Patient-reported outcomes during pelvic radiation therapy: A secondary analysis on sexual function from NRG-RTOG 1203.

person Kelsey L Corrigan Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX info_outline Kelsey L Corrigan, Rebecca Paulus, Ann Klopp, Lari B. Wenzel, Anamaria R Yeung, J Spencer Thompson, Desiree E. Doncals, Vijayananda Kundapur, Nancy H Wiggers, Dasarahally S. Mohan, Sharad A. Ghamande, Shannon Neville Westin, Kara Schnarr, Michael Haas, David K. Gaffney, Steven E. Waggoner, Pamela Vanderwall, Noha Jastaniyah, Stephanie L. Pugh, Lisa A. Kachnic

Authors person Kelsey L Corrigan Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX info_outline Kelsey L Corrigan, Rebecca Paulus, Ann Klopp, Lari B. Wenzel, Anamaria R Yeung, J Spencer Thompson, Desiree E. Doncals, Vijayananda Kundapur, Nancy H Wiggers, Dasarahally S. Mohan, Sharad A. Ghamande, Shannon Neville Westin, Kara Schnarr, Michael Haas, David K. Gaffney, Steven E. Waggoner, Pamela Vanderwall, Noha Jastaniyah, Stephanie L. Pugh, Lisa A. Kachnic Organizations Department of Radiation Oncology, University of Texas MD Anderson Cancer Center, Houston, TX, NRG Oncology Statistics and Data Management Center, Philadelphia, PA, University of Texas MD Anderson Cancer Center, Houston, TX, University of California - Irvine, Irvine, CA, University of Florida, Gainesville, FL, University of Oklahoma Health Sciences Center, Oklahoma City, OK, Summa Health Medical Group, Akron, OH, Saskatchewan Cancer Agency, Saskatoon, SK, Canada, Northside Radiation Oncology, Alpharetta, GA, The Permanente Medical Group, South San Francisco, CA, Augusta University, Augusta, GA, McMaster University and Juravinski Cancer Centre, Hamilton, ON, Canada, Berks Radiation Oncology Associates, West Reading, PA, University of Utah, Salt Lake City, UT, Case Western Reserve University and Cleveland Clinic, Cleveland, OH, Aurora BayCare Medical Center, Green Bay, WI, King Faisal Specialist Hospital, Riyadh, Saudi Arabia, New York Presbyterian - Columbia, New York, NY Abstract Disclosures Research Funding U.S. National Institutes of Health U.S. National Institutes of Health Background: NRG-RTOG 1203 reported that intensity-modulated radiation therapy (IMRT) reduced patient-reported GI and GU toxicities in cervical/endometrial cancer patients receiving adjuvant RT, as compared to standard whole field pelvic RT (WPRT). We conducted a secondary analysis of patient-reported sexual function (PR-SF) to compare this endpoint among treatment groups and identify factors associated with sexual dysfunction. Methods: Patients on NRG-RTOG 1203 were randomly assigned to WPRT vs. IMRT and completed the PRO-CTCAE for GI toxicity and the cervical cancer FACT-Cx at baseline, week 5 of RT, and at 4-6 weeks, 1-year, and 3-years post-RT. Patient responses to FACT-Cx sexual function questions were analyzed. The between arm frequency and severity of responses were tested using chi-square. PR-SF was compared with PRO-CTCAE GI toxicity using chi-square. A repeated measures logistic regression model was used to determine the impact of clinical/treatment factors on sexual function by dichotomizing the responses. Results: Of the 279 patients included for primary analysis, 236 (85%) completed PR-SF questions; 125 (53%) in the WPRT arm and 111 (47%) IMRT. There were no significant differences in PR-SF between treatment groups (p>0.05). PR-SF improved for both groups post-RT, except responses to “my vagina feels too narrow or short” worsened (Table). Women without abdominal pain interference at 4-6 weeks post-RT were less likely to fear sex (74.2% vs. 25.8%, P =0.03) and more likely to like their body appearance at 1 year (95.7% vs. 4.3%, P <0.01) compared to women with interference. Women liked the appearance of their body less during RT vs. at baseline (OR 1.95, 95% CI 1.04-3.64, P =0.04). Women were less interested in sex during RT in both arms (WPRT: OR 3.61, 95% CI 1.40-9.34; IMRT: OR 3.96, 95% CI 1.02-15.34) and at 4-6 weeks post-RT for IMRT (OR 3.16, 95% CI 1.14-8.72) vs. at baseline. Conclusions: PR-SF was similar between treatment groups. PR-SF during and post-RT was not significantly reduced compared to baseline with the exception of patients with abdominal pain interference, who had significantly worse PR-SF at 4-6 weeks and 1-year post-RT. Clinical trial information: NCT01672892. Longitudinal change in the percent of women reporting “very much” or “quite a bit”. Baseline During RT 4-6 Weeks Post-RT 1-Year Post-RT 3-Years Post-RT "I am bothered by discharge/bleeding from my vagina" (n=201) 3.1% (n=203) 1.5% (n=201) 0.5% (n=179) 1.1% (n=49) 0% "I am afraid to have sex" (n=192) 14.9% (n=184) 19% (n=192) 12.5% (n=174) 12.6% (n=48) 6.3% "My vagina feels too narrow/short" (n=190) 6% (n=183) 8.2% (n=190) 8.9% (n=171) 11.1% (n=47) 10.6% "I feel sexually attractive" (n=190) 25.2% (n=189) 21.7% (n=190) 18.9% (n=173) 24.9% (n=47) 23.4% "I am interested in sex" (n=192) 24.3% (n=192) 14.1% (n=192) 20.8% (172) 22.1% (n=47) 19.1% "I like the appearance of my body" (n=198) 29.9% (n=197) 22.8% (n=198) 26.8% (178) 27.0% (n=48) 29.2%

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