Hépato-gastroentérologie et oncologie digestive, Assistance Publique des Hôpitaux de Paris, Hôpital Ambroise Paré, 92104, Boulogne Billancourt, France.
Cancer Chemother Pharmacol. 2010 Jul;66(2):395-403. doi: 10.1007/s00280-010-1299-8. Epub 2010 Apr 4.
To evaluate the efficacy and safety of masitinib combined with gemcitabine in patients with advanced pancreatic cancer.
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.
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.
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.
评估马替尼联合吉西他滨治疗晚期胰腺癌的疗效和安全性。
22 名不可切除的局部晚期（n=9）或转移性胰腺癌（n=13）患者接受了口服马替尼（9mg/kg/天）联合标准吉西他滨治疗。所有患者均未接受过系统化疗或放疗。主要终点是无进展生存期（TTP），采用意向治疗人群进行疗效和安全性分析。次要终点包括总生存期（OS），以及根据基线疾病和表现状态进行的亚组分析。
总体中位 TTP 为 6.4 个月（95%CI[2.7-11.7]）；局部晚期和转移性患者分别为 8.3 和 2.7 个月；KPS[80-100]或 KPS[70]患者分别为 6.4 和 0.8 个月。中位 OS 为 7.1 个月（95%CI[4.8-17.0]）；局部晚期或转移性患者分别为 8.4 和 6.8 个月；KPS[80-100]或 KPS[70]患者分别为 8.0 和 4.4 个月。局部晚期（22%）和转移性患者（23%）的 18 个月观察生存率相似，KPS[80-100]患者为 28%。最常见的疑似不良反应有恶心、呕吐、皮疹、腹泻、外周水肿、贫血、淋巴细胞减少、血小板减少、发热、中性粒细胞减少、乏力、白细胞减少和腹痛，大多数为 1-2 级严重程度。
马替尼联合吉西他滨的疗效和安全性令人鼓舞，延长了生存时间和中位 TTP，支持开展 3 期临床试验。
