Table.
Results of Patient-Reported Outcome Comparisons in Randomized Clinical Trialsa
| Source/NCT (if applicable) | Comparison | Absolute Between-Arm Differences in Patients With Toxic Effects, % | Patient-Reported Outcome Measures | Results of Patient-Reported Outcome Comparisons |
|---|---|---|---|---|
| Eckhardt et al,6 2009 | Tipifarnib + gemcitabine vs placebo + gemcitabine | Anorexia, 31 Diarrhea, 10 Rash, 14 |
MPAC pain intensity; VAS | Daily diaries of pain intensity showed no differences between arms |
| Kindler et al,7 2011 NCT00471146 | Axitnib + gemcitibine vs placebo + gemcitabine | Anorexia, 10 Diarrhea, 11 Dysphonia, 18 Hypertension, 19 Mucositis, 13 Nausea, 10 |
EORTC QLQ-C30; EORTC QLQ-PAN26 | Patients in both arms reported ≥5-point mean improvement from baseline pain on the EORTC QLQ-C30 and pancreatic pain on the EORTC QLQ-PAN26 |
| Michaelson et al,8 2014 NCT00676650 | Sunitinib + prednisone vs placebo + prednisone | Anorexia, 23 Diarrhea, 31 Dysgeusia, 20 Fatigue, 26 Hand-foot syndrome, 26 Hypertension, 17 Mucositis, 24 Nausea, 22 |
mBPI-SF worst pain score | No difference in percentage of patient-reported pain between arms at 2 mo (17.3% vs 12.5%; P = .25), 4 mo (20.9% vs 16.3%; P = .32), or 6 mo (21.4% vs 17.3%; P = .39) |
| Natale et al,9 2011 NCT00364351 | Vandetanib vs erlotinib | Diarrhea, 12 Hypertension, 14 Rash, 10 |
EORTC QLQ-C30 | No significant differences between study arms in time to deterioration of disease-associated symptoms for patient-reported pain (HR, 0.96; 95% CI, 0.83–1.11; P = .58), cough (HR, 0.94; 95% CI, 0.80–1.09; P = .40), or dyspnea (HR, 1.08; 95% CI, 0.93–1.25; P = .33) |
| Sonpavde et al,10 2012 NCT00286793 | AT-101 + docetaxel + prednisone vs placebo + docetaxel + prednisone | Dehydration, 10 Nausea, 15 Peripheral neuropathy, 12 |
PPI | Patient-reported pain response rates did not differ significantly between study arms across all postcycle assessments (29% vs 28%) |
Abbreviations: AT-101, R-(–)-gossypol acetic acid; EORTC QLQ-C30, European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30; EORTC QLQ-PAN26, European Organisation for the Research and Treatment of Cancer Pancreatic Cancer Module; HR, hazard ratio; mBPI-SF, Modified Brief Pain Inventory-Short Form; MPAC, Memorial Pain Assessment Card; NCT, clinicaltrials.gov registration number; PPI, Present Pain Index; VAS, visual analog scale.
a
Trials had negative efficacy results but imbalances in toxic effects between arms by ≥10% for at least 3 toxic effects.