A Phase II Trial of Gemcitabine and Erlotinib (GE) plus Proton Chemotherapy (PCT) and Capecitabine and Oxaliplatin (CapOx) for Locally Advanced Pancreatic Cancer

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Abstract

Purpose/Objective(s): Epidermal growth factor receptor (EGFR) is overexpressed in pancreatic cancer. EGFR expression plays a potentially important role in modulation of tumor sensitivity to either chemotherapy or radiotherapy. Erlotinib is a receptor tyrosine kinase inhibitor with specificity for EGFR/HER1. A phase II trial was conducted to explore the efficacy of a regimen utilizing erlotinib and proton therapy. Materials/Methods: Patients with unresectable or borderline resectable non-metastatic adenocarcinoma of the pancreas, as defined by 2012 NCCN guidelines, were included. Patients received neoadjuvant gemcitabine 1000 mg/m2 IV on days 1, 8, 15, 22, 29, 36, and 43 and erlotinib 100 mg by mouth every day for 1-43 days (GE). If there was no evidence of metastatic disease after GE, then patients preceded with proton therapy to 50.4 Gy in 28 fractions with concurrent capecitabine 825 mg/m2 twice per day (PCT). This was followed with maintenance oxaliplatin 130 mg/m2 on day 1 and capecitabine 1000 mg/m2 twice per day on days 2 to 15 (CapOx) for 4 cycles. The primary study objective was 1-year overall survival (OS). The benchmark was 43% 1-year survival as demonstrated in RTOG/NRG 98-12. The Kaplan-Meier method was used to estimate the one-year OS and the median OS and progression-free survival (PFS). Results: The study enrolled 9 patients (5 male) ages 47-81 years old (median 62) between January 2013 and March 2016, when the trial was closed due to poor accrual. The 1-year OS rate was 55.6% (95% CI, 31% to 99%). The median OS was 14.1 months (95% CI, 11.4-NE) and the median PFS was 10.8 months (95% CI, 7.44-NE). A majority of patients completed PCT and GE, but only 33.3% completed the four cycles of CapOx. A third of patients experienced grade 3 toxicities, which were all hepatic along with one patient who also had grade 3 diarrhea. There were no grade 4 or 5 toxicities. Four patients were enrolled with borderline resectable disease (NCCN), three of which were eligible for pancreaticoduodenectomy after GE and PCT treatment. One of two patients who underwent resection had a negative margin. Conclusion: This regimen for locally advanced pancreatic cancer exceeded the pre-specified benchmark and was safe and well tolerated. Additional investigations utilizing more current systemic treatment regimens with proton therapy are warranted.
Original languageAmerican English
Pages (from-to)e599-e600
JournalInternational Journal of Radiation Oncology Biology Physics
Volume108
Issue number3
DOIs
StatePublished - Nov 1 2020

Disciplines

  • Oncology
  • Internal Medicine
  • Medicine and Health Sciences

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