Pielichowski, W., Barzal, J., Gawronski, K., Mlot, B., Oborska, S., Wasko-Grabowska, A., & Rzepecki, P. (2011). A triple-drug combination to prevent nausea and vomiting following BEAM chemotherapy before autologous hematopoietic stem cell transplantation. Transplantation Proceedings, 43(8), 3107–3110.

To evaluate the efficacy of a triple-drug combination (palonosetron + aprepitant + dexamethasone) to prevent acute and delayed emesis after high-dose chemotherapy with BEAM (carmustine + etoposide + cytarabine + melphalan) before hematopoietic stem cell transplantation (HSCT) by comparison with historical control of patients treated with dexamethasone + ondansetron or dexamethasone + palonosetron

Triple drug antiemetic regimen (aprepitant 1 hour before chemotherapy [125 mg on day one and 80 mg on days 2 & 3] + 0.25 mg IV palonosetron 30 minutes before chemotherapy and 20 mg IV dexamtheasone 15 minutes before chemotherapy for day 1 and 12 mg daily for rest of chemotherapy regimen) was compared to data from historical control patients that received 32 mg ondansetron and IV dexamethasone daily during chemotherapy or palonosetron and dexamethasone (dexamethasone given as 20 mg IV day 1 and 12 mg daily for rest of chemotherapy regimen in all cases). Acute phase was defined as the first 24 hours after receiving chemotherapy, and delayed phase was definied as days 2–5.

• The study consisted of 96 participants.
• The age and gender of patients was not provided.
• The study group sample consisted of 54 patients with non-Hodgkin lymphoma and 42 patients with Hodgkin lymphoma for patients receiving “triple drug regimen.” Historical controls were described as “comparable in terms of numbers, age, sex, weight and underlying diseases.\"
• Historical control patients received ondansetron (32 mg IV daily during HDC) or palonosetron (assumed to be daily). Both regimens included dexamethasone.

The study was conducted at a single inpatient setting in Warsaw, Poland.

All patients were in active treatment.

This was a descriptive study with comparison to historical controls.

• Severity of nausea was measured on a 4-point scale with none = no nausea; mild = slight nausea but no disruption to daily activities; moderate = nausea and some disruption to daily activities; and severe = extreme nausea and severe disruption to daily activities. 
• Emetic response rate was evaluated using the following criteria: complete response = no emetic episodes; major response = 1-2 episodes; minor response = 3-5 episodes; and treatment failure = more than 5 episodes.
• Response to study drugs was measured on 4-point scale based on the relief of nausea and vomiting: highly effective, moderately effective, slightly effective, and not effective.

Patients treated with the triple-drug antiemetic combination showed higher response rates than those receiving palonosetron or ondansetron (+ dexamethasone) during both the acute and delayed phases in reduction of chemotherapy-induced nausea and vomiting (CINV).

Drawing conclusions based on the information provided in the study is difficult.

• The sample size was small with fewer than 100 participants.
• The researchers did not use validated tools to measure response.
• The article does not clearly indicate whether the study was observation or self-report. 
• The authors did not provide clear descriptions of the patients in the historical controls (e.g., number of patients, diagnosis, ages, sex). 
• The authors did not describe the statistical analysis process.
• The method of describing the results was confusing and difficult to interpret.

Although the study appeared to support the use of established CINV guidelines established by the National Comprehenaive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), the data in this study were of questionable significance because of the information provided and poor quality of the study.