Abstract 2505
Background
Worldwide, according to WHO 2014, over 19 million patients are in need of palliative care, 34% of them will die of cancer. Palliative care research brings many challenges. This metaresearch study aims to evaluate how clinical research on palliative care is conducted within the setting of incurable cancer.
Methods
Clinicaltrials.gov was searched to identify all registered studies investigating palliative care in patients with advanced or metastatic cancer. The EORTC QLQ-C15-PAL questionnaire was used to define the domains of interest. We excluded studies investigating cancer-directed therapy, management of cancer treatment-related adverse events, and diagnostic tests. Publication status was crosschecked using PubMed.
Results
Of 3950 identified studies, 514 studies were included. The most frequent reason for exclusion was cancer-directed therapy (2491). In 2007-2012, 161 studies were registered vs 245 in 2013-2018. Included studies were interventional (84%, 430/514) or observational (16%, 84/514). Most studies were sponsored by academia (79%), and conducted in North America (57%) or Europe (25%). 67% of studies evaluated a heterogeneous population (any tumour type). 60% were monocentric studies. Interventional studies most frequently investigated systemic drugs (34%, 148/430), behavioural interventions (29%, 125/430), and procedures for pain (24%, 103/430). Pain, quality of life and physical function were the most studied palliative issues (188, 95, 52 studies respectively). Fewer studies investigated health care planning (45), emotional function (35), appetite (22), social function (22), fatigue (20), dyspnea (18), sleep disturbance (5), cognitive function (5), nausea (4), and constipation (3). The most applied primary outcome measures were efficacy/symptom control (61.5%, 316), quality of life (14.2%, 73) and feasibility (11.7%, 60). Only 16% of the closed studies had published results.
Conclusions
The studies investigating palliative care in patients with incurable tumours constitute a very small part of cancer clinical research. More than one third of studies examine pain, leaving other palliative issues less explored in clinical research. Furthermore, the results of these studies are under reported in the literature.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5751 - Phase 3 ALTA-3 study of brigatinib (BRG) vs alectinib (ALC) in patients (pts) with advanced anaplastic lymphoma kinase (ALK)−positive non–small cell lung cancer (NSCLC) that progressed on crizotinib (CRZ)
Presenter: Sanjay Popat
Session: Poster Display session 1
Resources:
Abstract
5103 - CANOPY phase 3 program: Three studies evaluating canakinumab in patients with non-small cell lung cancer (NSCLC)
Presenter: Luis Paz-Ares
Session: Poster Display session 1
Resources:
Abstract
3666 - The Elderly Patient Individualized Chemotherapy (EPIC) trial, a study for an aged population of non-small cell lung cancer.
Presenter: Francesco Passiglia
Session: Poster Display session 1
Resources:
Abstract
4799 - KEYNOTE-495/KeyImPaCT: A Randomized, Biomarker-Directed, Phase 2 Trial of Pembrolizumab-Based Therapy for Non–Small Cell Lung Cancer (NSCLC)
Presenter: Martin Gutierrez
Session: Poster Display session 1
Resources:
Abstract
6035 - Safety, tolerability and activity of autologous T cells with enhanced T-cell receptors specific to NY ESO 1/LAGE 1a (GSK3377794) alone, or in combination with pembrolizumab, in advanced non small cell lung cancer: A Phase 1b/2a randomised pilot study
Presenter: Karen Reckamp
Session: Poster Display session 1
Resources:
Abstract
2176 - IFCT-1701 DICIPLE: a randomized phase 3 trial comparing continuation Nivolumab-Ipilimumab doublet immunotherapy until progression versus observation in patients with PDL1-positive stage IV Non-Small Cell Lung Cancer (NSCLC) after Nivolumab-Ipilimumab induction treatment
Presenter: Gerard Zalcman
Session: Poster Display session 1
Resources:
Abstract
2352 - ATALANTE-1 randomized phase 3 trial, OSE-2101 versus standard treatment as second or third line in HLA-A2 positive advanced non-small cell lung cancer (NSCLC) patients
Presenter: Enriqueta Felip
Session: Poster Display session 1
Resources:
Abstract
2451 - Phase Ib dose-escalation/expansion study of BI 836880, a VEGF/Ang2-blocking nanobody®, in combination with BI 754091, an anti-PD-1 antibody, in patients with advanced solid tumours
Presenter: Nicolas Girard
Session: Poster Display session 1
Resources:
Abstract
4285 - Radiosurgery followed by Tumor Treating Fields (TTFields) for brain metastases (1-10) from NSCLC in the phase 3 METIS trial
Presenter: Minesh Mehta
Session: Poster Display session 1
Resources:
Abstract
4909 - Nivolumab plus ipilimumab (NI) versus chemotherapy plus nivolumab (CN) in squamous cell lung cancer (SqCLC): the SQUINT trial
Presenter: Lorenza Landi
Session: Poster Display session 1
Resources:
Abstract