Comparison of performance of various tumour response criteria in assessment of regorafenib activity in advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib |
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| Institution: | 1. Department of Internal Medicine, Martini Hospital, Groningen, The Netherlands;2. Department of Research, Comprehensive Cancer Centre the Netherlands, Utrecht, The Netherlands;3. Department of Internal Medicine, Isala Klinieken Zwolle, Zwolle, The Netherlands;4. MIRA Institute, Health Technology and Services Research, University of Twente, Enschede, The Netherlands;5. Department of Medical Oncology, University Medical Center Groningen and University of Groningen, Groningen, The Netherlands;6. Department of Pathology, Isala Klinieken Zwolle, Zwolle, The Netherlands;1. Oncology Centre, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK;2. Department of Oncology, Colchester Hospital University NHS Foundation Trust, Essex, UK;3. Cambridge Cancer Trials Centre, Cambridge Clinical Trials Unit – Cancer Theme, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK;4. School of Clinical Medicine, University of Cambridge, Cambridge, UK;5. Cancer Research UK Centre for Genetic Epidemiology and Department of Oncology, University of Cambridge, Strangeways Research Laboratory, Cambridge, UK;1. Department of Population Health, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia;2. School of Medicine, University of Queensland, Brisbane, Queensland, Australia;3. School of Population Health, University of Queensland, Brisbane, Australia;4. Western Australian Institute for Medical Research, University of Western Australia, Nedlands, Western Australia, Australia;1. Division of Pediatric Endocrinology, Department of Pediatrics, University of Torino, Torino, Italy;2. Department of Pediatrics, University Federico II of Naples, Naples, Italy;3. Division of Pediatrics, Department of Medical Sciences, University of Piemonte Orientale, Novara, Italy;4. Department of Pediatrics, University of Messina, Messina, Italy;5. Department of Pediatrics, 1st Faculty, La Sapienza University, Rome, Italy;6. Department of Pediatrics, University of Bologna, Bologna, Italy;7. Department of Pediatrics, University of Milan, Milan, Italy;8. Department of Pediatrics, University of Genoa, Genoa, Italy;9. Department of Pediatrics, University of Modena and Reggio Emilia, Modena and Reggio Emilia, Italy;1. Division of Cardiology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania;2. Department of Radiology, The Children’s Hospital of Philadelphia, Philadelphia, Pennsylvania;3. Department of Pediatrics, The Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;4. Center for Clinical Epidemiology and Biostatistics, The Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania;1. Radiotherapy Department, Royal Marsden NHS Foundation Trust, Sutton/London, United Kingdom;2. Colorectal Research Fellow, Department of Colorectal Surgery, Croydon University Hospital, Croydon CR7 7YE, United Kingdom;3. Radiology Department, Royal Marsden NHS Foundation Trust, London, United Kingdom |
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| Abstract: | PurposeTo compare performance of various tumour response criteria (TRCs) in assessment of regorafenib activity in patients with advanced gastrointestinal stromal tumour (GIST) with prior failure of imatinib and sunitinib.MethodsTwenty participants in a phase II trial received oral regorafenib (median duration 47 weeks; interquartile range (IQR) 24–88) with computed tomography (CT) imaging at baseline and every two months thereafter. Tumour response was prospectively determined on using Response Evaluation Criteria in Solid Tumours (RECIST) 1.1, and retrospectively reassessed for comparison per RECIST 1.0, World Health Organization (WHO) and Choi criteria, using the same target lesions. Clinical benefit rate CBR; complete or partial response (CR or PR) or stable disease (SD) ? 16 weeks] and progression-free survival (PFS) were compared between various TRCs using kappa statistics. Performance of TRCs in predicting overall survival (OS) was compared by comparing OS in groups with progression-free intervals less than or greater than 20 weeks by each TRC using c-statistics.ResultsPR was more frequent by Choi (90%) than RECIST 1.1, RECIST 1.0 and WHO (20% each), however, CBR was similar between various TRCs (overall CBR 85–90%, 95–100% agreement between all TRC pairs). PFS per RECIST 1.0 was similar to RECIST 1.1 (median 44 weeks versus 58 weeks), and shorter for WHO (median 34 weeks) and Choi (median 24 weeks). With RECIST 1.1, RECIST 1.0 and WHO, there was moderate concordance between PFS and OS (c-statistics 0.596–0.679). Choi criteria had less favourable concordance (c-statistic 0.506).ConclusionsRECIST 1.1 and WHO performed somewhat better than Choi criteria as TRC for response evaluation in patients with advanced GIST after prior failure on imatinib and sunitinib. |
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| Keywords: | Gastrointestinal stromal tumour Regorafenib Tumour response criteria RECIST Choi |
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