13-cis-retinoic acid in combination with gemcitabine in the treatment of locally advanced and metastatic pancreatic cancer -: Report of a pilot phase II study

被引:29
|
作者
Michael, A.
Hill, M.
Maraveyas, A.
Dalgleish, A.
Lofts, F.
机构
[1] Gen Hosp St Georg, Dept Oncol, London SW17 0QT, England
[2] Maidstone Gen Hosp, Maidstone ME16 9QQ, Kent, England
[3] Princess Royal Hosp, Kingston Upon Hull HU8 9HE, N Humberside, England
关键词
13-cis-retinoic acid; gemcitabine; pancreatic cancer;
D O I
10.1016/j.clon.2006.11.008
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Aims: Adenocarcinoma of the pancreas is a cancer with extremely poor prognosis and limited therapeutic options. Retinoids are derivatives of vitamin A involved in the control of many biological functions, including cell growth and differentiation and the induction of apoptosis. On the basis of pre-clinical evidence and some clinical data, we conducted a phase II study of 13-cis-retinoic acid (13-cis-RA) in combination with gemcitabine in patients with unresectable pancreatic carcinoma. Materials and methods: Patients with histologically confirmed unresectable pancreatic carcinoma were treated with gemcitabine 1000 mg/m(2) on days 8, 15, 22 plus 13-cis-RA 1 mg/kg on days 1-14 for six cycles. The end points included the objective response rate and median survival. Results: Thirty patients were recruited, 15 men and 15 women; 20 patients were evaluable. The median age was 65 years (range 44-79 years) and the median Karnofsky performance status was 80% (range 60-100%). The median follow-up was 21 months. One patient achieved a partial remission, seven patients had stable disease and 12 patients developed progressive disease. Toxicity was mainly haematological, with eight cases of grade 3 and four cases of grade 4 neutropenia, thrombocytopenia and anaemia. The median survival was 7.8 months (range 2.6-21.6 months). Conclusions: The combination of gemcitabine and 13-cis-RA was well tolerated, but we did not see improvement in the response rate. Further studies with other retinoids may be beneficial to patients with unresectable pancreatic cancer.
引用
收藏
页码:150 / 153
页数:4
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