Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03)
Identifieur interne : 001276 ( Main/Exploration ); précédent : 001275; suivant : 001277Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03)
Auteurs : Jens Jakob [Allemagne] ; Anna Simeonova [Allemagne] ; Bernd Kasper [Allemagne] ; Ulrich Ronellenfitsch [Allemagne] ; Geraldine Rauch [Allemagne] ; Frederik Wenz [Allemagne] ; Peter Hohenberger [Allemagne]Source :
- Radiation Oncology (London, England) [ 1748-717X ] ; 2016.
Abstract
Experimental data demonstrated that concurrent anti-angiogenic treatment with sunitinib may improve the efficacy of radiation therapy (RT). Here we report the results of a phase I trial performed within the German Interdisciplinary Sarcoma Group (GISG-03) of combined sunitinib and RT for neoadjuvant treatment of locally advanced soft tissue sarcoma (STS).
The primary endpoint of the study was to explore the recommended dose of sunitinib combined with RT for subsequent trials. Treatment response, postoperative complications after tumor resection and toxicity according to CTCAE 4.0 were secondary endpoints. The study used a 3 + 3 design. Patients received either 25 mg (dose level 1) or 37.5 mg (dose level 2) sunitinib two weeks prior to and throughout RT (28 × 1.8 Gy). Surgery was scheduled 5–8 weeks after completion of neoadjuvant treatment. Study registration: NCT01498835.
Six patients were enrolled in dose level 1 and three patients in dose level 2. Median tumor size was 11 cm. Tumors were located in the retroperitoneum (4/9), lower leg (3/9) or trunk (2/9). At dose level 1, 1/6 patients developed dose limiting lymphopenia. At dose level 2, no patient developed dose limiting toxicity. Most frequent toxicities were hematological (8/9) and oral (5/9). Dose adjustments of sunitinib were necessary in 5/9 patients. All patients received full dose RT and underwent tumor resection (8/9 R0 and 1/9 R1). Local toxicity of RT did not exceed Grade 2. 2/9 patients had postoperative complications requiring re-intervention. Treatment response according to RECIST was as follows: partial response 1/9, stable disease 7/9, and progressive disease 1/9. Pathological examination revealed ≥ 95 % tumor necrosis in 3/9 resected specimens.
Combined sunitinib and RT was tolerable as neoadjuvant treatment for locally advanced STS patients regardless of tumor localization. The recommended sunitinib dose for subsequent trials is 37.5 mg.
Url:
DOI: 10.1186/s13014-016-0654-2
PubMed: 27255678
PubMed Central: 4891890
Affiliations:
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type="wicri:Area/Main/Exploration">001276</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Combined sunitinib and radiation therapy for preoperative treatment of soft tissue sarcoma: results of a phase I trial of the German interdisciplinary sarcoma group (GISG-03)</title><author><name sortKey="Jakob, Jens" sort="Jakob, Jens" uniqKey="Jakob J" first="Jens" last="Jakob">Jens Jakob</name><affiliation wicri:level="3"><nlm:aff id="Aff1">Division of Surgical, Oncology and Thoracic Surgery, Department of Surgery, University Medical Center and Medical Faculty Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim, 68137 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Division of Surgical, Oncology and Thoracic Surgery, Department of Surgery, University Medical Center and Medical Faculty Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Simeonova, Anna" sort="Simeonova, Anna" uniqKey="Simeonova A" first="Anna" last="Simeonova">Anna Simeonova</name><affiliation wicri:level="3"><nlm:aff id="Aff2">Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Th.-Kutzer-ufer 1-3, Mannheim, 68137 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University Medical Center Mannheim, University of Heidelberg, Th.-Kutzer-ufer 1-3, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Kasper, Bernd" sort="Kasper, Bernd" uniqKey="Kasper B" first="Bernd" last="Kasper">Bernd Kasper</name><affiliation wicri:level="3"><nlm:aff id="Aff3">Sarcoma Unit, Interdisciplinary Tumor Center Mannheim, Mannheim University Medical Center, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim, 68137 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Sarcoma Unit, Interdisciplinary Tumor Center Mannheim, Mannheim University Medical Center, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Ronellenfitsch, Ulrich" sort="Ronellenfitsch, Ulrich" uniqKey="Ronellenfitsch U" first="Ulrich" last="Ronellenfitsch">Ulrich Ronellenfitsch</name><affiliation wicri:level="3"><nlm:aff id="Aff4">Division of Surgical, Oncology and Thoracic Surgery, Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim, 68137 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Division of Surgical, Oncology and Thoracic Surgery, Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Rauch, Geraldine" sort="Rauch, Geraldine" uniqKey="Rauch G" first="Geraldine" last="Rauch">Geraldine Rauch</name><affiliation wicri:level="3"><nlm:aff id="Aff5">Institute of Medical Biometry and Informatics, University of Heidelberg, ImNeuenheimer Feld 305, Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Institute