Meeting
2018 ASCO Annual Meeting
Short, full-dose neoadjuvant chemotherapy in localized high-risk adult soft tissue sarcomas (STS): An exploratory subgroup analysis on responding patients in a randomized controlled trial comparing 3 neoadjuvant versus 3 neoadjuvant + 2 adjuvant cycles of full dose anthracycline and ifosfamide chemotherapy at a 10yr median FU.
Authors
Silvia Stacchiotti
Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Silvia Stacchiotti , Sara Pizzamiglio , Antonella Messina , Carlo Morosi , Paola Collini , Antonio Llombart-Bosch , Javier Martin Broto , Alessandro Comandone , Josefina Cruz , Giovanni Grignani , Vittorio Quagliuolo , Piero Picci , Antonino De Paoli , Angelo Paolo Dei Tos , Paolo Verderio , Paolo Giovanni Casali , Alessandro Gronchi
Organizations
Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Department of Pathology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy, Milan, Italy, University of Valencia, Valencia, Spain, Virgen del Rocio University Hospital, Institute of Biomedicine Research (IBIS)/CSIC/Universidad de Sevilla, Seville, Spain, Humanitas Gradenigo Torino, Turin, Italy, Hospital Universitario de Canarias, Santa Cruz De Tenerife, Spain, Candiolo Cancer Institue - FPO, IRCCS, Turin, Italy, Istituto Clinico Humanitas, Milan, Italy, Istituto Ortopedico Rizzoli, Bologna, BO, Italy, Centro di Riferimento Oncologico, Pordenone, Italy, Department of Pathology, General Hospital of Treviso, Treviso, Italy, Medical Oncology Unit 2, Medical Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy, Department of Surgery, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
Research Funding
Other Foundation
Background: We already reported (Cancer 2012;118:5857) the correlation of Choi criteria (Choi) and RECIST with outcome of pts affected by high-risk STS entering a multicentric Italian/Spanish Phase 3 trial comparing 3 vs 5 cycles of (neo)adjuvant CT with full-dose epirubicin + ifosfamide (JCO 2012;30:850; Ann Oncol 2016;27:2283). We investigated whether the non inferiority of 3 vs 5 cycles held also in the subgroup of patients responsive to preoperative treatment. Methods: Patients were randomized to receive 3 cycles of preoperative CT with epirubicin 120 mg/m2 and ifosfamide 9 g/m2 (Arm A) or to receive the same 3 cycles of preoperative CT followed by 2 further cycles of post-operative CT (Arm B). Radiotherapy could be delivered in the preoperative or in the post-operative setting. Non-inferiority of the primary end-point, overall survival (OS), was assessed by the confidence interval of the hazard ratio (HR; Arm A/Arm B) derived from Cox model. Response was assessed by RECIST and Choi. Results: Between January 2002 and April 2007, 160 pts were assigned to Arm A and 161 to Arm B, 158 patients received preoperative RT (Arm A = 77; Arm B = 81). At a median FU of 117 months (IQR 103-135 months), 123 deaths were recorded, 58 in Arm A and 65 in Arm B. Ten-year OS was 61% for the entire group of patients, 64% in Arm A and 59% in Arm B (HR 0.92, 90% confidence interval [CI] :0.68–1.23). Of 243 patients evaluable for RECIST, 208 achieved a partial response (PR) or stable disease (SD), 93 in Arm A and 115 in Arm B. Ten year OS was 62% in Arm A and 59% in Arm B (HR 1.02; 90% CI 0.70-1.48). Of 166 pts evaluable for Choi, 135 achieved a PR, 60 in Arm A and 75 in Arm B. Ten-year OS was 60% in Arm A and 66% in Arm B (HR 1.29; 90% CI 0.80-2.07). Conclusions: In this (neo)adjuvant trial, the non inferiority of 3 vs 5 cycles of full dose anthracycline and ifosfamide /neo)adjuvant chemotherapy was confirmed also in the subgroup of patients with evidence of radiologic response to the preoperative treatment Clinical trial information: 2004-003979-36.
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Abstract Details
Session Type
Poster Session
Session Title
Sarcoma
Track
Sarcoma
Sub Track
Soft Tissue Tumors
Clinical Trial Registration Number
2004-003979-36
Citation
J Clin Oncol 36, 2018 (suppl; abstr 11558)
DOI
10.1200/JCO.2018.36.15_suppl.11558
Abstract #
11558
Poster Bd #
303
Abstract Disclosures
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