Patients with HR+/HER2- Metastatic Breast Cancer Treated with CDK4/6 Inhibitors: A Real-World Study in Italy

References

• Alkabban FM , Ferguson T . Breast Cancer. StatPearls Publishing, FL, USA (2022).
   Google Scholar
• World Health Organization . Breast cancer (2021). https://www.who.int/news-room/fact-sheets/detail/breast-cancer (Accessed 20 April 2023 ).
   Google Scholar
• Momenimovahed Z , Salehiniya H . Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med. Press) 11, 151–164 (2019).
   PubMed Web of Science ®Google Scholar
• Thakur P , Seam RK , Gupta MK , Gupta M , Sharma M , Fotedar V . Breast cancer risk factor evaluation in a Western Himalayan state: a case-control study and comparison with the Western World. South Asian J. Cancer 6(3), 106–109 (2017).
   PubMedGoogle Scholar
• AIOM . I numeri del cancro in Italia (2022). https://www.aiom.it/wp-content/uploads/2022/12/2022_AIOM_NDC-web (Accessed 20 April 2023 ).
   Google Scholar
• AIOM . Linea guida sul cancro della mammella (2021). https://snlg.iss.it/wp-content/uploads/2021/11/LG_260_mammella_agg2021.pdf (Accessed 20 April 2023 ).
   Google Scholar
• Ferretti S , Guzzinati S , Zambon P et al. [Stima dell’incidenza del carcinoma mammario attraverso il flusso dei ricoveri ospedalieri: confronto con i dati dei Registri tumori]. Cancer incidence estimation by hospital discharge flow as compared with cancer registries data. Epidemiol Prev. 33(4–5), 147–153 (2009).
   PubMed Web of Science ®Google Scholar
• Perrone V , Giacomini E , Sangiorgi D et al. Description of characteristics, management of care and healthcare direct costs of patients with HR+/HER2- early breast cancer in Italy: a real-world study involving administrative and pathological anatomy databases. Expert Rev Pharmacoecon Outcomes Res. 23(9), 1077–1085 (2023).
   PubMedGoogle Scholar
• Crocetti E , Gori S , Falcini F . Metastatic breast cancers: estimates for Italy. Tumori 104(2), 116–120 (2018).
   PubMed Web of Science ®Google Scholar
• Poetto AS , Posocco B , Gagno S et al. A new dried blood spot LC-MS/MS method for therapeutic drug monitoring of palbociclib, ribociclib, and letrozole in patients with cancer. J. Chromatogr. B Analyt. Technol. Biomed. Life Sci. 1185, 122985 (2021).
   PubMed Web of Science ®Google Scholar
• Reddy PM , Martin JM , Montero AJ . CDK 4/6 inhibitors: evolution and revolution in the management of ER+ metastatic breast cancer. JCO Oncol. Pract. 18(5), 329–330 (2022).
   PubMedGoogle Scholar
• Johnston SRD , Harbeck N , Hegg R et al. Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2-, node-positive, high-risk, early breast cancer (monarchE). J. Clin. Oncol. 38(34), 3987–3998 (2020).
   PubMed Web of Science ®Google Scholar
• 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 (2019).
   Web of Science ®Google Scholar
• Johnston S , Martin M , Di Leo A et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 5, 5 (2019).
   PubMed Web of Science ®Google Scholar
• Turner NC , Slamon DJ , Ro J et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N. Engl. J. Med. 379(20), 1926–1936 (2018).
   PubMed Web of Science ®Google Scholar
• Rugo HS , Finn RS , Diéras V et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res. Treat. 174(3), 719–729 (2019).
   PubMed Web of Science ®Google Scholar
• Hortobagyi GN , Stemmer SM , Burris HA et al. Updated results from MONALEESA-2, a phase III trial of first-line ribociclib plus letrozole versus placebo plus letrozole in hormone receptor-positive, HER2-negative advanced breast cancer. Ann. Oncol. 29(7), 1541–1547 (2018).
   PubMed Web of Science ®Google Scholar
• Slamon DJ , Neven P , Chia S et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N. Engl. J. Med. 382(6), 514–524 (2020).
   PubMed Web of Science ®Google Scholar
• Im SA , Lu YS , Bardia A et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N. Engl. J. Med. 381(4), 307–316 (2019).
   PubMed Web of Science ®Google Scholar
• Adon T , Shanmugarajan D , Kumar HY . CDK4/6 inhibitors: a brief overview and prospective research directions. RSC Adv. 11(47), 29227–29246 (2021).
   PubMed Web of Science ®Google Scholar
• George MA , Qureshi S , Omene C , Toppmeyer DL , Ganesan S . Clinical and pharmacologic differences of CDK4/6 inhibitors in breast cancer. Front Oncol. 11, 693104 (2021).
   PubMed Web of Science ®Google Scholar
• Braal CL , Jongbloed EM , Wilting SM , Mathijssen RHJ , Koolen SLW , Jager A . Inhibiting CDK4/6 in breast cancer with palbociclib, ribociclib, and abemaciclib: similarities and differences. Drugs 81(3), 317–331 (2021).