of Medical Biometry and Informatics, University of Heidelberg, ImNeuenheimer Feld 305, Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Wenz, Frederik" sort="Wenz, Frederik" uniqKey="Wenz F" first="Frederik" last="Wenz">Frederik Wenz</name><affiliation wicri:level="3"><nlm:aff id="Aff6">Department of Radiation Oncology, University Medical Center and Medical Faculty Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim, 68137 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of Radiation Oncology, University Medical Center and Medical Faculty Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author><author><name sortKey="Hohenberger, Peter" sort="Hohenberger, Peter" uniqKey="Hohenberger P" first="Peter" last="Hohenberger">Peter Hohenberger</name><affiliation wicri:level="3"><nlm:aff id="Aff4">Division of Surgical, Oncology and Thoracic Surgery, Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim, 68137 Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Division of Surgical, Oncology and Thoracic Surgery, Department of Surgery, University Medical Center Mannheim, University of Heidelberg, Th.-Kutzer-Ufer 1-3, Mannheim</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Mannheim</settlement></placeName></affiliation></author></analytic><series><title level="j">Radiation Oncology (London, England)</title><idno type="eISSN">1748-717X</idno><imprint><date when="2016">2016</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Experimental data demonstrated that concurrent anti-angiogenic treatment with sunitinib may improve the efficacy of radiation therapy (RT). Here we report the results of a phase I trial performed within the German Interdisciplinary Sarcoma Group (GISG-03) of combined sunitinib and RT for neoadjuvant treatment of locally advanced soft tissue sarcoma (STS).</p></sec><sec><title>Methods</title><p>The primary endpoint of the study was to explore the recommended dose of sunitinib combined with RT for subsequent trials. Treatment response, postoperative complications after tumor resection and toxicity according to CTCAE 4.0 were secondary endpoints. The study used a 3 + 3 design. Patients received either 25 mg (dose level 1) or 37.5 mg (dose level 2) sunitinib two weeks prior to and throughout RT (28 × 1.8 Gy). Surgery was scheduled 5–8 weeks after completion of neoadjuvant treatment. Study registration: NCT01498835.</p></sec><sec><title>Results</title><p>Six patients were enrolled in dose level 1 and three patients in dose level 2. Median tumor size was 11 cm. Tumors were located in the retroperitoneum (4/9), lower leg (3/9) or trunk (2/9). At dose level 1, 1/6 patients developed dose limiting lymphopenia. At dose level 2, no patient developed dose limiting toxicity. Most frequent toxicities were hematological (8/9) and oral (5/9). Dose adjustments of sunitinib were necessary in 5/9 patients. All patients received full dose RT and underwent tumor resection (8/9 R0 and 1/9 R1). Local toxicity of RT did not exceed Grade 2. 2/9 patients had postoperative complications requiring re-intervention. Treatment response according to RECIST was as follows: partial response 1/9, stable disease 7/9, and progressive disease 1/9. Pathological examination revealed ≥ 95 % tumor necrosis in 3/9 resected specimens.</p></sec><sec><title>Conclusions</title><p>Combined sunitinib and RT was tolerable as neoadjuvant treatment for locally advanced STS patients regardless of tumor localization. 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uniqKey="Borys D">D Borys</name></author><author><name sortKey="Martinez, Sr" uniqKey="Martinez S">SR Martinez</name></author><author><name sortKey="Li, Cs" uniqKey="Li C">CS Li</name></author><author><name sortKey="Tamurian, Rm" uniqKey="Tamurian R">RM Tamurian</name></author><author><name sortKey="Bold, Rj" uniqKey="Bold R">RJ Bold</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li></country><region><li>Bade-Wurtemberg</li><li>District de Karlsruhe</li></region><settlement><li>Heidelberg</li><li>Mannheim</li></settlement></list><tree><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Jakob, Jens" sort="Jakob, Jens" uniqKey="Jakob J" first="Jens" last="Jakob">Jens Jakob</name></region><name sortKey="Hohenberger, Peter" sort="Hohenberger, Peter" uniqKey="Hohenberger P" first="Peter" last="Hohenberger">Peter Hohenberger</name><name sortKey="Kasper, Bernd" sort="Kasper, Bernd" uniqKey="Kasper B" first="Bernd" last="Kasper">Bernd Kasper</name><name sortKey="Rauch, Geraldine" sort="Rauch, Geraldine" uniqKey="Rauch G" first="Geraldine" last="Rauch">Geraldine Rauch</name><name sortKey="Ronellenfitsch, Ulrich" sort="Ronellenfitsch, Ulrich" uniqKey="Ronellenfitsch U" first="Ulrich" last="Ronellenfitsch">Ulrich Ronellenfitsch</name><name sortKey="Simeonova, Anna" sort="Simeonova, Anna" uniqKey="Simeonova A" first="Anna" last="Simeonova">Anna Simeonova</name><name sortKey="Wenz, Frederik" sort="Wenz, Frederik" uniqKey="Wenz F" first="Frederik" last="Wenz">Frederik Wenz</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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