Palbociclib versus abemaciclib in HR+/HER2- advanced breast cancer: an indirect comparison of patient-reported end points
Publication: Journal of Comparative Effectiveness Research
Abstract
Aim: To assess the relative impact of palbociclib plus fulvestrant (PAL + FUL) and abemaciclib plus fulvestrant (ABEM + FUL) on patient-reported outcomes in patients with hormone receptor-positive, HER2-negative (HR+/HER2-) advanced breast cancer. Patients & methods: Anchored matching-adjusted indirect comparisons were conducted using individual patient data from PALOMA-3 (PAL + FUL) and summary-level data from MONARCH-2 (ABEM + FUL). Outcomes included the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30) and its breast cancer-specific module (QLQ-BR23). Results: Significantly different changes from baseline favoring PAL + FUL compared with ABEM + FUL were observed in global quality of life (6.95 [95% CI: 2.19–11.71]; p = 0.004) and several functional/symptom scales, including emotional functioning, nausea/vomiting, appetite loss, diarrhea and systemic therapy side effects. Conclusion: PAL + FUL was associated with more favorable patient-reported outcomes than ABEM + FUL in patients with HR+/HER2- advanced breast cancer.
Supplementary Material
References
Papers of special note have been highlighted as: • of interest; •• of considerable interest
1.
United States Food & Drug Administration. Drugs@FDA: FDA-approved drugs - palbociclib (IBRANCE) (2019). http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&var ApplNo=207103
2.
Turner NC, Ro J, André F et al. Palbociclib in hormone-receptor-positive advanced breast cancer. N. Engl. J. Med. 373(3), 209–219 (2015).
• Presents results for the primary outcome (progression-free survival) and baseline patient characteristics from the PALOMA-3 trial.
3.
United States Food & Drug Administration. Drugs@FDA: FDA-approved drugs - ribociclib (KISQALI) (2020). http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=209092
4.
Slamon DJ, Neven P, Chia S et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J. Clin. Oncol. 36(24), 2465–2472 (2018).
5.
United States Food & Drug Administration. Drugs@FDA: FDA-approved drugs - abemaciclib (VERZENIO) (2020). http://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&varApplNo=208716
6.
Sledge GW Jr, Toi M, Neven P et al. MONARCH 2: abemaciclib in combination with fulvestrant in women With HR+/HER2- advanced breast cancer who had progressed while receiving endocrine therapy. J. Clin. Oncol. 35(25), 2875–2884 (2017).
• Presents results for the primary outcome (progression-free survival) and baseline patient characteristics from the MONARCH 2 trial.
7.
Cristofanilli M, Rugo HS, Im S-A et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor–positive (HR+), human epidermal growth factor receptor 2–negative (HER2–) advanced breast cancer (ABC): Updated analyses from PALOMA-3. J. Clin. Oncol. 39(Suppl. 15), 1000–1000 (2021).
8.
Petrelli F, Ghidini A, Pedersini R et al. Comparative efficacy of palbociclib, ribociclib and abemaciclib for ER+ metastatic breast cancer: an adjusted indirect analysis of randomized controlled trials. Breast Cancer Res. Treat. 174(3), 597–604 (2019).
9.
Rugo HS, Haltner A, Zhan L et al. Matching-adjusted indirect comparison of palbociclib versus ribociclib and abemaciclib in hormone receptor-positive/HER2-negative advanced breast cancer. J. Comp. Eff. Res. 10(6), 457–467 (2021).
•• Presents results of matching-adjusted indirect comparisons assessing relative overall survival with palbociclib compared with abemaciclib and ribociclib.
10.
De Mello Ramirez Medina J, De Araujo Trugilho I, Mendes GNB et al. Advanced clinical stage at diagnosis of breast cancer is associated with poorer health-related quality of life: a cross-sectional study. Eur. J. Breast Health 15(1), 26–31 (2019).
11.
Harbeck N, Iyer S, Turner N et al. Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial. Ann. Oncol. 27(6), 1047–1054 (2016).
•• Presents results for patient-reported outcomes from the PALOMA-3 trial.
12.
