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SOLTI NeoPARP: a phase II randomized study of two schedules of iniparib plus paclitaxel versus paclitaxel alone as neoadjuvant therapy in patients with triple-negative breast cancer.
Llombart-Cussac, Antonio; Bermejo, Begoña; Villanueva, Cristian; Delaloge, Suzette; Morales, Serafín; Balmaña, Judith; Amillano, Kepa; Bonnefoi, Hervé; Casas, Ana; Manso, Luis; Roché, Henri; Gonzalez-Santiago, Santiago; Gavilá, Joaquín; Sánchez-Rovira, Pedro; Di Cosimo, Serena; Harbeck, Nadia; Charpentier, Eric; Garcia-Ribas, Ignacio; Radosevic-Robin, Nina; Aura, Claudia; Baselga, Jose.
Afiliación
  • Llombart-Cussac A; SOLTI Breast Cancer Research Group, Barcelona, Spain. allombart1@yahoo.com.
  • Bermejo B; Medical Oncology, Arnau de Vilanova Hospital, Valencia, Spain. allombart1@yahoo.com.
  • Villanueva C; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Delaloge S; Medical Oncology, University Clinic Hospital, Valencia, Spain.
  • Morales S; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Balmaña J; Universitary Hospital of Besançon, Besançon, France.
  • Amillano K; Gustave Roussy Institute, Villejuif, France.
  • Bonnefoi H; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Casas A; Medical Oncology, Arnau de Vilanova Hospital, Lleida, Spain.
  • Manso L; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Roché H; Medical Oncology, Vall d'Hebron University Hospital, Barcelona, Spain.
  • Gonzalez-Santiago S; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Gavilá J; Medical Oncology, Sant Joan de Reus Hospital, Reus, Spain.
  • Sánchez-Rovira P; Institut Bergonié, University of Bordeaux, INSERM U916, Bordeaux, France.
  • Di Cosimo S; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Harbeck N; Medical Oncology, Virgen del Rocío Hospital, Sevilla, Spain.
  • Charpentier E; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Garcia-Ribas I; Medical Oncology, 12 de Octubre Hospital, Madrid, Spain.
  • Radosevic-Robin N; Institut Claudius Regaud, Toulouse, France.
  • Aura C; SOLTI Breast Cancer Research Group, Barcelona, Spain.
  • Baselga J; Medical Oncology, Cáceres Hospital, Cáceres, Spain.
Breast Cancer Res Treat ; 154(2): 351-7, 2015 Nov.
Article en En | MEDLINE | ID: mdl-26536871
Iniparib is an investigational agent with antitumor activity of controversial mechanism of action. Two previous trials in advanced triple-negative breast cancer (TNBC) in combination with gemcitabine and carboplatin showed some evidence of efficacy that was not confirmed. This phase II randomized neoadjuvant study was designed to explore its activity and tolerability with weekly paclitaxel (PTX) as neoadjuvant treatment in TNBC patients. 141 patients with Stage II-IIIA TNBC were randomly assigned to receive PTX (80 mg/m(2), d1; n = 47) alone or in combination with iniparib, either once-weekly (PWI) (11.2 mg/kg, d1; n = 46) or twice-weekly (PTI) (5.6 mg/kg, d1, 4; n = 48) for 12 weeks. Primary endpoint was pathologic complete response (pCR) in the breast. pCR rate was similar among the three arms (21, 22, and 19 % for PTX, PWI, and PTI, respectively). Secondary efficacy endpoints were comparable: pCR in breast and axilla (21, 17, and 19 %); best overall response in the breast (60, 61, and 63 %); and breast conservation rate (53, 54, and 50 %). Slightly more patients in the PTI arm presented grade 3/4 neutropenia (4, 0, and 10 %). Grade 1/2 (28, 22, and 29 %), but no grade 3/4 neuropathy, was observed. There were no differences in serious adverse events and treatment-emergent adverse events leading to treatment discontinuation among the three arms. Addition of iniparib to weekly PTX did not add relevant antitumor activity or toxicity. These results do not support further evaluation of the combination of iniparib at these doses plus paclitaxel in early TNBC.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Paclitaxel / Neoplasias de la Mama Triple Negativas Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Breast Cancer Res Treat Año: 2015 Tipo del documento: Article País de afiliación: España Pais de publicación: Países Bajos
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Protocolos de Quimioterapia Combinada Antineoplásica / Paclitaxel / Neoplasias de la Mama Triple Negativas Tipo de estudio: Clinical_trials Límite: Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Breast Cancer Res Treat Año: 2015 Tipo del documento: Article País de afiliación: España Pais de publicación: Países Bajos