KEY TAKEAWAYS
- GALLANT is a phase II trial that assessed the effectiveness of metronomic Gemcitabine, Doxorubicin, Docetaxel, and Nivolumab as second/third-line therapy for advanced sarcoma
- The study’s primary objective was to evaluate the best overall response, PFS at 6 and 9 months, OS at 6 and 12 months, and TRAEs incidence.
- The study reported that nivolumab plus metronomic chemotherapy may be as effective as standard first-line therapy for advanced sarcoma.
The GALLANT phase II trial evaluated the effectiveness of metronomic Gemcitabine, Doxorubicin, Docetaxel, and Nivolumab as second/third-line therapy for advanced sarcoma.
They investigated progression-free survival (PFS) in previously treated subjects with locally advanced, unresectable, or metastatic sarcoma. Secondary objectives included evaluating the best overall response, PFS rate at 6 and 9 months, overall survival (OS) rate at 6 and 12 months, and the incidence of treatment-related adverse events (TRAEs). Inclusion criteria were age ≥18, confirmed sarcoma diagnosis, measurable disease, and acceptable hematologic and organ functions. Exclusion criteria involved a history of autoimmune disorders. The treatment schedule consisted of metronomic gemcitabine (600 mg/m2 max:1000 mg), doxorubicin (18 mg/m2; max: 32 mg), docetaxel (25 mg/m2; max:42 mg) on Day 1 and Day 8, and nivolumab (240 mg) on Day 1 only. Treatment cycles were repeated every three weeks if the toxicity grade was ≤1.
The treatment resulted in an 88.1% disease control rate (CR+PR+SD), with a median progression-free survival of 5.1 months (95% CI: 2.837-7.363) and a median overall survival of 15.3 months (95% CI: 5.48-25.12). Grade 3/4 treatment-related adverse events included fatigue (n=18), nausea (n=13), neutropenia (n=10), thrombocytopenia (n=9), anemia (n=9), and diarrhea (n=1). No unexpected adverse events were reported.
The study suggested that combining nivolumab with metronomic gemcitabine, doxorubicin, and docetaxel may show synergistic activity and be equally effective as standard first-line therapy for advanced sarcoma with manageable side effects.
Source: https://meetings.asco.org/abstracts-presentations/227063
Clinical Trial: https://clinicaltrials.gov/study/NCT04535713
Nadezhda Omelchenko, Neal Shiv Chawla, Stefan Makrievski, Guilherme Leao De Melo, Chrysler Valencia, Amir Ahari, Ania Moradkhani, Victoria Chua, Doris Quon, Don Arlen Brigham, Sant P. Chawla, and Erlinda Maria Gordon. Journal of Clinical Oncology (2023).
