Clinical Trial Report

Cancer Chemotherapy and Pharmacology

, Volume 66, Issue 2, pp 395-403

Safety and activity of masitinib in combination with gemcitabine in patients with advanced pancreatic cancer

  • Emmanuel MitryAffiliated withHépato-gastroentérologie et oncologie digestive, Assistance Publique des Hôpitaux de Paris, Hôpital Ambroise ParéEA4340, Université Versailles Saint Quentin
  • , Pascal HammelAffiliated withService de gastroentérologie, Fédération médico-chirurgicale d’hépato-gastroentérologie, Hôpital Beaujon
  • , Gaël DeplanqueAffiliated withService d’Oncologie, Groupe Hospitalier Paris Saint Joseph
  • , Françoise MornexAffiliated withService de radiothérapie, Hôpital Lyon Sud
  • , Philippe LevyAffiliated withService de gastroentérologie, Fédération médico-chirurgicale d’hépato-gastroentérologie, Hôpital Beaujon
  • , Jean-François SeitzAffiliated withService d’hépato-gastroentérologie et oncologie digestive, Hôpital de la Timone
  • , Alain MoussyAffiliated withAB Science SA
  • , Jean-Pierre KinetAffiliated withDepartment of Pathology, Beth Israel Deaconess Medical center and Harvard Medical School
  • , Olivier HermineAffiliated withHépato-gastroentérologie et oncologie digestive, Assistance Publique des Hôpitaux de Paris, Hôpital Ambroise ParéService d’Hématologie and CNRS UMR 8147, Hôpital Necker, Assistance Publique des Hôpitaux de Paris, Université Paris Descartes
    • , Philippe RougierAffiliated withHépato-gastroentérologie et oncologie digestive, Assistance Publique des Hôpitaux de Paris, Hôpital Ambroise ParéEA4340, Université Versailles Saint Quentin
    • , Eric RaymondAffiliated withService de cancérologie, Hôpital Beaujon Email author 

Rent the article at a discount

Rent now

* Final gross prices may vary according to local VAT.

Get Access

Abstract

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 naıve 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, leucopoenia, 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.

Keywords

Advanced pancreatic cancer Masitinib Gemcitabine c-kit FGFR PDGFR