A randomized, open‐label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft‐tissue sarcoma
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...
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| Published in: | Cancer Vol. 127; no. 6; pp. 894 - 904 |
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| Main Authors: | , , , , , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
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15.03.2021
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| ISSN: | 0008-543X, 1097-0142, 1097-0142 |
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| 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.
The results of the current trial suggest similar efficacy and tolerability when comparing the gemcitabine and pazopanib (G+P) regimen with the gemcitabine and docetaxel (G+T) regimen. In patients who are not suitable for treatment with G+T, the G+P regimen is a reasonable alternate for the second‐line treatment of patients with metastatic nonadipocytic sarcomas. |
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| AbstractList | 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.
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
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
on days 1 and 8 and docetaxel at a dose of 100 mg/m
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).
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).
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. 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.BACKGROUNDTherapeutic 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.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).METHODSThe 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).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).RESULTSA 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).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.CONCLUSIONSThe 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. BackgroundTherapeutic 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.MethodsThe 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).ResultsA 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).ConclusionsThe 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. 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. The results of the current trial suggest similar efficacy and tolerability when comparing the gemcitabine and pazopanib (G+P) regimen with the gemcitabine and docetaxel (G+T) regimen. In patients who are not suitable for treatment with G+T, the G+P regimen is a reasonable alternate for the second‐line treatment of patients with metastatic nonadipocytic sarcomas. The results of the current trial suggest similar efficacy and tolerability when comparing the gemcitabine and pazopanib (G+P) regimen with the gemcitabine and docetaxel (G+T) regimen. In patients who are not suitable for treatment with G+T, the G+P regimen is a reasonable alternate for the second‐line treatment of patients with metastatic nonadipocytic sarcomas. |
| Author | Garrett‐Mayer, Elizabeth Chawla, Sant P. Meyer, Christian F. Van Tine, Brian Andrew Wahlquist, Amy E. Schuetze, Scott M. Armeson, Kent E. Milhem, Mohammed M. Read, William L. Somaiah, Neeta Kraft, Andrew S. Hill, Elizabeth G. Reuben, Daniel Y. Elias, Anthony D. |
| Author_xml | – sequence: 1 givenname: Neeta orcidid: 0000-0002-0146-7732 surname: Somaiah fullname: Somaiah, Neeta organization: The University of Texas MD Anderson Cancer Center – sequence: 2 givenname: Brian Andrew orcidid: 0000-0003-4572-6668 surname: Van Tine fullname: Van Tine, Brian Andrew organization: Washington University School of Medicine in St. Louis – sequence: 3 givenname: Amy E. surname: Wahlquist fullname: Wahlquist, Amy E. organization: Medical University of South Carolina – sequence: 4 givenname: Mohammed M. surname: Milhem fullname: Milhem, Mohammed M. organization: University of Iowa – sequence: 5 givenname: Elizabeth G. surname: Hill fullname: Hill, Elizabeth G. organization: Medical University of South Carolina – sequence: 6 givenname: Elizabeth orcidid: 0000-0003-4709-0333 surname: Garrett‐Mayer fullname: Garrett‐Mayer, Elizabeth organization: American Society of Clinical Oncology – sequence: 7 givenname: Kent E. surname: Armeson fullname: Armeson, Kent E. organization: Medical University of South Carolina – sequence: 8 givenname: Scott M. orcidid: 0000-0002-7167-4163 surname: Schuetze fullname: Schuetze, Scott M. organization: University of Michigan – sequence: 9 givenname: Christian F. surname: Meyer fullname: Meyer, Christian F. organization: Johns Hopkins Hospital – sequence: 10 givenname: Daniel Y. surname: Reuben fullname: Reuben, Daniel Y. organization: Medical University of South Carolina – sequence: 11 givenname: Anthony D. surname: Elias fullname: Elias, Anthony D. organization: University of Colorado Comprehensive Cancer Center – sequence: 12 givenname: William L. orcidid: 0000-0001-6946-5250 surname: Read fullname: Read, William L. organization: , Emory Clinic – sequence: 13 givenname: Sant P. surname: Chawla fullname: Chawla, Sant P. organization: Sarcoma Oncology Research Center – sequence: 14 givenname: Andrew S. orcidid: 0000-0003-3417-4845 surname: Kraft fullname: Kraft, Andrew S. email: akraft@uacc.arizona.edu organization: University of Arizona Cancer Center |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33231866$$D View this record in MEDLINE/PubMed |
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| Copyright | 2020 American Cancer Society 2020 American Cancer Society. 2021 American Cancer Society |
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Therapeutic options for patients with advanced soft‐tissue sarcoma (STS) are limited. The goal of the current phase 2 study was to examine the... The results of the current trial suggest similar efficacy and tolerability when comparing the gemcitabine and pazopanib (G+P) regimen with the gemcitabine and... 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... BackgroundTherapeutic options for patients with advanced soft‐tissue sarcoma (STS) are limited. The goal of the current phase 2 study was to examine the... |
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| Title | A randomized, open‐label, phase 2, multicenter trial of gemcitabine with pazopanib or gemcitabine with docetaxel in patients with advanced soft‐tissue sarcoma |
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