SAFETY PROFILE OF PALBOCICLIB IN ELDERLY PATIENTS WITH HORMONE RECEPTOR-POSITIVE/HER2 NEGATIVE METASTATIC BREAST CANCER: REGIONAL CANCER CENTER EXPERIENCE IN SOUTH INDIA
Main Article Content
Keywords
Metastatic breast cancer, elderly patients, palbociclib, toxicity profile
Abstract
Aim: Palbociclib plus endocrine therapy recommended for metastatic hormone receptor positive/ human epidermal growth factor receptor 2-negative (HER2 -) breast cancer regardless of age. Prevalence of advanced cancer is more in elderly population, patients age > 65 years usually treated with conservative approach considering the toxicity of aggressive curative intent. These patients are rarely included in clinical trials. This study evaluated the safety profile of palbociclib in elderly patients treated in regional cancer centre in south india.
Materials and methods: Retrospective analysis of elderly patients age > 65 years treated with palbociclib plus letrozole for metastatic hormone receptor positive/ human epidermal growth factor receptor 2-negative (HER2 -) breast cancer treated in regional cancer institute, Madras medical college, Chennai. Safety profile analysed with CTCAE version 4 criteria.
Results: 43 patients details analysed between January 2021 to December 2023.Median age of 68 years.90% patients had adverse events any grade, 81.3 % had any grade neutropenia, 58.1% had grade 3-4 neutropenia. These adverse events well managed with supportive care measures, dose delays and dose reductions.
Conclusion: Patients aged more than 65 years tolerated palbociclib well in patients with the metastatic hormone receptor-positive/Her2 negative subtype. Addition of palbociclib to endocrine therapy should be evaluated in elderly and frailer patients individually
Materials and methods: Retrospective analysis of elderly patients age > 65 years treated with palbociclib plus letrozole for metastatic hormone receptor positive/ human epidermal growth factor receptor 2-negative (HER2 -) breast cancer treated in regional cancer institute, Madras medical college, Chennai. Safety profile analysed with CTCAE version 4 criteria.
Results: 43 patients details analysed between January 2021 to December 2023.Median age of 68 years.90% patients had adverse events any grade, 81.3 % had any grade neutropenia, 58.1% had grade 3-4 neutropenia. These adverse events well managed with supportive care measures, dose delays and dose reductions.
Conclusion: Patients aged more than 65 years tolerated palbociclib well in patients with the metastatic hormone receptor-positive/Her2 negative subtype. Addition of palbociclib to endocrine therapy should be evaluated in elderly and frailer patients individually
References
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12. Howie LJ,Singh H, Bloomquist: E et al.Outcomes of older women with hormone positive, human epidermal growth factor receptor-negative metastasis breast cancer treated with a CDK4/6 inhibitor and an aromatose inhibitor:an FDA pooled analysis.J clinical. oncol. 2019, 37:3475-83. 10.1200/JCO.18.02217
13. Bergen ES,Tichy C,Berghoff AS, et al.: Prognostic impact of breast cancer subtypes in elderly
population.Breast cancer. Res treat. 2016:157. 10.1007/s10549-016-3787-y
14. Omarini C,Piacentini F,Sperduti I, et al.: Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor positive,Her 2 negative,advanced breast cancer:to prescribe for the physician ?BMC cancer. 202020, 418:10.1186/s12885-020-06933-y
15. Caillet P,Pulido M, Brain E, et al.: PALOMAGE,a French real world cohort of elderly women beyond age 70 years with advanced breast cancer receiving palbociclib.Baseline characteristics and safety evaluation. JCO. 2021, 39:1012-1012. 10.1200/JCO.2021.39.15_suppl.1012
16. wildiers H,Heeren P,Puts M et al,International society of geriatric oncology consensus on geriatric assessment in older patients with cancer,J clin oncol. 2014:2595-603. 10.1200/JCO.2013.54.8347
17. Varella L,Eziokwu As,Jia X, et al.: .Real world -clinical outcomes and toxicity in metastatic breast cancer patients treated. with palbociclib & endocrine therapy.Breast cancer Res Treat. 2019:429-34. 10.1007/s10549-019-05176-1
2. Vanitha Norohna,Abhijth Rajaram rao,Anant Ramaswamy, et al.: The current status of geriatric oncology in India.e cancer. 202317, 1595:10.3332/ecancer.2023.1595
3. Yersal O, Baructa S.Biological subtypes of breast cancer: Prognosis and therapeutic . implications.World JClinOncol. 2014, 5:412-24. 10.5306/wjco.v5.i3.412
4. Bergen ES,Tichy C,Berghoff AS et al.Prognostic impact of breast cancer subtypes in elderly patients.Breast . Cancer Res Treat. 2016, 157:91-9. 10.1007/s10549-016-3787-y Epub 2016 April 23.