Marandino L, La Salvia A, Sonetto C et al. Deficiencies in health-related quality-of-life assessment and reporting: a systematic review of oncology randomized Phase III trials published between 2012 and 2016. Ann. Oncol. 29(12), 2288–2295 (2018).
13.
Kaufman PA, Toi M, Neven P et al. Health-related quality of life in MONARCH 2: abemaciclib plus fulvestrant in hormone receptor-positive, HER2-negative advanced breast cancer after endocrine therapy. Oncologist 25(2), e243–e251 (2020).
•• Presents results for patient-reported outcomes from the MONARCH 2 trial.
14.
Miles D, Von Minckwitz G, Seidman AD. Combination versus sequential single-agent therapy in metastatic breast cancer. Oncologist 7(Suppl. 6), 13–19 (2002).
15.
Dear RF, Mcgeechan K, Jenkins MC, Barratt A, Tattersall MH, Wilcken N. Combination versus sequential single agent chemotherapy for metastatic breast cancer. Cochrane Database Syst. Rev. 2013(12), Cd008792 (2013).
16.
Cardoso F, Costa A, Senkus E et al. 3rd ESO-ESMO International Consensus guidelines for advanced breast cancer (ABC 3). Ann. Oncol. 28(1), 16–33 (2017).
17.
Rugo HS, Huober J, García-Sáenz JA et al. Management of abemaciclib-associated adverse events in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: safety analysis of MONARCH 2 and MONARCH 3. Oncologist 26(1), e53–e65 (2021).
18.
Maculaitis MC, Liu X, Will O et al. Oncologist and patient preferences for attributes of CDK4/6 inhibitor regimens for the treatment of advanced/metastatic HR Positive/HER2 negative breast cancer: discrete choice experiment and best-worst scaling. Patient Prefer. Adherence 14, 2201–2214 (2020).
• Describes a discrete choice experiment/best-worst scaling study of patient and oncologist preferences for properties of CDK4/6is used to treat HR+/HER2- advanced breast cancer.
19.
Fasching PA, Beck JT, Chan A et al. Ribociclib plus fulvestrant for advanced breast cancer: health-related quality-of-life analyses from the MONALEESA-3 study. Breast 54, 148–154 (2020).
20.
NICE. NICE DSU Technical Support Document 18: methods for population-adjusted indirect comparisons in submission to NICE. (2021). http://nicedsu.org.uk/wp-content/uploads/2018/08/Population-adjustment-TSD-FINAL-ref-rerun.pdf
21.
Sledge GW Jr, Toi M, Neven P et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptor-positive, ERBB2-negative breast cancer that progressed on endocrine therapy-MONARCH 2: a randomized clinical trial. JAMA Oncol. 6(1), 116–124 (2020).
22.
Bucher HC, Guyatt GH, Griffith LE, Walter SD. The results of direct and indirect treatment comparisons in meta-analysis of randomized controlled trials. J. Clin. Epidemiol. 50(6), 683–691 (1997).
23.
Cocks K, King MT, Velikova G et al. Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. Eur. J. Cancer 48(11), 1713–1721 (2012).
24.
Musoro JZ, Coens C, Fiteni F et al. Minimally important differences for interpreting EORTC QLQ-C30 scores in patients with advanced breast cancer. JNCI Cancer Spectr. 3(3), 1–7 (2019).
25.
National Pharmaceutical Council. Guiding practices for patient-centered value assessment (2021). https://www.npcnow.org/sites/default/files/2021-04/npc-guiding-practices-for-patient-centered-value-assessment.pdf
26.
Institute for Clinical and Economic Review (ICER). 2020–2023 value assessment framework (2020). https://34eyj51jerf417itp82ufdoe-wpengine.netdna-ssl.com/wp-content/uploads/2021/03/ICER_2020_2023_VAF_013120-4-2.pdf
27.
Schnipper LE, Davidson NE, Wollins DS et al. Updating the American Society of Clinical Oncology Value Framework: revisions and reflections in response to comments received. J. Clin. Oncol. 34(24), 2925–2934 (2016).
28.
Cherny NI, Dafni U, Bogaerts J et al. ESMO-magnitude of clinical benefit scale version 1.1. Ann. Oncol. 28(10), 2340–2366 (2017).
