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 Journal Article


Authors: 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.; Aura, C.; Baselga, J.
Article Title: 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
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. © 2015, Springer Science+Business Media New York.
Keywords: adult; controlled study; treatment outcome; major clinical study; constipation; drug tolerability; fatigue; neutropenia; paresthesia; cancer combination chemotherapy; diarrhea; drug efficacy; drug safety; drug withdrawal; treatment duration; paclitaxel; cancer adjuvant therapy; cancer staging; phase 2 clinical trial; breast cancer; nausea; randomized controlled trial; stomatitis; myalgia; peripheral neuropathy; arthralgia; asthenia; rash; drug response; peripheral edema; preoperative treatment; neoadjuvant chemotherapy; alopecia; rhinopharyngitis; vertigo; iniparib; triple negative breast cancer; triple-negative breast cancer; conjunctivitis; human; female; priority journal; article
Journal Title: Breast Cancer Research and Treatment
Volume: 154
Issue: 2
ISSN: 0167-6806
Publisher: Springer  
Date Published: 2015-11-01
Start Page: 351
End Page: 357
Language: English
DOI: 10.1007/s10549-015-3616-8
PROVIDER: scopus
PUBMED: 26536871
PMCID: PMC4971774
DOI/URL:
Notes: Export Date: 2 December 2015 -- Source: Scopus
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MSK Authors
  1. Jose T Baselga
    481 Baselga