agency (EMA). Lynparza. 2019. European Medicines Agency (EMA). Lynparza. 2019. Available at: https:// www.ema.europa.eu/en/medicines/human/EPAR/lynparza (Accessed: 20 August 2021).
 Food and Drug Administration (FDA). Lynparza (olaparib) tablets, for oral use: prescribing information. 2018. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/ 208558s001lbl.pdf (Accessed: 20 August 2021).
 Jorge S, Gray HJ, Goff BA, Doll KM. Impact of research findings and NCCN guidelines on use of bevacizumab for newly diagnosed ovarian cancer in the United States. Gynecologic Oncology. 2019; 154: 217.
 Audibert C, Perlaky A, Stuntz M, Glass D. Variability in the therapeutic management of advanced ovarian cancer patients: a five-country survey of oncologists. Drug Design, Development and Therapy. 2017; 11: 3471–3479.
 Walsh CS. Latest clinical evidence of maintenance therapy in ovarian cancer. Current Opinion in Obstetrics & Gynecology. 2020; 32: 15–21.
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