The chemotherapy drug capecitabine gives patients a better quality of life and is as effective at preventing breast cancer from returning as the alternative regimen called CMF, when given following epirubicin. These are the results of a clinical trial part-funded by Cancer Research UK and published* in The Lancet Oncology today (Tuesday).
Around 4,400 patients** on the TACT2 clinical trial were treated with the chemotherapy drug epirubicin followed by either capecitabine or CMF, after surgery.
Researchers at The Institute of Cancer Research, London, and the Cancer Research UK Edinburgh Centre found that capecitabine resulted in patients experiencing fewer side effects and having a better quality of life, and it was as effective at preventing cancer’s return as CMF.***
Most patients experienced some side effects regardless of the treatment they were given. But those taking CMF were more likely to experience severe side effects including early menopause, nausea, infection, thrombosis, and anaemia.****
During the trial, patients were followed up after 12, 18 and 24 months, and then yearly for at least 10 years, to see if their cancer had returned and to monitor side effects. More than 85 per cent of patients did not experience their cancer returning for at least five years.
Professor Judith Bliss, director of the Clinical Trials and Statistics Unit at The Institute of Cancer Research, London, who led the management of the trial said: “The TACT2 trial is the largest single study to look at the benefits of these different treatment approaches and schedules for chemotherapy to treat breast cancer.
“We’ve been able to show that capecitabine can be used as an alternative to CMF for part of the chemotherapy regime, giving patients a better quality of life without reducing their chances of survival.”
The researchers also tested whether having an accelerated course of epirubicin – given every two weeks instead of three – was more effective or better tolerated by patients, but the results showed that it wasn’t.
This trial was the first to look in detail at experience of accelerated chemotherapy from the patient’s perspective, with some patients completing self-assessments of their symptoms and side effects.
Professor David Cameron, clinical chief investigator on TACT2, clinical director of the Cancer Research UK Edinburgh Centre and director of cancer services in NHS Lothian, said: “Using patient-reported data was extremely valuable because we could learn what patients find tolerable and where they struggle to cope during treatment.
“This new approach to chemotherapy may benefit a range of breast cancer patients, including younger women who want to preserve their fertility.”
Professor Arnie Purushotham, Cancer Research UK’s senior clinical adviser, said: “Treatment for many breast cancer patients is very successful and now it’s important to research how to improve patient experience and minimise the adverse effects of treatment.
“The results of this trial will form an important part of the discussions doctors have with patients when deciding on the most appropriate chemotherapy.”
The TACT2 trial was funded by Cancer Research UK, Roche UK, Pfizer UK and Amgen UK, and co-sponsored by The Institute of Cancer Research, London, and NHS Lothian.
*Cameron, D., et al. Accelerated versus standard epirubicin followed by cyclophosphamide, methotrexate, and fluorouracil or capecitabine as adjuvant therapy for breast cancer in the randomised UK TACT2 trial (CRUK/05/19): a multicentre, phase 3, open-label, randomised, controlled trial. The Lancet Oncology.
**4391 Patients were recruited from 129 UK centres. Eligible patients were women or men aged 18 or over with histologically confirmed invasive primary breast carcinoma. The patients had all undergone complete surgical excision and were due to receive adjuvant chemotherapy to decrease the chance of recurrence.
The aim of the study was to determine what effects these variations would have on the likelihood that a patient’s cancer would return, and also the side effects experienced.
Patients were randomised to receive either standard epirubicin followed by CMF, accelerated epirubicin followed by CMF, standard epirubicin followed by capecitabine, or accelerated epirubicin followed by capecitabine.
***For more information about CMF and capecitabine including a list of side effects, please follow these links.
****A higher proportion of patients taking CMF experienced toxicity at grade 3 or above for fatigue, nausea, mucositis/stomatitis, thrombosis/embolism, infection, anaemia, leucpenia, neutropenia, thrombocytopenia and febrile neutropenia. A higher proportion of patients taking capecitabine experienced toxicity at grade 3 or above for hand-foot syndrome.
From self-reported quality of life analysis, it was found that patients taking CMF had significantly worse tiredness, constipation, sore mouth, mouth ulcers and breathlessness whereas patients on capecitabine had significantly worse dry/sensitive skin and tingling/numb/sore hands and feet.
74.8 per cent of patients on CMF and 42.3 per cent on capecitabine had permanently discontinued periods.