Lari Wenzel1, Helen Q Huang2, David Cella3, Chelsea O McKinney4, Michael A Zevon5, Jason A LaChance6, Joan L Walker7, Ritu Salani8, Susan C Modesitt9, Robert T Morris10, William H Bradley11, Matthew P Boente12, Vivian E von Gruenigen13. 1. Department of Medicine, Program in Public Health and Chao Family Comprehensive Cancer Center, University of California, Irvine, CA 92697, United States of America. Electronic address: lwenzel@uci.edu. 2. NRG Oncology Statistics & Data Center, Roswell Park Cancer Institute, Buffalo, NY 14263, United States of America. Electronic address: hhuang@gogstats.org. 3. Department of Medical Social Sciences and Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, IL 60612, United States of America. Electronic address: d-cella@northwestern.edu. 4. Department of Medicine, Program in Public Health and Chao Family Comprehensive Cancer Center, University of California, Irvine, CA 92697, United States of America. Electronic address: comckinn@uci.edu. 5. Department of Health Behavior, Roswell Park Cancer Institute, Buffalo, NY 14263, United States of America. 6. Maine Medical Partners Women's Health Division of Gynecologic Oncology, Scarborough, ME 04074, United States of America. Electronic address: lachaj1@mmc.org. 7. Stephenson Cancer Center, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Oklahoma, Oklahoma City, OK, United States of America. Electronic address: joan-walker@ouhsc.edu. 8. Division of Gynecologic Oncology, David Geffen School of Medicine at UCLA, Los Angeles, CA, United States of America. Electronic address: rsalani@mednet.ucla.edu. 9. Gynecologic Oncology Division, OB/GYN Department, University of Virginia, Charlottesville, VA 22908, United States of America. Electronic address: scm6h@virginia.edu. 10. Gynecologic Oncology Barbara Ann Karmanos Cancer Institute, Wayne State University School of Medicine, Detroit, MI, United States of America. Electronic address: rmorris@med.wayne.edu. 11. Department of OB/GYN, Medical College of Wisconsin, Milwaukee, WI 53226, United States of America. Electronic address: wbradley@mcw.edu. 12. U.S. Medical Affairs, Gyn-Oncology, Genentech, South San Francisco, CA 94080, United States of America. Electronic address: boente.matthew@gene.com. 13. Division of Gynecologic Oncology, Summa Health System, NEOMED, Akron, OH 44310, United States of America. Electronic address: vongruev@summahealth.org.
Abstract
OBJECTIVES: In a prospective study of platinum-resistant ovarian cancer patients, we examined whether the Disease-related Symptoms-Physical (DRS--P) scale of the NCCN/FACT-Ovarian Cancer Symptom Index-18 (NFOSI-18) is responsive to clinical change in patients estimated by their provider to survive at least six months. METHODS: The NFOSI-18, and other FACT measures, was collected at study entry and 3 and 6 months post-enrollment. Measures were compared for those who died or dropped off study prior to 3 months or prior to 6 months (assumed as health deterioration over time), or those who stayed on study through 6 months (presumed as stable disease over time). Statistical analyses included a fitted linear mixed model for estimating the group differences over time, Cox regression to assess the probability of survival with patient-reported outcomes, and effect size. RESULTS: DRS-P scores of patients who completed only one assessment were significantly lower compared to patients who were able to complete two assessments [5.9 points lower (2.0-9.8); p < 0.01], or three assessments [8.1 points lower (4.8-11.5); p < 0.01]. Measures of abdominal discomfort, functional well-being, emotional well-being, and quality of life were also significant, but treatment side effects were not. Further, in every scale except for neurotoxicity, higher (better) baseline scores were associated with a decreased likelihood of death, after adjusting for age, performance and disease status. CONCLUSION: The NFOSI-18 DRS-P scale is responsive to clinical change. It has potential as an indicator of changing health status with ovarian cancer disease progression, distinct from treatment side effects.
OBJECTIVES: In a prospective study of platinum-resistant ovarian cancer patients, we examined whether the Disease-related Symptoms-Physical (DRS--P) scale of the NCCN/FACT-Ovarian Cancer Symptom Index-18 (NFOSI-18) is responsive to clinical change in patients estimated by their provider to survive at least six months. METHODS: The NFOSI-18, and other FACT measures, was collected at study entry and 3 and 6 months post-enrollment. Measures were compared for those who died or dropped off study prior to 3 months or prior to 6 months (assumed as health deterioration over time), or those who stayed on study through 6 months (presumed as stable disease over time). Statistical analyses included a fitted linear mixed model for estimating the group differences over time, Cox regression to assess the probability of survival with patient-reported outcomes, and effect size. RESULTS: DRS-P scores of patients who completed only one assessment were significantly lower compared to patients who were able to complete two assessments [5.9 points lower (2.0-9.8); p < 0.01], or three assessments [8.1 points lower (4.8-11.5); p < 0.01]. Measures of abdominal discomfort, functional well-being, emotional well-being, and quality of life were also significant, but treatment side effects were not. Further, in every scale except for neurotoxicity, higher (better) baseline scores were associated with a decreased likelihood of death, after adjusting for age, performance and disease status. CONCLUSION: The NFOSI-18 DRS-P scale is responsive to clinical change. It has potential as an indicator of changing health status with ovarian cancer disease progression, distinct from treatment side effects.
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