Updated results of European Organization for Research and Treatment of Cancer (EORTC) phase 2 trial 1202 cabazitaxel in patients with metastatic or inoperable locally advanced dedifferentiated liposarcoma.

Authors

null

Roberta Sanfilippo

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy

Roberta Sanfilippo , Richard L Hayward , Jammbe Musoro , Charlotte Benson , Michael Gordon Leahy , Antonella Brunello , Jean-Yves Blay , Neeltje Steeghs , Ingrid Desar , Nasim Ali , Alice Hervieu , Khin Thway , Sandrine Marreaud , Saskia Litiere , Bernd Kasper

Organizations

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Western General Hospital, Edinburgh, United Kingdom, EORTC, Brussels, Belgium, The Royal Marsden Hospital, London, United Kingdom, Christie Hosp NHS Trust, Manchester, United Kingdom, Medical Oncology Unit 1, Department of Oncology, Istituto Oncologico Veneto IOV IRCCS, Padua, Italy, Centre Léon Bérard, Lyon, France, The Netherlands Cancer Institute, Amsterdam, Netherlands, Radboud University Medical Center, Nijmegen, Netherlands, Clatterbrige Cancer Centre, Wirral, United Kingdom, Centre Georges-François Leclerc, Dijon, France, The Royal Marsden NHS Foundation Trust, London, United Kingdom, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium, Mannheim University Medical Center, Mannheim, Germany

Research Funding

Pharmaceutical/Biotech Company
Sanofi Aventis

Background: Treatment options for patients with unresectable and/or metastatic dedifferentiated liposarcoma (DDLPS) are limited. The most effective agents include doxorubicin, ifosfamide, trabectedin and eribulin, but, in general, objective response rates (ORR) and progression free survival (PFS) are modest. Cabazitaxel exerts its effect through inhibition of microtubular disassembly and has been shown to be relatively safe, effective and well-tolerated. EORTC 1202 assessed whether cabazitaxel demonstrated sufficient antitumor activity in patients with metastatic or inoperable locally advanced DD LPS to justify further investigation in a phase III setting. Methods: This was an international multi-center, open label single arm phase II trial. The clinical cut-off date for the primary analysis was performed on August 31, 2020. Data base lock was performed on February 2, 2021. Eligible patients with metastatic or inoperable locally advanced DD LPS, after a centralized pathological review, were treated with cabazitaxel 25mg/m² IV infusion over 1 hour every 21 days. Primary endpoint was PFS rate at 12 weeks assessed by local investigator per RECIST 1.1. Based on a Simon two-stage design, at least 4 out of 17 (Stage 1) and 11 out of 37 (Stage 2) eligible and evaluable patients who are progression-free at 12 weeks were needed. Currently, a centralized radiological assessment is ongoing. Results: Forty patients were registered by 10 institutions in 4 countries between March 2015 and March 2019, with 2 patients being ineligible. One patient was still on treatment at the clinical cut-off date. The number of cycles ranged from 1 to 30, with a median of 5; 26 patients (65%) received at least 4 cycles of cabazitaxel. PFS at 12 weeks was 55% (conditional 1-sided 95% CI 40.8-100), achieving the primary study endpoint. The median FU was 21.6 months, median PFS was 6 months and median OS 21 months. RR was 8% with one CR and two PR. Twenty-three(60.5%) pts had a SD. Disease control (PR+SD) was achieved in 26 patients (68%). The most common cabazitaxel -related grade >3 adverse events in all 40 registered patients were Neutrophil count decreased (50%), febrile neutropenia (25%), fatigue (12.5%), and anemia (10%). There were no cabazitaxel-related deaths. Conclusions: EORTC 1202 met its primary endpoint, with 21/38 pts (55%) being progression-free at 12 weeks. Results of this trial confirm activity of cabazitaxel in patients with metastatic or inoperable locally advanced DD LPS and looks interesting if compared to the other available options and experimental drugs recently reported in this patient population. Clinical trial information: NCT01913652

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Sarcoma

Track

Sarcoma

Sub Track

Bone Tumors

Clinical Trial Registration Number

NCT01913652

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 11518)

DOI

10.1200/JCO.2021.39.15_suppl.11518

Abstract #

11518

Abstract Disclosures