ABSTRACT: 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.
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.
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.
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.
Gynecologic Oncology 12/2010; 119(3):538-42. · 3.89 Impact Factor