Switch maintenance gemcitabine after first-line chemotherapy in patients with malignant mesothelioma: A multicenter open label phase II trial (NVALT19)
| Autor: | J H E M Schijen, Ferry Lalezari, Elisa Giovannetti, F.A. Hogenboom, C.J. de Gooijer, M.C.W. Mahn Schaefers, D. de Wit, Robin Cornelissen, A.J. Staal-van den Brekel, M. Youssef-El Soud, Robbert C. van Heemst, Joachim G.J.V. Aerts, J.F. de Vries, Bonne Biesma, Paul Baas, Gerben Bootsma, Sjaak Burgers, Harry J.M. Groen, Jos A. Stigt, V. van de Noort |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Oncology medicine.medical_specialty education.field_of_study business.industry Population Phases of clinical research Hematology Chemotherapy regimen Gemcitabine 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Pemetrexed Response Evaluation Criteria in Solid Tumors 030220 oncology & carcinogenesis Internal medicine medicine Clinical endpoint Progression-free survival business education medicine.drug |
| Zdroj: | Annals of Oncology, 30. Oxford University Press |
| ISSN: | 0923-7534 |
| Popis: | Background All malignant mesothelioma (MM) patients progress after first-line therapy. We examined whether switch maintenance gemcitabine in patients, who did not show progression after first-line platinum-pemetrexed, could prolong time to disease progression. Methods NVALT19 was an open label, randomized phase II trial, conducted in The Netherlands. Main eligibility criteria were pathologically proven MM, ECOG-PS 0-2 and completion of 4-6 cycles of first-line platinum-pemetrexed without progression. Patients were randomized 1:1 between gemcitabine (1250 mg/m2 day 1 and 8 of 3 weekly schedule) or best supportive care (BSC). Gemcitabine was given until disease progression, severe toxicity or patient request for discontinuation. Primary endpoint was progression free survival (PFS) determined by local physician according to modified RECIST (mRECIST) or death in the intention-to-treat population. It was computed that 118 events would yield 90% power to detect an increase in PFS from median 3.5 months to median 6 months at 90% confidence level. Results Between March 2014 and February 2019, 130 patients were randomized, 65 in each arm. PFS was significantly longer with gemcitabine (median 6.2 months [range 4.6-8.7m]) than in the BSC arm (3.2 [2.8-4.2m]; hazard ratio 0.42; 95% confidence interval [CI], 0.28-0.63; p Conclusions Switch maintenance gemcitabine after first-line chemotherapy significantly improves the PFS in malignant mesothelioma, with a manageable toxicity profile. Clinical trial identification NTR4132. Legal entity responsible for the study Stichting NVALT studies. Funding Dutch Cancer Society and Stichting NVALT studies. Disclosure All authors have declared no conflicts of interest. |
| Databáze: | OpenAIRE |
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