Peter Hohenberger1, Sylvie Bonvalot2, Frits van Coevorden3, Pjotr Rutkowski4, Eberhard Stoeckle5, Christine Olungu6, Saskia Litiere6, Eva Wardelmann7, Alessandro Gronchi8, Paolo Casali9. 1. Division of Surgical Oncology & Thoracic Surgery, Mannheim University Medical Center, University of Heidelberg, Germany. Electronic address: peter.hohenberger@umm.de. 2. Department of Surgery, Department of Surgery, Institut Curie, PSL University, Paris, France. 3. Department of Surgical Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands. 4. Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Memorial Center and Institute of Oncology, Roentgen Str 5, 02-781, Warsaw, Poland. 5. Surgery Department, Institut Bergonie, 229 Cours de L'Argonne, 33000 Bordeaux, France. 6. Department of Biostatistics, European Organization for Research and Treatment of Cancer, Brussels, Belgium. 7. Gerhard-Domagk-Institute of Pathology, University of Münster Medical Center, Münster, Germany. 8. Department of Surgery, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy. 9. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.
Abstract
BACKGROUND: EORTC (European Organisation of Research and Treatment of Cancer) 62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated. As surgical treatment aspects (tumour rupture and incomplete resection) contribute to the risk of recurrence, the data of primary surgery were reviewed. METHODS: The surgical record, local pathology report and a surgical questionnaire on details of the operation had to be completed when patients entered the study. Surgeons from 5 countries, covering 8 languages, reviewed the full set of data being available from 793 patients (87.3%). RESULTS: A known GIST was the reason for surgery in only 58% of the cases, and 12% of the patients were treated as an emergency. The R0-resection rate was 87%. The extent of resection was local excision in 17%, segmental resection in 59%, full-organ resection in 11% and multivisceral resection in 11%, with lymphadenectomy performed in 24% of the patients. Shelling out of the tumour was performed in 9.7%, and the proportion of tumours removed in parts was higher in the endoscopy/laparoscopy group. The incidence of tumour rupture (representing M1) was 9%. The consistency between preoperative and intraoperative findings was 82%. The postoperative complication rate was 7.3%. CONCLUSION: The standardisation of surgery in this study was inferior. Given the review data, 18% of the patients should not have participated in the trial. Quality of surgery and improperly reported intraoperative details might influence the trial results. A detailed surgical questionnaire filled out by the surgeon is mandatory before entering the patient in an adjuvant trial in GIST.
RCT Entities:
BACKGROUND: EORTC (European Organisation of Research and Treatment of Cancer) 62024 is a phase III randomised trial evaluating adjuvant imatinib in patients with gastrointestinal stromal tumours (GISTs) and no evidence of residual disease after surgery in 908 patients from 11 countries participated. As surgical treatment aspects (tumour rupture and incomplete resection) contribute to the risk of recurrence, the data of primary surgery were reviewed. METHODS: The surgical record, local pathology report and a surgical questionnaire on details of the operation had to be completed when patients entered the study. Surgeons from 5 countries, covering 8 languages, reviewed the full set of data being available from 793 patients (87.3%). RESULTS: A known GIST was the reason for surgery in only 58% of the cases, and 12% of the patients were treated as an emergency. The R0-resection rate was 87%. The extent of resection was local excision in 17%, segmental resection in 59%, full-organ resection in 11% and multivisceral resection in 11%, with lymphadenectomy performed in 24% of the patients. Shelling out of the tumour was performed in 9.7%, and the proportion of tumours removed in parts was higher in the endoscopy/laparoscopy group. The incidence of tumour rupture (representing M1) was 9%. The consistency between preoperative and intraoperative findings was 82%. The postoperative complication rate was 7.3%. CONCLUSION: The standardisation of surgery in this study was inferior. Given the review data, 18% of the patients should not have participated in the trial. Quality of surgery and improperly reported intraoperative details might influence the trial results. A detailed surgical questionnaire filled out by the surgeon is mandatory before entering the patient in an adjuvant trial in GIST.
Authors: Alessandro Gronchi; Sylvie Bonvalot; Andres Poveda Velasco; Dusan Kotasek; Piotr Rutkowski; Peter Hohenberger; Elena Fumagalli; Ian R Judson; Antoine Italiano; Hans J Gelderblom; Frits van Coevorden; Nicolas Penel; Hans-Georg Kopp; Florence Duffaud; David Goldstein; Javier Martin Broto; Eva Wardelmann; Sandrine Marréaud; Mark Smithers; Axel Le Cesne; Facundo Zaffaroni; Saskia Litière; Jean-Yves Blay; Paolo G Casali Journal: JAMA Surg Date: 2020-06-17 Impact factor: 14.766
Authors: Nikolaos Vassos; Jens Jakob; Georg Kähler; Peter Reichardt; Alexander Marx; Antonia Dimitrakopoulou-Strauss; Nils Rathmann; Eva Wardelmann; Peter Hohenberger Journal: Cancers (Basel) Date: 2021-02-03 Impact factor: 6.639