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Cancer Chemother Pharmacol. 2010 Jul;66(2):395-403. doi: 10.1007/s00280-010-1299-8. Epub 2010 Apr 4.

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

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  • 1Hépato-gastroentérologie et oncologie digestive, Assistance Publique des Hôpitaux de Paris, Hôpital Ambroise Paré, 92104, Boulogne Billancourt, France.

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 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.

PMID:
20364428
[PubMed - indexed for MEDLINE]
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