Real-world experience of palbociclib and ribociclib: novel oral therapy in metastatic breast cancer

Cabetas, M García-Trevijano; Martínez, Purificación; Nácher, I Jiménez; Almirón, Mariana Díaz; Auñón, Pilar; Ambrosio, Alícia Herrero

doi:10.1007/s11096-020-01193-z

Cited by 17 publications

(29 citation statements)

References 18 publications

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“…For instance, patients in Hungary treated with palbociclib had a discontinuation rate of 56.0% at 12 months while 49.6% of patients switched to other therapies 26 . In other studies, a 72.2% discontinuation rate was reported among patients in Spain 19 , while in the US this was 19.9% 24 and in Argentina, 2.0% 13 . In the case of Colombia, the health care system is obliged to guarantee the treatment after approval by the HMO, thus the present study shows that discontinuation was more associated with progression of the disease and safety causes than administrative issues related to insurance.…”

Section: Discussionmentioning

confidence: 78%

“…The Ibrance Real World Insights Study (IRIS), with results from Argentina, Canada, Germany, and United States, supports the effectiveness and tolerability of palbociclib [13][14][15] . RENATA, POLARIS, and PALPract are other real-world ongoing studies that provide additional data on palbociclib prescribing and treatment patterns in routine clinical practice [16][17][18][19] .…”

Section: Introductionmentioning

confidence: 99%

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Effectiveness of Palbociclib in Combination with Fulvestrant in Patients with Advanced or Metastatic, Hormone Receptor Positive, Her2-Negative Breast Cancer: a Real-World Study from Colombia

Alarcón

Castaño

Reyes

et al. 2022

Preprint

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Objective To evaluate progression free survival (PFS) in patients with advanced or metastatic, hormone receptor positive (HR+), HER2-negative (HER2-) breast cancer treated with palbociclib in combination with fulvestrant as second or later lines of treatment. Method: An observational, retrospective study with cohorts in 11 sites in Colombia, extracted from the medical records of women who began treatment between February 2018 and August 2019. Index date was first prescription, and patients were followed until they experienced disease progression, death, treatment discontinuation, were lost to follow-up, or until 12 months of follow-up, whichever occurred first. Kaplan Meier were used to estimate PFS. Results Sixty-nine patients who received at least one dose of the drugs were included in the analysis. Median follow-up was 10.81 ± 3.18 months, mean age was 61.2 ± 11.14 years and 96.3% were postmenopausal. At the time of starting treatment, 52 were in stage IV, with 59 with > 2 sites of metastasis. All patients started on palbociclib 125 mg. 23 reported discontinuation, 10 of them permanently but none due to neutropenia. Clinical benefit rate was 69.35%, and median PFS was not achieved at 12 months. One death was reported due to disease progression. Conclusion Effectiveness of Palbociclib for patients with HR+/HER2- advanced or metastatic breast cancer treated with palbociclib in combination with fulvestrant as second or later lines of treatment in Colombia is consistent with the efficacy observed in clinical trials while maintaining a good safety profile. Implications for practice: Real-world data from Colombia for the first time indicates the combination of palbociclib + fulvestrant is associated with high levels of effectiveness in women with HR+/HER2- advanced or metastatic breast cancer, even in third or later lines of treatment. Although neutropenia was frequent and, in some cases, clinically significant, no patients required permanent treatment discontinuation due to this event. All of the adverse effects resolved without sequelae, and no deaths due to this cause were seen. This confirms an adequate safety profile for the drug combination.

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Section: Discussionmentioning

confidence: 78%

Section: Introductionmentioning

confidence: 99%

Effectiveness of Palbociclib in Combination with Fulvestrant in Patients with Advanced or Metastatic, Hormone Receptor Positive, Her2-Negative Breast Cancer: a Real-World Study from Colombia

Alarcón

Castaño

Reyes

et al. 2022

Preprint

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“…• Ribociclibe + letrozol: o tratamento combinado foi avaliado pelo ensaio clínico MONALEESA-2 e resultou em SLP média de 27,6 meses, demonstrando benefício significativo na sobrevida livre de progressão em mulheres na pósmenopausa com câncer de mama metastático RH+/HER2-, quando comparada com o uso de letrozol mais placebo. Foi verificado ainda que tal benefício se estende por todos subgrupos analisados pelos estudos, comprovando sua alta eficácia na primeira linha de tratamento (García-Trevijano Cabetas et al, 2021;Hortobagyi et al, 2016;O'Shaughnessy et al, 2018;Sonke et al, 2018;Yardley et al, 2019).…”

