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A randomized, open‐label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft‐tissue sarcoma
- Source :
- Cancer. 127:894-904
- Publication Year :
- 2020
- Publisher :
- Wiley, 2020.
-
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/m2 on days 1 and 8 with pazopanib at a dose of 800 mg daily (G+P) or gemcitabine at a dose of 900 mg/m2 on days 1 and 8 and docetaxel at a dose of 100 mg/m2 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.
- Subjects :
- Adult
Male
Cancer Research
medicine.medical_specialty
Indazoles
Phases of clinical research
Soft Tissue Neoplasms
Docetaxel
Neutropenia
Deoxycytidine
Gastroenterology
Pazopanib
Young Adult
03 medical and health sciences
0302 clinical medicine
Internal medicine
Multicenter trial
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
030212 general & internal medicine
Adverse effect
Aged
Aged, 80 and over
Sulfonamides
Cross-Over Studies
business.industry
Common Terminology Criteria for Adverse Events
Middle Aged
medicine.disease
Gemcitabine
Pyrimidines
Oncology
030220 oncology & carcinogenesis
Female
business
medicine.drug
Subjects
Details
- ISSN :
- 10970142 and 0008543X
- Volume :
- 127
- Database :
- OpenAIRE
- Journal :
- Cancer
- Accession number :
- edsair.doi.dedup.....43ac6a840d7c38cbaf4d42791f6496b6