1. A phase II study of gemcitabine, erlotinib and S-1 in patients with advanced pancreatic cancer
- Author
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Hyeong Su Kim, Bum Jun Kim, Jong Hyeok Kim, Boram Han, Jung Woo Lee, Jung Han Kim, Byoung Yong Shim, H. Song, Kyung Hee Lee, Dae Ro Choi, Jin Won Kim, Min-Jeong Kim, Choong Kee Park, and Dae Young Zang
- Subjects
0301 basic medicine ,erlotinib ,medicine.medical_specialty ,medicine.medical_treatment ,Phases of clinical research ,Neutropenia ,Gastroenterology ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Pancreatic cancer ,Mucositis ,medicine ,Chemotherapy ,business.industry ,gemcitabine ,pancreatic neoplasms ,S-1 ,medicine.disease ,Gemcitabine ,030104 developmental biology ,Oncology ,030220 oncology & carcinogenesis ,Erlotinib ,phase II study ,business ,Febrile neutropenia ,Research Paper ,medicine.drug - Abstract
Background: We evaluated the efficacy and safety of gemcitabine in combination with erlotinib and S-1 for the treatment of advanced pancreatic cancer. Methods: Chemotherapy-naïve patients with pathologically-proven locally advanced, recurrent, or metastatic pancreatic adenocarcinoma were assessed for eligibility. Gemcitabine was administered at 1,000 mg/m2 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/m2 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/m2 was permitted from the second cycle for pre-defined tolerable patients. Results: 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. Conclusion: The combination of gemcitabine, erlotinib, and S-1 provided an acceptable toxicity profile and modest clinical benefits in patients with advanced pancreatic cancer.
- Published
- 2021