Test group and control group had achieved better efficacy without of acute nausea and vomiting prior to level 3 and delayed acute nausea and vomiting prior to level 4. Complete response for level 1 acute nausea, level 3 delayed nausea and vomiting
were 100% in test group, but there were no statistically difference compared with control group (p > 0.05). The efficacy for level 2 acute or delayed nausea and vomiting in test group were superior to control group (p < 0.05). Table 3 Complete response of CINV in different grade Complete response (%) AN AV DN DV L1 L2 L1 L2 L1 L2 L3 L1 L2 L3 TG 96.70 97.52 97.52 99.17 90.08 94.21 100 93.39 96.70
100 CG 100 87.04 97.22 91.66 82.40 62.96 99.07 89.81 76.85 99.07 P value > 0.05 www.selleckchem.com/products/Neratinib(HKI-272).html < 0.05 > 0.05 < 0.05 > 0.05 < 0.05 > 0.05 > 0.05 < 0.05 > 0.05 Definition of nausea according to CTCAE V 3.0 L1: Loss HDAC inhibitor of appetite without alteration in eating habits L2: Oral intake decreased without significant weight loss, dehydration or malnutrition; IV fluids, indicated < 24 hrs. L3: inadequate oral caloric and/or fluid intake, IV fluids, tube feedings, or TPN indicated ≥ 24 hrs L4: Life-threatening consequences L5: Death Definition of nausea according to CTCAE V 3.0 L1: 1 episode in 24 hrs L2: 2-5 episodes in 24 hrs; IV fluids indicated < 24 hrs L3: > = 6 episodes in 24 hrs; IV fluids, or TPN indicated > = 24 hrs L4: Life-threatening consequences L5: Death Secondary efficacy parameters There were 214 patients whose QoL data could be evaluated. The QLQ-C30 responses were scored and analyzed according
to algorithms in a scoring manual supplied by the EORTC Study Group on Quality of life. An increased score for a functional domain and global QoL scale represents an improvement of functioning, an decreased score for a symptom scale represents an improvement of symptomatic problem. After chemotherapy an improvement in global health status, emotional functioning, cognitive functioning, pain, dyspnoea, Aspartate insomnia, appetite loss were seen in test group, but no difference in cognitive functioning, dyspnoea and appetite loss were seen (p > 0.05). After chemotherapy an improvement in pain and dyspnoea were seen in the control group, but no difference in pain was seen (p > 0.05). Comparing test group and control group in QoL evolution, significant differences were seen in global health status, emotional functioning, social functioning, fatigue, nausea and vomiting, insomnia and appetite loss evolution in favour of test group (p < 0.01). All the enrolled patients had completed the study.