Real-world clinical outcome and toxicity data and economic aspects in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy: the experience of the Hellenic Cooperative Oncology Group

Fountzilas, Elena; Koliou, Georgia-Angeliki; Vozikis, Athanassios; Rapti, Vassiliki; Nikolakopoulos, Achilleas; Boutis, Anastasios; Christopoulou, Athina; Kontogiorgos, Ioannis; Karageorgopoulou, Sofia; Lalla, Efthalia; Tryfonopoulos, Dimitrios; Boukovinas, Ioannis; Rapti, Cleopatra; Nikolaidi, Adamantia; Karteri, Sofia; Moirogiorgou, Evangelia; Binas, Ioannis; Mauri, Davide; Aravantinos, Gerasimos; Zagouri, Flora; Saridaki, Zacharenia; Psyrri, Amanda; Bafaloukos, Dimitrios; Koumarianou, Anna; Res, Eleni; Linardou, Helena; Mountzios, Giannis; Razis, Evangelia; Fountzilas, George; Koumakis, Georgios

doi:10.1136/esmoopen-2020-000774

Cited by 26 publications

(21 citation statements)

References 24 publications

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“…It is important to note that the majority of the patients included in our study had locally advanced/metastatic disease at presentation (76.1%) as also observed in the IRIS study which had enrolled 79.3% patients with metastatic disease at presentation 9 . This is in contrast to the study by Fountzilas et al in which the distribution of the patients in the different groups was more even 17 . Indian breast cancer patients present at a younger age with an advanced stage of the disease including larger tumor size, higher histopathological grade and more aggressive disease.…”

Section: Discussioncontrasting

confidence: 96%

Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

Agrawal

Goyal

Agarwal

et al. 2021

Sci Rep

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The combination of cyclin dependent kinase 4/6 inhibitors with endocrine therapy is the standard therapy in hormone receptor positive HER-2 negative metastatic breast cancer (HR+/HER2− MBC). Several randomized trials have shown the benefits of this combination, however, real world evidence in the Indian patients is warranted. The present study reports the largest real world multicentric data from Indian population on the use of Palbociclib in HR+/HER2− MBC. A multicentric study on the HR+/HER2− MBC patients who received palbociclib with hormonal agent (Aromatase inhibitors/Fulvestrant) between February 2017 and May 2020 was conducted. Clinical and demographic information and survival data was retrieved from the Hospital medical records. Among a total of 188 patients, 57% patients were premenopausal and 17% patients had bone only disease. Altogether, 115 (61%) patients received palbociclib with Aromatase inhibitors in the first line whereas 73 (39%) patients received it in the second line with Fulvestrant. The median follow up period with advanced disease was 13 months. The median progression free survival in the first line and second line was 20.2 months and 12 months, respectively (p-value < 0.0001). The objective response rate was 80% and 47.9% in first and second lines, respectively. Dose interruptions/ discontinuation were done in 14.9% and 2.7% patients in the first and second lines, respectively. In terms of toxicity, 10% patients had grade 3–4 adverse events. The present real world data of the use of palbociclib in Indian population suggests similar effectiveness to previously published real world evidences and has been adapted as the standard of care in the first and second line treatment of HR+/HER2− MBC.

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Section: Discussioncontrasting

confidence: 96%

Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

Agrawal

Goyal

Agarwal

et al. 2021

Sci Rep

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“…Upfront dose reduction and subsequent dose reduction due to toxicity could reflect poor patient-related prognostic factors, such as less favourable performance status and comorbidities. Although we were unable to adjust for these patient-related variables, our CDK4/6i discontinuation rate due to toxicity was slightly higher (13%) than that encountered in the RCTs (4–10%) [ 4 , 6 , 9 ] and other retrospective studies (2–10%) [ 14 , 15 , 17 , 22 , 41 ]. It follows that if PFS had also been adjusted for performance status and comorbidities, CDK4/6i dose reduction may not have been significantly associated with a worse outcome.…”

Section: Discussionmentioning

confidence: 61%

“…Smaller institution-based retrospective cohorts [ 14 , 15 , 16 , 17 ] have estimated median PFS ranging from 15.1 months [ 14 ] up to 36.7 months [ 17 ] for CDK4/6i + ET. Although the ET backbone in these small studies was largely an AI, a few studies included patients treated with fulvestrant as first-line treatment, suggesting a mix of patients with hormone-resistant disease and less favourable prognoses.…”

