Palliative Care

SS 10 - Palliative 2

74 - Celiac Plexus Radiosurgery, a New Modality for Cancer Pain Management - Final Results of a Phase II Clinical Trial

Monday, October 22
8:15 AM - 8:25 AM
Location: Room 007 C/D

Celiac Plexus Radiosurgery, a New Modality for Cancer Pain Management – Final Results of a Phase II Clinical Trial
L. Hammer1,2, D. Hausner2,3, O. Morag2, M. ben-Ayun2, D. Alezra2, S. Dubinski2, L. Tsvang2, G. Jacobson2, U. Amit2, T. Katzman2, H. Gnessin2, K. Shefer2, I. Weiss2, I. Yanovsky2, T. Golan2, Z. Symon2, and Y. Lawrence2; 1The Weizmann Institute of Science, Rehovot, Israel, 2Radiation Oncology, Sheba Medical Center, Ramat Gan, Israel, 3Princess Maragret Hospital, Toronto, Toronto, ON, Canada

Purpose/Objective(s): Many patients with upper-abdominal malignancies suffer from a characteristic syndrome of severe lower back pain radiating to the epigastrium, thought to be caused by involvement of the celiac plexus. Contemporary approaches (opioids, celiac blocks, systemic chemotherapy) are often inadequate. We hypothesized that ablative radiation delivered to the celiac plexus would alleviate pain levels.

Materials/Methods: We performed a single-institution prospective clinical trial to evaluate a novel therapeutic approach: stereotactic radiation therapy focused on the celiac plexus. Eligibility criteria included typical celiac-pain syndrome, significant pain despite opioid usage (Numerical Rating Scale, NRS > 4/10), prognosis > 8 weeks, ECOG 0-3. Evaluable patients were defined as those completing treatment per protocol and completed at least one post-treatment visit. Exclusion criteria included previous abdominal RT. The anterolateral aspect of the aorta from D12 to L2 was used as a surrogate marker for the celiac plexus; primary tumor was irradiated according to physicians’ discretion. Radiation dose was originally 9 Gy*5, and later amended to a single fraction 25 Gy, both using VMAT. A dose-painting technique was used to limit dose to duodenum. The primary endpoint was pain-relief 3 weeks post-treatment, measured using NRS. Secondary endpoints included pain at 6 weeks, analgesic use, toxicity (CTCAE v4.03), and pain interference with seven daily activities as evaluated by the ‘Brief Pain Inventory' (BPI) instrument before and after radiation therapy. Analgesic use was not restricted.

Results: Twenty-one subjects were evaluable: 2 received 9Gy*5, 19 received 25Gy*1. The median age was 65 (range 37-83 years) with a Median ECOG of 1, 86% had pancreatic cancer. Median volume of celiac plexus was 30.8 cc, median dose to celiac plexus was 25 Gy. All patients reported decreased celiac pain: median pain level prior to RT was 6/10 (IQR 5-7.5) and reduced to 2.3/10 NRS score (IQR 0.9-3.3) (p <0.0005 compared to baseline) at 3 weeks (primary endpoint), and to 1.8/10 (IQR 0-3) (p <0.0005 compared to baseline) at 6 weeks’ post-treatment. 76% of patients reported a significant decrease of pain at primary endpoint (two point decrease), and in one third of patients the celiac pain had been eliminated entirely during follow-up. Toxicity was minimal and limited to grade 1-2 (2 patients reported mild worsening of pain immediately following treatment, some limited nausea/vomiting). Median daily morphine equivalent dose consumption decreased (NS). A significant improvement was noted in all evaluated measures of quality of life.

Conclusion: Celiac plexus radiosurgery is well tolerated, substantially decreases pain, and improves quality of life amongst patients with advanced upper-GI cancer. An international multicenter phase II trial is currently accruing.

Author Disclosure: L. Hammer: None. D. Hausner: None. O. Morag: None. M. ben-Ayun: None. U. Amit: None. Y. Lawrence: Research Grant; Gateway for Cancer research. Advisory Board; celgene. committee member; RTOG.

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