PURPOSE: To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Twenty-two non-randomised patients with unresectable, locally advanced (n = 9) or metastatic pancreatic cancer (n = 13) received oral masitinib (9 mg/kg/day) combined with standard gemcitabine. All patients were naive to systemic chemotherapy or radiotherapy. The primary endpoint was time-to-progression (TTP) with efficacy and safety analyses performed on the intent-to-treat population. Secondary endpoints included overall survival (OS), as well as, subgroup analyses according to baseline disease, and performance status. RESULTS: Overall median TTP was 6.4 months (95% CI [2.7-11.7]); 8.3 and 2.7 months, respectively, for locally advanced and metastatic patients; 6.4 and 0.8 months, respectively, for patients with KPS [80-100] or KPS [70]. Median OS was 7.1 months (95% CI [4.8-17.0]); 8.4 and 6.8 months for locally advanced or metastatic patients, respectively; 8.0 and 4.4 months in patients with KPS [80-100] or KPS [70], respectively. The 18-month observed survival rate was similar for locally advanced (22%) and metastatic patients (23%) and reached 28% for KPS [80-100] patients. The most common suspected adverse events were nausea, vomiting, rash, diarrhoea, peripheral oedema, anaemia, lymphopenia, thrombocytopenia, pyrexia, neutropenia, asthenia, leucopenia, and abdominal pain, and most were of grades 1-2 severity. CONCLUSIONS: The efficacy and safety of masitinib combined with gemcitabine are encouraging, with extended survival and median TTP that support initiation of a phase 3 trial.
PURPOSE: To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer. PATIENTS AND METHODS: Twenty-two non-randomised patients with unresectable, locally advanced (n = 9) or metastatic pancreatic cancer (n = 13) received oral masitinib (9 mg/kg/day) combined with standard gemcitabine. All patients were naive to systemic chemotherapy or radiotherapy. The primary endpoint was time-to-progression (TTP) with efficacy and safety analyses performed on the intent-to-treat population. Secondary endpoints included overall survival (OS), as well as, subgroup analyses according to baseline disease, and performance status. RESULTS: Overall median TTP was 6.4 months (95% CI [2.7-11.7]); 8.3 and 2.7 months, respectively, for locally advanced and metastatic patients; 6.4 and 0.8 months, respectively, for patients with KPS [80-100] or KPS [70]. Median OS was 7.1 months (95% CI [4.8-17.0]); 8.4 and 6.8 months for locally advanced or metastatic patients, respectively; 8.0 and 4.4 months in patients with KPS [80-100] or KPS [70], respectively. The 18-month observed survival rate was similar for locally advanced (22%) and metastatic patients (23%) and reached 28% for KPS [80-100] patients. The most common suspected adverse events were nausea, vomiting, rash, diarrhoea, peripheral oedema, anaemia, lymphopenia, thrombocytopenia, pyrexia, neutropenia, asthenia, leucopenia, and abdominal pain, and most were of grades 1-2 severity. CONCLUSIONS: The efficacy and safety of masitinib combined with gemcitabine are encouraging, with extended survival and median TTP that support initiation of a phase 3 trial.
Authors: Willemieke S Tummers; Sarah E Miller; Nutte T Teraphongphom; Adam Gomez; Idan Steinberg; David M Huland; Steve Hong; Sri-Rajasekhar Kothapalli; Alifia Hasan; Robert Ertsey; Bert A Bonsing; Alexander L Vahrmeijer; Rutger-Jan Swijnenburg; Teri A Longacre; George A Fisher; Sanjiv S Gambhir; George A Poultsides; Eben L Rosenthal Journal: Ann Surg Oncol Date: 2018-04-17 Impact factor: 5.344
Authors: Robert Klopfleisch; Anja Meyer; Patricia Schlieben; Angelika Bondzio; Chris Weise; Dido Lenze; Michael Hummel; Ralf Einspanier; Achim D Gruber Journal: BMC Vet Res Date: 2012-06-29 Impact factor: 2.741
Authors: G Deplanque; M Demarchi; M Hebbar; P Flynn; B Melichar; J Atkins; E Nowara; L Moyé; D Piquemal; D Ritter; P Dubreuil; C D Mansfield; Y Acin; A Moussy; O Hermine; P Hammel Journal: Ann Oncol Date: 2015-04-09 Impact factor: 32.976
Authors: Aaron T Wild; Xiaobu Ye; Susannah G Ellsworth; Jessica A Smith; Amol K Narang; Tanu Garg; Jian Campian; Daniel A Laheru; Lei Zheng; Christopher L Wolfgang; Phuoc T Tran; Stuart A Grossman; Joseph M Herman Journal: Am J Clin Oncol Date: 2015-06 Impact factor: 2.339