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 consisted of 52 patients.
• Patient ages ranged from 18–70 years. The median age in group AB was 55.5 years, and the median age in group BA was 54 years.
• The sample was 33% female and 67% male.
• Cancer diagnoses were gastric (40%), colorectal (52%), and other (8%).
• Just over half (52%) of patients had a European Cooperative Oncology Group (ECOG) performance status of 0, and the balance (48%) had an ECOG performance status of 1.

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.

• For five days, patients recorded any episodes of vomiting and the degree of nausea and anorexia as well as peripheral neuropathy, sedation, hot flushes, headache, dry mouth, and rash. The article did not address where these effects were documented.
• Side effects were graded with the Common Toxicity Criteria of Adverse Events, version 2.0 (CTAE v.2.0).

• Complete response rates (CRR) and effective rates (ER) for acute nausea were not different on day 1. However, they were statistically significant for delayed nausea on days 2-4 for group B. The CRR and ER for both groups on day five were similar and showed no significance (CRR: p = 0.309, ER: p = 0.050).
• Efficacy for acute vomiting showed no significant difference between the groups. Group B's delayed vomiting rates were higher and statistically significant on days 2–3.
• No significant differences in adverse events was noted.

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.

• The sample size was small with fewer than 100 participants.
• No mention was made of how patients recorded their symptoms.
• Confirmation of clinical value is warranted with a larger study.
• The control group did not receive any placebo medication so patients knew when they were in the treatment phase because they received more medication; this may have biased the results.

Thalidomide has some efficacy in controlling delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving FOLFOX7 therapy in combination with other antiemetic regimens.