Highlights
- •Prospective study of pre-operative margin intensified SBRT in borderline resectable pancreatic cancer.
- •All SBRT was completed, dose was escalated one level without encountering DLT.
- •Few patients had resection after SBRT, suitability of treatments combination is difficult to appraise.
Abstract
Background and purpose
Following resection of pancreatic cancer, risk of positive margins and local recurrence
remain high, especially for borderline-resectable pancreatic cancer (BRPC). We aimed
to establish the maximum tolerated dose of a margin-intensified five-fraction stereotactic
body radiotherapy (SBRT) regimen designed to treat the region at risk.
Materials and methods
We conducted a prospective multicentre phase-1 rolling-six dose-escalation study.
BRPC patients received pre-operative SBRT, with one dose to the primary tumour and
an integrated boost to the region where tumour was in contact with vasculature. Four
dose-levels were proposed, with starting dose 30 Gy to primary PTV and 45 Gy to boost
volume (PTV_R), in five daily fractions. Primary endpoint was maximum tolerated dose
(MTD), defined as highest dose where zero of three or one of six patients experienced
dose-limiting toxicity (DLT).
Results
Twelve patients were registered, eleven received SBRT. Radiotherapy was well tolerated
with all treatment completed as scheduled. Dose was escalated one level up from starting
dose without encountering any DLT (prescribed 32.5 Gy PTV, 47.5 Gy PTV_R). Nine serious
adverse reactions or events occurred (seven CTCAE Grade 3, two Grade 4). Two patients
went on to have surgical resection. Median overall survival for SBRT patients was
8.1 months. The study closed early when it was unable to recruit to schedule.
Conclusion
Toxicity of SBRT was low for the two dose-levels that were tested, but MTD was not
established. Few patients subsequently underwent resection of pancreatic tumour after
SBRT, and it is difficult to draw conclusions regarding the safety or toxicity of
these therapies in combination.
Keywords
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Article info
Publication history
Published online: November 17, 2020
Accepted:
November 8,
2020
Received in revised form:
October 19,
2020
Received:
June 15,
2020
Identification
Copyright
© 2020 Elsevier B.V. All rights reserved.
