Abstract
Introduction: Chemotherapy plus radiation (Cis-RT + CP) did not demonstrate superiority in prolonging relapse-free survival compared to chemotherapy alone in patients with stage III or IVA endometrial carcinoma. The impact of treatment on quality of life (QOL), neurotoxicity (NTX) and psychometric properties of the gastrointestinal (GI) symptoms subscale during treatment and up to 1 year are described herein. Methods: QOL assessments were scheduled at baseline, 6 weeks (post completion of RT (Cis-RT + CP) or prior to cycle 3 (CP)), then 18 weeks (end of treatment) and 70 weeks (1 year after the end of treatment) after starting treatment. QOL instruments included the FACT-En TOI, FACT/GOG-neurotoxicity (Ntx) subscale (short), and the gastrointestinal (GI) symptoms subscale. Results: At the end of treatment, patients receiving Cis-RT + CP reported a statistically significant decreased QOL when compared to CP. The decline in QOL was reflected in physical well-being, functional well-being, and endometrial cancer specific concerns, but the minimally important differences (MID) were not considered clinically meaningful. Patients in both groups reported increased chemotherapy-induced Ntx symptoms with the CP group having worse scores and reaching peak symptoms at the time of chemotherapy completion. Patients on Cis-RT + CP reported statistically significantly worse GI symptoms after radiation therapy compared to patients on CP, this occurred across assessment intervals, though the MID was not meaningful. Psychometric evaluations indicated that the GI symptom scale is reliable, valid, and responsive to change. Conclusions: PROs indicate that the chemoradiotherapy group experienced worse HRQoL and GI toxicity compared to patients randomized to chemotherapy alone for locally advanced endometrial cancer though based on the MID, these were not clinically meaningful differences. The GI symptom subscale was a reliable and valid scale that has value for future trials.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 428-436 |
| Number of pages | 9 |
| Journal | Gynecologic oncology |
| Volume | 164 |
| Issue number | 2 |
| DOIs | |
| State | Published - Feb 2022 |
Funding
This study was funded by the National Cancer Institute awards to NRG Oncology SDMC ( 1U10 CA180822 ), NRG Operations ( U10CA180868 ), and NCORP ( UG1CA189867 ). Dr. Virginia L. Filiaci reports receiving support for the present manuscript from NCTN and NCORP SDMC grant funding from the NIH/NCI. She also reports grants from GOG Foundation, Inc. for contracts with institution for clinical trial work and NCI/NIH for IOTN, BIQSFP, MP2PRT and miscellaneous other subcontracts. Dr. Filiaci also reports receiving support for attending IDMC meeting from VBL Therapeutics as well as participating on Advisory Board for Tesaro. Monitoring Board. Dr. Katherine Moxley reports P20 grant to University of Oklahoma for Drug Resistance Core from the NIH as well as support for travel to attend NRG Oncology 2019 Winter and Summer meetings. Additionally, Dr. Moxley reports serving in a Leadership role for the SGO Program Committee.This study was funded by the National Cancer Institute awards to NRG Oncology SDMC (1U10 CA180822), NRG Operations (U10CA180868), and NCORP (UG1CA189867). The following NRG Oncology/Gynecologic Oncology Group institutions participated in this study: Seoul National University Hospital, Women and Infants Hospital, University of Oklahoma Health Sciences Center, Ohio State University Comprehensive Cancer Center, Washington University School of Medicine, Women's cancer Center of Nevada, University of California Medical Center at Irvine-Orange Campus, Georgia Center for Oncology Research and Education (CORE), Case Western Reserve University, Cancer Trials Support Unit, University of Colorado Cancer Center-Anschutz Cancer Pavilion, University of North Carolina at Chapel Hill, Cancer Research Consortium of West Michigan NCORP, University of Iowa Hospitals and Clinics, Abington Memorial Hospital, University of Kentucky, Cooper Hospital University Medical Center Stony Brook University Medical Center, Yale University, Cancer Research for the Ozarks NCORP, Metro-Minnesota CCOP, University of New Mexico, MD Anderson Cancer Center, Fox Chase Cancer Center, University of Chicago, Walter Reed National Military Medical Center, Rush University Medical Center, State University of New York Downstate Medical Center, Memorial Sloan Kettering Cancer Center, The Hospital of Central Connecticut, Wake Forest University Health Sciences, Cleveland Clinic Foundation, Aurora Women's Pavilion of Aurora West Allis Medical Center, University of Hawaii, Mayo Clinic, Wayne State University/Karmanos Cancer Institute, University of Cincinnati, University of Texas Southwestern Medical Center, Indiana University Hospital/Melvin and Bren Simon Cancer Center, University of Wisconsin Hospitals and Clinics, Kaiser Permanente-Vallejo, Iowa-Wide Oncology Research Coalition NCORP, Duke University Medical Center, University of California at Los Angeles Health System, Fred Hutchinson Cancer Research Center, University of Pittsburgh Cancer Institute (UPCI), Saint Joseph's Hospital and Medical Center, Carolinas Medical Center/Levine Cancer Institute, Lewis Cancer and Research Pavilion at St. Joseph's/Candler, Kalamazoo CCOP, University of Alabama at Birmingham, University of Mississippi Medical Center, Abramson Cancer Center of The University of Pennsylvania, Penn State Milton S Hershey Medical Center, Gynecologic Oncology of West Michigan PLLC, UCSF-Mount Zion, Froedtert and the Medical College of Wisconsin, Geisinger Medical Center, Saint Vincent Hospital, Wichita CCOP, Sanford NCI Community Oncology Research Program of the North Central Plains, Columbus NCI Community Oncology Research Program, Southeast Cancer Control Consortium CCOP, Sanford NCI Community Oncology Research Program of the North Central Plains, Columbus NCI Community Oncology Research Program, Southeast Cancer Control Consortium CCOP, University of Virginia, University of Texas - Galveston, Baystate Medical Center, Evanston CCOP-NorthShore University Health System, Greenville Health System Cancer Institute/Greenville CCOP, Florida Hospital Cancer Institute CCOP, University of Minnesota Medical Center - Fairview, Henry Ford Hospital, Rutgers Cancer Institute of New Jersey, Thomas Jefferson University Hospital, Huntsman Cancer Institute/University of Utah, Emory University School of Medicine, Johns Hopkins University/Sidney Kimmel Cancer Center, Allegheny General Hospital, Wisconsin NCI Community Oncology Research Program, Central Illinois CCOP, Northern Indiana Cancer Research Consortium, Virginia Mason CCOP, Nevada Cancer Research Foundation CCOP, Sanford Roger Maris Cancer Center, Montana Cancer Consortium-CCOP, University of New Mexico and John H. Stroger Jr. Hospital of Cook County. Dr. Katherine Moxley reports P20 grant to University of Oklahoma for Drug Resistance Core from the NIH as well as support for travel to attend NRG Oncology 2019 Winter and Summer meetings. Additionally, Dr. Moxley reports serving in a Leadership role for the SGO Program Committee.
Keywords
- Chemotherapy
- Combined radiation therapy
- Endometrial cancer
- Patient reported outcomes
- Quality of life
ASJC Scopus subject areas
- Obstetrics and Gynecology
- Oncology
