Han Boram, Kim Bum Jun, Kim Hyeong Su, Choi Dae Ro, Shim Byoung Yong, Lee Kyung Hee, Kim Jin Won, Kim Jung Han, Song Hunho, Kim Jong Hyeok, Park Choong Kee, Lee Jung Woo, Kim Min-Jeong, Zang Dae Young
Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Gyeongigi-do, Korea.
Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
J Cancer. 2021 Jan 1;12(3):912-917. doi: 10.7150/jca.50514. eCollection 2021.
We evaluated the efficacy and safety of gemcitabine in combination with erlotinib and S-1 for the treatment of advanced pancreatic cancer. Chemotherapy-naïve patients with pathologically-proven locally advanced, recurrent, or metastatic pancreatic adenocarcinoma were assessed for eligibility. Gemcitabine was administered at 1,000 mg/m intravenously on days 1 and 8, erlotinib was administered at 100 mg/day on days 1-21, and S-1 was administered at 60 mg/m on days 1-14 every 21 days and continued to a maximum of 8 cycles of treatment. Dose escalation of S-1 to 80 mg/m was permitted from the second cycle for pre-defined tolerable patients. Thirty-seven patients (median age 61.5 years) were enrolled. A total of 140 cycles of chemotherapy were administered (median of 3.8; range 1-8 cycles). Toxicities were evaluated in 36 patients, and the responses were evaluated in 32 patients. Major grade 3/4 toxicities included neutropenia (25%), febrile neutropenia (2.8%), fatigue (22.2%), infection (8.3%), vomiting (5.6%), and mucositis (5.6%). The confirmed overall response rate was 12.5% [95% confidence interval (CI), 5.1-28.9%] and the disease control rate was 71.9% (95% CI, 56.8-86.3%). The median progression-free survival and overall survival were 3.7 months (95% CI, 2.8-4.6 months) and 6.7 months (95% CI, 3.4-9.9 months), respectively. The combination of gemcitabine, erlotinib, and S-1 provided an acceptable toxicity profile and modest clinical benefits in patients with advanced pancreatic cancer.
我们评估了吉西他滨联合厄洛替尼和S-1治疗晚期胰腺癌的疗效和安全性。对未经化疗、经病理证实为局部晚期、复发或转移性胰腺腺癌的患者进行了资格评估。吉西他滨在第1天和第8天静脉注射，剂量为1000mg/m²；厄洛替尼在第1 - 21天每天口服100mg；S-1在第1 - 14天每天口服60mg/m²，每21天为一个周期，最多持续8个周期。对于预先定义的可耐受患者，从第二个周期起允许将S-1剂量增至80mg/m²。共纳入37例患者（中位年龄61.5岁）。总共进行了140个化疗周期（中位周期数为3.8；范围1 - 8个周期）。对36例患者评估了毒性，对32例患者评估了疗效。主要的3/4级毒性包括中性粒细胞减少（25%）、发热性中性粒细胞减少（2.8%）、疲劳（22.2%）、感染（8.3%）、呕吐（5.6%）和黏膜炎（5.6%）。确认的总缓解率为12.5% [95%置信区间（CI），5.1 - 28.9%]，疾病控制率为71.9%（95% CI，56.8 - 86.3%）。中位无进展生存期和总生存期分别为3.7个月（95% CI，2.8 - 4.6个月）和6.7个月（95% CI，3.4 - 9.9个月）。吉西他滨、厄洛替尼和S-1联合方案在晚期胰腺癌患者中具有可接受的毒性特征和适度的临床获益。
