Adding Thalidomide to Palonosetron, Dexamethasone Reduces CINV
Patients who received the THD addition experienced improved delayed CINV prevention.
The addition of thalidomide (THD) to palonosetron (PAL) and dexamethasone (DEX) significantly improved delayed chemotherapy-induced nausea and vomiting (CINV) prevention in patients with cancer receiving highly emetogenic chemotherapy (HEC), according to a study published in The Journal of Clinical Oncology.
For this double-blind, phase 3 study (ClinicalTrials.gov Identifier: NCT02203253), researchers assigned 638 chemotherapy naive patients who received a cisplatin or cyclophosphamide-doxorubicin/epirubicin containing HEC regimen to receive PAL and DEX with THD or placebo. The 4-point Likert scale was used to assess nausea and anorexia on days 1 to 5, and quality of life (QOL) was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 version 3 questionnaire on days –1 and 6.
Patients who received THD experienced greater complete response rates in the delayed period compared with patients receiving placebo (76.9% vs 61.7%; P <.001). Patients in the THD group also had greater response rates compared with those in the placebo group (66.1% vs 53.3%; P =.001).
The THD group also experienced higher rates of no nausea in the delayed phase compared with those receiving placebo (47.3% vs 33.3%; P <.001) and in the overall period (41.0% vs 29.63%; P =.003), respectively. Mean scores of anorexia were lower overall (0.44 ± 0.717 vs 0.64 ± 0.844; P =.003).
Patients in the THD arm experienced higher rates of mild to moderate adverse events, including sedation, dizziness, constipation, and dry mouth, but reported having a greater QOL after chemotherapy.
The study authors conclude saying “the current study may justify the use of THD combined with PAL and DEX as a new option to prevent CINV after HEC”.
1. Zhang L, Qu X, Teng Y, et al. Efficacy of thalidomide in preventing delayed nausea and vomiting induced by highly emetogenic chemotherapy: a randomized, multicenter, double-blind, placebo-controlled phase III trial (CLOG1302 study) [published online August 30, 2017]. J Clin Oncol. doi: 10.1200/JCO.2017.72.2538