SAN DIEGO, Sept. 24, 2017 /PRNewswire-USNewswire/ -- Findings from a new multicenter, international clinical trial confirm the effectiveness of high-dose brachytherapy, or internal radiation therapy, for managing locally advanced cervical cancer. Tumor control was significantly better following four fractions of 7 Gray (Gy) each than following two, 9-Gy fractions of high-dose-rate (HDR) brachytherapy, but neither overall survival nor severe treatment-related side effects differed between the treatment groups. Findings from the International Atomic Energy Agency (IAEA) trial will be presented today at the 59th Annual Meeting of the American Society for Radiation Oncology (ASTRO).

"Cervical cancer is a leading cause of cancer death among women in the developing world, and 80 percent of these patients live in lower- or middle-income countries, such as the ones in our trial. It is essential that we have data applicable to these real-world settings," said May Abdel-Wahab, MD, PhD, FASTRO, a study co-author and director of the Division of Human Health at the International Atomic Energy Agency in Vienna, Austria.

"Our trial demonstrates that combining pelvic radiation therapy with four fractions of 7 Gy HDR brachytherapy is effective for locally advanced cervical cancer. In addition, it gives physicians data-supported guidance from a large, randomized study on what to expect in terms of outcomes if a regimen of two, 9-Gy fractions is used in resource-constrained settings."
The prospective, randomized multicenter trial tested two approaches to delivering HDR brachytherapy with or without chemotherapy for patients with intermediate-stage cervical cancer. All patients received 46 Gy of curative-intent pelvic external beam radiation therapy in 23 fractions. All patients also received HDR brachytherapy in one of two dosing schedules. Half of the patients received four applications of 7 Gy each (4x7 Gy), while the other half received two applications of 9 Gy each (2x9 Gy). Additionally, half of the patients in each brachytherapy group received chemotherapy (cisplatin 40 mg/m2 in weeks 1-5), while the other half did not. The median follow-up for surviving patients was 48 months (range 1-84 months).

A total of 601 patients with intermediate-stage cervical cancer were enrolled between September 2005 and May 2010. Patients in this international trial represented seven countries, including Mumbai (257 cases), Peru (147), South Africa (76), Brazil (53), Pakistan (31), Morocco (19) and Macedonia (18). The average patient age was 49 years (range 26-71). All patients had either stage IIB (73.2%) or stage IIIB (26.8%) disease, and no patients had contraindications for radiation therapy or chemotherapy.

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