Preoperative chemo-radiation therapy for localised retroperitoneal sarcoma: A phase I-II study from the Italian Sarcoma Group

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Abstract

Background To study feasibility, safety and activity of the combination of high-dose long-infusion ifosfamide (HLI) and radiotherapy (RT) as preoperative treatment for resectable localised retroperitoneal sarcoma (RPS). Methods Patients received three cycles of HLI (14 g/m2). RT was started in combination with second cycle and administered up to a total dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the end of RT. Primary end-point was 3-year relapse free survival (RFS). The trial is registered with ITASARC-â̂ - II-2004-003. Findings Between December 2003 and 2010, 83 patients were recruited. Main histological subtypes were well differentiated liposarcoma (19/83, 23%), dedifferentiated liposarcoma (26/83, 31%), leiomyosarcoma (14/83, 17%). Median tumour size was 120 mm (interquartile (IQ) range = 82-160). The overall preoperative treatment was completed in 60 patients. Chemotherapy (CT) was completed in 65, while RT in 73. Four patients progressed before surgery and were not operated. 79 patients underwent surgery. At a median follow-up of 4.8 years (IQ range = 3-6.1), 23 and 15 patients developed local recurrence (LR) and distant metastases (DM); 30 patients died of disease. 3 and 5-year RFS and overall survival were 0.56 (90% confidence interval (CI): 0.45, 0.65) and 0.44 (90% CI: 0.27, 0.48), and 0.74 (90% CI: 0.62, 0.81) and 0.59 (90% CI: 0.33, 0.58). Crude cumulative incidence of LR and DM at 5 years were 0.37 (standard error (SE): 0.06) and 0.26 (SE: 0.06). Interpretation The combination of preoperative HLI and RT was feasible in two thirds of patients, while preoperative RT could be completed in most (73/83). Although a systemic coverage can be added to RT when this is felt to be appropriate, the ongoing international phase III trial is exploring the role of RT alone. Funding This is a pure academic trial. No funding sources contributed to it.

Original languageEnglish
Pages (from-to)784-792
Number of pages9
JournalEuropean Journal of Cancer
Volume50
Issue number4
DOIs
Publication statusPublished - Mar 2014

Fingerprint

Sarcoma
Radiotherapy
Ifosfamide
Confidence Intervals
Recurrence
Liposarcoma
Survival
Neoplasm Metastasis
Leiomyosarcoma
Feasibility Studies
Safety
Drug Therapy
Incidence
Therapeutics
Neoplasms

Keywords

  • Chemotherapy
  • Radiation therapy
  • Retroperitoneal sarcoma
  • Soft tissue sarcoma

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

@article{256c06c6b06540dfbc8357d53a8568ea,
title = "Preoperative chemo-radiation therapy for localised retroperitoneal sarcoma: A phase I-II study from the Italian Sarcoma Group",
abstract = "Background To study feasibility, safety and activity of the combination of high-dose long-infusion ifosfamide (HLI) and radiotherapy (RT) as preoperative treatment for resectable localised retroperitoneal sarcoma (RPS). Methods Patients received three cycles of HLI (14 g/m2). RT was started in combination with second cycle and administered up to a total dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the end of RT. Primary end-point was 3-year relapse free survival (RFS). The trial is registered with ITASARC-{\^a}̂ - II-2004-003. Findings Between December 2003 and 2010, 83 patients were recruited. Main histological subtypes were well differentiated liposarcoma (19/83, 23{\%}), dedifferentiated liposarcoma (26/83, 31{\%}), leiomyosarcoma (14/83, 17{\%}). Median tumour size was 120 mm (interquartile (IQ) range = 82-160). The overall preoperative treatment was completed in 60 patients. Chemotherapy (CT) was completed in 65, while RT in 73. Four patients progressed before surgery and were not operated. 79 patients underwent surgery. At a median follow-up of 4.8 years (IQ range = 3-6.1), 23 and 15 patients developed local recurrence (LR) and distant metastases (DM); 30 patients died of disease. 3 and 5-year RFS and overall survival were 0.56 (90{\%} confidence interval (CI): 0.45, 0.65) and 0.44 (90{\%} CI: 0.27, 0.48), and 0.74 (90{\%} CI: 0.62, 0.81) and 0.59 (90{\%} CI: 0.33, 0.58). Crude cumulative incidence of LR and DM at 5 years were 0.37 (standard error (SE): 0.06) and 0.26 (SE: 0.06). Interpretation The combination of preoperative HLI and RT was feasible in two thirds of patients, while preoperative RT could be completed in most (73/83). Although a systemic coverage can be added to RT when this is felt to be appropriate, the ongoing international phase III trial is exploring the role of RT alone. Funding This is a pure academic trial. No funding sources contributed to it.",
keywords = "Chemotherapy, Radiation therapy, Retroperitoneal sarcoma, Soft tissue sarcoma",
author = "Alessandro Gronchi and {De Paoli}, Antonino and Carla Dani and Merlo, {Domenico Franco} and Vittorio Quagliuolo and Giovanni Grignani and Giulio Bertola and Piera Navarria and Claudia Sangalli and Angela Buonadonna and {De Sanctis}, Rita and Roberta Sanfilippo and {Dei Tos}, {Angelo Paolo} and Silvia Stacchiotti and Laura Giorello and Marco Fiore and Paolo Bruzzi and Casali, {Paolo Giovanni}",
year = "2014",
month = "3",
doi = "10.1016/j.ejca.2013.11.021",
language = "English",
volume = "50",
pages = "784--792",
journal = "European Journal of Cancer",
issn = "0959-8049",
publisher = "Elsevier Ltd",
number = "4",

