Phase II study of dovitinib in patients with metastatic and/or unresectable gastrointestinal stromal tumours after failure of imatinib and sunitinib
| العنوان: | Phase II study of dovitinib in patients with metastatic and/or unresectable gastrointestinal stromal tumours after failure of imatinib and sunitinib |
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| المؤلفون: | J-S Ryu, Changhoon Yoo, Eugene Tan, J.H. Park, Y J Choi, J J Lee, Y-K. Kang, B-Y. Ryoo, M-H. Ryu, J Jo, Inkeun Park |
| المصدر: | British Journal of Cancer |
| بيانات النشر: | Nature Publishing Group, 2013. |
| سنة النشر: | 2013 |
| مصطلحات موضوعية: | Adult, Male, Cancer Research, medicine.medical_specialty, Pathology, Indoles, Gastrointestinal Stromal Tumors, sunitinib, Phases of clinical research, Administration, Oral, Antineoplastic Agents, Neutropenia, Quinolones, Gastroenterology, gastrointestinal stromal tumour, Disease-Free Survival, Piperazines, Internal medicine, medicine, Clinical endpoint, Humans, Pyrroles, Prospective Studies, Prospective cohort study, Adverse effect, Protein Kinase Inhibitors, Aged, Sunitinib, business.industry, Cancer, Middle Aged, medicine.disease, Pyrimidines, Oncology, imatinib, Drug Resistance, Neoplasm, Benzamides, Clinical Study, Disease Progression, Imatinib Mesylate, Benzimidazoles, Female, dovitinib, business, Progressive disease, medicine.drug |
| الوصف: | Background: This prospective, phase II trial evaluated the efficacy and safety of dovitinib in patients with metastatic and/or unresectable gastrointestinal stromal tumours (GISTs) after failure of at least imatinib and sunitinib. Methods: Patients received oral dovitinib, 500 mg once daily, for 5 consecutive days, followed by a 2-day rest, every 28 days. The primary endpoint was disease control rate (DCR; objective response+stable disease (SD)) at 24 weeks, assessed by computed tomography (CT) scan according to RECIST v1.0. Metabolic response was evaluated by positron emission tomography (PET)–CT scans performed at baseline and after 4 weeks of treatment. Results: Between September 2011 and April 2012, 30 patients were enroled. DCR at 24 weeks by RECIST v1.0 was 13% and one patient (3%) had a partial response. Based on the European Organization for Research and Treatment of Cancer PET response criteria, four patients (13%) had a metabolic partial response after 4 weeks of treatment. At a median follow-up of 8.3 months (range, 6.3–12.2 months), median progression-free survival (PFS) was 3.6 months (95% confidence interval (CI), 3.5–3.7 months) and median overall survival was 9.7 months (95% CI, 6.0–13.4 months). Metabolic progressive disease at Week 4 was significantly associated with shorter PFS (P=0.03). Grade 3/4 adverse events included asthenia (20%), neutropenia (13%), thrombocytopenia (10%), and hypertriglyceridaemia (10%). Most toxicities were manageable by dose modification. Conclusion: Dovitinib showed modest antitumour activity with manageable toxicities in heavily pretreated patients with advanced GISTs. |
| اللغة: | English |
| تدمد: | 1532-1827 0007-0920 |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ebd59c2bf5f7671d204bbfd11a8542d7 http://europepmc.org/articles/PMC3817332 |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....ebd59c2bf5f7671d204bbfd11a8542d7 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15321827 00070920 |
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