Although random studies have always indicated that radiotherapy, or radiation therapy, offers an added benefit to cancer treatment when used in conjunction with chemotherapy and surgery, a randomized multicenter phase 2 trial is suggesting that it adds no benefit at all. In fact, radiation therapy may actually cause more harm and good.
The multicenter phase 2 trial, known as the SAKK 17/04 trial, has been studying people with malignant pleural mesothelioma who were treated with chemotherapy and extrapleural pneumonectomy surgery. Random patients in the study were given a high dosage of radiation therapy, whereas the remaining patients were not. Per Rolf A. Stahel, MD, from the University Hospital of Zurich, those who were given radiation therapy has a shorter median overall survival rate when compared to those that did not.
“Our findings do not support the routine use of hemithoracic radiotherapy for malignant pleural mesothelioma after neoadjuvant chemotherapy and extrapleural pneumonectomy.”
Due to the results, the physicians conducting the study indicate that treatment methods for mesothelioma need to be revised. However, they welcome the results of the trial, as it clearly helps them see that radiation therapy may not be as promising as once thought.
“We welcome the findings of the SAKK 17/04 trial. The heterogeneity of mesothelioma and the multiplicity of treatments make it impossible to separate the signal from the noise without control groups. More randomized trials are needed so that even if the lives of patients with mesothelioma cannot be extended, at least they will not be given treatments that make their lives worse.”
All patients that participated in the study were confirmed to have pleural mesothelioma prior to the phase 2 trial beginning. Each patient’s mesothelioma was considered to be resectable prior to the trial starting. The median dosage of radiation therapy administered to those chosen to receive was 55.9 Gy.
Adverse Reactions to Radiation Therapy
The most common adverse reactions to chemotherapy were nausea and vomiting, pneumonitis, and esophagitis. At least one person passed away from these adverse reactions. Other adverse reactions to radiation therapy included:
- Weight loss
- An increase in creatinine concentration
- Radiation dermatitis
- An increase in phosphatase concentration
- Extreme fatigue
The survival rate of those who didn’t undergo radiation therapy was 20.8 months, whereas the overall survival rate of the group that had radiation therapy was 19.3 months. According to the physicians that conducted the trial,
“The overall median survival of 20 months in part 2 was less than expected when compared with — often retrospective — clinical reports. According to the results of our trial, hemithoracic radiotherapy after extrapleural pneumonectomy resulting in a macroscopically complete resection provides an additional treatment burden without benefiting the patient.”
The study was carried out in 12 different hospitals in Switzerland, as well as one hospital in Germany, and another in Belgium. For more information, refer to the November 2 issue of the online journal, Lancet Oncology.
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