Dopamine Receptor are rated based on their presence and severity and six symptom interference

All patients who received the Hedgehog Pathway APD regimen received on the day of chemotherapy, day 1, an antiemetic regimen consisting of dexamethasone 12 mg IV, palonosetron 0.25 mg IV, and aprepitant 125 mg PO, 30 60 minutes prior to chemotherapy. Postchemotherapy, patients received oral aprepitant 80 mg/day on days 2 and 3 and oral dexamethasone 4 mg BID on days 2 4. Protocol therapy continued with each chemotherapy cycle until discontinuation of the same regimen of chemotherapy or at the discretion of the treating investigator up to a maximum of six cycles. Patients were permitted to take rescue therapy of the treating investigators choice for nausea and/or emesis or retching based on clinical circumstances. Patients who required rescue therapy were permitted to continue on the study at the discretion of the treating investigator in consultation with the patient. STUDY VISITS AND ASSESSMENT PROCEDURES In the prestudy period, all pertinent demographics and medical data were recorded. For the purposes of this study, the M.D. Anderson Symptom Inventory 26 was utilized to allow for simple, expedient measures of key symptom variables being examined daily for the entire study period. The main purpose of the use of the MDASI in this Dopamine Receptor study was to determine if there were any major or minor toxicities related to the antiemetic regimens.
The MDASI is a flexible system for the assessment of symptoms experienced by patients with cancer. It consists of 13 core symptom items that are rated based on their presence and severity and six symptom interference items that are rated based on the level of symptom interference with P2X Receptor function.26 Beginning with the first day of chemotherapy and daily through day 5, patients were asked to record daily episodes of vomiting/retching, the daily intensity of symptoms utilizing the MDASI, and the utilization of rescue therapy. Patients were also asked to record daily episodes of nausea using a visual analogue scale from 0 to 10, with 0 indicating no nausea and 10 indicating a maximal level of nausea. A nurse/research coordinator contacted each patient each day to remind the patient to complete forms and to query toxicities. STATISTICAL METHODS The primary end point in the study was complete response for the overall period. Secondary end points were CR in the acute and delayed periods and no nausea in the acute, delayed, and overall periods. The HA-1077 study was powered with a sample size to detect a 15% difference between the two antiemetic regimens.
With a tolerance of 15%, 111 subjects were needed in each arm to obtain a 0.80 power at a Type I error level of 0.05. The total number of patients was elevated to account for a 10% dropout rate. Demographic data and patient characteristics were examined descriptively. The frequencies of severe toxicities patients and adverse events were calculated. The percentage of patients with CR for the acute period, the delayed period, and the overall period was calculated. The percentage of patients with no nausea was calculated. The mean, median, and standard deviation of the maximum MDASI symptom scores over days 1 5 were calculated for cycle 1. A repeated measures analysis of variance was performed to test for a change in symptom scores across cycles and over days within cycles.