Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial
| العنوان: | Efficacy and safety of regorafenib for advanced gastrointestinal stromal tumours after failure of imatinib and sunitinib (GRID): an international, multicentre, randomised, placebo-controlled, phase 3 trial |
|---|---|
| المؤلفون: | Demetri, G.D., Reichardt, P., Kang, Y.K., Blay, J.Y., Rutkowski, P., Gelderblom, H., Hohenberger, P., Leahy, M., Mehren, M. von, Joensuu, H., Badalamenti, G., Blackstein, M., Cesne, A. le, Schoffski, P., Maki, R.G., Bauer, S., Nguyen, B.B., Xu, J., Nishida, T., Chung, J., Kappeler, C., Kuss, I., Laurent, D., Casali, P.G., Graaf, W.T.A. van der |
| المساهمون: | Demetri, GD, Reichardt, P, Kang, YK, Blay, JY, Rutkowski, P, Gelderblom, H, Hohenberger, P, Leahy, M, von Mehren, M, Joensuu, H, Badalamenti, G, Blackstein, M, Le Cesne, A, Schöffski, P, Maki, RG, Bauer, S, Nguyen, BB, Xu, J, Nishida, T, Chung, J, Kappeler, C, Kuss, I, Laurent, D, Casali, PG, Demetri, Gd, Kang, Yk, Blay, Jy, Maki, Rg, Nguyen, Bb, Casali, Pg, Biasco, G, study investigators, Grid |
| المصدر: | The Lancet (London), 381, 9863, pp. 295-302 Lancet, 381(9863), 295-302 The Lancet (London), 381, 295-302 |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | Oncology, Male, Indoles, Pyridines, Settore MED/06 - Oncologia Medica, SU11248, Medizin, Piperazines, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Clinical endpoint, Sunitinib, Treatment Failure, regorafenib, gastrointestinal stromal tumours, imatinib and sunitinib, Gastrointestinal Neoplasms, education.field_of_study, GiST, KIT, Age-related aspects of cancer Quality of hospital and integrated care [ONCOL 2], General Medicine, Middle Aged, Survival Rate, Benzamides, Imatinib Mesylate, Female, ADJUVANT IMATINIB, TYROSINE KINASE INHIBITOR, Colorectal Neoplasms, Life Sciences & Biomedicine, medicine.drug, GROWTH-FACTOR, medicine.medical_specialty, Gastrointestinal Stromal Tumors, Population, MESYLATE, Antineoplastic Agents, IMATINIB, Article, MECHANISMS, Medicine, General & Internal, Double-Blind Method, Translational research [ONCOL 3], General & Internal Medicine, Regorafenib, Internal medicine, MANAGEMENT, medicine, Humans, Pyrroles, education, Protein Kinase Inhibitors, Aged, Science & Technology, GASTROINTESTINAL STROMAL TUMOURS, MUTATIONS, business.industry, Phenylurea Compounds, GIST, regorafenib, imatinib, sunitinib, phase III trial, Surgery, Clinical trial, Imatinib mesylate, Pyrimidines, chemistry, business, RESISTANCE |
| الوصف: | Contains fulltext : 118365.pdf (Publisher’s version ) (Closed access) BACKGROUND: Until now, only imatinib and sunitinib have proven clinical benefit in patients with gastrointestinal stromal tumours (GIST), but almost all metastatic GIST eventually develop resistance to these agents, resulting in fatal disease progression. We aimed to assess efficacy and safety of regorafenib in patients with metastatic or unresectable GIST progressing after failure of at least imatinib and sunitinib. METHODS: We did this phase 3 trial at 57 hospitals in 17 countries. Patients with histologically confirmed, metastatic or unresectable GIST, with failure of at least previous imatinib and sunitinib were randomised in a 2:1 ratio (by computer-generated randomisation list and interactive voice response system; preallocated block design (block size 12); stratified by treatment line and geographical region) to receive either oral regorafenib 160 mg daily or placebo, plus best supportive care in both groups, for the first 3 weeks of each 4 week cycle. The study sponsor, participants, and investigators were masked to treatment assignment. The primary endpoint was progression-free survival (PFS). At disease progression, patients assigned placebo could crossover to open-label regorafenib. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01271712. RESULTS: From Jan 4, to Aug 18, 2011, 240 patients were screened and 199 were randomised to receive regorafenib (n=133) or matching placebo (n=66). Data cutoff was Jan 26, 2012. Median PFS per independent blinded central review was 4.8 months (IQR 1.4-9.2) for regorafenib and 0.9 months (0.9-1.8) for placebo (hazard ratio [HR] 0.27, 95% CI 0.19-0.39; p |
| وصف الملف: | STAMPA; application/pdf; Print-Electronic |
| اللغة: | English |
| تدمد: | 0140-6736 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4681c22856abd188b199ad13193af123Test https://hdl.handle.net/1887/100965Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....4681c22856abd188b199ad13193af123 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 01406736 |
|---|