Hesketh, P.J., Bosnjak, S.M., Nikolic, V., & Rapoport, B. (2011). Incidence of delayed nausea and vomiting in patients with colorectal cancer receiving irinotecan-based chemotherapy. Supportive Care in Cancer: Official Journal of the Multinational Association of Supportive Care in Cancer, 19, 2063–2066.

To prospectively determine the frequency of delayed nausea and vomiting with irinotecan-based chemotherapy following day 1 prophylaxis with a 5-HT₃ receptor antagonist and dexamethasone

All patients received irinotecan-based chemotherapy. All patients received a standard antiemetic regimen prior to chemotherapy consisting of dexamethasone (8 mg oral or IV) and a 5-HT₃ receptor antagonist (8 mg IV or 24 mg oral ondansetron, 100 mg IV or oral dolasetron, and 1 mg IV or 2 mg oral granisetron) given immediately prior to the start of chemotherapy only. No routine antiemetics were prescribed after day one for prophylaxis or delayed emesis. Palonosetron was not permitted in this study. All patients received a prescription for rescue therapy, only to be used during the first 120 hours. Patients were monitored for 120 hours after the initiation of irinotecan by the study coordinator who called at timed intervals to assist patients in completing diaries. During this study, patients only were observed on their first cycle of the irinotecan-based chemotherapy.

• This study consisted of 44 patients.
• The median age was 61 years with a range of 39-79 years.
• The sample was 84% male and 16% female.
• Patients had been diagnosed with colorectal cancer.
• All patients were receiving irinotecan-based chemotherapy (38 patients received a FOLFIRI regimen, five patients, received irinotecan in combination with cetuximab, and only one patient received irinotecan alone).
• One patient had a history of motion sickness, and three of the seven female patients (43%) had a history of morning sickness.
• To be included in the study, patients had to be older than 18 years of age and have European Cooperative Oncology Group Performance Status of 0–2.
• Patients with history of moderate to severe nausea or any vomiting with prior chemotherapy were not eligible.

The study was conducted at multiple outpatient settings through the St. Elizabeth’s Medical Center in Boston, MA; Holy Family Hospital in Methuen, MA; and the Institute for Radiology and Oncology of Serbia.

• All patients were in active treatment.
• This study has application to late effects and survivorship.

This was a prospective, observational study.

• Patient diaries were used to record the frequency and timing of vomiting or retching episodes and the use of rescue meds (1–5 retches over 5 minutes was counted as a single emetic episode).
• A four-point categorical scale was used to assess the extent of nausea experienced in the preceding 24-hour period (0 = none, 1 = mild [did not interfere with normal daily life], and 3 = severe [patients bedridden because of nausea]). 
• Complete control was defined as no emesis, no nausea, and no use of rescue antiemetics.
• Complete response was defined as no emesis and no use of rescue antiemetics.

• The majority (89%) of the 44 patients enrolled in the study had no emesis during the overall period, 9% experienced vomiting or retching during the delayed period, and 7% vomited during the first 24 hours after irinotecan administration.
• Fifteen patients (34%) experienced delayed nausea (mild in 11 patients, moderate in 4 patients). Six patients (14%) took rescue antiemetics during the delayed period.
• Delayed and overall complete response rates were 86% (acute), 82% (delayed), and 77% (overall).
• Complete control was 86% (acute), 64%(acute), and 59%(delayed).
• Achieving a complete response during the acute period predicted for a high likelihood of attaining a complete response during the delayed period (95%).

The results of the study showed efficacy in reducing or controlling delayed nausea and vomiting during the 24-hour period following administration of a camptothecin analogue, a moderately ematogenic  antineoplastic agent, when dexamethasone and a 5-HT₃ receptor antagonist was used as prophylaxis for acute chemotherapy-induced nausea and vomiting (CINV).

• The sample size was small.
• The sample was primarily male. No comparative control group and the male-to-female ratio may have affected results because of gender imbalance with a larger male population.

The use of dexamethasone and a 5-HT₃ receptor antagonist prior to administration of a camptothecin analogue is recommended in the literature and has been shown to be beneficial in controlling acute CINV, which contributes in reducing delayed nausea and vomiting.