Abstract CT147: Celiac plexus radiosurgery a new palliative modality for upper gastrointestinal malignancies - final quality of life results from a proof-of-concept clinical trial

Abstract Background: Background Neoadjuvant chemoradiotherapy (naCRT) for upper gastrointestinal malignancies induces a pathological complete response (pCR) in 25–85% of patients, depending on disease stage and regimen chosen. All patients with a pCR will have a clinical complete response (cCR). Avoidance of surgery is desirable where feasible, as operative intervention entails morbidity and mortality risks and a reduction in lifelong health related quality of life (HRQoL). Pursuant on a policy of permitting selected patients with a cCR to opt for surveillance, this study aims to compare the QoL of patients who chose surveillance over adjuvant surgery following a cCR to naCRT. Methods: Methods One hundred and fourteen patients participated in the study. These comprised 4 groups; Group 1 (n = 31) were healthy controls; Group 2 (n = 26) had chemoradiotherapy only; Group 3 (n = 31) had oesophagectomy post naCRT and Group 4(n = 26) had gastrectomy alone. A novel 33 point questionnaire assessing 5 functional domains was completed focusing on symptoms of antro-pyloric function, respiratory reflux and post-vagotomy symptoms, as well as a previously validated questionnaire instrument for purposes of comparison and external validation. The data was aggregated to produce a total score ranging from 20–93 with 20 representing the least symptomatic. Results: Results Mean(± sd) overall QoL scores were significantly better in patients avoiding resection (28.9 ± 4.5) vs oesophagectomy (32.3 ± 58. P = 0.042) and vs gastrectomy(33.19 ± 5.9, P = 0.004. Scores did not differ between patients undergoing oesophagectomy or gastrectomy (P = 0.889). Oesophagectomy was associated with a trend towards increased reflux-related respiratory symptoms (7.3 ± 2.2 vs 6.5 ± 1.9; P = 0.396) while gastrectomy patients reported more symptoms related to vagotomy (1.82 ± 0.9 vs 1.4 ± 0.6; P = 0.438) and early dumping (8.2 ± 1.4 vs 7.1 ± 1.7; P = 0.239). The mean score for the control group administered the novel questionnaire was 20.74, approaching the lowest possible score of 20. This was significantly lower than any of the scores recorded for the treatment groups (P = < 0.001). Conclusion: Discussion A strategy of active surveillance in complete responders to neoadjuvant chemoradiotherapy is rewarded with a superior quality of life than in those undergoing surgery. Disclosure All authors have declared no conflicts of interest.

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Celiac plexus radiosurgery for pain management in advanced cancer patients: An international phase II trial.

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.4_suppl.tps466 ◽

2019 ◽

Vol 37 (4_suppl) ◽

pp. TPS466-TPS466

Author(s):

Yaacov Richard Lawrence ◽

Tikva Meron ◽

Adam P. Dicker ◽

Camilla Zimmermann ◽

Maoz Ben-Ayun ◽

...

Keyword(s):

Quality Of Life ◽

Pancreatic Cancer ◽

Clinical Trial ◽

Cancer Patients ◽

Short Form ◽

Pilot Trial ◽

Celiac Plexus ◽

High Dose ◽

Analgesic Use

TPS466 Background: Many cancer patients, especially those with pancreatic cancer, suffer from severe back/epigastric pain. Contemporary approaches (opioids, celiac blocks, systemic chemotherapy) are often inadequate. This clinical trial investigates a new approach in which high-dose radiation (radiosurgery) is focused on the retroperitoneal celiac plexus nerve bundle. Preliminary results from a single institution pilot trial NCT02356406 are promising: pain relief is substantial and side effects minimal. The main aim of the trial is to establish safety/efficacy in the setting of an international multicenter study. Exploratory analyses will examine the relationship between pain reduction and subjects’ quality-of-life, functionality, and caregiver burden. Methods: Eligibility criteria include a diagnosis of metastatic/unresectable malignancy, uncontrolled pain defined as ≥ 5 on 11-point BPI-SF scale despite analgesic use, typical retroperitoneal pain syndrome, prognosis > 8 weeks, ECOG 0-2, anatomical involvement of the celiac plexus (e.g. any pancreatic cancer, or any other cancer involving the celiac trunk). Exclusion criteria include previous upper abdo. radiation. The intervention consists of a single 25 Gy radiation fraction delivered to the celiac plexus, using anterolateral aspect of the aorta from the 12th thoracic to 2nd lumbar vertebral body as a surrogate structure. The primary tumour may be irradiated at physicians’ discretion. Dose-painting technique limits dose to organs at risk. Pain intensity will be measured using Brief Pain Inventory Short Form (BPI-SF), and quality of life with FACT-Hep. The primary endpoint is complete or partial pain response, defined as a decrease between the score immediately before treatment and 3 weeks’ post-treatment. A change of two or more on the BPI 11-point pain scale is defined as clinically significant. Secondary endpoints include other BPI pain endpoints, pain at 6 weeks, analgesic use, toxicity (CTCAE v4.03), quality of life and functional measures. Analgesia is not restricted. Expected accrual is 100 subjects over three years. Supported by Gateway for Cancer Research, additional support from Israel Cancer Association. Clinical trial information: NCT03323489.

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