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丝裂霉素C、顺铂和持续输注5-氟尿嘧啶治疗晚期胰腺癌的II期研究:疗效与低毒性

A phase II study of mitomycin C, cisplatin and protracted infusional 5-fluorouracil in advanced pancreatic carcinoma: efficacy and low toxicity.

作者信息

Petty R D, Nicolson M C, Skaria S, Sinclair T S, Samuel L M, Koruth M

机构信息

Department of Oncology, ANCHOR Unit, Aberdeen Royal Infirmary, and University of Aberdeen, Institute of Medical Sciences, Foresterhill, UK.

出版信息

Ann Oncol. 2003 Jul;14(7):1100-5. doi: 10.1093/annonc/mdg278.

DOI:10.1093/annonc/mdg278
PMID:12853353
Abstract

BACKGROUND

The effective treatment of unresectable pancreatic carcinoma represents a formidable challenge. There is a need to develop systemic therapies which combine efficacy with acceptable toxicity. The current 'gold standard' gemcitabine gives an objective response rate of the order of 20% and median survival up to 6 months. Here we have evaluated the efficacy and toxicity of mitomycin C, cisplatin and protracted infusional 5-fluorouracil (MCF).

PATIENTS AND METHODS

Forty-five patients with locally advanced (13 patients) or metastatic (32 patients) pancreatic carcinoma were treated with mitomycin C 7 mg/m(2) 6 weekly, cisplatin 60 mg/m(2) 3 weekly and protracted venous infusion 5-FU 300 mg/m(2)/day. Patients were evaluated for response after three cycles and received six cycles in total in the absence of progressive disease or poor tolerance. Median age was 62 (45-75) years; 41 patients were World Health Organization performance status 0-1.

RESULTS

Treatment was well tolerated with 36 (84%) patients completing three or more cycles. Grade 3 or 4 toxicities were uncommon: anaemia in three patients (7%), mucositis in two (5%), nausea and vomiting in three (7%) and diarrhoea in one (1%). An objective response was seen in 21 (46%) patients. There was one complete response. The median survival overall was 7.1 months and 10.5 months in responders. The median duration of response was 4.3 months. One-year survival was 29%, 2-year survival was 18%.

CONCLUSIONS

MCF combines efficacy with low toxicity in the treatment of advanced pancreatic carcinoma. The efficacy is at least comparable and may be superior to single-agent gemcitabine and MCF may therefore provide a cost-effective alternative.

摘要

背景

不可切除胰腺癌的有效治疗是一项艰巨挑战。需要研发出疗效与可接受毒性相结合的全身治疗方法。目前的“金标准”吉西他滨客观缓解率约为20%,中位生存期可达6个月。在此,我们评估了丝裂霉素C、顺铂和持续输注5-氟尿嘧啶(MCF)的疗效和毒性。

患者与方法

45例局部晚期(13例)或转移性(32例)胰腺癌患者接受丝裂霉素C 7mg/m²,每6周一次;顺铂60mg/m²,每3周一次;持续静脉输注5-氟尿嘧啶300mg/m²/天的治疗。三个周期后评估患者反应,若无疾病进展或耐受性差,则总共接受六个周期治疗。中位年龄为62(45 - 75)岁;41例患者世界卫生组织体能状态为0 - 1级。

结果

治疗耐受性良好,36(84%)例患者完成三个或更多周期治疗。3级或4级毒性不常见:3例(7%)患者出现贫血,2例(5%)出现黏膜炎,3例(7%)出现恶心和呕吐,1例(1%)出现腹泻。21(46%)例患者出现客观缓解。有1例完全缓解。总体中位生存期为7.1个月,缓解者为10.5个月。中位缓解持续时间为4.3个月。1年生存率为29%,2年生存率为18%。

结论

MCF在晚期胰腺癌治疗中疗效与低毒性兼具。其疗效至少相当,可能优于单药吉西他滨,因此MCF可能提供一种具有成本效益的替代方案。

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