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A Phase III Randomized Trial Comparing Patient-Reported Toxicity and Quality of Life (QOL) During Pelvic Intensity Modulated Radiation Therapy as Compared to Conventional Radiation Therapy

      Purpose/Objective(s)

      To determine if pelvic intensity modulated radiation therapy (IMRT) results in a significant reduction in patient reported acute toxicity, and better QOL as compared to standard radiation.

      Materials/Methods

      Patients with cervical and endometrial cancer who received pelvic radiation postoperatively were stratified by dose (45 or 50.4 Gy), use of chemotherapy (none or 5 cycles of weekly cisplatin at 40 mg/m2), and disease site, and then randomly assigned to standard 4-field radiation or IMRT. The primary endpoint was change in acute gastrointestinal (GI) toxicity from baseline to 5 weeks measured by the bowel domain of Expanded Prostate Cancer Index Composite (EPIC). Change in EPIC score was calculated such that a negative change score indicated a decline in function. With an effect size of 0.4, a t test with 1 interim look and a 2-sided alpha = 0.05, 225 patients were needed for 85% power. Secondary endpoints included a comparison of adverse events, urinary toxicity using EPIC and QOL using the FACT-G with cervix subscale. A Wilcoxon signed rank test was used for non-normal data.

      Results

      There were 289 patients enrolled between November 2012 and August 2015; 11 patients were found to be ineligible, leaving 278 eligible patients. The conventional RT arm had a significantly larger mean decline in EPIC bowel summary score at 5 weeks as compared to the IMRT arm (-23.6 vs. -18.6, P = 0.048). The median change in bowel function subscale was -17.9 for the conventional RT arm, as compared to -14.3 for the IMRT arm (P = 0.03). For the bother subscale, the median change in score was -21.4 as compared to -21.4 (P = 0.18). The conventional arm experienced a significantly larger mean decline in EPIC urinary summary score at 5 weeks as compared to the IMRT arm (-10.4 vs. -5.6, P = 0.03). At 5 weeks from the start of RT, the conventional arm experienced more high-level adverse events measured by the Patient-Reported Outcomes version of the Common Terminology for Adverse Events(PRO-CTCAE) for diarrhea (frequency, P = 0.01), and fecal incontinence (frequency, P = 0.01; interference, P = 0.04). In addition, 20.4% of women on the standard RT arm took 4 or more antidiarrheal medications daily, as compared to 7.8% of women on the IMRT arm (P = 0.04). Quality of life measured with the FACT-Cx demonstrated a greater decline in the trial outcome index score in patients treated with conventional radiation as compared to patients receiving IMRT (-12.8 vs. -8.8, P = 0.03).

      Conclusion

      Intensity modulated radiation therapy reduces acute patient reported GI and GU toxicity as compared to standard RT. Furthermore, patients treated with IMRT experienced better QOL during treatment. Longer follow-up will be needed to determine if differences in acute toxicity result in lower rates of chronic toxicity.

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