Liu, Y., Zhang, J., Teng, Y., Zhang, L., Yu, P., Jin, B., … Li, Z. (2009). Thalidomide improves prevention of chemotherapy-induced gastrointestinal side effects following a modified FOLFOX7 regimen: Results of a prospective randomized crossover study. Tumori, 95, 691–696.
To evaluate the safety and effectiveness of thalidomide plus ramosetron and dexamethasone in controlling delayed chemotherapy-induced GI side effects following a moderately emetogenic FOLFOX7 regimen
Patients who were chemotherapy-naïve and scheduled to receive a moderately emetogenic FOLFOX7 regimen were randomized to two groups. Group A-B received ramosetron plus dexamethasone on day 1 in the first cycle. Group B received thalidomide twice a day on days 2-5 in cycle 1. Group B-A received the same drugs in reverse sequence.
All patients received ramosetron. All patients were permitted to receive a rescue dose of 10 mg dexamethasone IV if vomiting occurred more than two times within 24 hours.
The study was conducted at a single site at the China Medical University in China.
All patients were in active treatment.
This was a prospective, randomized, crossover-controlled study.
Neither palonosetron or aprepitant are commercially available in China. Thalidomide was associated with greater complete response of delayed nausea and delayed emesis. No significant adverse effects were noted with thalidomide.
Thalidomide has some efficacy in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving FOLFOX7 therapy in combination with other antiemetic regimens.