1. MR-Guided Radiation Therapy With Concurrent Gemcitabine/Nab-Paclitaxel Chemotherapy in Inoperable Pancreatic Cancer: A TITE-CRM Phase I Trial
- Author
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Hyun Kim, Jeffrey R. Olsen, Olga L. Green, Re-I Chin, William G. Hawkins, Ryan C. Fields, Chet Hammill, Majella B. Doyle, William Chapman, Rama Suresh, Benjamin Tan, Katrina Pedersen, Brandi Jansen, Todd A. DeWees, Esther Lu, Lauren E. Henke, Shahed Badiyan, Parag J. Parikh, Michael C. Roach, Andrea Wang-Gillam, and Kian-Huat Lim
- Subjects
Cancer Research ,Radiation ,Oncology ,Radiology, Nuclear Medicine and imaging - Abstract
Ablative radiation therapy for borderline resectable or locally advanced pancreatic ductal adenocarcinoma (BR/LA-PDAC) may limit concurrent chemotherapy dosing and usually is only safely deliverable to tumors distant from gastrointestinal organs. Magnetic resonance guided radiation therapy may safely permit radiation and chemotherapy dose escalation.We conducted a single-arm phase I study to determine the maximum tolerated dose of ablative hypofractionated radiation with full-dose gemcitabine/nab-paclitaxel in patients with BR/LA-PDAC. Patients were treated with gemcitabine/nab-paclitaxel (1000/125 mg/mThirty patients enrolled (March 2015-February 2019), with 26 evaluable patients (2 progressed before radiation, 1 was determined ineligible for radiation during planning, 1 withdrew consent). One DLT was observed. The DLT rate was 14.1% (3.3%-24.9%) with a maximum tolerated dose of gemcitabine/nab-paclitaxel (1000/100 mg/mFull-dose gemcitabine/nab-paclitaxel with ablative magnetic resonance guided radiation therapy dosing is safe in patients with BR/LA-PDAC, with promising LPFS and DMFS.
- Published
- 2022