Journal
NANOMEDICINE-NANOTECHNOLOGY BIOLOGY AND MEDICINE
Volume 18, Issue -, Pages 189-195Publisher
ELSEVIER SCIENCE BV
DOI: 10.1016/j.nano.2019.02.021
Keywords
Nanoparticle; Camptothecin; Neoadjuvant; Rectal cancer; Maximum tolerated dose; Pathologic complete response
Funding
- Cerulean Pharma Inc.
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CRLX101 is a nanoparticle-drug conjugate with a camptothecin payload. We assessed the toxicity and pathologic complete response (pCR) rate of CRLX101 with standard neoadjuvant chemoradiotherapy (CRT) in locally advanced rectal cancer. A single-arm study was conducted with a 3 + 3 dose escalation phase Ib followed by phase II at the maximum tolerated dose (MTD). Thirty-two patients were enrolled with 29 (91%) patients having T3/4 and 26 (81%) N1/2 disease. In phase Ib, no patient experienced a dose limiting toxicity (DLT) with every other week dosing, while 1/9 patients experienced a DLT with weekly dosing. The weekly MID was identified as 15 mg/m(2). The most common grade 3-4 toxicity was lymphopenia, with only 1 grade 4 event. pCR was achieved in 6/32 (19%) patients overall and 2/6 (33%) patients at the weekly MTD. CRLX101 at 15 mg/m(2) weekly with neoadjuvant CRT is a feasible combination strategy with an excellent toxicity profile. (C) 2019 Elsevier Inc. All rights reserved.
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