• Yaacov R Lawrence, Marcin Miszczyk, Laura A Dawson, Dayssy Alexandra Diaz Pardo, Artur Aguiar, Dror Limon, Raphael M Pfeffer, Michael Buckstein, Aisling S Barry, Tikva Meron, Adam P Dicker, Jerzy Wydmański, Camilla Zimmermann, Ofer Margalit, David Hausner, Ofir Morag, Talia Golan, Galia Jacobson, Sergey Dubinski, Teo Stanescu, Ronen Fluss, Laurence S Freedman, Maoz Ben-Ayun, and Zvi Symon.
• Department of Radiation Oncology, Sheba Medical Center, Ramat Gan, Israel; School of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Radiation Oncology, Thomas Jefferson University, Philadelphia, PA, USA. Electronic address: yaacov.lawrence@sheba.health.gov.il.
• Lancet Oncol. 2024 Aug 1; 25 (8): 107010791070-1079.

BackgroundRefractory upper abdominal pain or lower back pain (retroperitoneal pain syndrome) related to celiac plexus involvement characterises pancreatic and other upper gastrointestinal malignancies and is an unmet need. We hypothesised that ablative radiation delivered to the celiac plexus would decrease pain.MethodsThis multicentre, single-arm, phase 2 study was done at eight hospitals in five countries (Israel, Poland, Canada, the USA, and Portugal). Eligible patients aged 18 years or older with an average pain level of 5-10 on the Brief Pain Inventory short form (BPI-SF), an Eastern Cooperative Oncology Group performance status score of 0-2, and either pancreatic cancer or other tumours involving the celiac axis, received a single fraction of 25 Gy of external-beam photons to the celiac plexus. The primary endpoint was complete or partial pain response based on a reduction of the BPI-SF average pain score of 2 points or more from baseline to 3 weeks after treatment. All evaluable patients with stable pain scores were included in response assessment. The trial is registered with ClinicalTrials.gov, NCT03323489, and is complete.FindingsBetween Jan 3, 2018, and Dec 28, 2021, 125 patients were treated, 90 of whom were evaluable. Patients were followed up until death. Median age was 65·5 years (IQR 58·3-71·8), 50 (56%) were female and 40 (44%) were male, 83 (92%) had pancreatic cancer, and 77 (86%) had metastatic disease. Median baseline BPI-SF average pain score was 6 (IQR 5-7). Of the 90 evaluable patients at 3 weeks, 48 (53%; 95% CI 42-64) had at least a partial pain response. The most common grade 3-4 adverse events, irrespective of attribution, were abdominal pain (35 [28%] of 125) and fatigue (23 [18%]). 11 serious adverse events of grade 3 or worse were recorded. Two grade 3 serious adverse events were probably attributed to treatment by the local investigators (abdominal pain [n=1] and nausea [n=1]), and nine were possibly attributed to treatment (seven were grade 3: blood bilirubin increased [n=1], duodenal haemorrhage [n=2], abdominal pain [n=2], and progressive disease [n=2]; and two were grade 5: gastrointestinal bleed from suspected varices 24 days after treatment [n=1] and progressive disease [advanced pancreatic cancer] 89 days after treatment [n=1]).InterpretationCeliac plexus radiosurgery could potentially be a non-invasive palliative option for patients with retroperitoneal pain syndrome. Further investigation by means of a randomised comparison with conventional celiac block or neurolysis is warranted.FundingGateway for Cancer Research and the Israel Cancer Association.Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.

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