Phase I trialMulti-institutional phase I study of low-dose ultra-fractionated radiotherapy as a chemosensitizer for gemcitabine and erlotinib in patients with locally advanced or limited metastatic pancreatic cancer
Section snippets
Eligibility
Patients ⩾18 years of age able to provide written informed consent with locally advanced or minimally metastatic adenocarcinoma of the pancreas with ECOG performance status of 0–1 were eligible for this study. Minimally metastatic was defined as having limited metastatic disease in the upper abdomen or liver that could be included in the upper abdominal radiation port. Patients with prior chemotherapy for metastatic pancreatic cancer were initially ineligible but the study was subsequently
Results
A total of 27 patients were enrolled in the study. One patient withdrew consent before treatment shortly after enrollment leaving 26 analyzable patients. The median follow-up from study enrollment was 8.4 (range: 2.3–47.9) months. The median follow-up from the end of treatment was 4.1 (range: 0–41.2) months. Table 1 summarizes patient characteristics. Patients were relatively evenly split between locally advanced and metastatic disease. Of those patients with metastatic disease, the most common
Discussion
This phase I study combining standard dose chemotherapy with a novel delivery of radiotherapy (low dose per fraction radiotherapy or ultra-fractionation) utilized as a chemosensitizer was found to be relatively well tolerated and safe in patients with locally advanced and metastatic pancreatic cancer. Our efficacy results also compare favorably with other studies utilizing chemotherapy alone for locally advanced and metastatic pancreatic cancer.
Until recently, the standard treatment for
Conflict of interest
Steven J. Cohen has received grant and consulting fees from Genentech.
Dr. Philip Philip has had grant and consulting fees from Genentech outside of work for the study.
Funding
Genentech United States.
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