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The standard treatment for women with stage III / IVA endometrial cancer after surgery is chemotherapy and radiation therapy to prevent recurrence. But in a surprising new finding, radiation therapy combined with chemotherapy has not increased survival without recurrence in these women, reports a study of the Gynecology Oncology Group sponsored by the National Cancer Institute and led by a scientist / physician from Northwestern Medicine.
This is the first study comparing the combination regimen with chemotherapy alone. It was published June 12 in the New England Journal of Medicine.
"The trial was supposed to be a positive test demonstrating that the combination regimen was superior to chemotherapy alone," said Dr. Daniela Matei, Senior Researcher, Professor of Medicine at Feinberg School of Medicine at Northwestern University and Oncologist Northwestern Medicine gynecological chart. "Our results indicate that combined radiotherapy / chemotherapy treatment did not result in improved survival without recurrence and that chemotherapy alone remains the standard of treatment for stage III uterine cancer."
Matei is also co-leader of the solid tumors translational research program at Robert H. Lurie Cancer Research Center, Northwestern University.
Endometrial cancer, which begins in the uterus, is the most common gynecologic cancer. Most cases occur in women after the age of 55. About 62,000 new cases will be diagnosed this year. The frequency and mortality of endometrial cancer are increasing, which could be related to the obesity epidemic, said Matei.
Usually, endometrial cancer presents with irregular postmenopausal bleeding. There is no screening, but any bleeding after menopause should trigger a visit and examination of a doctor, said Matei. Most cases are diagnosed at an early stage and cured by surgery alone.
The Phase 3 trial randomly badigned 736 eligible patients to one of two possible treatment arms. A group of 346 people received combined treatment consisting of chemotherapy and radiation therapy for 21 weeks, and a second group of 361 women received chemotherapy alone for 17 weeks.
A median follow-up of six months after the randomized phase 3 trial showed that the recurrence-free survival of the two arms of the trial was very similar: 59% for the group receiving chemotherapy and radiotherapy and 58% % for chemotherapy alone.
Patients treated with both chemotherapy and radiotherapy had fewer recurrences in the pelvis, but this did not result in improved survival without recurrence, as there were recurrences outside the radiation.
"For patients at high risk of local relapse, radiation may sometimes be needed to prevent pelvic recurrence," said Matei.
Radiation can cause immediate and chronic side effects that impact the quality of life of treated patients. These include diarrhea, low blood counts, urinary symptoms and others.
"An important consideration is the fact that concomitant administration of chemotherapy and radiotherapy may result in decreased tolerance to treatment and incomplete administration of chemotherapy," Matei said. "More than 25% of patients badigned to the combined arm have not been able to complete chemotherapy during this study."
Historically, radiation was first used before recognizing that chemotherapy could play a role in the treatment of endometrial cancer. After the addition of chemotherapy to treatment, radiotherapy continued to be used as a standard approach.
Listen to the podcast on this study right here.
This study was funded by grants CA 27469, CA 37517, 1 U10 CA180822, U10CA180868 and UG1 CA189867 from the National Cancer Institute of the National Institutes of Health.
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