title: Factors associated with grade 3 or 4 treatment-related toxicity in women with advanced or recurrent cervical cancer: an exploratory analysis of NRG Oncology/Gynecologic Oncology Group trials 179 and 204.
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.
authors.affiliation: *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.
authors.forename: Dana M
authors.initials: DM
authors.lastname: Chase
authors.forename: James
authors.initials: J
authors.lastname: Kauderer
authors.forename: Lari
authors.initials: L
authors.lastname: Wenzel
authors.forename: Lois
authors.initials: L
authors.lastname: Ramondetta
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Harry J
authors.initials: HJ
authors.lastname: Long
authors.forename: Bradley J
authors.initials: BJ
authors.lastname: Monk
mesh_terms: D000740:Anemia / Q000453:epidemiology / Q000209:etiology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D064146:Chemotherapy-Induced Febrile Neutropenia / Q000453:epidemiology / Q000209:etiology; D018450:Disease Progression; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology* / Q000209:etiology*; D005221:Fatigue / Q000453:epidemiology / Q000209:etiology; D005260:Female; D005767:Gastrointestinal Diseases / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000453:epidemiology; D012008:Recurrence; D012307:Risk Factors; D012720:Severity of Illness Index; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000453:epidemiology* / Q000473:pathology