29.
Canadian Agency for Drugs and Technologies in Health: pan-Canadian Oncology Drug Review (pCODR) expert review committee deliberative framework (2016). https://www.cadth.ca/sites/default/files/pcodr/The%20pCODR%20Expert%20Review%20Committee%20%28pERC%29/pcodr_perc_deliberative_frame.pdf
30.
Raymakers AJN, Regier DA, Peacock SJ. Health-related quality of life in oncology drug reimbursement submissions in Canada: a review of submissions to the pan-Canadian Oncology Drug Review. Cancer 126(1), 148–155 (2020).
31.
Kleijnen S, Leonardo Alves T, Meijboom K et al. The impact of quality-of-life data in relative effectiveness assessments of new anti-cancer drugs in European countries. Qual. Life Res. 26(9), 2479–2488 (2017).
32.
Kotronoulas G, Kearney N, Maguire R et al. What is the value of the routine use of patient-reported outcome measures toward improvement of patient outcomes, processes of care, and health service outcomes in cancer care? A systematic review of controlled trials. J. Clin. Oncol. 32(14), 1480–1501 (2014).
33.
Velikova G, Booth L, Smith AB et al. Measuring quality of life in routine oncology practice improves communication and patient well-being: a randomized controlled trial. J. Clin. Oncol. 22(4), 714–724 (2004).
34.
Basch E, Deal AM, Dueck AC et al. Overall survival results of a trial assessing patient-reported outcomes for symptom monitoring during routine cancer treatment. JAMA 318(2), 197–198 (2017).
35.
Denis F, Basch E, Septans AL et al. Two-year survival comparing web-based symptom monitoring vs routine surveillance following treatment for lung cancer. JAMA 321(3), 306–307 (2019).
36.
Song F, Loke YK, Walsh T, Glenny A-M, Eastwood AJ, Altman DG. Methodological problems in the use of indirect comparisons for evaluating healthcare interventions: survey of published systematic reviews. BMJ 338, 1–7 (2009).
Information & Authors
Information
Published In
Pages: 109 - 120
PubMed: 34751591
Copyright
© 2021 Chris Cameron. This work is licensed under the Attribution-NonCommercial-NoDerivatives 4.0 Unported License
History
Received: 17 September 2021
Accepted: 21 October 2021
Published online: 9 November 2021
Keywords:
Topics
Authors
Funding Information
Pfizer, Inc.
Metrics & Citations
Metrics
Article Usage
Article usage data only available from February 2023. Historical article usage data, showing the number of article downloads, is available upon request.
Citations
How to Cite
Palbociclib versus abemaciclib in HR+/HER2- advanced breast cancer: an indirect comparison of patient-reported end points. (2021) Journal of Comparative Effectiveness Research. DOI: 10.2217/cer-2021-0221
Export citation
Select the citation format you wish to export for this article or chapter.
Citing Literature
- Diana Lüftner, Maggie Banys-Paluchowski, Andreas D. Hartkopf, Manuel Hörner, Wolfgang Janni, Dagmar Langanke, Volkmar Müller, Andreas Schneeweiss, Marcus Schmidt, Marc Thill, Michael Untch, Achim Wöckel, Lukas Höllrich, Julia Kreuzeder, Almuth Marx, Julia Meinzinger, Hanna Regus-Leidig, Christian Roos, Hien Wohlgemuth, Stephanie Sussmann, Peter A. Fasching, Indirect Treatment Comparison between Ribociclib Combined with Non-Steroidal Aromatase Inhibitors and Ovarian Function Suppression vs. Tamoxifen in Premenopausal Women with Early Breast Cancer, Senologie - Zeitschrift für Mammadiagnostik und -therapie, 10.1055/a-2784-6305, 23, 01, (63-74), (2026).