   PubMed Web of Science ®Google Scholar
• Adamson BJ , Waskom M , Blarre A et al. Approach to machine learning for extraction of real-world data variables from electronic health records (2023). https://www.medrxiv.org/content/10.1101/2023.03.02.23286522v1 (Accessed: 19 April 2023 ).
   Google Scholar
• Charlson ME , Pompei P , Ales KL , MacKenzie CR . A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J. Chronic Dis. 40(5), 373–383 (1987).
   PubMedGoogle Scholar
• Salas M , Henderson M , Sundararajan M et al. Use of comorbidity indices in patients with any cancer, breast cancer, and human epidermal growth factor receptor-2-positive breast cancer: a systematic review. PLOS ONE 16(6), e0252925 (2021).
   PubMed Web of Science ®Google Scholar
• Cohen J . A power primer. Psychol. Bull. 112(1), 155–159 (1992).
   PubMed Web of Science ®Google Scholar
• Austin PC . An introduction to propensity score methods for reducing the effects of confounding in observational studies. Multivariate Behav. Res. 46(3), 399–424 (2011).
   PubMed Web of Science ®Google Scholar
• Zhang Z , Kim HJ , Lonjon G , Zhu Y . Balance diagnostics after propensity score matching. Ann. Transl. Med. 7(1), 16 (2019).
   PubMed Web of Science ®Google Scholar
• Battisti NML , De Glas N , Sedrak MS et al. Use of cyclin-dependent kinase 4/6 (CDK4/6) inhibitors in older patients with ER-positive HER2-negative breast cancer: Young International Society of Geriatric Oncology review paper. Ther. Adv. Med. Oncol. 10 (2018). https://doi.org/10.1177/1758835918809610
   Web of Science ®Google Scholar
• Olazagasti C , Lee CS , Liu A , Stefanov D , Cheng K . A deep dive into CDK4/6 inhibitors: evaluating real world toxicities and treatment paradigms in the elderly population. J. Oncol. Pharm. Pract. 29(1), 14–21 (2023).
   PubMed Web of Science ®Google Scholar
• Schettini F , Giudici F , Giuliano M et al. Overall survival of CDK4/6-inhibitor-based treatments in clinically relevant subgroups of metastatic breast cancer: systematic review and meta-analysis. J. Natl Cancer Inst. 112(11), 1089–1097 (2020).
   PubMedGoogle Scholar
• Finn RS , Crown JP , Lang I et al. The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised Phase II study. Lancet Oncol. 16(1), 25–35 (2015).
   PubMed Web of Science ®Google Scholar
• Finn RS , Martin M , Rugo HS et al. Palbociclib and letrozole in advanced breast cancer. N. Engl. J. Med. 375(20), 1925–1936 (2016).
   PubMed Web of Science ®Google Scholar
• Cristofanilli M , Turner NC , Bondarenko I et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, Phase III randomised controlled trial. Lancet Oncol. 17(4), 425–439 (2016).
   PubMed Web of Science ®Google Scholar
• 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).
   PubMed Web of Science ®Google Scholar
• Goetz MP , Toi M , Campone M et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J. Clin. Oncol. 35(32), 3638–3646 (2017).
   PubMed Web of Science ®Google Scholar
• 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).
   PubMed Web of Science ®Google Scholar
• Tripathy D , Im SA , Colleoni M et al. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised Phase III trial. Lancet Oncol. 19(7), 904–915 (2018).
   PubMed Web of Science ®Google Scholar
• Hortobagyi GN , Stemmer SM , Burris HA et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N. Engl. J. Med. 375(18), 1738–1748 (2016).
   PubMed Web of Science ®Google Scholar
• Werutsky G , Reinert T , Rosa ML , Barrios CH . Real-world data on first-line systemic therapy for hormone receptor-positive HER2-negative metastatic breast cancer: a trend shift in the era of CDK 4/6 inhibitors. Clin. Breast Cancer 21(6), e688–e692 (2021).
   PubMed Web of Science ®Google Scholar
• Llombart-Cussac A , Pérez-García JM , Bellet M et al. Fulvestrant-palbociclib vs letrozole-palbociclib as initial therapy for endocrine-sensitive, hormone receptor-positive, ERBB2-negative advanced breast cancer: a randomized clinical trial. JAMA Oncol. 7(12), 1791–1799 (2021).
   PubMed Web of Science ®Google Scholar
• Toi M , Huang CS , Im YH et al. Abemaciclib plus fulvestrant in East Asian women with HR+, HER2- advanced breast cancer: overall survival from MONARCH 2. Cancer Sci. 114(1), 221–226 (2022).
   PubMed Web of Science ®Google Scholar
• Wong V , De Boer R , Baron-Hay S et al. Real-world outcomes of ribociclib and aromatase inhibitor use in first line hormone receptor positive, HER2-negative metastatic breast cancer. Clin. Breast Cancer 22(8), 792–800 (2022).
