Clinical Trial, Phase II Multicenter Study Journal Article Research Support, Non-U.S. Gov't Ppublish 2 citations
PubMed: 37437608 DOI: 10.1016/j.radonc.2023.109791
High dose (54 Gy) pre-operative helical tomotherapy for retroperitoneal liposarcoma: Results of a phase II multicenter study.
Radiother Oncol 186:109791
Authors: Paul Sargos, Eberhard Stoeckle, Anne Ducassou, Antoine Giraud, Augustin Mervoyer, Antoine Italiano, Sabrina Albert, Gwenael Ferron, Carine Bellera, Guy Kantor
Affiliations
- Department of Radiotherapy, Institut Bergonie, 229 cours de l'Argonne, 33076 Bordeaux, France.
- Department of Surgery, Institut Bergonie, 229 cours de l'Argonne, 33076 Bordeaux, France.
- Department of Radiotherapy, Institut Claudius Regaud- Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.
- Clinical and Epidemiological Research Unit, INSERM CIC1401, Institut Bergonié, Comprehensive Cancer Center, F-33000 Bordeaux, France.
- Department of Radiotherapy, Institut de Cancerologie de l'Ouest, Nantes, France.
- Department of Medical Oncology, Institut Bergonie, 229 cours de l'Argonne, 33076 Bordeaux, France.
- Department of Surgical Oncology, INSERM CRCT19 (Oncogenesis of Sarcoma), Institut Claudius Regaud- Institut Universitaire du Cancer de Toulouse-Oncopole, Toulouse, France.
- Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, Epicene team, UMR 1219, F-33000 Bordeaux, France; Inserm CIC1401, Clinical and Epidemiological Research Unit, Institut Bergonié, Comprehensive Cancer Center, F-33000 Bordeaux, France.
- Department of Radiotherapy, Institut Bergonie, 229 cours de l'Argonne, 33076 Bordeaux, France.
Abstract
PURPOSE
To evaluate efficacy and feasibility of high-dose intensity-modulated radiotherapy (RT) with pre-operative helical tomotherapy, delivering 54 Gy/30 fractions in patients with retroperitoneal liposarcomas (RPLS).
MATERIALS AND METHODS
Patients with operable, biopsy-proven, RPLS were included in this phase II multicenter study (ClinicalTrials.gov: NCT01841047). The primary objectives were to analyze loco-regional relapse free survival (LRFS), overall survival (OS) and toxicities, graded according to CTCAE V3.0.
RESULTS
From April 2009 to September 2013, 48 patients were included. Histological types were: 20 well differentiated and 28 dedifferentiated liposarcomas. Median clinical target volume (CTV) was 2570 cc (range, 230-8734 cc). The radio-surgical schedule was completed as planned in all patients apart from one. A monobloc wide excision was achieved for all patients. Surgical margins were R0 (16; 34%), R1 (28; 60%), R2 (2; 4%) or missing (1, 2%).With a median follow-up of 5.5 years, 3-year LRFS rate was 74.2% (95%CI: [59.1%; 84.5%]). At 5 years, cumulative incidence of loco-regional relapse for well differentiated and dedifferentiated RPLS was 10% and 18%, respectively. The 5-year OS was 73.9% [95%CI: 58.7-84.3%]. During RT, the most common grade 3-4 adverse events were hematological (N = 20; 41.6%). After surgery and during follow-up, 17 patients (35.4%) presented a grade 3-4 toxicity. Two patients (4.1%) died due to a duodenal toxicity. Nine second cancers were observed.
CONCLUSION
From this phase II trial of preoperative RT in RPLS patients, the dose level proposed cannot be considered safe, leading to non-negligible toxicity and second cancers rates. Our results, combined with STRASS-1 study, suggest that the ideal indication of RT for patients with RPLS still remains to be determined.
MeSH
Radiotherapy, Liposarcoma, Neoplasms, Neoplasms, Second Primary, Medical Oncology, Chemotherapy