Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance

N/ACompletedNCT06202599

Peking University People's Hospital124 enrolled

Overview

This multicenter retrospective study assessed the efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after several lines of TKIs' resistance.

The short-lived duration of disease control and secondary drug resistance have posed a threat to the effect of TKIs. Fruquintinib is a novel TKI with a high selectivity of VEGFR-1,2,3 without metabolism by liver enzymes and was approved for application in mCRC. Serious drug resistance and the unique characteristics of fruquintinib have prompted us to verify whether this drug can reverse TKIs' resistance at a higher dose.

Study Type

OBSERVATIONAL

Enrollment

124

Conditions

Bone Sarcoma Soft Tissue Sarcoma Refractory Tumor

Interventions

FruquintinibDRUG

For patients with pulmonary metastasis only, we mostly gave them fruquintinib with 7 mg in adults and 3-5 mg in children (\<10 years) orally per day (5 days on and 2 days off). If patients were extrapulmonary metastasis, we usually used combinations with metronomic chemotherapy (2/3 or 3/5 or even 1/2 of the usual dose) or immunotherapy.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: 1. Histologically confirmed bone or soft tissue sarcomas; 2. Progressed after several lines of therapy; 3. Previously treated with other TKIs before fruquintinib; 4. Received fruquintinib-based treatment; 5. Measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST) version1.1; 6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3 Exclusion Criteria: 1. Failure to complete regular follow-up after administration. 2. Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

PFS

The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first.

Time frame: 4months

Secondary Outcomes

OS was calculated from the use of fruquintinib until death from any cause

Time frame: 1year

ORR

ORR was defined as the proportion of patients with the best overall response of complete or partial response(CR+PR) according to the Response Evaluation Criteria for Solid Tumors(RECIST) version 1.1.

Time frame: 1year

DCR

DCR was defined as the proportion of patients with the best overall response of complete or partial response or stable disease(CR+PR+SD) according to RECIST 1.1.

Time frame: 1year

AEs

AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0.

Time frame: 1year

Data from ClinicalTrials.gov

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