Section: Discussionmentioning

confidence: 99%

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

2021

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In this analysis, we describe population-based outcomes for first-line treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) combined with an aromatase inhibitor (AI). All patients who were prescribed CDK4/6i + AI from January 2016 through June 2019 were included. Patient demographics, tumour and treatment characteristics were collected and described. Survival distributions were estimated using the Kaplan–Meier method. Multivariate analysis (MVA) was constructed to examine associations between potentially prognostic clinical variables and progression-free survival (PFS). In total, 316 patients were included. The median age was 61 years. After a median follow-up of 28.1 months, the median PFS was 37.9 months (95% CI, 26.7–NR). In the MVA, PR-negative tumour (HR, 2.37; 95% CI, 1.45–3.88; p = 0.001) and CDK4/6i dose reduction (HR, 1.51; 95% CI, 1.06–2.16; p = 0.022) predicted worse PFS. Median overall survival (OS) was not reached. The 30-month and 36-month OS rates were 74% and 68%, respectively. Of patients who progressed, 89% received second-line treatment. Median time to progression on second-line chemotherapy was 9.0 (5.8–17.6) months, and median time to progression on second-line hormonal therapy +/− targeted agent was 4.0 (3.4–8.6) months (p = 0.012). CDK4/6i + AI as first-line treatment for HR-positive, HER2-negative MBC in Alberta is justified based on favourable PFS and early OS outcomes.

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“…Therefore, appraisal of new treatments in routine practice is an important component of the evidence base. Although a few studies have analyzed the real-world outcomes with CDK 4/6 inhibitors [11][12][13][14] such data from India is scant [15,16].…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of palbociclib and ribociclib in patients with estrogen and/or progesterone receptor positive, HER2 receptor negative metastatic breast cancer in routine clinical practice

et al. 2021

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Background There is scant data from India on efficacy and safety of palbociclib and ribociclib in routine clinical practice. Methods This retrospective, observational, single institution study included patients with estrogen and/or progesterone receptor positive and human epidermal growth factor receptor 2 (HER2) negative metastatic breast cancers, who received palbociclib or ribociclib with any partner endocrine therapy in any line of treatment between January 2016 and June 2019. Data were analyzed for progression-free survival (PFS), overall survival (OS) and toxicity. Results The study included 101 female patients with median age of 57 (IQR 48–62) years, of whom 80 (79.2%) were postmenopausal, 79 (78.2%) received palbociclib or ribociclib in second- or later-line treatment, 59 (58.4%) received fulvestrant and 41 (40.6%) received an aromatase inhibitor. In first-line treatment, at a median follow-up of 21.7 (0.5–41.9) months, median PFS and OS were 21.1 (95%CI 16.36-not estimable) months and not reached, respectively. In second- or later-line setting, at a median follow-up of 17.2 (0.5–43.7) months, median PFS and OS were 5.98 (95%CI 4.96–7.89) months and 20.2 (95%CI 14.1-not estimable) months, respectively. Grade 3–4 neutropenia and febrile neutropenia were seen in 45 (45.0%) and 9 (9.0%) patients, respectively while dose reduction was required in 32 (31.7%) patients. In multivariable Cox regression analysis, first-line setting (HR 0.49, 95%CI 0.25–0.97, p = 0.043) and ECOG performance status 1 (HR 0.43, 95%CI 0.20–0.91, p = 0.028) were significantly associated with PFS while only ECOG PS 1 was significantly associated (HR 0.04, 95%CI 0.008–0.206, p = 0.000) with OS. Conclusion Palbociclib and ribociclib, when used in routine clinical practice in first or subsequent lines of treatment, resulted in efficacy and toxicity outcomes in concordance with those expected from pivotal trials.

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Real-world clinical outcome and toxicity data and economic aspects in patients with advanced breast cancer treated with cyclin-dependent kinase 4/6 (CDK4/6) inhibitors combined with endocrine therapy: the experience of the Hellenic Cooperative Oncology Group

Cited by 26 publications

References 24 publications

Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

Multicentric real world evidence with palbociclib in hormone positive HER2 negative metastatic breast cancer in Indian population

First-Line Treatment with a Cyclin-Dependent Kinase 4/6 Inhibitor Plus an Aromatase Inhibitor for Metastatic Breast Cancer in Alberta

Efficacy and safety of palbociclib and ribociclib in patients with estrogen and/or progesterone receptor positive, HER2 receptor negative metastatic breast cancer in routine clinical practice

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