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

Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance:A Multicenter Retrospective Study

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.

Study Overview

• Status: Completed
• Conditions: Soft Tissue Sarcoma; Bone Sarcoma; Refractory Tumor
• Intervention / Treatment: Drug: Fruquintinib

Detailed Description

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 (Actual): 124

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received fruquintinib-based treatment with refractory bone and soft tissue sarcomas in Peking University People's Hospital and The Second Affiliated Hospital ZheJiang University School of Medicine was included.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study group; Fruquintinib treatment group	Drug: Fruquintinib; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PFS	The time from the first administration of fruquintinib to the date of first documentation of disease progression or death, whichever occurred first.	4months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OS	OS was calculated from the use of fruquintinib until death from any cause	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.	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.	1year
AEs	AEs were graded and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events(CTCAE ) version 5.0.	1year

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Investigators: Principal Investigator: Lu Xie, M.D., Musculoskeletal Tumor Center of Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2021
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: January 1, 2024
• First Posted (Actual): January 11, 2024

Study Record Updates

• Last Update Posted (Actual): January 17, 2024
• Last Update Submitted That Met QC Criteria: January 15, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Ewing sarcoma; Osteosarcoma; Fruquintinib; Soft Tissue Sarcomas; TKIs
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma
• Other Study ID Numbers: PKUPH-sarcoma 17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No