Gynecological Cancer

PV 04 - Poster Viewing Q&A - Session 4

TU_37_2729 - Patient Reported Outcomes and Acute Adverse Events of Definitive Radiotherapy for Cervical and Vaginal Cancer

Tuesday, September 17
2:45 PM - 4:00 PM
Location: ASTRO Innovation Hub

Patient Reported Outcomes and Acute Adverse Events of Definitive Radiotherapy for Cervical and Vaginal Cancer
K. Aziz1, A. E. Garda2, T. C. Mullikin2, B. J. Stish2, M. G. Haddock2, and I. A. Petersen2; 1Mayo Clinic Medical Scientist Training Program, Rochester, MN, 2Department of Radiation Oncology, Mayo Clinic, Rochester, MN

Purpose/Objective(s): Radiation therapy is a definitive treatment modality for many patients with cervical and vaginal cancers. We report prospectively collected physician-reported adverse events (AEs) and patient reported outcomes (PRO) for patients treated with definitive radiation therapy (RT) for cervical or vaginal cancer.

Materials/Methods: We identified patients with cervical or vaginal cancer treated at our institution between 2013 and 2018. For inclusion in this analysis, receipt of definitive RT and completion of baseline and post-treatment questionnaires were required. Physician-reported AEs were prospectively assessed prior to, immediately upon completion, and within 3 months of RT using CTCAE Version 4.0. AEs were categorized and reported with the highest grade per patient. For PRO assessment, a gynecologic specific subset of the PRO-CTCAE designed to assess symptom impact on daily living was used.

Results: 67 patients (55 cervical, 12 vaginal) met inclusion criteria. 98.6% of patients received concurrent chemotherapy and 27.6% received adjuvant chemotherapy. Median external beam RT elective dose was 4500 cGy (range 4500-5625 cGy) with a simultaneous integrated boost (73.1%) to involved lymph nodes (median 5625 cGy, range 5000-6250 cGy) or parametria (median 5500 cGy, range 5000-5625 cGy). Median brachytherapy dose was 3000 cGy in 5 fractions. There was no grade 4 or 5 physician-reported AEs. There were 6 grade 3 AEs: anemia (3), proctitis (1), nausea (1), fatigue (1). There were 103 grade 1 or 2 AEs including gastrointestinal (64%), urinary (22%), pelvic pain (15%), and constitutional (43%). At 3 months, there were 8 grade 1 and 2 AEs and no grade 3 or higher AEs. 20 patients completed PRO surveys sufficient for analysis. PRO questions were assessed on a 5-point scale with high toxicity considered level 3, 4, or 5: occasionally, frequently or almost constantly; somewhat, quite a bit or very much; moderate, severe or very severe. Proportions of patients reporting high scores for each symptom are shown in the table below. Most PRO-CTCAE symptoms increased at end of treatment with return to baseline by 3 months post-RT.

Conclusion: Definitive RT for cervical and vaginal cancers is well tolerated acutely with minimal early serious physician-reported adverse events. However, patients report more severe GI, urinary, gynecologic effects, and interference with daily activities. Both physician reported adverse events and patient reported outcomes are generally improved by 3 months post-treatment.
Symptom Baseline (%) End of RT (%) 3 Months Post-RT (%)
Diarrhea 18 65 14
Flatulence 50 65 40
Bowel incontinence 6 30 15
Urinary frequency 23 55 29
Urinary urgency 14 30 19
Urinary incontinence 6 21 5
Pain with urination 17 25 10
Vaginal dryness 12 5 24
Fatigue 29 45 24
Pain 25 13 17

Author Disclosure: K. Aziz: None. A.E. Garda: None. T.C. Mullikin: None. M.G. Haddock: Board Member; ISIORT. Stock ownership, no oncologic products; Amarin. I.A. Petersen: Co-chair Radiation Oncology Committee; NRG Oncology.

Khaled Aziz, MS, BS

Mayo Clinic Alix School of Medicine

Biography:
Khaled Aziz is a MSTP student at Mayo Clinic school of medicine. His clinical research focuses on toxicity outcomes after radiation therapy in various malignancies and doctoral dissertation focused on chromosomal instability. Previously, he studied oxidatively induced complex DNA damage as an undergraduate student at East Carolina University. He was previously employed as a research technologist at Johns Hopkins Department of Radiation Oncology studying epithelial mesenchymal transition and mechanisms of radiation sensitization. His passion outside of aademics are running and soccer.

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