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    Activity of cabazitaxel in metastatic or inoperable locally advanced dedifferentiated liposarcoma: A phase 2 study of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG)

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    Authors
    Sanfilippo, R.
    Hayward, R. L.
    Musoro, J.
    Benson, C.
    Leahy, Michael G
    Brunello, A.
    Blay, J. Y.
    Steeghs, N.
    Desar, I. M. E.
    Ali, N.
    Hervieu, A.
    Thway, K.
    Marreaud, S.
    Litiere, S.
    Kasper, B.
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    Affiliation
    Medical Oncology Unit 2, Medical Oncology Dpt, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano, Milan, Italy
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Importance: Treatment options for patients with unresectable and/or metastatic dedifferentiated liposarcoma (DDLPS) are limited. New drugs are required. Objective: To assess whether cabazitaxel demonstrated sufficient antitumor activity in patients with metastatic or inoperable locally advanced DDLPS to justify further investigation in a phase 3 setting. Design, setting, and participants: This international multicenter, open-label single-arm phase 2 trial was conducted at 10 institutions in 4 European countries from March 2015 to March 2019. Eligible patients had to have metastatic or locally advanced histologically proven DDLPS with evidence of disease progression within the past 6 months and had to have received no more than 1 previous line of chemotherapy. Interventions: After mandatory central review of tumor blocks, if the DDLPS diagnosis was confirmed, patients started treatment within 72 hours after registration. Cabazitaxel was administered at a dose of 25 mg/m2 IV infusion over 1 hour every 21 days until intolerance, progression, or withdrawal of consent. Main outcomes and measures: The primary end point was progression-free survival (PFS) rate at 12 weeks per RECIST 1.1. Based on a Simon 2-stage design, at least 4 of 17 (stage 1) and 11 of 37 (stage 2) eligible and evaluable patients who were progression free at 12 weeks were needed. The final analysis report was completed on November 17, 2021. Results: Forty patients were registered, with 2 patients being ineligible. The number of cycles ranged from 1 to 30, with a median of 5; 26 patients (65%) received at least 4 cycles of cabazitaxel. Progression-free survival at 12 weeks was 55%, achieving the primary study end point. At a median follow-up of 21.6 months, median PFS was 6 months and median OS 21 months. Response rate (RR) was 8% with 1 clinical response (CR) and 2 partial responses (PR). Twenty-three (60.5%) patients had a stable disease (SD). Disease control (PR+SD) was achieved in 26 patients (68%). Conclusions and relevance: This nonrandomized phase 2 clinical trial met its primary end point, with 21 of 38 patients (55%) being progression free at 12 weeks. These results suggest important activity of cabazitaxel in patients with metastatic or inoperable locally advanced DDLPS. The drug is worth being further studied in these tumors in a phase 3 setting.
    Citation
    Sanfilippo R, Hayward RL, Musoro J, Benson C, Leahy MG, Brunello A, et al. Activity of Cabazitaxel in Metastatic or Inoperable Locally Advanced Dedifferentiated Liposarcoma: A Phase 2 Study of the EORTC Soft Tissue and Bone Sarcoma Group (STBSG). JAMA Oncol. 2022 Aug 18. PubMed PMID: 35980618. Epub 2022/08/19. eng.
    Journal
    JAMA Oncology
    URI
    http://hdl.handle.net/10541/625573
    DOI
    10.1001/jamaoncol.2022.3218
    PubMed ID
    35980618
    Additional Links
    https://dx.doi.org/10.1001/jamaoncol.2022.3218
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1001/jamaoncol.2022.3218
    Scopus Count
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