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RESEARCH PRODUCT
A retrospective multicentric observational study of trastuzumab emtansine in HER2 positive metastatic breast cancer: A real-world experience
Patrizia ViciLaura PizzutiAndrea MichelottiIsabella SperdutiClara NatoliLucia MentucciaLuigi Di LauroDomenico SergiPaolo MarchettiDaniele SantiniEmanuela MagnolfiLaura IezziLuca MoscettiAgnese FabbriAlessandra CassanoAntonino GrassadoniaClaudia OmariniFederico PiacentiniAndrea BotticelliIlaria BertoliniAngelo Fedele ScintoGermano ZampaMaria MauriLoretta D'onofrioValentina SiniMaddalena BarbaMaugeri-saccã Marcello Ernesto RossiElisabetta LanducciSilverio TomaoAntonio Maria AlbertiFrancesco GiottaCorrado FicorellaVincenzo AdamoAntonio RussoVito LorussoKatia CannitaSandro BarniLucio LaudadioFilippo GrecoOrnella GarroneMarina Della GiuliaPaolo MarollaGiuseppe SanguinetiBarbara Di CoccoGennaro CilibertoRuggero De MariaTeresa Gamuccisubject
0301 basic medicineOncologyHER2 positivereal-worldmedicine.medical_specialtyHER2 positive; T-DM1; metastatic breast cancer; previous pertuzumab; real-worldHER2 positive; Metastatic breast cancer; Previous pertuzumab; Real-world; T-DM1; OncologyT-DM1Previous pertuzumabHER2 positive; metastatic breast cancer; previous pertuzumab; real-world; T-DM1; oncologyECOG Performance Statuslaw.invention03 medical and health scienceschemistry.chemical_compound0302 clinical medicineRandomized controlled trialSettore MED/04 - PATOLOGIA GENERALElawInternal medicineMedicineUnivariate analysisSettore MED/06 - ONCOLOGIA MEDICAbusiness.industryCancerprevious pertuzumabmedicine.diseaseMetastatic breast cancerMetastatic breast cancerHER2 positive; Metastatic breast cancer; Previous pertuzumab; Real-world; T-DM1Log-rank testtrastuzumab030104 developmental biologyOncologychemistryReal-worldTrastuzumab emtansine030220 oncology & carcinogenesisHER2 positive Metastatic breast cancer Previous pertuzumab Real-world T-DM1 Oncologymetastatic breast cancerPertuzumabbusinessmedicine.drugResearch Paperdescription
We addressed trastuzumab emtansine (T-DM1) efficacy in HER2+ metastatic breast cancer patients treated in real-world practice, and its activity in pertuzumab-pretreated patients. We conducted a retrospective, observational study involving 23 cancer centres, and 250 patients. Survival data were analyzed by Kaplan Meier curves and log rank test. Factors testing significant in univariate analysis were tested in multivariate models. Median follow-up was 15 months and median T-DM1 treatment-length 4 months. Response rate was 41.6%, clinical benefit 60.9%. Median progression-free and median overall survival were 6 and 20 months, respectively. Overall, no differences emerged by pertuzumab pretreatment, with median progression-free and median overall survival of 4 and 17 months in pertuzumab-pretreated (p=0.13), and 6 and 22 months in pertuzumab-naïve patients (p=0.27). Patients who received second-line T-DM1 had median progression-free and median overall survival of 3 and 12 months (p=0.0001) if pertuzumab-pretreated, and 8 and 26 months if pertuzumab-naïve (p=0.06). In contrast, in third-line and beyond, median progression-free and median overall survival were 16 and 18 months in pertuzumab-pretreated (p=0.05) and 6 and 17 months in pertuzumab-naïve patients (p=0.30). In multivariate analysis, lower ECOG performance status was associated with progression-free survival benefit (p < 0.0001), while overall survival was positively affected by lower ECOG PS (p < 0.0001), absence of brain metastases (p 0.05), and clinical benefit (p < 0.0001). Our results are comparable with those from randomized trials. Further studies are warranted to confirm and interpret our data on apparently lower T-DM1 efficacy when given as second-line treatment after pertuzumab, and on the optimal sequence order.
year | journal | country | edition | language |
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2017-01-01 |