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 3h ("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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA. d-cella@northwestern.edu
authors.forename: David
authors.initials: D
authors.lastname: Cella
authors.forename: Helen
authors.initials: H
authors.lastname: Huang
authors.forename: Howard D
authors.initials: HD
authors.lastname: Homesley
authors.forename: Anthony
authors.initials: A
authors.lastname: Montag
authors.forename: Ritu
authors.initials: R
authors.lastname: Salani
authors.forename: Koen
authors.initials: K
authors.lastname: De Geest
authors.forename: Roger
authors.initials: R
authors.lastname: Lee
authors.forename: Nick M
authors.initials: NM
authors.lastname: Spirtos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced*; D057566:Self Report
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D004317:Doxorubicin; D017239:Paclitaxel; D002945:Cisplatin