51. SOLTI NeoPARP: A phase II, randomized study of two schedules of iniparib plus paclitaxel and paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer (TNBC)
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Pedro Sánchez-Rovira, Judith Balmaña, Santiago González-Santiago, Eric Charpentier, José Baselga, Kepa Amillano, Ana Lluch, Luis Manso, Antonio Llombart, Serafin Morales, Suzette Delaloge, Henri Roché, Ana Casas, Serena Di Cosimo, Claudia Aura, Cristian Villanueva, Hervé Bonnefoi, Ignacio Garcia-Ribas, Joaquín Gavilá, and Frédérique Penault-Llorca
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Oncology ,Cancer Research ,medicine.medical_specialty ,business.industry ,medicine.medical_treatment ,Neoadjuvant Study ,Surgery ,law.invention ,chemistry.chemical_compound ,Paclitaxel ,chemistry ,Randomized controlled trial ,law ,Internal medicine ,medicine ,In patient ,Iniparib ,business ,Triple-negative breast cancer ,Neoadjuvant therapy - Abstract
1011 Background: Iniparib is an anticancer agent with a mechanism of action still under investigation. A phase 2 randomized neoadjuvant study in patients (pts) with TNBC was designed to explore the activity and tolerability of two schedules of iniparib with weekly paclitaxel (PTX). Here we report the efficacy and safety results from a planned interim analysis (IA). Methods: The trial accrued a total of 141 pts in October 2011, of whom, 74 are included in this IA. All were chemo-naive, histologicallyconfirmed Stage II-IIIA TNBC (IIA 47%; IIB 35%; IIIA 16%) with a median age of 50 yr. Triple negative status was centrally confirmed [ER/PR 2, IV, d 1; N=25) alone or in combination with iniparib, either on a once weekly (QW) (11.2 mg/kg, IV, d 1; N=25) or twice weekly (BIW) (5.6 mg/kg, IV, d 1, 4; N=24) schedule. The total planned treatment duration was 12 wks. The IA endpoint is pathological complete response in the breast (pCR) as assessed by independent pathologists. Results: Two/2/3 pts in the PTX/QW/BIW arms, respectively, discontinued due to progressive disease per RECIST. Another 3/2/2 pts, respectively, discontinued due to investigator decision or an adverse event (AE). Thirteen pts presented with Grade 3/4 Treatment Emergent AE: 3 pts in PTX arm (1 neutropenia, 1 presyncope, 1 ALT elevation), 3 in QW arm (1 lymphopenia, 1 hyperkalemia, 1 pulmonary embolism), and 8 in the BIW arm (1 febrile neutropenia, 3 neutropenia, 1 aphonia, 1 syncope, 1 radius fracture and 1 vertigo). Laboratory Grade 3/4 neutropenia occurred in 4% of pts in PTX, 0% in QW and 21% of BIW arms, with 1/2/3 pts, respectively, requiring G-CSF usage. There were 4/7/6 pts in the PTX/QW/BIW arms with PTX dose modifications. Four pts (16%) in PTX arm, 4 pts (16%) in the QW arm and 6 pts (25%) in the BIW arm had confirmed pCR in the breast. Conclusions: In this IA population, the addition of iniparib regardless of the schedule to weekly PTX did not seem to add clinically significant toxicity. pCR rate in the breast is similar across treatment arms at this IA. NCT01204125.