5. Kartal M, Tezcan S,Canda T.Diagnosis,treatment characteristics and survival of women with cancer aged 65 years and above,a hospital based retrospective study.BMC Women health. 201313, 34. 10.1186/1472-6874- 13-34
6. Baban CK,Devane L,Geraghty J.Change of paradigm in treating elderly with breast cancer :are we undertreating elderly patients?. Ir J med Sci. 2019, 188:379-88. 10.1007/s11845-018-1851-9
7. 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 2 study. Lancet Oncol. 2015, 16:25-35. 10.1016/S1470-2045(14)71159-3
8. Turner NC, Ro J, André F, et al.: Palbociclib in hormone-receptor-positive advanced breast cancer . N Engl J Med. 2015, 373:209-19. 10.1056/NEJMoa1810527
9. Finn RS, Martin M, Rugo HS, et al.: Palbociclib and letrozole in advanced breast cancer . N Engl J Med. 2016, 375:1925-36. 10.1056/NEJMoa1607303
10. Accessed: Ibrance -EMEA/H/C/003853-IB/0032: http://EMEA/H/C/003853-IB/0032.
11. Rugo HS,Turner NC,Bondarenko I et al.palbociclib plus endocrine therapy in older women with HR+/HER2 - advanced breast cancer:a pooled analysis of randomised PALOMA clinical studies.Eur. J cancer. 2018, 101:123-33. 10.1016/j.ejca.2018.05.017
12. Howie LJ,Singh H, Bloomquist: E et al.Outcomes of older women with hormone positive, human epidermal growth factor receptor-negative metastasis breast cancer treated with a CDK4/6 inhibitor and an aromatose inhibitor:an FDA pooled analysis.J clinical. oncol. 2019, 37:3475-83. 10.1200/JCO.18.02217
13. Bergen ES,Tichy C,Berghoff AS, et al.: Prognostic impact of breast cancer subtypes in elderly
population.Breast cancer. Res treat. 2016:157. 10.1007/s10549-016-3787-y
14. Omarini C,Piacentini F,Sperduti I, et al.: Combined endocrine approaches vs endocrine therapy alone as first line treatment in elderly patients with hormone receptor positive,Her 2 negative,advanced breast cancer:to prescribe for the physician ?BMC cancer. 202020, 418:10.1186/s12885-020-06933-y
15. Caillet P,Pulido M, Brain E, et al.: PALOMAGE,a French real world cohort of elderly women beyond age 70 years with advanced breast cancer receiving palbociclib.Baseline characteristics and safety evaluation. JCO. 2021, 39:1012-1012. 10.1200/JCO.2021.39.15_suppl.1012
16. wildiers H,Heeren P,Puts M et al,International society of geriatric oncology consensus on geriatric assessment in older patients with cancer,J clin oncol. 2014:2595-603. 10.1200/JCO.2013.54.8347
17. Varella L,Eziokwu As,Jia X, et al.: .Real world -clinical outcomes and toxicity in metastatic breast cancer patients treated. with palbociclib & endocrine therapy.Breast cancer Res Treat. 2019:429-34. 10.1007/s10549-019-05176-1
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Published
Oct 23, 2024
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How to Cite
Dr.Vino Anand S, Dr.Kannan J, Dr.Satheesh Kumar D, Dr.Kavithendral K, & Dr.Vinodh Kumar S. (2024). SAFETY PROFILE OF PALBOCICLIB IN ELDERLY PATIENTS WITH HORMONE RECEPTOR-POSITIVE/HER2 NEGATIVE METASTATIC BREAST CANCER: REGIONAL CANCER CENTER EXPERIENCE IN SOUTH INDIA. Journal of Population Therapeutics and Clinical Pharmacology, 31(10), 469-473. https://doi.org/10.53555/fyxdh871
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Author Biographies
Dr.Vino Anand S
Senior Resident, Department of Medical Oncology Madras Medical College, Chennai. The Tamil Nadu Dr.M.G.R. Medical University, Tamil Nadu. Phone (or Mobile) No.: 8248466310
Dr.Kannan J
Professor and Head, Department Of Medical Oncology, Madras Medical college, Chennai
Dr.Satheesh Kumar D
Assistant Professor, Department Of Medical Oncology, Madras Medical college, Chennai
Dr.Kavithendral K
Assistant Professor, Department Of Medical Oncology, Madras Medical college, Chennai
Dr.Vinodh Kumar S
Senior Resident, Department Of Medical Oncology, Madras Medical college, Chennai
How to Cite
Dr.Vino Anand S, Dr.Kannan J, Dr.Satheesh Kumar D, Dr.Kavithendral K, & Dr.Vinodh Kumar S. (2024). SAFETY PROFILE OF PALBOCICLIB IN ELDERLY PATIENTS WITH HORMONE RECEPTOR-POSITIVE/HER2 NEGATIVE METASTATIC BREAST CANCER: REGIONAL CANCER CENTER EXPERIENCE IN SOUTH INDIA. Journal of Population Therapeutics and Clinical Pharmacology, 31(10), 469-473. https://doi.org/10.53555/fyxdh871