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吉西他滨-卡培他滨联合动脉内表柔比星-顺铂用于经治胰腺癌患者:一项I期研究。

Gemcitabine-capecitabine plus intra-arterial epirubicin-cisplatin in pretreated pancreatic cancer patients: a phase I study.

作者信息

Mambrini Andrea, Pacetti Paola, Del Freo Alfonso, Seta Roberta Della, Pezzuolo Debora, Torri Tito, Orlandi Massimo, Tartarini Roberta, Cantore Maurizio

机构信息

Department of Oncology, Carrara city Hospital, piazza Sacco e Vanzetti, 54033 Carrara (MS), Italy.

出版信息

Anticancer Res. 2009 May;29(5):1547-9.

PMID:19443364
Abstract

BACKGROUND

Gemcitabine plus capecitabine are active in patients (pts) with advanced pancreatic cancer (APC). Intra-arterial chemotherapy showed activity and low toxicity. Combination of systemic and intra-arterial chemotherapy was investigated.

PATIENTS AND METHODS

Patients with APC, progressed after a first-line chemotherapy, were included. Fixed doses of epirubicin 35 mg/m(2) and cisplatin 42 mg/m(2) intra-arterially every 28 days, and capecitabine 650 mg/m(2) twice a day on days 2-15; gemcitabine systemically in increasing doses on day 2. The purpose was to find maximum-tolerated dose (MTD) and dose-limiting toxicity (DLT).

RESULTS

Fifteen patients were enrolled. DLT occurred at 1300 mg/m(2) of gemcitabine and consisted of myelotoxicity (grade 4 febrile neutropenia and grade 4 thrombocytopenia).

CONCLUSION

Limiting toxicity was hematological. For further studies intra-arterial epirubicin 35 mg/m(2) and cisplatin 42 mg/m(2); systemic gemcitabine at 1,000 mg/m(2) on day 2, and capecitabine at 650 mg/m(2) twice a day PO on days 2-15 are suggested.

摘要

背景

吉西他滨联合卡培他滨对晚期胰腺癌(APC)患者有效。动脉内化疗显示出活性且毒性较低。对全身化疗与动脉内化疗的联合应用进行了研究。

患者和方法

纳入一线化疗后病情进展的APC患者。每28天动脉内给予固定剂量的表柔比星35mg/m²和顺铂42mg/m²,在第2 - 15天口服卡培他滨650mg/m²,每日两次;在第2天全身给予递增剂量的吉西他滨。目的是确定最大耐受剂量(MTD)和剂量限制性毒性(DLT)。

结果

纳入15例患者。DLT发生在吉西他滨剂量为1300mg/m²时,表现为骨髓毒性(4级发热性中性粒细胞减少和4级血小板减少)。

结论

限制性毒性为血液学毒性。建议进一步研究采用动脉内给予表柔比星35mg/m²和顺铂42mg/m²;第2天全身给予吉西他滨1000mg/m²,第2 - 15天口服卡培他滨650mg/m²,每日两次。

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