J Cancer 2021; 12(3):912-917. doi:10.7150/jca.50514

Research Paper

A phase II study of gemcitabine, erlotinib and S-1 in patients with advanced pancreatic cancer

Boram Han1, Bum Jun Kim1, Hyeong Su Kim1, Dae Ro Choi1, Byoung Yong Shim2, Kyung Hee Lee3, Jin Won Kim4, Jung Han Kim1, Hunho Song1, Jong Hyeok Kim1, Choong Kee Park1, Jung Woo Lee5, Min-Jeong Kim6, Dae Young Zang1✉

1. Department of Internal Medicine, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Gyeongigi-do, Korea.
2. Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.
3. Department of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu, Korea.
4. Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam-si, Gyeonggi-do, Korea.
5. Department of General Surgery, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Gyeongigi-do, Korea.
6. Departement of Radiology, Hallym University Medical Center, Hallym University College of Medicine, Anyang-si, Gyeongigi-do, Korea.

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Citation:
Han B, Kim BJ, Kim HS, Choi DR, Shim BY, Lee KH, Kim JW, Kim JH, Song H, Kim JH, Park CK, Lee JW, Kim MJ, Zang DY. A phase II study of gemcitabine, erlotinib and S-1 in patients with advanced pancreatic cancer. J Cancer 2021; 12(3):912-917. doi:10.7150/jca.50514. Available from https://www.jcancer.org/v12p0912.htm

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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.

Keywords: pancreatic neoplasms, gemcitabine, erlotinib, S-1, phase II study