@article{c76fcea8e1324c40a651058e7643d5ba,
title = "Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer: Results from GOG 184",
abstract = "Objective: In GOG 184, the addition of paclitaxel to cisplatin and doxorubicin offered no additional clinical benefit, yet was associated with increased provider-rated toxicity. We now compare patient-reported neuropathy between treatment arms and patient reports to the clinician reports of neuropathy. Methods: Of 659 enrolled patients, 552 were randomly assigned to receive either cisplatin 50 mg/m2 + doxorubicin 45 mg/m2 + G-CSF 5 μg/kg on days 2-11 ({"}CD{"}), or the above regimen plus paclitaxel 160 mg/m2 infused over 3 h ({"}CDP{"}). Patient-reported neuropathy was measured with 11-item Functional Assessment of Cancer Therapy - Neurotoxicity (FACT-Ntx) Scale, at baseline, and 4 weeks and 6 months post chemotherapy. Group differences on patient-reported neuropathy over time, and correspondence between patient and provider ratings, were evaluated by fitting linear mixed models to the data. Results: After adjusting for non-significant baseline differences in neuropathy, the average neuropathy (FACT-Ntx) score of CDP-treated patients was 5.2 points lower/worse (95% CI: 4.0-6.5; p < 0.001) than the average score observed in CD-treated patients. The difference diminished after 6 months but still remained statistically significant (difference = 1.6; 95% CI: 0.3-2.8; p = 0.014). The sensory component was most significantly affected. Each increase (worsening) of grade in provider-rated toxicity was significantly associated with change in patient-reported severity of 4-6 points in the 11-item total score and 2-3 points in the 4-item sensory neuropathy score. Conclusion: Patient-reported neuropathy was worse in CDP-treated patients compared to CD-treated patients, especially in the sensory component. Patient-reported change corresponded with provider grade, but offered more detail on the nature of impact.",
keywords = "Endometrial cancer, Neuropathy, Neurotoxicity, Peripheral neuropathy, Quality of life",
author = "David Cella and Helen Huang and Homesley, {Howard D.} and Anthony Montag and Ritu Salani and {De Geest}, Koen and Roger Lee and Spirtos, {Nick M.}",
note = "Funding Information: This study was supported by National Cancer Institute grants to the Gynecologic Oncology Group Administrative Office ( CA 27469 ) and the Gynecologic Oncology Group Statistical and Data Center ( CA 37517 ). The following Gynecologic Oncology Group member institutions participated in this study: Roswell Park Cancer Institute, University of Alabama at Birmingham, Duke University Medical Center, Abington Memorial Hospital, Walter Reed Army Medical Center, Wayne State University, University of Minnesota Medical School, University of Mississippi Medical Center, Colorado Gynecologic Oncology Group P.C., University of Washington, University of Pennsylvania Cancer Center, Milton S. Hershey Medical Center, University of Cincinnati, University of North Carolina School of Medicine, University of Iowa Hospitals and Clinics, University of Texas Southwestern Medical Center at Dallas, Indiana University School of Medicine, Wake Forest University School of Medicine, University of California Medical Center at Irvine, Tufts-New England Medical Center, Rush-Presbyterian-St. Luke's Medical Center, Magee Women's Hospital, SUNY Downstate Medical Center, University of Kentucky, University of New Mexico, The Cleveland Clinic Foundation, State University of New York at Stony Brook, Washington University School of Medicine, Memorial Sloan-Kettering Cancer Center, Cooper Hospital/University Medical Center, Columbus Cancer Council, University of Massachusetts Medical School, Fox Chase Cancer Center, Women's Cancer Center, University of Oklahoma, University of Virginia Health Sciences Center, University of Chicago, Eastern Collaborative Oncology Group, Mayo Clinic, Case Western Reserve University, Tampa Bay Cancer Consortium, Gynecologic Oncology Network, Fletcher Allen Health Care, 107, 114, and Community Clinical Oncology Program.",
year = "2010",
month = dec,
doi = "10.1016/j.ygyno.2010.08.022",
language = "English (US)",
volume = "119",
pages = "538--542",
journal = "Gynecologic oncology",
issn = "0090-8258",
publisher = "Academic Press Inc.",
number = "3",
}