Abstract
Phase II trial of gemcitabine (G) with pazopanib (P) or gemcitabine with docetaxel (T) in advanced soft tissue sarcoma (STS)
Journal of clinical oncology, Vol.37(15_suppl), pp.11008-11008
05/20/2019
DOI: 10.1200/JCO.2019.37.15_suppl.11008
Abstract
11008
Background: P is a multi-tyrosine kinase inhibitor with efficacy in many sarcoma subtypes. We designed a trial to assess the benefit of adding P to G as an alternative regimen to the commonly used combination of G+T in pts with STS (NCT01593748). Methods: We performed an open-label, randomized phase 2 trial enrolling pts with advanced non-adipocytic STS who had received prior anthracycline based therapy. Pts were assigned (1:1 stratified randomization based on leiomyosarcoma and prior pelvic radiation) to receive G 1000 mg/m
2
on days 1 and 8 with P 800 mg daily or G 900 mg/m2 on days 1 and 8 and T 100 mg/m2 on day 8, repeated q 3 wks. The primary objectives were estimating median PFS and rate of grade ≥3 adverse events (AEs). Secondary objectives included estimating the hazard ratio (HR) and response rates. Cross-over was allowed for RECIST progression. Sample size of 90 was derived based on the precision of 95% confidence intervals (CI) for reporting toxicity and PFS in each arm. Results: A total of 90 pts enrolled; 45 on each arm. Pt characteristics and results are detailed in Table. Median PFS was 4.1 months for each arm (p= 0.3, based on stratified log-rank test). The clinical benefit rate (PR+SD) was 29% for each arm (p>0.99, based on Fisher’s exact test). The rate of related grade ≥3 AEs were 20.6% with G+T and 19.9% with G+P. Related grade ≥3 AEs (%) occurring in ≥10% of pts (G+T; G+P): anemia (36, 20), fatigue (29; 13), low platelets (56; 51), low neutrophils (20; 49), AST increase (2; 13) and hypertension (2; 20). Conclusions: This study demonstrates comparable efficacy between G+P and G+T, suggesting that G+P can be considered for second-line therapy in advanced non-adipocytic STS. Pt Characteristics and Results. Clinical trial information: NCT01593748. [Table: see text]
Details
- Title: Subtitle
- Phase II trial of gemcitabine (G) with pazopanib (P) or gemcitabine with docetaxel (T) in advanced soft tissue sarcoma (STS)
- Creators
- Neeta Somaiah - The University of Texas MD Anderson Cancer CenterBrian Andrew Van Tine - Washington University in St. LouisElizabeth Goodwin Hill - Medical University of South CarolinaMohammed M. Milhem - University of IowaScott Schuetze - University of Michigan–Ann ArborChristian Frederick Meyer - Johns Hopkins HospitalDaniel Y. Reuben - Smilow Cancer HospitalAnthony D. Elias - University of Colorado Cancer CenterWilliam L. Read - Emory ClinicSant P. Chawla - Sarcoma Oncology CenterAmy E. Wahlquist - Medical University of South CarolinaElizabeth Garrett-Mayer - Medical University of South CarolinaAndrew S. Kraft - University of Arizona
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.37(15_suppl), pp.11008-11008
- DOI
- 10.1200/JCO.2019.37.15_suppl.11008
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 05/20/2019
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984363311302771
Metrics
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