Nio Yoshinori, Hashimoto Koji, Yano Seiji, Itakura Masayuki, Koike Makoto, Yamaguchi Kazushige, Endo Shinichiro, Tsuji Munechika, Higami Tetsuya, Maruyama Riruke
Department of Cardiovascular and Digestive Surgery, Shimane University School of Medicine, 89-1 Enya-cho, Izumo, Shimane 693-8501, Japan.
Oncol Rep. 2005 Aug;14(2):401-8.
The present study assessed the anti-tumor effects and clinical benefits of intravenous (i.v.) or intra-arterial (i.a.) gemcitabine (GEM) at low dose plus oral chemotherapy with uracil-tegafur (UFT) and cyclophosphamide (CPA) in combination with radiotherapy (RT) against recurrent and advanced pancreatic cancers. A total of 22 patients with 15 advanced or 7 recurrent pancreatic cancer were enrolled. The target lesions included 15 primary tumors, 9 liver metastases, 3 local recurrences, 1 lung metastasis and 1 pleural effusion. The patients were each given GEM at 200-400 mg weekly or biweekly, UFT at 300 mg/day daily and CPA at 50 mg/day every other day in combination with RT at a total dose of 40-60 Gy. The primary efficacy measures were the overall response rate (RR) and survival. Furthermore, the clinical benefit response (CBR) was classified by measuring the pain intensity, analgesic consumption, Karnofsky performance status and body weight. The regimen was well tolerated, and the major side effects included anorexia, general malaise and myelo-suppression. In each case, dose reduction was effective in resolving these side effects. The dose limiting side effect was thrombocytopenia. Eleven patients received i.v. GEM alone, 6 patients received i.a. GEM alone and 5 patients received both. The objective responses were evaluated in all patients, and the overall RR was 27% (2 complete responses, 4 partial responses, 6 stable diseases and 10 progressive diseases). A CBR was experienced in 22.7% of the patients. The mean survival period was 10.6 months (2-20 months), and the 1-year survival rate was 42.2%. There were no differences in RR and survival among the different administration methods of GEM. In conclusion, i.v. or i.a. GEM at low dose, UFT and CPA in combination with RT is a well-tolerated regimen with beneficial clinical efficacy, and is worthy of further study.
本研究评估了低剂量静脉注射（i.v.）或动脉内注射（i.a.）吉西他滨（GEM）联合口服化疗药物替加氟尿嘧啶（UFT）和环磷酰胺（CPA）并结合放疗（RT）对复发和晚期胰腺癌的抗肿瘤作用及临床疗效。共纳入22例患者，其中15例为晚期胰腺癌，7例为复发性胰腺癌。靶病变包括15个原发性肿瘤、9个肝转移灶、3个局部复发灶、1个肺转移灶和1个胸腔积液。患者分别接受每周或每两周200 - 400 mg的GEM、每日300 mg的UFT和隔日50 mg的CPA，并结合总剂量为40 - 60 Gy的放疗。主要疗效指标为总缓解率（RR）和生存率。此外，通过测量疼痛强度、镇痛药消耗量、卡诺夫斯基功能状态和体重对临床获益反应（CBR）进行分类。该方案耐受性良好，主要副作用包括厌食、全身不适和骨髓抑制。在每种情况下，降低剂量对解决这些副作用有效。剂量限制性副作用为血小板减少症。11例患者仅接受静脉注射GEM，6例患者仅接受动脉内注射GEM，5例患者同时接受两种注射。对所有患者评估客观缓解情况，总RR为27%（2例完全缓解，4例部分缓解，6例病情稳定，10例病情进展）。22.7%的患者出现CBR。平均生存期为10.6个月（2 - 20个月），1年生存率为42.2%。GEM不同给药方式之间的RR和生存率无差异。总之，低剂量静脉注射或动脉内注射GEM、UFT和CPA联合放疗是一种耐受性良好且具有有益临床疗效的方案，值得进一步研究。
