The efficacy of palbociclib and ribociclib in the first-line treatment of metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer in male patients: a Turkish oncology group (TOG) study

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dc.contributor.authorYıldırım H.Ç.
dc.contributor.authorKutlu Y.
dc.contributor.authorMutlu E.
dc.contributor.authorAykan M.B.
dc.contributor.authorKorkmaz M.
dc.contributor.authorYalçın S.
dc.contributor.authorŞakalar T.
dc.contributor.authorCelayir Ö.M.
dc.contributor.authorKayıkçıoğlu E.
dc.contributor.authorAslan F.
dc.contributor.authorHafızoğlu E.
dc.contributor.authorAltıntaş Y.E.
dc.contributor.authorKeskinkılıç M.
dc.contributor.authorChalabiyev E.
dc.contributor.authorÇelebi A.
dc.contributor.authorDursun B.
dc.contributor.authorKapar C.
dc.contributor.authorÖzen M.
dc.contributor.authorAcar Ö.
dc.contributor.authorDülgar Ö.
dc.contributor.authorKut E.
dc.contributor.authorBiter S.
dc.contributor.authorKus F.
dc.contributor.authorAlmuradova E.
dc.contributor.authorErdoğan A.P.
dc.contributor.authorSaray S.
dc.contributor.authorGüven D.C.
dc.contributor.authorŞimşek E.T.
dc.contributor.authorÜskent N.
dc.contributor.authorKemal Y.
dc.contributor.authorÇakar B.
dc.contributor.authorAçıkgöz Ö.
dc.contributor.authorKılıçkap S.
dc.contributor.authorAksoy S.
dc.date.accessioned2024-07-22T08:01:43Z
dc.date.available2024-07-22T08:01:43Z
dc.date.issued2024
dc.description.abstractIntroduction: Male breast cancer, comprising approximately 1% of all breast cancer cases, often leads to the exclusion of male patients as a criterion in clinical trials. While the efficacy of Cyclin-dependent kinases 4 and 6 (CDK 4/6) inhibitors has been established in metastatic hormone receptor-positive (HR +) and human epidermal growth factor receptor 2-negative (HER2 −) breast cancer in women, limited data exist on their effectiveness in male patients. We aimed to evaluate the efficacy and safety of palbociclib or ribociclib in male patients with breast cancer. Methods: This study is a multicenter, retrospective study. We included male patients with HR + and HER2-metastatic breast cancer who received palbociclib or ribociclib as first-line treatment. Our primary endpoints were progression-free survival (PFS), overall response rates (ORR), and drug-related adverse effects. Results: A total of 46 male patients from 27 institutions were enrolled. The median age at initiation of CDK 4/6 inhibitors was 63.64 ± 13.69 years, with a median follow-up of 21.33 (95% CI 14.92–27.74) months. The ORR were 84% for palbociclib and 76.2% for ribociclib. The mPFS for the entire cohort was 28.06 months (95% CI 18.70–37.42). No significant difference in PFS was observed between palbociclib and ribociclib (mPFS: 24.46 months (95% CI 11.51–37.42) vs 28.33 months (95% CI 14.77–41.88), respectively, p = 0.211). No new adverse events were reported. Discussion: This study demonstrates that palbociclib and ribociclib are effective and safe options for first-line treatment in male patients with HR + /HER2 − metastatic breast cancer. However, further prospective studies are warranted to establish their efficacy in this population. © The Author(s) under exclusive licence to Japan Society of Clinical Oncology 2024.
dc.identifier.DOI-ID10.1007/s10147-023-02460-5
dc.identifier.issn13419625
dc.identifier.urihttp://akademikarsiv.cbu.edu.tr:4000/handle/123456789/11567
dc.language.isoEnglish
dc.publisherSpringer
dc.subjectAged
dc.subjectAminopyridines
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectBreast Neoplasms
dc.subjectBreast Neoplasms, Male
dc.subjectFemale
dc.subjectHumans
dc.subjectMale
dc.subjectMiddle Aged
dc.subjectPiperazines
dc.subjectPurines
dc.subjectPyridines
dc.subjectReceptor, ErbB-2
dc.subjectRetrospective Studies
dc.subjectalanine aminotransferase
dc.subjectaromatase inhibitor
dc.subjectBRCA1 protein
dc.subjectBRCA2 protein
dc.subjectcreatinine
dc.subjectfulvestrant
dc.subjectgonadorelin derivative
dc.subjectpalbociclib
dc.subjectribociclib
dc.subjectaminopyridine derivative
dc.subjectantineoplastic agent
dc.subjectepidermal growth factor receptor 2
dc.subjectERBB2 protein, human
dc.subjectpalbociclib
dc.subjectpiperazine derivative
dc.subjectpurine derivative
dc.subjectpyridine derivative
dc.subjectribociclib
dc.subjectadult
dc.subjectalanine aminotransferase level
dc.subjectanemia
dc.subjectArticle
dc.subjectasthenia
dc.subjectbone metastasis
dc.subjectcancer control
dc.subjectcancer recurrence
dc.subjectcancer regression
dc.subjectclinical article
dc.subjectclinical feature
dc.subjectcohort analysis
dc.subjectCommon Terminology Criteria for Adverse Events
dc.subjectcreatinine blood level
dc.subjectdeath
dc.subjectdemographics
dc.subjectdiarrhea
dc.subjectdisease exacerbation
dc.subjectdrug dose reduction
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectfirst-line treatment
dc.subjectfollow up
dc.subjectgene mutation
dc.subjecthormone receptor-positive, HER2-negative breast cancer
dc.subjecthuman
dc.subjectKaplan Meier method
dc.subjectliver metastasis
dc.subjectlung metastasis
dc.subjectmale
dc.subjectmale breast cancer
dc.subjectmedian survival time
dc.subjectmetastatic breast cancer
dc.subjectmulticenter study
dc.subjectneutropenia
dc.subjectoutcome assessment
dc.subjectoverall response rate
dc.subjectprogression free survival
dc.subjectQTc interval
dc.subjectresponse evaluation criteria in solid tumors
dc.subjectretrospective study
dc.subjectside effect
dc.subjectthrombocytopenia
dc.subjecttreatment interruption
dc.subjecttreatment response
dc.subjectTurkey (republic)
dc.subjectaged
dc.subjectbreast tumor
dc.subjectclinical trial
dc.subjectfemale
dc.subjectmetabolism
dc.subjectmiddle aged
dc.subjectpathology
dc.titleThe efficacy of palbociclib and ribociclib in the first-line treatment of metastatic hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer in male patients: a Turkish oncology group (TOG) study
dc.typeArticle

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