Journal article
Vorinostat and bortezomib as third-line therapy in patients with advanced non-small cell lung cancer: a Wisconsin Oncology Network Phase II study
Investigational new drugs, Vol.32(1), pp.195-199
02/01/2014
DOI: 10.1007/s10637-013-9980-5
PMCID: PMC4310688
PMID: 23728919
Abstract
Introduction The primary objective of this phase II trial was to evaluate the efficacy and tolerability of vorinostat and bortezomib as third-line therapy in advanced non-small cell lung cancer (NSCLC) patients. Methods Eligibility criteria included recurrent/metastatic NSCLC, having received 2 prior systemic regimens, and performance status 0-2. Patients took vorinostat 400 mg PO daily days 1-14 and bortezomib 1.3 mg/m2 IV day 1, 4, 8 and 11 in a 21-day cycle. Primary endpoint was 3-month progression free survival (3m-PFS), with a goal of at least 40 % of patients being free of progression at that time point. This study followed a two-stage minimax design. Results Eighteen patients were enrolled in the first stage. All patients had two prior lines of treatment. Patients received a median of two treatment cycles (range: 1-6) on study. There were no anti-tumor responses; stable disease was observed in 5 patients (27.8 %). Median PFS was 1.5 months, 3m-PFS rate 11.1 %, and median overall survival 4.7 months. The most common grade 3/4 toxicities were thrombocytopenia and fatigue. Two patients who had baseline taxane-related grade 1 peripheral neuropathy developed grade 3 neuropathy. The study was closed at its first interim analysis for lack of efficacy. Conclusions Bortezomib and vorinostat displayed minimal anti-tumor activity as third-line therapy in NSCLC. We do not recommend this regimen for further investigation in unselected patients.
Details
- Title: Subtitle
- Vorinostat and bortezomib as third-line therapy in patients with advanced non-small cell lung cancer: a Wisconsin Oncology Network Phase II study
- Creators
- Tien Hoang - University of Wisconsin–MadisonToby C. Campbell - University of Wisconsin Carbone Cancer CenterChong Zhang - University of Wisconsin Carbone Cancer CenterKyungMann Kim - University of Wisconsin Carbone Cancer CenterJill M. Kolesar - University of Wisconsin Carbone Cancer CenterKurt R. Oettel - Center for Cancer and Blood DisordersJules H. Blank - Green Bay Oncol, Green Bay, WI USAEmily G. Robinson - Regional Cancer CenterHarish G. Ahuja - Regional Cancer CenterRon J. Kirschling - Riverview UW Canc Ctr, Wisconsin Rapids, WI USAPeter H. Johnson - ProHealth CareMichael S. Huie - University of Wisconsin Carbone Cancer CenterMary E. Wims - University of Wisconsin Carbone Cancer CenterMartha M. Larson - University of Wisconsin Carbone Cancer CenterHilary R. Hernan - University of Wisconsin Carbone Cancer CenterAnne M. Traynor - University of Wisconsin Carbone Cancer Center
- Resource Type
- Journal article
- Publication Details
- Investigational new drugs, Vol.32(1), pp.195-199
- DOI
- 10.1007/s10637-013-9980-5
- PMID
- 23728919
- PMCID
- PMC4310688
- NLM abbreviation
- Invest New Drugs
- ISSN
- 0167-6997
- eISSN
- 1573-0646
- Publisher
- Springer Nature
- Number of pages
- 5
- Grant note
- Merck; Merck & Company Millennium; Takeda Pharmaceutical Company Ltd P30 CA014520 / University of Wisconsin Carbone Cancer Center P30CA014520 / NATIONAL CANCER INSTITUTE; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI)
- Language
- English
- Date published
- 02/01/2014
- Academic Unit
- Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984696544902771
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