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- Title
Gemcitabine and Erlotinib with or without Oxaliplatin in Previously Untreated Advanced Pancreatic Cancer: A Randomized Phase II Trial.
- Authors
Sung Hee Lim; Jina Yun; Min-Young Lee; Han Jo Kim; Kyoung Ha Kim; Se Hyung Kim; Sang-Chul Lee; Sang Byung Bae; Chan Kyu Kim; Namsu Lee; Kyu Taek Lee; Seong Kyu Park; Yun Nah Lee; Jong Ho Moon
- Abstract
Purpose: Erlotinib has been the only targeted agent to show significantly improved outcomes in pancreatic adenocarcinoma when combined with gemcitabine. We aimed to evaluate whether the addition of oxaliplatin to a combination gemcitabine/erlotinib treatment conferred a clinical benefit in patients with locally advanced unresectable or metastatic pancreatic cancer. Materials and Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned to receive GEMOX-T [gemcitabine 1000 mg/m2 and oxaliplatin 50 mg/m2 on day 1 (D1) and D8 plus erlotinib 100 mg daily for 3 weeks] or GT (gemcitabine 1000 mg/m2 on D1 and D8 plus erlotinib 100 mg daily for 3 weeks). The primary endpoint was the overall response rate (ORR). Results: Between 2013 and 2016, 65 patients were assigned to a treatment group (33 in the GEMOX-T arm, 32 in the GT arm). The ORR was 18.2% [95% confidence interval (CI), 8.82-27.58] in the GEMOX-T arm and 6.2% (95% CI, 0.34-12.06) in the GT arm (p=0.051). The disease control rate was significantly superior in the GEMOX-T arm compared to the GT arm (72.7% vs. 43.8%, p=0.019). After a median follow-up of 19.7 months, the median progression-free survival (PFS) was 3.9 months for the GEMOX-T arm and 1.4 months for the GT arm (p=0.033). However, this did not translate to an improvement in overall survival. The most common grade 3 or higher hematologic adverse events were neutropenia (16.9%) and anemia (13.8%). Conclusion: The addition of oxaliplatin to a first-line gemcitabine/erlotinib regimen demonstrated higher response rates and significantly improved PFS in patients with locally advanced or metastatic pancreatic cancer.
- Subjects
PANCREATIC cancer; ERLOTINIB; OVERALL survival; OXALIPLATIN; SURVIVAL rate; PANCREATIC tumors
- Publication
Yonsei Medical Journal, 2021, Vol 62, Issue 8, p671
- ISSN
0513-5796
- Publication type
Article
- DOI
10.3349/ymj.2021.62.8.671