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ABSTRACT: Purpose
The main objective was to evaluate the activity and tolerability of TEMIRI as a front-line treatment in primary disseminated Ewing sarcoma (PDMES) using the RECIST 1.1 criteria. The secondary objectives included the assessment of toxicity and the performance status/symptom changes.Methods
Between 2012 and 2018, patients with PDMES received two courses of temozolomide 100 mg/sqm/day + irinotecan 50 mg/sqm/day for 5 days every 3 weeks as an amendment to the Italian Sarcoma Group/Associazione Italiana EmatoIogia ed Oncologia Pediatrica (ISG/AIEOP) EW-2 protocol (EUDRACT#2009-012353-37, Vers. 1.02).Results
Thirty-four patients were enrolled. The median age at diagnosis was 19 years (range 3-55). After TEMIRI, the RECIST response was as follows: a partial response in 20 (59%) patients, stable disease in 11 (32%), and disease progression in 3 (9%). The ECOG/Lansky score was improved in 25/34 (73.5%) cases, and a reduction or disappearance of pain was observed in 31/34 patients (91%). The incidence of grade 3-4 toxicity was 3%. The 3-year event-free survival (EFS) and overall survival (OS) were 21% (95% CI 6-35%) and 36% (95% CI: 18-54%), respectively.Conclusion
the smooth handling and encouraging activity demonstrated by up-front TEMIRI did not change the EFS in PDMES, so this result suggests the need for the further evaluation of the efficacy of TEMIRI in combination with conventional treatments in non-metastatic patients.
SUBMITTER: Asaftei SD
PROVIDER: S-EPMC8234176 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
Asaftei Sebastian Dorin SD Puma Nadia N Paioli Anna A Petraz Marco M Morosi Carlo C Podda Marta M Tamburini Angela A Palmerini Emanuela E Coccoli Luca L Grignani Giovanni G Manzitti Carla C Bertulli Rossella R De Leonardis Francesco F Rabusin Marco M Campello Anna A Tirtei Elisa E Picci Piero P Prete Arcangelo A Longhi Alessandra A Fagioli Franca F Luksch Roberto R
Cancers 20210618 12
<h4>Purpose</h4>The main objective was to evaluate the activity and tolerability of TEMIRI as a front-line treatment in primary disseminated Ewing sarcoma (PDMES) using the RECIST 1.1 criteria. The secondary objectives included the assessment of toxicity and the performance status/symptom changes.<h4>Methods</h4>Between 2012 and 2018, patients with PDMES received two courses of temozolomide 100 mg/sqm/day + irinotecan 50 mg/sqm/day for 5 days every 3 weeks as an amendment to the Italian Sarcoma ...[more]