GS方案一线化疗后序贯替吉奥治疗晚期胰腺癌的临床观察

Effects of Sequential Chemotherapy with S-1 Followed by First-line Chemotherapy in Advanced Pancreatic Cancer

关键词:  替吉奥  吉西他滨  胰腺癌  序贯化疗

Key words:  S-1  gemcitabine  pancreatic cancer  sequential chemotherapy

摘要:

目的 比较晚期胰腺癌一线GS方案化疗后疾病得到控制者序贯替吉奥(S-1)单药治疗的疗效和对生存期的影响。方法 32例患者经一线GS(吉西他滨+替吉奥)方案化疗4周期后，获得疾病控制的晚期胰腺癌患者，随机(1∶1)分为序贯S-1组(S-1组)和随访观察组(观察组)。每治疗2周期后评价疗效，观察无进展生存时间(PFS)、总生存时间(OS)及不良反应。结果 32例患者均可评价疗效。S-1组共接受93周期单药S-1化疗，S-1组和观察组中位PFS分别为7.0个月和5.2个月，中位OS分别为10.7个月和7.5个月，2组PFS和OS比较差异均有统计学意义(P<0.05)。S-1组不良反应大多数表现为1~2级，3~4级仅有1例粒细胞减少及1例腹泻，2组之间差异无统计学意义(P>0.05)。结论 晚期胰腺癌一线GS方案化疗后疾病得到控制者序贯S-1单药治疗安全有效，能显著延长患者的PFS及OS，且不良反应轻。

Abstract:

OBJECTIVE To observe the efficacy and safety in patients with advanced pancreatic cancer sequential chemotherapy with single-agent S-1 following gemcitabine plus S-1 initial first-line therapy. METHODS Thirty-two patients of advanced pancreatic cancer who received first-line chemotherapy with gemcitabine plus S-1 for 4 cycles, after achieving disease stabilization were randomized(1∶1 fashion) to receive single-agent S-1 sequential chemotherapy (80 mg·m·d^-1) for 14 days(S-1 group) or observation without treatment (observation group) until progression of disease, 21 days for a period of treatment. The outcomes of eligible randomized controlled trials included progression-free survival(PFS), overall survival(OS) and toxicities. RESULTS Thirty-two patients were evaluable for toxicity and survival in two groups. Median PFS and OS of S-1 group versus observation group were 7.0 months(95%CI, 6.6-7.4) vs 5.2 months(95%CI, 4.6-5.8) (P<0.05), and 10.7 months(95%CI, 9.9-11.5) vs 7.5 months(95%CI, 6.3-8.7) (P<0.05), respectively. The median PFS and OS showed significant difference between two groups. Toxicity including hematologic and non-hematologic toxicity in S-1 group was little higher than that in observation group(P>0.05), only two patients developed toxicities of National Cancer Institute Common Toxicity Criteria(NCI CTC) Grade 3-4. CONCLUSION Single-agent S-1 sequential chemotherapy therapy following gemcitabine plus S-1 initial first-line therapy is feasible, and extended the PFS and OS, and showed a favorable toxicity profile.