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International trial confirms safety, effectiveness of high-dose brachytherapy plus pelvic radiation for cervical cancer

Press releases may be edited for formatting or style | September 25, 2017 ASTRO Rad Oncology Radiation Therapy

Overall survival at five years following treatment was 67.2 percent for all patients (95% CI = 62.7-71.2%). The survival rate was higher for women with stage IIB disease (71%) than for stage IIIB disease (58%) (p = 0.03). Overall survival rates for patients who received pelvic radiation and 4x7 Gy HDR brachytherapy were 73.1 and 62.2 percent with and without chemotherapy, respectively. Among patients in the 2x9 Gy HDR brachytherapy group, rates were 65.1 and 68.3 percent with and without chemotherapy, respectively (p = 0.1 between the four arms).

Among patients with stage IIB disease, neither brachytherapy dosing nor the addition of chemotherapy had a significant influence on the overall survival rate. Survival rates were estimated using the Kaplan-Meier method and compared between arms using the log-rank test.

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Five-year rates of locoregional control, or tumor control in the site and surrounding area of the primary tumor, favored the 4x7 Gy brachytherapy approach, with or without the addition of systemic therapy (p = 0.0007). Rates for patients who received pelvic radiation and 4x7 Gy brachytherapy were 88 and 89 percent with and without chemotherapy, respectively, compared to control rates on the 2x9 Gy brachytherapy arm of 78 and 75 percent with and without chemotherapy, respectively.

Severe treatment-related side effects did not differ significantly between treatment arms. Actuarial rates of grade 3 or higher genitourinary side effects for patients who received pelvic radiation and 4x7 Gy brachytherapy were 5.9 and 7.3 percent with and without chemotherapy, respectively; for the 2x9 Gy brachytherapy arm, they were 7.2 and 7.3 percent with and without chemotherapy, respectively. Actuarial rates of grade 3 or higher gastrointestinal side effects for patients who received pelvic radiation and 4x7 Gy brachytherapy were 6 and 5.3 percent with and without chemotherapy, respectively; for the 2x9 Gy brachytherapy arm, rates were 5.9 and 5.3 percent with and without chemotherapy, respectively.

There was a modest positive effect of cisplatin on toxicity in the 2x9 Gy brachytherapy arm only (p = 0.066), but chemotherapy did not significantly influence overall survival, cancer-specific survival or tumor control in the cervix and surrounding region.

"The findings that chemotherapy did not significantly affect survival or tumor control in this setting seem to be different than the results of the meta-analysis from the Chemoradiotherapy for Cervical Cancer Meta-Analysis Collaboration, which found six percent differences in local control due to the effect of chemotherapy," explained Dr. Abdel-Wahab. "However, it is important to note that our study was not powered to detect differences in local control that are less than 10 percent. In other words, the results of the two studies are not mutually exclusive."

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