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