Dana M Chase1, James Kauderer, Lari Wenzel, Lois Ramondetta, David Cella, Harry J Long, Bradley J Monk. 1. *Creighton University School of Medicine at the University of Arizona Cancer Center at St. Joseph's Hospital and Medical Center, Phoenix, AZ; †NRG Oncology/Gynecologic Oncology Group Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY; ‡University of California at Irvine, Irvine, CA; §MD Anderson Cancer Center, Houston, TX; ∥Northwestern University/Prentice Women's Hospital, Chicago, IL; and ¶Mayo Clinic, Rochester, MN.
Abstract
OBJECTIVE: This study aimed to describe pretreatment patient characteristics and baseline quality-of-life scores as they relate to the development of grade 3 or 4 toxicity in patients receiving chemotherapy for advanced/recurrent cervical cancer. METHODS: The study sample was drawn from Gynecologic Oncology Group protocols 179 and 204. Grade 3 or 4 toxicities were considered in 4 specified categories as follows: peripheral neuropathy, fatigue, hematological, and gastrointestinal (GI). The data variables explored included age, stage, pretreatment radiation, performance status (PS) at treatment initiation, and baseline Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) score. A logistic regression model was developed with various adverse events as binary (0/1) outcomes. RESULTS:Six hundred seventy-three patient-reported questionnaires were used in the analyses. At baseline, pain was the most severe patient-reported symptom. Baseline line-item patient concerns did demonstrate specific correlations with the development of individual toxicities. In 401 patients who were enrolled on Gynecologic Oncology Group 204 (fatigue not measured on 179), a worse PS predicted the development of grade 3 or 4 fatigue (odds ratio, 2.78; 95% confidence interval, 1.66-4.68). Exposure to previous radiation, treatment regimen, and a worse FACT-Cx score were associated with the reporting of both grade 3 or 4 leukopenia (P < 0.05) and anemia (P < 0.0005). Performance status and treatment regimen (P < 0.05) were associated with the development of grade 3 or 4 thrombocytopenia. Age and treatment regimen (P < 0.05) were associated with the development of grade 3 or 4 neutropenia. The FACT-Cx score (P = 0.0016) predicted grade 3 or 4 GI toxicity. CONCLUSIONS: The development of fatigue, hematological, and GI toxicity might be predictable based on factors other than treatment assignment such as age, PS, and patient-reported quality-of-life measurement.
RCT Entities:
OBJECTIVE: This study aimed to describe pretreatment patient characteristics and baseline quality-of-life scores as they relate to the development of grade 3 or 4 toxicity in patients receiving chemotherapy for advanced/recurrent cervical cancer. METHODS: The study sample was drawn from Gynecologic Oncology Group protocols 179 and 204. Grade 3 or 4 toxicities were considered in 4 specified categories as follows: peripheral neuropathy, fatigue, hematological, and gastrointestinal (GI). The data variables explored included age, stage, pretreatment radiation, performance status (PS) at treatment initiation, and baseline Functional Assessment of Cancer Therapy-Cervix (FACT-Cx) score. A logistic regression model was developed with various adverse events as binary (0/1) outcomes. RESULTS: Six hundred seventy-three patient-reported questionnaires were used in the analyses. At baseline, pain was the most severe patient-reported symptom. Baseline line-item patient concerns did demonstrate specific correlations with the development of individual toxicities. In 401 patients who were enrolled on Gynecologic Oncology Group 204 (fatigue not measured on 179), a worse PS predicted the development of grade 3 or 4 fatigue (odds ratio, 2.78; 95% confidence interval, 1.66-4.68). Exposure to previous radiation, treatment regimen, and a worse FACT-Cx score were associated with the reporting of both grade 3 or 4 leukopenia (P < 0.05) and anemia (P < 0.0005). Performance status and treatment regimen (P < 0.05) were associated with the development of grade 3 or 4 thrombocytopenia. Age and treatment regimen (P < 0.05) were associated with the development of grade 3 or 4 neutropenia. The FACT-Cx score (P = 0.0016) predicted grade 3 or 4 GI toxicity. CONCLUSIONS: The development of fatigue, hematological, and GI toxicity might be predictable based on factors other than treatment assignment such as age, PS, and patient-reported quality-of-life measurement.
Authors: Deborah K Armstrong; Brian Bundy; Lari Wenzel; Helen Q Huang; Rebecca Baergen; Shashikant Lele; Larry J Copeland; Joan L Walker; Robert A Burger Journal: N Engl J Med Date: 2006-01-05 Impact factor: 91.245
Authors: David S Ettinger; Philip J Bierman; Bob Bradbury; Carli C Comish; Georgiana Ellis; Robert J Ignoffo; Steve Kirkegaard; Dwight D Kloth; Mark G Kris; Dean Lim; Michael Anne Markiewicz; Robert McNulty; Lidia Nabati; Barbara Todaro; Susan Urba; Sally Yowell Journal: J Natl Compr Canc Netw Date: 2007-01 Impact factor: 11.908
Authors: Andreas A Argyriou; Panagiotis Polychronopoulos; Angelos Koutras; Gregoris Iconomou; Alexander Iconomou; Haralabos P Kalofonos; Elisabeth Chroni Journal: Support Care Cancer Date: 2005-02-15 Impact factor: 3.603
Authors: Peter Barrett-Lee; Carsten Bokemeyer; Pere Gascón; J W R Nortier; Maurice Schneider; Dirk Schrijvers; Simon Van Belle Journal: Oncologist Date: 2005-10
Authors: Andreas A Argyriou; Panagiotis Polychronopoulos; Angelos Koutras; Gregoris Iconomou; Philippos Gourzis; Konstantinos Assimakopoulos; Haralabos P Kalofonos; Elisabeth Chroni Journal: Support Care Cancer Date: 2005-07-15 Impact factor: 3.603
Authors: Harry J Long; Brian N Bundy; Edward C Grendys; Jo Ann Benda; D Scott McMeekin; Joel Sorosky; David S Miller; Lynne A Eaton; James V Fiorica Journal: J Clin Oncol Date: 2005-05-23 Impact factor: 44.544
Authors: Sandro Pignata; Sabino De Placido; Rosalbino Biamonte; Giovanni Scambia; Giovanni Di Vagno; Giuseppe Colucci; Antonio Febbraro; Marco Marinaccio; Alessandra Vernaglia Lombardi; Luigi Manzione; Giacomo Cartenì; Mario Nardi; Saverio Danese; Maria Rosaria Valerio; Andrea de Matteis; Bruno Massidda; Giampietro Gasparini; Massimo Di Maio; Carmela Pisano; Francesco Perrone Journal: BMC Cancer Date: 2006-01-07 Impact factor: 4.430
Authors: Dana Chase; Helen Q Huang; Bradley J Monk; Lois Michelle Ramondetta; Richard T Penson; Karen Gil; Lisa M Landrum; Mario Leitao; Ana Oaknin; Warner K Huh; Heather L Pulaski; Katina Robison; Saketh R Guntupalli; Debra Richardson; Ritu Salani; Michael W Sill; Lari B Wenzel; Krishnansu Sujata Tewari Journal: Int J Gynecol Cancer Date: 2020-02-28 Impact factor: 3.437