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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
  1. Dana M. Chase, MD*,
  2. James Kauderer, MA,
  3. Lari Wenzel, PhD,
  4. Lois Ramondetta, MD§,
  5. David Cella, PhD,
  6. Harry J. Long, MD and
  7. Bradley J. Monk, MD*
  1. *Creighton University School of Medicine at the University of Arizona Cancer Center at St. Joseph’s Hospital and Medical Center, Phoenix, AZ;
  2. NRG Oncology/Gynecologic Oncology Group Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY;
  3. University of California at Irvine, Irvine, CA;
  4. §MD Anderson Cancer Center, Houston, TX;
  5. Northwestern University/Prentice Women’s Hospital, Chicago, IL; and
  6. Mayo Clinic, Rochester, MN.
  1. Address correspondence and reprint requests to Dana M. Chase, MD, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Arizona Cancer Center, Creighton University School of Medicine at St. Joseph’s Hospital and Medical Center, a Dignity Health Member, 500 W Thomas Rd, Suite 600 Phoenix, AZ 85013. E-mail: Dana.chase{at}chw.edu.

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.

  • Quality of life
  • Gynecologic Oncology Group
  • Cervical cancer
  • Grade 3
  • Grade 4
  • Toxicity

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Footnotes

  • Harry J. Long III, MD, died January 2013.

  • This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group (GOG) Administrative Office (CA 27469) and the Gynecologic Oncology Group Statistical Office (CA 37517) and NRG Oncology Grant 1 U10 CA180822.

  • The authors declare no conflicts of interest.

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