   PubMed Web of Science ®Google Scholar
• Borstnar S , Palacova M , Łacko A et al. Ribociclib plus letrozole in patients with hormone receptor-positive, HER2-negative advanced breast cancer with no prior endocrine therapy: subgroup safety analysis from the Phase IIIb CompLEEment-1 trial. Radiol. Oncol. 56(2), 238–247 (2022).
   PubMed Web of Science ®Google Scholar
• Hortobagyi GN , Stemmer SM , Burris HA et al. Overall survival with ribociclib plus letrozole in advanced breast cancer. N. Engl. J. Med. 386(10), 942–950 (2022).
   PubMed Web of Science ®Google Scholar
• Staropoli N , Geuna E , Rinaldi G et al. Real-world clinical outcomes of ribociclib in combination with a non-steroidal aromatase inhibitor and a luteinizing hormone-releasing hormone agonist in premenopausal HR+/HER2- advanced breast cancer patients: an Italian managed access program. Curr. Oncol. 29(9), 6635–6641 (2022).
   PubMed Web of Science ®Google Scholar
• Harbeck N , Bartlett M , Spurden D et al. CDK4/6 inhibitors in HR+/HER2- advanced/metastatic breast cancer: a systematic literature review of real-world evidence studies. Future Oncol. 17(16), 2107–2122 (2021).
   PubMed Web of Science ®Google Scholar
• Kish J , Miller T , Nero D et al. Abstract P5-14-13: real-world dosing and CBC monitoring in patients with metastatic breast cancer during palbociclib plus letrozole therapy. Presented at: Proceedings of the 2019 San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–14 December 2019.
   Google Scholar
• Stearns V , Brufsky AM , Verma S et al. Expanded-access study of palbociclib in combination with letrozole for treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer. Clin. Breast Cancer 18(6), e1239–e1245 (2018).
   PubMed Web of Science ®Google Scholar
• Mycock K , Hanson KA , Taylor-Stokes G et al. Real-world treatment patterns and clinical outcomes associated with palbociclib combination therapy: a multinational, pooled analysis from the Ibrance real world insights study. Clin. Ther. 44(12), 1588–1601 (2022).
   PubMed Web of Science ®Google Scholar
• Taylor-Stokes G , Mitra D , Waller J , Gibson K , Milligan G , Iyer S . Treatment patterns and clinical outcomes among patients receiving palbociclib in combination with an aromatase inhibitor or fulvestrant for HR+/HER2-negative advanced/metastatic breast cancer in real-world settings in the US: results from the IRIS study. Breast 43, 22–27 (2019).
   PubMed Web of Science ®Google Scholar
• Nero D , Feinberg BA , Yu HT et al. Real-world dosing patterns among metastatic breast cancer patients initiating first line (1L) palbociclib (PAL) therapy. J. Clin. Oncol. 36(Suppl. 15), e13050 (2018).
   Web of Science ®Google Scholar
• Du Rusquec P , Palpacuer C , Campion L et al. Efficacy of palbociclib plus fulvestrant after everolimus in hormone receptor-positive metastatic breast cancer. Breast Cancer Res. Treat. 168(2), 559–566 (2018).
   PubMed Web of Science ®Google Scholar
• Lok SW , Baron-Hay S , Lim E et al. Abstract OT2-02-01: a ‘real world’ experience of CDK4/6 inhibition with ribociclib and endocrine therapy in hormone receptor positive metastatic breast cancer in Australia. Presented at: Proceedings of the 2019 San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–14 December 2019.
   Google Scholar
• Carter G , Sheffield K , Gossai A et al. Abstract P2-08-12: initial real world treatment patterns and outcomes of abemaciclib for the treatment of HR+, HER2- metastatic breast cancer. Presented at: Proceedings of the 2019 San Antonio Breast Cancer Symposium. San Antonio, TX, USA, 10–14 December 2019.
   Google Scholar
• Gazzetta Ufficiale . Determina 27 novembre 2019 Riclassificazione del medicinale per uso umano «Verzenios» (2019). https://www.gazzettaufficiale.it/eli/gu/2019/12/12/291/sg/pdf (Accessed 20 April 2023 ).
   Google Scholar
• 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).
   PubMedGoogle Scholar
• Musicco F , Lasala R , Santoleri F et al. A multicentre study with real-world data of the use of palbociclib in the treatment of breast cancer: treatment duration correlates with dose reductions. J. Oncol. Pharm. Pract. 29(8), 1806–1815 (2023).
   PubMed Web of Science ®Google Scholar
• Colombo GL , Valentino MC , Fabi A et al. Economic evaluation for palbociclib plus fulvestrant vs ribociclib plus fulvestrant and abemaciclib plus fulvestrant in endocrine-resistant advanced or metastatic breast cancer in Italy. Ther. Clin. Risk Manag. 19, 301–312 (2023).
   PubMed Web of Science ®Google Scholar