Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes
Introduction: In addition to clinical trials, real-world data is needed to verify the effectiveness of the CDK 4/6 inhibitor palbociclib. The primary aim was to examine real-world variation in treatment modification strategies for neutropenia and its relation to progression-free survival (PFS). The...
| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | Cancer Treatment and Research Communications |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2468294223000126 |
| _version_ | 1797828155640119296 |
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| author | Mariska Q.N. Hackert Cornelia F. van Uden-Kraan Mariette J. Agterof Annette W.G. van der Velden Birgit E.P.J. Vriens Johan J.B. Janssen Maud Geenen Annemieke van der Padt-Pruijsten Ewoudt M.W. van de Garde |
| author_facet | Mariska Q.N. Hackert Cornelia F. van Uden-Kraan Mariette J. Agterof Annette W.G. van der Velden Birgit E.P.J. Vriens Johan J.B. Janssen Maud Geenen Annemieke van der Padt-Pruijsten Ewoudt M.W. van de Garde |
| author_sort | Mariska Q.N. Hackert |
| collection | DOAJ |
| description | Introduction: In addition to clinical trials, real-world data is needed to verify the effectiveness of the CDK 4/6 inhibitor palbociclib. The primary aim was to examine real-world variation in treatment modification strategies for neutropenia and its relation to progression-free survival (PFS). The secondary aim was to assess if there is a gap between real-world and clinical trial outcomes. Materials and Methods: In this multicenter, retrospective observational cohort study 229 patients were analyzed who started palbociclib and fulvestrant as second- or later-line therapy for HR-positive, HER2-negative metastatic breast cancer in the Santeon hospital group in the Netherlands between September 2016 and December 2019. Data were manually retrieved from patients’ electronic medical records. PFS was examined using the Kaplan-Meier method to compare neutropenia-related treatment modification strategies within the first three months after neutropenia grade 3 – 4 occurred, as well as patients’ eligibility to have participated in the PALOMA-3 clinical trial or not. Results: Even though treatment modification strategies differed from those in PALOMA-3 (dose interruptions: 26 vs 54%, cycle delays: 54 vs 36%, and dose reductions: 39 vs 34%), these did not influence PFS. Patients who were PALOMA-3 ineligible experienced a shorter median PFS than those who were eligible (10.2 vs. 14.1 months; HR 1.52; 95% CI 1.12 – 2.07). An overall longer median PFS was found compared to PALOMA-3 (11.6 vs. 9.5 months; HR 0.70; 95% CI 0.54 – 0.90). Conclusion: This study suggests no impact of neutropenia-related treatment modifications on PFS and confirms inferior outcomes outside clinical trial eligibility. |
| first_indexed | 2024-04-09T12:59:55Z |
| format | Article |
| id | doaj.art-f3ce0380b4b446d4a164e1f9ae6a6f58 |
| institution | Directory Open Access Journal |
| issn | 2468-2942 |
| language | English |
| last_indexed | 2024-04-09T12:59:55Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Cancer Treatment and Research Communications |
| spelling | doaj.art-f3ce0380b4b446d4a164e1f9ae6a6f582023-05-13T04:25:28ZengElsevierCancer Treatment and Research Communications2468-29422023-01-0135100691Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomesMariska Q.N. Hackert0Cornelia F. van Uden-Kraan1Mariette J. Agterof2Annette W.G. van der Velden3Birgit E.P.J. Vriens4Johan J.B. Janssen5Maud Geenen6Annemieke van der Padt-Pruijsten7Ewoudt M.W. van de Garde8Santeon hospital group, Utrecht, The NetherlandsSanteon hospital group, Utrecht, The NetherlandsDepartment of Internal Medicine, St. Antonius Hospital, Utrecht/Nieuwegein, The NetherlandsDepartment of Internal Medicine, Martini Hospital, Groningen, The NetherlandsDepartment of Medical Oncology, Catharina Hospital, Eindhoven, The NetherlandsDepartment of Medical Oncology, Canisius Wilhelmina Hospital, Nijmegen, The NetherlandsDepartment of Medical Oncology, OLVG, Amsterdam, The NetherlandsDepartment of Internal Medicine, Maasstad Hospital, Rotterdam, The NetherlandsDepartment of Clinical Pharmacy, St. Antonius Hospital, Utrecht/Nieuwegein, The Netherlands; Division of Pharmacoepidemiology and Clinical Pharmacology, Department of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands; Corresponding author at: Department of Clinical Pharmacy, St. Antonius Hospital, Koekoekslaan 1, 3435 CM Nieuwegein, The Netherlands.Introduction: In addition to clinical trials, real-world data is needed to verify the effectiveness of the CDK 4/6 inhibitor palbociclib. The primary aim was to examine real-world variation in treatment modification strategies for neutropenia and its relation to progression-free survival (PFS). The secondary aim was to assess if there is a gap between real-world and clinical trial outcomes. Materials and Methods: In this multicenter, retrospective observational cohort study 229 patients were analyzed who started palbociclib and fulvestrant as second- or later-line therapy for HR-positive, HER2-negative metastatic breast cancer in the Santeon hospital group in the Netherlands between September 2016 and December 2019. Data were manually retrieved from patients’ electronic medical records. PFS was examined using the Kaplan-Meier method to compare neutropenia-related treatment modification strategies within the first three months after neutropenia grade 3 – 4 occurred, as well as patients’ eligibility to have participated in the PALOMA-3 clinical trial or not. Results: Even though treatment modification strategies differed from those in PALOMA-3 (dose interruptions: 26 vs 54%, cycle delays: 54 vs 36%, and dose reductions: 39 vs 34%), these did not influence PFS. Patients who were PALOMA-3 ineligible experienced a shorter median PFS than those who were eligible (10.2 vs. 14.1 months; HR 1.52; 95% CI 1.12 – 2.07). An overall longer median PFS was found compared to PALOMA-3 (11.6 vs. 9.5 months; HR 0.70; 95% CI 0.54 – 0.90). Conclusion: This study suggests no impact of neutropenia-related treatment modifications on PFS and confirms inferior outcomes outside clinical trial eligibility.http://www.sciencedirect.com/science/article/pii/S2468294223000126PalbociclibReal-worldClinical practiceTreatment modification strategiesEfficacy-effectiveness gapMetastatic breast cancer |
| spellingShingle | Mariska Q.N. Hackert Cornelia F. van Uden-Kraan Mariette J. Agterof Annette W.G. van der Velden Birgit E.P.J. Vriens Johan J.B. Janssen Maud Geenen Annemieke van der Padt-Pruijsten Ewoudt M.W. van de Garde Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes Cancer Treatment and Research Communications Palbociclib Real-world Clinical practice Treatment modification strategies Efficacy-effectiveness gap Metastatic breast cancer |
| title | Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes |
| title_full | Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes |
| title_fullStr | Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes |
| title_full_unstemmed | Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes |
| title_short | Real-world palbociclib effectiveness in patients with metastatic breast cancer: Focus on neutropenia-related treatment modification strategies and clinical outcomes |
| title_sort | real world palbociclib effectiveness in patients with metastatic breast cancer focus on neutropenia related treatment modification strategies and clinical outcomes |
| topic | Palbociclib Real-world Clinical practice Treatment modification strategies Efficacy-effectiveness gap Metastatic breast cancer |
| url | http://www.sciencedirect.com/science/article/pii/S2468294223000126 |
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