A trial led from Cambridge has demonstrated improved survival and quality of life with the use of second line docetaxel chemotherapy in patients with advanced oesophago-gastric cancer that is resistant to first line chemotherapy.
This is the first study to evaluate patient-reported outcomes and quality of life in this treatment setting.
The trial, known as the COUGAR-02 study, was funded by Cancer Research UK and supported by the NIHR Cambridge Biomedical Research Centre and the Cambridge Clinical Trials Unit – Cancer Theme. The study was led by Dr Hugo Ford and colleagues from the thoracic oncology team and oesophago-gastric unit at Addenbrooke’s Hospital.
The trial recruited 168 patients from 30 centres in the UK between 2008 and 2012, and randomly assigned each patient to receive either docetaxel chemotherapy for up to six cycles (18 weeks) or active symptom control with no chemotherapy.
Docetaxel is an established treatment for some other cancers including breast, lung and prostate cancer, and is known to cause side effects including hair loss, gastrointestinal disturbance, tiredness and infection. This trial was specifically designed to demonstrate whether the chemotherapy allowed people to live longer and, importantly, to assess the effect of the treatment on their quality of life.
Patients on both arms of the trial were regularly assessed clinically and were asked to complete standard questionnaires every six weeks which assessed various elements of quality of life including function scores such as physical, social, cognitive and emotional functioning, and symptoms such as pain, nausea, hair loss and fatigue.
The results of the trial showed that patients treated with docetaxel lived longer on average than patients treated with symptom control alone, and that there was no overall adverse effect of chemotherapy on quality of life. There were significant improvements in a number of important symptoms such as pain, swallowing and nausea.
Dr Hugo Ford, Consultant in Medical Oncology said, ‘Unfortunately, the prognosis for patients when their tumour progresses after first line treatment can be very poor. Until now we were not certain whether offering these patients chemotherapy might do as much harm as good. From the results of this trial we can now see that chemotherapy is of benefit to patients both in terms of improving survival times, but also, critically, that it can improve symptoms and does not worsen quality of life. This will be of great benefit to patients and clinicians as they discuss treatment options available.’
The conclusion of the paper, published this week online in the Lancet Oncology is that docetaxel can be recommended as an appropriate second-line treatment for patients with oesophago-gastric adenocarcinoma that is resistant to first line treatment.
Dr Se Hoon Park, of the Samsung Medical Centre in Seoul, South Korea commenting in the Lancet Oncology said, ‘The COUGAR-02 investigators should be commended for doing this trial – their findings seem to end the debate about the benefits of second-line chemotherapy in patients with advanced oesophago-gastric adenocarcinoma… Any oncologists who do not recommend further treatment in this setting should change their care of patients with pre-treated oesophago-gastric adenocarcinoma immediately.’