- Benlong Yang, Zhengkui Sun, Quchang Ouyang, Zhongsheng Tong, Shu Wang, Hongyuan Li, Zhaofeng Niu, Yiding Chen, Lin-xiaoxi Ma, Haoqi Wang, Mu Tang, Zheyu Hu, Xueqiang Gao, Xu Wang, Fei Xie, Qiao Cheng, Yong Shen, Cuizhi Geng, Haibo Wang, Jiong Wu, Safety and quality of life of CDK4/6 inhibitors therapy for hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: a multicenter cross-sectional survey in China, BMC Cancer, 10.1186/s12885-025-14223-8, 25, 1, (2025).
- Cecília Menezes Farinasso, Vinícius Lins Ferreira, Flávia Cordeiro Medeiros, Aline Pereira da Rocha, Patrícia do Carmo Silva Parreira, Layssa Andrade Oliveira, Lays Pires Marra, Rosa Camila Lucchetta, Haliton Alves de Oliveira, Matching-Adjusted Indirect Comparison Studies in Oncology: A Scoping Review Focused on Reporting Quality, Value in Health Regional Issues, 10.1016/j.vhri.2025.101088, 47, (101088), (2025).
- Diana Lüftner, Maggie Banys-Paluchowski, Andreas D. Hartkopf, Manuel Hörner, Wolfgang Janni, Dagmar Langanke, Volkmar Müller, Andreas Schneeweiss, Marcus Schmidt, Marc Thill, Michael Untch, Achim Wöckel, Lukas Höllrich, Julia Kreuzeder, Almuth Marx, Julia Meinzinger, Hanna Regus-Leidig, Christian Roos, Hien Wohlgemuth, Stephanie Sussmann, Peter A. Fasching, Indirect Treatment Comparison between Ribociclib Combined with Non-Steroidal Aromatase Inhibitors and Ovarian Function Suppression vs. Tamoxifen in Premenopausal Women with Early Breast Cancer, Geburtshilfe und Frauenheilkunde, 10.1055/a-2561-6640, 85, 06, (599-610), (2025).
- Shogo Nakamoto, Tadahiko Shien, Takayuki Iwamoto, Shinichiro Kubo, Mari Yamamoto, Tetsumasa Yamashita, Chihiro Kuwahara, Masahiko Ikeda, Absolute lymphocyte count and neutrophil-to-lymphocyte ratio as predictors of CDK 4/6 inhibitor efficacy in advanced breast cancer, Scientific Reports, 10.1038/s41598-024-60101-x, 14, 1, (2024).
- Fatima Cardoso, Julie Rihani, Victoria Harmer, Nadia Harbeck, Ana Casas, Hope S Rugo, Peter A Fasching, Adam Moore, Joanna de Courcy, Purnima Pathak, Sina Haftchenary, Dawn Aubel, Eva Schumacher-Wulf, Quality of Life and Treatment-Related Side Effects in Patients With HR+/HER2− Advanced Breast Cancer: Findings From a Multicountry Survey, The Oncologist, 10.1093/oncolo/oyad207, 28, 10, (856-865), (2023).
- Ernest H Law, Chris Cameron, Letter in Reply: indirect comparison of quality-of-life scores between patients with advanced breast cancer receiving palbociclib and abemaciclib in combination with fulvestrant, Journal of Comparative Effectiveness Research, 10.57264/cer-2023-0009, 12, 6, (2023).
- Vittorio Gebbia, Maria Rosaria Valerio, Federica Martorana, Maria Vita Sanò, Paolo Vigneri, Letter to the Editor: statistics and clinical perception of patients’ reported outcomes for palbociclib and abemaciclib: a sliding doors story, Journal of Comparative Effectiveness Research, 10.57264/cer-2022-0212, 12, 6, (2023).
- Erilaine de F Corpes, Romel J V Yanez, Denise M da Silva, Kauane M Leite, Milena C T Martins, Milena M Vieira, Cristina P R S dos Santos, Ana F C Fernandes, Régia C M B Castro, Health-related quality of life of women with breast cancer being treated with hormone therapy: A scoping review, Journal of Oncology Pharmacy Practice, 10.1177/10781552231168071, 29, 4, (944-955), (2023).
- Laura Dormer, Journal of Comparative Effectiveness Research: 2022 year in review, Journal of Comparative Effectiveness Research, 10.57264/cer-2023-0026, 12, 4, (2023).
