Nakamura K, Yamaguchi T, Ishihara T, Sudo K, Kato H, Saisho H
Department of Medicine and Clinical Oncology, Graduate School of Medicine, Chiba University, 1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan.
Br J Cancer. 2006 Jun 5;94(11):1575-9. doi: 10.1038/sj.bjc.6603168.
We conducted a phase II trial of gemcitabine with S-1, oral fluorouracil (5-FU) prodrug tegafur combined with two modulators, 5-chloro-2, 4-dihydroxypyridine and potassium oxonate, to evaluate the activity and toxicity of such a combination in metastatic pancreatic cancer (MPC) patients. Patients who had pathologically proven pancreatic cancer with metastatic lesions were eligible candidates for entry into the study. S-1 was given orally (30 mg m(-2)) b.i.d. for 14 consecutive days and gemcitabine (1000 mg m(-2)) was given on days 8 and 15. The cycle was repeated every 21 days. We enrolled 33 MPC patients. The median number of cycles was eight (range 1-20). Grade 3-4 toxicities were leucopenia (33%), neutropenia (55%), anaemia (9%), thrombocytopenia (15%), anorexia (6%), fever (9%), and interstitial pneumonia (6%). Objective responses were obtained in 16 patients (one complete response and 15 partial responses; response rate, 48%; 95% confidence interval (CI), 33-65). Median survival and 1-year survival rate were 12.5 months (95% CI, 5.9-19.1) and 54% (95% CI, 36-72), respectively. Combination chemotherapy with GEM and S-1 was well tolerated and yielded a significantly high response rate.
我们开展了一项吉西他滨联合S-1（口服氟尿嘧啶（5-FU）前体药物替加氟与两种调节剂5-氯-2,4-二羟基吡啶和奥索利酸钾的组合）的II期试验，以评估这种联合用药方案在转移性胰腺癌（MPC）患者中的活性和毒性。经病理证实患有伴转移病灶的胰腺癌患者符合纳入本研究的条件。S-1口服给药（30 mg m(-2)），每日两次，连续给药14天，吉西他滨（1000 mg m(-2)）在第8天和第15天给药。每21天重复一个周期。我们纳入了33例MPC患者。中位周期数为8个（范围1 - 20）。3 - 4级毒性反应包括白细胞减少（33%）、中性粒细胞减少（55%）、贫血（9%）、血小板减少（15%）、厌食（6%）、发热（9%）和间质性肺炎（6%）。16例患者获得客观缓解（1例完全缓解和15例部分缓解；缓解率为48%；95%置信区间（CI），33 - 65）。中位生存期和1年生存率分别为12.5个月（95% CI，5.9 - 19.1）和54%（95% CI，36 - 72）。吉西他滨与S-1的联合化疗耐受性良好，缓解率显著较高。
