Journal article
A randomized, open-label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft-tissue sarcoma
Cancer, Vol.127(6), pp.894-904
03/15/2021
DOI: 10.1002/cncr.33216
PMID: 33231866
Abstract
Background Therapeutic options for patients with advanced soft-tissue sarcoma (STS) are limited. The goal of the current phase 2 study was to examine the clinical activity and safety of the combination of gemcitabine plus pazopanib, a multityrosine kinase inhibitor with activity in STS.
Methods The current randomized, phase 2 trial enrolled patients with advanced nonadipocytic STS who had received prior anthracycline-based therapy. Patients were assigned 1:1 to receive gemcitabine at a dose of 1000 mg/m(2) on days 1 and 8 with pazopanib at a dose of 800 mg daily (G+P) or gemcitabine at a dose of 900 mg/m(2) on days 1 and 8 and docetaxel at a dose of 100 mg/m(2) on day 8 (G+T) every 3 weeks. Crossover was allowed at the time of disease progression. The study used a noncomparative statistical design based on the precision of 95% confidence intervals for reporting the primary endpoints of median progression-free survival (PFS) and rate of grade >= 3 adverse events (AEs) for these 2 regimens based on the intent-to-treat patient population (AEs were graded using version 4.0 of the National Cancer Institute Common Terminology Criteria for Adverse Events).
Results A total of 90 patients were enrolled: 45 patients on each treatment arm. The median PFS was 4.1 months for each arm (P = .3, log-rank test). The best overall response of stable disease or better (complete response + partial response + stable disease) was the same for both treatment arms (64% for both the G+T and G+P arms). The rate of related grade >= 3 AEs was 82% for the G+T arm and 78% for the G+P arm. Related grade >= 3 AEs occurring in >= 10% of patients in the G+T and G+P arms were anemia (36% and 20%, respectively), fatigue (29% and 13%, respectively), thrombocytopenia (53% and 49%, respectively), neutropenia (20% and 49%, respectively), lymphopenia (13% and 11%, respectively), and hypertension (2% and 20%, respectively).
Conclusions The data from the current study have demonstrated the safety and efficacy of G+P as an alternative to G+T for patients with nonadipocytic STS.
Details
- Title: Subtitle
- A randomized, open-label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft-tissue sarcoma
- Creators
- Neeta Somaiah - The University of Texas MD Anderson Cancer CenterBrian Andrew Van Tine - Washington University in St. LouisAmy E. Wahlquist - Medical University of South CarolinaMohammed M. Milhem - University of IowaElizabeth G. Hill - Medical University of South CarolinaElizabeth Garrett-Mayer - American Society of Clinical OncologyKent E. Armeson - Medical University of South CarolinaScott M. Schuetze - University of MichiganChristian F. Meyer - Johns Hopkins HospitalDaniel Y. Reuben - Medical University of South CarolinaAnthony D. Elias - University of Colorado Cancer CenterWilliam L. Read - Emory HealthcareSant P. Chawla - Sarcoma Oncology CenterAndrew S. Kraft - University of Arizona
- Resource Type
- Journal article
- Publication Details
- Cancer, Vol.127(6), pp.894-904
- DOI
- 10.1002/cncr.33216
- PMID
- 33231866
- NLM abbreviation
- Cancer
- ISSN
- 0008-543X
- eISSN
- 1097-0142
- Publisher
- Wiley
- Number of pages
- 11
- Grant note
- Novartis Corporation; Novartis P30 CA138313 / Biostatistics Shared Resource of the Hollings Cancer Center of the Medical University of South Carolina P30 CA08686217; P30 CA046592; P30 CA023074 / National Cancer Institute; United States Department of Health & Human Services; National Institutes of Health (NIH) - USA; NIH National Cancer Institute (NCI) GlaxoSmithKline
- Language
- English
- Date published
- 03/15/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359591402771
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