(RxWiki News) Sometimes clinical trials have to be stopped because the therapy being tested does more harm than good. This is what happened in recent esophageal cancer study.
A phase II trial looking at adding Erbitux (cetuximab) to chemotherapy/radiotherapy treatment for esophageal cancer has been halted.
Esophageal cancer patients who received cetuximab along with chemoradiotherapy (chemotherapy given at the same time as radiation) did not live as long as those treated only with chemoradiotherapy (CRT).
The medicine was also more toxic for patients than the standard treatment.
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Researchers in England, led by Thomas Crosby, FRCR, of the Velindre Cancer Centre in Cardiff, UK, conducted the trial to evaluate the safety and effectiveness of adding cetuximab to chemotherapy given to patients with esophageal cancer that had not spread (metastasized).
Esophageal cancer is very aggressive and often lethal. The cancer attacks the esophagus, the tube that connects the throat with the stomach. About 18,000 Americans will be diagnosed with esophageal cancer this year and 15,000 will die from the disease.
The disease is usually treated with surgery and/or chemotherapy and radiation.
In this trial, a total of 258 esophageal cancer patients were randomly assigned to receive CRT alone or CRT plus cetuximab. Participants were recruited from throughout the UK and treated between 2008 and 2012.
Half of the patients (129) received 400 mg/m2 on day one then 250 mg/m2 weekly of cetuximab. The CRT group received cisplatin and capecitabine (chemotherapy agents) at the same time they were receiving radiotherapy.
The researchers looked for patients whose treatment had not failed at 24 weeks. Overall survival was also measured.
The results were disappointing:
- 66.4 percent of patients who received cetuximab plus CRT were treatment failure-free at 24 months compared to 76.9 percent of patients who received only CRT.
- Median overall survival for the cetuximab group was also shorter than the CRT group – 22.1 months versus 25.4 months.
- 79 percent of the patients who received cetuximab had serious side effects compared to 63 percent of those who underwent CRT alone.
“The addition of cetuximab to standard chemotherapy and radiotherapy cannot be recommended for patients with oesophageal cancer suitable for definitive CRT,” the authors concluded.
Cetuximab is approved by the US Food and Drug Administration to treat metastatic (spread) colorectal cancer and head and neck cancer.
Findings from this trial were published in the June issue of The Lancet Oncology.
Cancer Research UK funded the study. No conflicts of interest were reported.