}

TY - JOUR

T1 - Preoperative chemo-radiation therapy for localised retroperitoneal sarcoma

T2 - A phase I-II study from the Italian Sarcoma Group

AU - Gronchi, Alessandro

AU - De Paoli, Antonino

AU - Dani, Carla

AU - Merlo, Domenico Franco

AU - Quagliuolo, Vittorio

AU - Grignani, Giovanni

AU - Bertola, Giulio

AU - Navarria, Piera

AU - Sangalli, Claudia

AU - Buonadonna, Angela

AU - De Sanctis, Rita

AU - Sanfilippo, Roberta

AU - Dei Tos, Angelo Paolo

AU - Stacchiotti, Silvia

AU - Giorello, Laura

AU - Fiore, Marco

AU - Bruzzi, Paolo

AU - Casali, Paolo Giovanni

PY - 2014/3

Y1 - 2014/3

N2 - Background To study feasibility, safety and activity of the combination of high-dose long-infusion ifosfamide (HLI) and radiotherapy (RT) as preoperative treatment for resectable localised retroperitoneal sarcoma (RPS). Methods Patients received three cycles of HLI (14 g/m2). RT was started in combination with second cycle and administered up to a total dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the end of RT. Primary end-point was 3-year relapse free survival (RFS). The trial is registered with ITASARC-â̂ - II-2004-003. Findings Between December 2003 and 2010, 83 patients were recruited. Main histological subtypes were well differentiated liposarcoma (19/83, 23%), dedifferentiated liposarcoma (26/83, 31%), leiomyosarcoma (14/83, 17%). Median tumour size was 120 mm (interquartile (IQ) range = 82-160). The overall preoperative treatment was completed in 60 patients. Chemotherapy (CT) was completed in 65, while RT in 73. Four patients progressed before surgery and were not operated. 79 patients underwent surgery. At a median follow-up of 4.8 years (IQ range = 3-6.1), 23 and 15 patients developed local recurrence (LR) and distant metastases (DM); 30 patients died of disease. 3 and 5-year RFS and overall survival were 0.56 (90% confidence interval (CI): 0.45, 0.65) and 0.44 (90% CI: 0.27, 0.48), and 0.74 (90% CI: 0.62, 0.81) and 0.59 (90% CI: 0.33, 0.58). Crude cumulative incidence of LR and DM at 5 years were 0.37 (standard error (SE): 0.06) and 0.26 (SE: 0.06). Interpretation The combination of preoperative HLI and RT was feasible in two thirds of patients, while preoperative RT could be completed in most (73/83). Although a systemic coverage can be added to RT when this is felt to be appropriate, the ongoing international phase III trial is exploring the role of RT alone. Funding This is a pure academic trial. No funding sources contributed to it.

AB - Background To study feasibility, safety and activity of the combination of high-dose long-infusion ifosfamide (HLI) and radiotherapy (RT) as preoperative treatment for resectable localised retroperitoneal sarcoma (RPS). Methods Patients received three cycles of HLI (14 g/m2). RT was started in combination with second cycle and administered up to a total dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the end of RT. Primary end-point was 3-year relapse free survival (RFS). The trial is registered with ITASARC-â̂ - II-2004-003. Findings Between December 2003 and 2010, 83 patients were recruited. Main histological subtypes were well differentiated liposarcoma (19/83, 23%), dedifferentiated liposarcoma (26/83, 31%), leiomyosarcoma (14/83, 17%). Median tumour size was 120 mm (interquartile (IQ) range = 82-160). The overall preoperative treatment was completed in 60 patients. Chemotherapy (CT) was completed in 65, while RT in 73. Four patients progressed before surgery and were not operated. 79 patients underwent surgery. At a median follow-up of 4.8 years (IQ range = 3-6.1), 23 and 15 patients developed local recurrence (LR) and distant metastases (DM); 30 patients died of disease. 3 and 5-year RFS and overall survival were 0.56 (90% confidence interval (CI): 0.45, 0.65) and 0.44 (90% CI: 0.27, 0.48), and 0.74 (90% CI: 0.62, 0.81) and 0.59 (90% CI: 0.33, 0.58). Crude cumulative incidence of LR and DM at 5 years were 0.37 (standard error (SE): 0.06) and 0.26 (SE: 0.06). Interpretation The combination of preoperative HLI and RT was feasible in two thirds of patients, while preoperative RT could be completed in most (73/83). Although a systemic coverage can be added to RT when this is felt to be appropriate, the ongoing international phase III trial is exploring the role of RT alone. Funding This is a pure academic trial. No funding sources contributed to it.

KW - Chemotherapy

KW - Radiation therapy

KW - Retroperitoneal sarcoma

KW - Soft tissue sarcoma

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U2 - 10.1016/j.ejca.2013.11.021

DO - 10.1016/j.ejca.2013.11.021

M3 - Article

C2 - 24316063

AN - SCOPUS:84894048263

VL - 50

SP - 784

EP - 792

JO - European Journal of Cancer

JF - European Journal of Cancer

SN - 0959-8049

IS - 4

ER -