Short summary

The use of anticancer treatment in the last month of life is questionable and should be avoided if possible. This population-based cohort study seeks to explore the magnitude and identify factors associated with its use. The study uses data from the CanEpid database on the population from 2010-2015.

Rationale

In Denmark, the medical specialty of clinical oncology provides complex and high-risk radiation therapy, medical treatment, and supportive care to patients diagnosed with solid malignancies. In this setting, anticancer treatment is prescribed with the aim to reduce risk of reoccurrence, cure the cancer, extent expected lifetime, and/or provide relief of symptoms. The decision to offer patients anti cancer treatment is made by physicians who continuously need to balance the expected effect and the possible side effects of the treatment, aiming to keep patients safe and the patient's quality of life at its maximum. 

Keeping patients safe throughout the course of their treatment is always given high priority; yet, predicting which patients are at particular risk at the time of prescription has proven difficult.

New research protocols and standard guidelines on curative and palliative treatments are rapidly introduced, and a historical underrepresentation of elderly cancer patients in clinical trials in combination with little focus on the treatments impact on quality of life2, makes transferal of results to the current and future population of elderly cancer patients difficult. 

In all leaving prescribing physicians with the difficult task of informing the patient of what to expect from the treatment in terms of anticancer effect, expected side effects, and impact on quality of life. 

An anticancer treatment received less than a month prior to the end of life can generally not be expected to provide any antitumor effect, and could leave the patient with only the possibility of experiencing unwanted and quality of life reducing side effects. Nevertheless, studies have shown that 9-33% of patients with incurable cancer receive anticancer treatment within the last months of life, most commonly in Non Small Cell Lung Cancer, colorectal cancer, and breast cancer groups. Recent studies are even questioning the effect of palliative anticancer treatment given to cancer patients in the last six months of life. A Dutch study of patients with advanced cancer showed a significantly higher healthcare consumption and a greater risk of dying in the hospital for patients treated with chemotherapy in the last tree months before death compared to patients who received best supportive care. 

Though patients have the right to receive information regarding the aim of therapy prior to initiation, a study showed that up to 80% of cancer patients who received therapy for incurable cancers reported not to be informed that the therapy was unlikely to cure their cancer. Conversely, studies have reported that when patients are offered end-of-life discussions, they are less likely to receive aggressive end-of-life care. Also, patients offered early palliative care as opposed to aggressive treatment, reported significant improvements in quality of life and mood. 

Due to the aging population, the economic burden of cancer is increasing rapidly. A disproportional share of healthcare costs is concentrated in the end-of-life period. A recent study found that aggressive end-of-life care (defined as chemotherapy administered 14 days prior to death, more than one admission to the hospital, or admission to intensive care unit in the last 30 days of life) incurred 43% higher costs than those managed non-aggressively. 

The magnitude of end-of-life treatment in the setting of Danish clinical oncology is unknown. We therefore find it important to explore both the magnitude of end-of-life treatment and the predisposing factors hereof in this setting. All in order to plan and evaluate the effect of future interventions aimed at reducing these treatments.

Research objectives:

1) To describe the magnitude of end-of-life treatment in the setting of Danish clinical oncology and to provide a baseline measurement

2) To identify subpopulations of patients more likely to receive ineffective anticancer treatment at the end of their life and their specific characteristics

3) To generate hypothesis to be tested in following research projects on how these patient populations at risk may receive a more patient centered integrated treatment and care plan focused on reducing the ineffective end-of-life anticancer treatments 

This project will be conducted as part of the postdoc project: 

Elderly Cancer Patients - moving towards at home curative intended antineoplastic therapy, early palliative care and "end-of-life discussion" by MD, PhD Thea Otto Mattsson, The Department of Clinical Oncology, Odense University Hospital 

Description of the cohort

Register-based  cohort study of all Danish cancer patients treated with anticancer medications at their "end-of-life" - defined as prescribed anticancer treatment in the last 30 days of life that died in 2010-2015. Only patients who died from cancer, with solid tumors, aged 18 years or above will be included. 

Data and biological material

Data will be retrieved from the CanEpid database within OPEN (Odense Patient data Explorative Network) , Odense Univeristy Hospital. This database holds data from the Danish Cancer Register, the Danish National Patient Registry, the Central Person Register, and the Cause of Death Register. 

We will use the following information:

Date of death, cancer diagnosis including stage, date of diagnosis, age, sex, number and type of anticancer treatment issued and received prior to date of death from a department of oncology, number of hospital admissions last year of life, other medications issued last year of life, status of terminal disease including date, referral to ambulatory or inpatient specialized palliative care. A Charlson Comorbidity Index (CCI) will be calculated from the available data on diagnosed comorbidity and age. 

Collaborating researchers and departments

Department of Clinical Oncology, Odense University Hospital

• Post Doc Trine Lembrecht Jørgensen, MD, PhD

OPEN - Odense Patient data Explorative Network, Odense University Hospital and Department of Clinical Research, University of Southern Denmark

• Postdoc Mette Bliddal, PhD, MHS 
• Professor, Anders Green, MD

Department of Clinical Oncology, University Hospital Zealand, Roskilde and Naestved

• Professor Jørn Herrstedt, MD

Academy of Geriatric Cancer Research - AgeCare, Odense University Hospital and Department of Clinical Oncology, Odense University Hospital

• Professor Dr. med. Marianne Ewertz

Research Unit of Clinical Pharmacy, Institute of Public Health, University of Southern Denmark and Department of Hospital Pharmacy, Odense University Hospital 

• Pharmacist Anton Pottegård, PhD

Future project protocols, based on the results from this study, is formed in cooperation with:    

Department of Clinical Oncology, Odense University Hospital

• Professor Olfred Hansen, MPO, PhD
• Post doc Karin Brochstedt Dieperink, RN, PhD