Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer: Results from GOG 184

David Cella, Helen Huang, Howard D. Homesley, Anthony Montag, Ritu Salani, Koenraad De Geest, Roger Lee, Nick M. Spirtos

Research output: Contribution to journalArticle

17 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)538-542
Number of pages5
JournalGynecologic Oncology
Volume119
Issue number3
DOIs
StatePublished - Dec 2010
Externally publishedYes

Fingerprint

Peripheral Nervous System Diseases
Endometrial Neoplasms
Paclitaxel
Doxorubicin
Cisplatin
Cytidine Diphosphate
Therapeutics
Granulocyte Colony-Stimulating Factor
Linear Models
Neoplasms

Keywords

  • Endometrial cancer
  • Neuropathy
  • Neurotoxicity
  • Peripheral neuropathy
  • Quality of life

ASJC Scopus subject areas

  • Obstetrics and Gynecology
  • Oncology

Cite this

Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer : Results from GOG 184. / Cella, David; Huang, Helen; Homesley, Howard D.; Montag, Anthony; Salani, Ritu; De Geest, Koenraad; Lee, Roger; Spirtos, Nick M.

In: Gynecologic Oncology, Vol. 119, No. 3, 12.2010, p. 538-542.

Research output: Contribution to journalArticle

Cella, David ; Huang, Helen ; Homesley, Howard D. ; Montag, Anthony ; Salani, Ritu ; De Geest, Koenraad ; Lee, Roger ; Spirtos, Nick M. / Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer : Results from GOG 184. In: Gynecologic Oncology. 2010 ; Vol. 119, No. 3. pp. 538-542.
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T1 - Patient-reported peripheral neuropathy of doxorubicin and cisplatin with and without paclitaxel in the treatment of advanced endometrial cancer

T2 - Results from GOG 184

AU - Cella, David

AU - Huang, Helen

AU - Homesley, Howard D.

AU - Montag, Anthony

AU - Salani, Ritu

AU - De Geest, Koenraad

AU - Lee, Roger

AU - Spirtos, Nick M.

PY - 2010/12

Y1 - 2010/12

N2 - 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.

AB - 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.

KW - Endometrial cancer

KW - Neuropathy

KW - Neurotoxicity

KW - Peripheral neuropathy

KW - Quality of life

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