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Somatostatin analogue continuation upon progression in patients with gastroenteropancreatic neuroendocrine tumour (SAUNA trial): a randomised controlled trial protocol

Por: Chhajlani · S. · Kuiper · J. · Beutels · P. · Borbath · I. · Dercksen · W. · Deroose · C. M. · Heemskerk · S. · Polinder · S. · Roelant · E. · Smits · E. · Verhaegen · I. · Van der Massen · I. · Walenkamp · A. · de Herder · W. W. · Peeters · M. · Hofland · J. · Vandamme · T. · for the SA
Introduction

Gastroenteropancreatic neuroendocrine tumours (GEP NET) are malignant neoplasms that impact survival. Somatostatin analogues (SSA) are used for treating hormonal symptoms caused by GEP NET and have antiproliferative effects. They are used as first-line therapy in patients with advanced GEP NET, but disease control is limited to a median progression-free survival (mPFS) of 14–32 months. Second-line treatment options include targeted therapy (everolimus or sunitinib), or peptide receptor radionuclide therapy (PRRT) with 177Lu-DOTATATE. In patients suffering from a NET-related hormonal syndrome, SSA is generally continued life-long. However, there is no consensus on whether it is beneficial to continue SSA in non-functional NET upon disease progression. Due to the ongoing activity of the somatostatin receptor pathway in GEP NET progressing on first-line SSA, we hypothesise that SSA have an added efficacy in second-line therapy.

Methods and analysis

The SAUNA trial is an international, multicentre, open-label, randomised, controlled, pragmatic clinical trial. 270 patients with advanced, non-functional GEP NET and progression under first-line SSA will be included in substudy 1 (PRRT; n=142) or substudy 2 (targeted therapy (everolimus/sunitinib); n=128) per investigator’s choice of second-line therapy and will be randomised (1:1) per substudy between SSA continuation or SSA withdrawal arms. Co-primary endpoints are the difference in progression-free survival (PFS) according to the RECIST (Response Evaluation Criteria In Solid Tumours) V.1.1 criteria and difference in time to deterioration (TTD) in quality of life (QoL) per substudy after initiating second-line therapy with or without SSA. Secondary endpoints include the PFS rate at 18 months, the difference in pooled PFS and TTD combining both substudies, overall survival, response rates, QoL, costs, cost-effectiveness and toxicity. The study design was developed in cooperation with the Belgium and Dutch patient organisations.

Ethics and dissemination

The study has been approved on 31 May 2023 by the Ethical Committees and Regulatory Authorities of the concerned member states (EU CT number 2022-502703-30-00). Both the trial management group and the steering committee will oversee good governance of this trial. Results of the study will be published in peer-reviewed international journals and presented at international conferences.

Trial registration number

NCT05701241.

Experience with hip denervation in non-operative hip fracture care for frail older patients in the Netherlands: an interview study

Objective

The objective was to explore treatment experience of hip denervation via PEricapsular Nerve Group block with phenol in non-operative management and end-of-life (EOL) care after hip fractures.

Design

A qualitative study was conducted with semistructured interviews. The interviews were analysed using thematic discourse analysis.

Setting and participants

The study was conducted in a large regional hospital in the Netherlands. Proxies (first-contact person, often a first-degree or second-degree relative) of frail older adults treated between January 2022 and June 2023 were included, as patients had either cognitive impairment or were deceased.

Results

The process surrounding hip denervation was emotionally charged due to the EOL setting and preceding discussion on whether or not to operate. The EOL setting impaired information uptake in participants and complicated communication. Hip denervation was experienced as a partial source of comfort. Logistics and aftercare were described as suboptimal. Participants emphasised the importance of a dignified and autonomous EOL phase.

Conclusions

This study describes treatment experience from the patient–proxy perspective. It highlights the importance of a provider setting attuned to EOL care needs. Adequate pain management, effective communication and realistic autonomy for patients and proxies are warranted.

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