6533b827fe1ef96bd128723f

RESEARCH PRODUCT

Palbociclib plus endocrine therapy in HER2 negative, hormonal receptor-positive, advanced breast cancer: A real-world experience

Michele De TursiMarco MazzottaArmando OrlandiMarina Elena CazzanigaEnrico CortesiMaddalena BarbaLaura IezziGiuseppe ToniniE. LanducciLucio LaudadioDomenico SergiAlessandra CassanoGiuseppe SanguinetiNicla La VerdeRiccardo SamaritaniPatrizia SeminaraAntonio RussoClaudio ZamagniSimone ScagnoliValentina MagriRamy KayalEnzo VeltriFrancesca AroldiClara NatoliIlaria PortarenaSamantha ForcinitiLaura FerrariLucia MentucciaGennaro CilibertoDaniele SantiniTeresa GamucciFilippo GrecoSilvia CarpanoMario RoselliSandro BarniA. FabbriIsabella SperdutiA. VaccaroIda ParisDaniela RubinoRuggero De MariaPatrizia ViciClaudia De AngelisGiulia PomatiLuisa CarbogninSimona VallarelliAntonino GrassadoniaMirco PistelliA.f. ScintoKatia CannitaAndrea MichelottiDomenico CorsiE. CapomollaCorrado FicorellaNicola TinariVito LorussoRossana BerardiAndrea BotticelliAntonio GiordanoSilverio TomaoLaura PizzutiPaolo MarchettiMaria Giuseppina SarobbaValentina SiniLuca MoscettiLucrezia DiodatiMaria Vincenza ManciniLuciano Mariani

subject

Male0301 basic medicineOncologyPyridinesReceptor ErbB-2PhysiologyClinical BiochemistryPiperazineschemistry.chemical_compound0302 clinical medicineExemestaneAntineoplastic Combined Chemotherapy Protocolsadvanced breast cancer; hormonal therapy; endocrine resistance; palbociclib; real-world settingBreastAged 80 and overadvanced breast cancerhormonal therapyadvanced breast cancer hormonal therapy; endocrine resistance; palbociclib; real-world settingMiddle AgedTreatment OutcomeReceptors Estrogen030220 oncology & carcinogenesisToxicityFemaleReceptors Progesteronemedicine.drugAdultadvanced breast cancer hormonal therapy; endocrine resistance; palbociclib; real-world setting; Physiology; Clinical Biochemistry; Cell Biologymedicine.medical_specialtypalbociclibBreast NeoplasmsPalbociclibNeutropeniaadvanced breast cancer hormonal therapyDisease-Free Survivalendocrine resistance03 medical and health sciencesInternal medicinereal-world settingmedicineHumansAgedEverolimusSettore MED/06 - ONCOLOGIA MEDICAbusiness.industryCancerCell Biologymedicine.diseaseConfidence interval030104 developmental biologychemistryMED/06 - ONCOLOGIA MEDICAbusinessHormone

description

Data from 423 human epidermal growth factor receptor 2-negative (HER2−), hormone receptor-positive (HR+) advanced breast cancer (aBC) patients treated with palbociclib and endocrine therapy (ET) were provided by 35 Italian cancer centers and analyzed for treatment outcomes. Overall, 158 patients were treated in first line and 265 in second/later lines. We observed 19 complete responses and 112 partial responses. The overall response rate (ORR) was 31% (95% confidence interval [CI], 26.6–35.4) and clinical benefit was 52.7% (95% CI, 48–57.5). ORR was negatively affected by prior exposure to everolimus/exemestane (p = 0.002) and favorably influenced by early line-treatment (p < 0.0001). At 6 months, median progression-free survival was 12 months (95% CI, 8–16) and median overall survival was 24 months (95% CI, 17–30). More favorable outcomes were associated with palbociclib in early lines, no visceral metastases and no prior everolimus/exemestane. The main toxicity reported was neutropenia. Our results provide further support to the use of palbociclib with ET in HER2−, HR+ aBC. Differences in outcomes across patients subsets remain largely unexplained.

10.1002/jcp.27832http://hdl.handle.net/10807/128351