1. PO62 FIRST LINE TRASTUZUMAB-BASED THERAPY IN HER2-POSITIVE METASTATIC BREAST CANCER PATIENTS PRESENTING WITH DE NOVO OR RECURRENT DISEASE: A MULTICENTER RETROSPECTIVE COHORT STUDY
- Author
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Arlindo R. Ferreira, Fabio Puglisi, Silvia Mura, Antonella Lai, S. Ziliani, Matteo Lambertini, Emma Pozzi, Gabriele Minuti, Federico Sottotetti, Valentina Sini, Elena Poletto, Paolo Pronzato, Lucia Del Mastro, Donatella Grasso, Chiara Dellepiane, Emanuela Risi, Francesca Poggio, and Sara Fancelli
- Subjects
Oncology ,medicine.medical_specialty ,education.field_of_study ,business.industry ,Anemia ,Population ,Phases of clinical research ,General Medicine ,Neutropenia ,medicine.disease ,Gastroenterology ,Loading dose ,Metastatic breast cancer ,Regimen ,Internal medicine ,medicine ,Surgery ,Progression-free survival ,education ,business - Abstract
s / The Breast 24 S3 (2015) S21–S75 S43 this setting. In order to improve pts’ comfort using the oral form of V, we conducted a multicenter phase II study to investigate efficacy and safety of the oral V-T (OVT) combination. Methods: Main eligibility criteria: HER-2Neu positive disease (3+ IHC or FISH+), no adjuvant CT within the last 6 months and no prior CT for MBC. Pts were treated with oral V (oV) 80 mg/m2 D1, D8, D15 (following first 3 administrations at 60 mg/m2 during the first cycle) for a total of 8 cycles (1 cycle = 3 weeks); in combination with (T) 6 mg/ kg on D1 (loading dose, 8 mg/kg) every 3 weeks or 4 mg/kg (loading dose, 6 mg/kg) weekly. Continuation and schedule of (T) were at investigator’s discretion. Response was evaluated every 2 cycles using RECIST 1.0.Primary endpoint: Objective response rate (ORR); secondary EPs: Duration of response (DOR), progression free survival (PFS), overall survival (OS), safety. Results: In the full population (n=26), median age was 50.7 years (range 31.3-80.7); median WHO PS 0 (range 0-1). 69% of pts were postmenopausal and 65% took prior (neo)adjuvant CT. Early stage treatment consisted of a combination of anthracyclines (AC) and taxanes (TX) in 27% of pts. Overall 46% of the pts were pretreated by AC, 38.5% by TX. Median disease free interval was 50.7 (95% CI [43.6-57.9]) months (m). Most frequent metastatic sites were bone (61.5%), liver (50%) and lymph nodes (42%). 73% of pts had 2 or more metastatic sites. A median of 8 oVT cycles were given (range: 3-12): 19% of oV doses were not escalated to 80mg/m2 starting cycle 2. 92% of pts administered T every 3 weeks. In the evaluable pts population, ORR was 56% (95% CI [34.9-75.6]), including 3 complete responses (12%) and 11 partial (44%), 8 pts (32%) had stable disease resulting in a clinical benefit [or disease control] rate of 88 % (95% CI [68.8-97.5]). Median DOR was 7.1m (95% CI [3.9-10.2]). At the time of the analysis, median PFS was 6.7m (95% CI [3.5-10]) and median OS 27.9m (95% CI [17.4-38.3]). Treatment was generally well tolerated with main observed grade 3-4 hematological toxicities being neutropenia (46%) and anemia (4%). Grade 3-4 nausea-vomiting were observed in 11.5% of pts. Conclusion: Our results confirm the efficacy of OVT combination as a first line treatment in Her2 Neu+ LA or MBC pts with an acceptable safety profile. OVT optimizes the convenience of this CT regimen, especially for the pts receiving T every 3 weeks.
- Published
- 2015
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