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Poster display session

4377 - Updated results of a phase II study of gemcitabine, erlotinib, and S-1 in patients with advanced pancreatic cancer

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Pancreatic Cancer

Presenters

Boram Han

Citation

Annals of Oncology (2017) 28 (suppl_5): v209-v268. 10.1093/annonc/mdx369

Authors

B. Han1, H.S. Kim1, D.R. Choi1, B.Y. Shim2, K.H. Lee3, J.W. Kim4, J.H. Kim1, H.Y. Kim1, H. Song1, D.Y. Zang1

Author affiliations

  • 1 Department Of Internal Medicine, Hallym University Medical Center Hallym University College of Medicine, 431-070 - Anyang/KR
  • 2 Department Of Internal Medicine, St. Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Suwon/KR
  • 3 Department Of Internal Medicine, Yeungnam University Medical Center, Yeungnam University College of Medicine, Daegu/KR
  • 4 Department Of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam/KR
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Resources

Abstract 4377

Background

Gemcitabine-based chemotherapy is considered as a standard front-line treatment for patients with advanced pancreatic cancer. Although addition of erlotinib or S-1 to gemcitabine has yielded better outcomes, it has showed just modest improvement in survival. To overcome this limitation, we evaluated the efficacy and safety of the combination of gemcitabine, 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 at 1,000 mg/m2 was administered intravenously on day 1, and 8, erlotinib at 100 mg/day was administered on days 1-21, and S-1 at 60 mg/m2 was administered on days 1-14 every 21 days and continued to maximum of 8 cycles of treatment. Dose escalation of S-1 to 80 mg/m2 was permitted from 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 overall response rate was 12.5% [95% confidence interval (CI), 5.1-28.9%] and 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.

Conclusions

The combination of gemcitabine, erlotinib, and S-1 provided an acceptable toxicity profile and modest clinical benefits in patients with advanced pancreatic cancer.

Clinical trial identification

Legal entity responsible for the study

Dae Young Zang

Funding

None

Disclosure

All authors have declared no conflicts of interest.

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