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

Antonio Llombart-Cussac, Begoña Bermejo, Cristian Villanueva, Suzette Delaloge, Serafín Morales, Judith Balmaña, Kepa Amillano, Hervé Bonnefoi, Ana Casas, Luis Manso, Henri Roché, Santiago Gonzalez-Santiago, Joaquín Gavilá, Pedro Sánchez-Rovira, Serena Di Cosimo, Nadia Harbeck, Eric Charpentier, Ignacio Garcia-Ribas, Nina Radosevic-Robin, Claudia AuraJose Baselga

Research output: Contribution to journalArticle

Abstract

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/m2, 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.

Original languageEnglish
Pages (from-to)351-357
Number of pages7
JournalBreast Cancer Research and Treatment
Volume154
Issue number2
DOIs
Publication statusPublished - Nov 1 2015

Keywords

  • Breast cancer
  • Iniparib
  • Neoadjuvant chemotherapy
  • Paclitaxel
  • Triple-negative breast cancer

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Llombart-Cussac, A., Bermejo, B., Villanueva, C., Delaloge, S., Morales, S., Balmaña, J., Amillano, K., Bonnefoi, H., Casas, A., Manso, L., Roché, H., Gonzalez-Santiago, S., Gavilá, J., Sánchez-Rovira, P., Di Cosimo, S., Harbeck, N., Charpentier, E., Garcia-Ribas, I., Radosevic-Robin, N., ... Baselga, J. (2015). 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. Breast Cancer Research and Treatment, 154(2), 351-357. https://doi.org/10.1007/s10549-015-3616-8