Cabozantinib and temozolomide in patients with unresectable or metastatic leiomyosarcoma and other soft tissue sarcomas: a multicentre, single-arm, lead-in phase 2 trial
Researchers conducted a multicenter, single-arm, lead-in phase 2 trial that used a combination of a drug that stops signaling of cancer cells to divide and the growth of new blood vessels into the tumor (cabozantinib) along with another drug that causes damage to tumor DNA leading to tumor cell death (temozolomide) in patients with unresectable or metastatic leiomyosarcoma and other soft tissue sarcomas.
Eligible patients had confirmed unresectable or metastatic uterine and non-uterine leiomyosarcoma (group 1) and other soft tissue sarcomas (group 2), and up to five previous chemotherapy regimens. Patients were given the combination therapy if their white blood cell and platelet counts were satisfactory until disease progression or unacceptable drug-related adverse events. The primary endpoint for group 1 was progression-free survival at 12 weeks. A total of 72 patients were enrolled between Jan 17, 2020, and Feb 6, 2023. There were 42 patients in group 1 and 30 patients in group 2, with a median follow-up of 18 months. In group 1, progression-free survival at 12 weeks was reached by 31 (74%) of 42 patients. Additionally, the combination therapy was tolerable and did not reveal any new safety signals. 20 (48%) patients in group 1 and 23 (77%) in group 2 had died due to disease progression at the end of the study. There were no treatment-related deaths.
These results indicate that, although additional studies need to be done, Cabozantinib with
temozolomide may be a treatment option for patients with unresectable or metastatic
leiomyosarcoma.
Read the full study in The Lancet Oncology.