Section: Discussionunclassified

“…• Palbociclibe + fulvestranto: foi a primeira combinação com um inibidor de CDK 4 e 6 aprovada para o tratamento de mulheres com câncer de mama que progrediram para doença metastática após terapia hormonal prévia, sendo Research, Society andDevelopment, v. 10, n. 14, e85101421940, 2021 (CC BY 4.0) | ISSN 2525-3409 | DOI: http://dx.doi.org/10.33448/rsd-v10i14.21940 geralmente empregada como terapia de segunda linha. No contexto de tratamento de primeira linha, sua eficácia é reduzida, com sobrevida livre de progressão em torno de 18,7 meses (García-Trevijano Cabetas et al, 2021;Mycock et al, 2021;Seki et al, 2019;Waller et al, 2019).…”

Section: Discussionunclassified

A eficácia dos novos tratamentos de hormonioterapia na sobrevida livre de progressão de pacientes com câncer de mama metastático RH+/HER2-: uma revisão sistemática

Silva

Queiroz

Menezes

et al. 2021

RSD

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Objetivo: O câncer de mama é o tipo de neoplasia que mais acomete as mulheres, ficando atrás apenas dos cânceres de pele não melanoma. Os inibidores de quinase dependente de ciclina 4 e 6 (CDK 4/6) são a mais recente opção de terapia hormonal para as pacientes com câncer de mama metastático RH+/HER2-. Dessa forma, o presente estudo busca compreender a eficácia dos novos tratamentos de hormonioterapia na sobrevida livre de progressão de pacientes com câncer de mama metastático RH+/HER2-. Metodologia: Foi realizada uma revisão sistemática da literatura utilizando o modelo Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA), mediante buscas nas bases de dados Pubmed, Lilacs, BioOne, The Cochrane Library, Scielo, IBECS e Medline. Resultados: A combinação de inibidores de CDK 4/6 com inibidores da aromatase demonstrou melhores resultados quanto à sobrevida livre de progressão para tratamento de primeira linha do câncer de mama metastático RH+/HER2-, sendo adotada pelas principais diretrizes das sociedades americana e europeia de Oncologia. A melhor sobrevida livre de progressão média foi de 28,2 meses, alcançada com a combinação abemaciclibe mais letrozol. No que se refere à sobrevida global, o melhor tempo obtido foi de 54,1 meses com fulvestranto em monoterapia. Conclusão: Os inibidores de CDK 4/6 são novidade no que diz respeito ao tratamento do câncer de mama metastático RH+/HER2-, tendo grandes resultados quanto à sobrevida livre de progressão quando combinados com inibidores de aromatase ou fulvestranto.

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“…Не исключено, что полученный эффект был обусловлен проведенной химиотерапией, позволившей добиться уменьшения клона раковых клеток, резистентных к анти CDK4 / 6 терапии, и что контроль над опухолью достигнут за счет чувствительности остаточной опухоли к проводимой терапии. Учитывая схожие механизмы действия и развития резистентности у препаратов рибоциклиб и палбоциклиб [8,11,12], а также отсутствие прямых сравнительных исследований, ожидать ответа на один препарат после прогрессии на другом могло бы показаться нецелесообразным. Но, рассматривая эффективность терапии рибоциклибом после прогрессии на палбоциклибе, следует отметить, что рибоциклиб более активен в CDK4-зависимых линиях клеток, чем в CDK6-зависимых клеточных линиях [13], что после химиотерапии позволяет рассматривать возможность повторного назначения анти-CDK4 / 6 препарата рибоциклиба.…”

Section: обсуждение и выводыunclassified

Sequential anticancer therapy in a patient with metachronous primary uterine cancer and breast cancer

et al. 2021

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Breast cancer (BC) is a heterogeneous disease characterized by the presence or absence of membrane receptor overexpression on tumor cells that correlates with the disease prognosis. Understanding of the patterns and mechanisms of tumor progression gained through clinical experience of managing BC patients is important. The treatment strategy depends on the hormone receptor status of the tumor, the HER2 / neu expression, and the proliferative activity level. A clinical case of advanced luminal A breast cancer is reported, and the rationale for sequential treatment strategy is provided taking into account the clinical situation and clinical course of the disease. Adequate endocrine therapy for hormone-positive metastatic BC provides long-term tumor control like in this case, as well as a high quality of life over the entire course of sequential treatment with anticancer drugs.

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Real-world experience of palbociclib and ribociclib: novel oral therapy in metastatic breast cancer

Cited by 17 publications

References 18 publications

Effectiveness of Palbociclib in Combination with Fulvestrant in Patients with Advanced or Metastatic, Hormone Receptor Positive, Her2-Negative Breast Cancer: a Real-World Study from Colombia

Effectiveness of Palbociclib in Combination with Fulvestrant in Patients with Advanced or Metastatic, Hormone Receptor Positive, Her2-Negative Breast Cancer: a Real-World Study from Colombia

A eficácia dos novos tratamentos de hormonioterapia na sobrevida livre de progressão de pacientes com câncer de mama metastático RH+/HER2-: uma revisão sistemática

Sequential anticancer therapy in a patient with metachronous primary uterine cancer and breast cancer

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