RCT in Mesothelioma Finds No Benefit From Early Palliative Care – Medscape

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YOKOHAMA, JAPAN ― Early specialist palliative care for patients newly diagnosed with mesothelioma did not improve quality of life and had no effect on survival in comparison with standard care.

These results, from an international randomized control trial known as RESPECT-MESO, were presented here by Fraser Brims, MD, from Curtin University, Perth, Australia.

Dr Brims said his team was inspired to conduct this trial by a landmark trial from 2010, led by Jennifer S. Temel, MD, that showed that early palliative care for lung cancer patients led to an increase in survival as well as quality of life. The findings led to new guidelines from the American Society of Clinical Oncology recommending that palliative care be started early for all cancer patients.

But, Dr Temel’s trial was conducted in the United States, which has a healthcare system different from those of other countries, he noted.

The mesothelioma trial was conducted in the United Kingdom and Australia.

Dr Brims and colleagues screened 687 patients newly diagnosed with mesothelioma (within a 6-week period before the trial). Of those patients, 150 either declined or refused to enter the trial; 93 other patients were excluded because their ECOG performance status was >2. Others were excluded because of comorbidities or for other reasons, leaving 174 trial participants.

The enrolled patients had a high symptom burden: 134 patients (77%) complained of dyspnea, and 100 (57.4%) had chest pain. A total of 103 patients (59.2%) completed at least one cycle of chemotherapy.

Patients were randomly allocated to receive either early specialist palliative care, which involved visits every 4 weeks, or standard care. The two groups were well matched, Dr Brims said. Most patients were male (79.9%). The median age was 72.6 years, as would be expected from a cancer that develops years after working with asbestos.

The results showed no difference between the two groups in the primary outcome ― quality of life at 12 weeks, measured on the EORTC C30 Global Health Status scale. There was also no difference at 12 weeks in scores on the General Health Questionnaire (GHQ-12) for mood and anxiety.

By 24 weeks, 30 patients had died. Assessment of the remaining patients again showed no difference in either quality of life or in mood/anxiety at 24 weeks.

There was some crossover, Dr Brims noted: 15 patients (17.2%) in the control arm were referred to specialist palliative care at 12 weeks, and 30 patients (34.5%) were referred by 24 weeks. Dr Brims did not feel these referrals would have affected the findings, and the study was not underpowered.

“I do reckon this is a real result,” he said. Offering early specialist palliative care to these patients did not alter the outcome and did not improve their quality of life, he concluded.

“At first I was disappointed with the results,” he told journalists here at a press briefing.

“Then I got to thinking, and I suspect that the current provision of care was already brilliant.” These patients would have been seen by an expert senior clinician, as well as by a specialist thoracic nurse or specialist chemotherapy nurse. Adding specialist palliative care to care at this level did not make much difference, he said.

“This is an vital study,” commented Sanjay Popat, MD, consultant thoracic medical oncologist at the Royal Marsden Hospital, London, United Kingdom. The burden of symptoms is very high for patients with mesothelioma, and so you would expect that early palliative care would help to alleviate these symptoms and help to make these patients feel better. The fact that it did not suggests that the standard care they had received was already very excellent and that everything that could be done had been done, he commented to Medscape Medical News.

The discussant of the presentation, Prasad Adusumilli, MD, from the Memorial Sloan Ketterring Cancer Center in New York City, said this was a “very vital” study. Randomized studies in mesothelioma are rare, he noted, and this result is new. Also, he commented that patients with mesothelioma do not have long to live (survival is typically 1 year) and that it is vital that they not suffer in the small time they have left, he said.

He also highlighted the role played by practice nurses. He said they are responsible for the fantastic care that the patients in the standard-care group received, which could not be bettered even by adding early specialist palliative care.

The study was funded by the British Lung Foundation and the Australian Foundation. Dr Brims and Dr Adusumilli have told no relevant financial relationships.

18th World Conference on Lung Cancer (WCLC). Abstract OA 02.05, presented October 16, 2017.

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