Ursula A Matulonis1, Helen Q Huang2, Virginia L Filiaci3, Marcus Randall4, Paul A DiSilvestro5, Katherine M Moxley6, Jeffrey M Fowler7, Matthew A Powell8, Nick M Spirtos9, Krishnansu S Tewari10, William E Richards11, John M Nakayama12, David G Mutch13, David S Miller14, Daniela Matei15, Lari B Wenzel16. 1. Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: Ursula_Matulonis@dfci.harvard.edu. 2. NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: HuangH@NRGOncology.org. 3. NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. Electronic address: FiliaciV@NRGOncology.org. 4. University of Kentucky, Department of Radiation Medicine, Lexington, KY, USA. Electronic address: merand2@uky.edu. 5. Women and Infants Hospital in Rhode Island/The Warren Alpert Medical School of Brown University, Providence, RI, USA. Electronic address: PDiSilvestro@Wihri.org. 6. Stephenson Cancer Center Gynecologic Cancers Clinic, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Electronic address: kmoxley@med.umich.edu. 7. Ohio State University Comprehensive Cancer Center, Obstetrics and Gynecology, Hilliard, OH, USA. Electronic address: Jeffrey.Fowler@osumc.edu. 8. Washington University School of Medicine, Siteman Cancer Center, St. Louis, MO, USA. Electronic address: mpowell@wustl.edu. 9. Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: nspirtos@wccenter.com. 10. University of California Irvine Medical Center, Irvine, CA, USA. Electronic address: ktewari@uci.edu. 11. Georgia Core, Gynecologic Oncology, St. Joseph's Candler Oncology, Savannah, GA, USA. 12. UH Cleveland Medical Center. University Hospitals, Cleveland, OH, USA. Electronic address: john.nakayama@ahn.org. 13. Washington University School of Medicine, Siteman Cancer Center, St. Louis, MO, USA. Electronic address: mutchd@wudosis.wustl.edu. 14. University of Texas Southwestern Medical Center, Dallas, TX, USA. Electronic address: David.Miller@utsouthwestern.edu. 15. Northwestern University, Division of Gynecologic Oncology Chicago, IL, USA. Electronic address: Daniela.matei@northwestern.edu. 16. University of California Irvine Medical Center, Irvine, CA, USA. Electronic address: lwenzel@uci.edu.
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. TRIAL REGISTRATION: NCT00942357.
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. TRIAL REGISTRATION: NCT00942357.
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Authors: Stephanie M de Boer; Melanie E Powell; Linda Mileshkin; Dionyssios Katsaros; Paul Bessette; Christine Haie-Meder; Petronella B Ottevanger; Jonathan A Ledermann; Pearly Khaw; Alessandro Colombo; Anthony Fyles; Marie-Helene Baron; Ina M Jürgenliemk-Schulz; Henry C Kitchener; Hans W Nijman; Godfrey Wilson; Susan Brooks; Silvestro Carinelli; Diane Provencher; Chantal Hanzen; Ludy C H W Lutgens; Vincent T H B M Smit; Naveena Singh; Viet Do; Romerai D'Amico; Remi A Nout; Amanda Feeney; Karen W Verhoeven-Adema; Hein Putter; Carien L Creutzberg Journal: Lancet Oncol Date: 2018-02-12 Impact factor: 41.316