Overview of the J-FORCE Trial
ascites, malignant solid tumors, nausea, morning sickness, emesis, nausea and vomiting, vomiting, hypoglycemic, diabetes
ASCITES, ONCOLOGY, MOTION SICKNESS, GASTROINTESTINAL OBSTRUCTION, DIABETES
Details on the design and results of the J-FORCE trial have been published.The J-FORCE trial, which was conducted in Japan from February 9, 2017, to July 13, 2018, had a superiority study design, which assumed a delayed CR of 65% in the placebo groupParticipants were enrolled from 26 hospitals across Japan. All participants were Japanese. Eligible patients were cisplatin-naive, were aged 20 to 75 years, had malignant solid tumors, had Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 to 2 (with 0 indicating being fully active without restriction, and 2 indicating being ambulatory and capable of all self-care but unable to carry out any work activities), maintained organ function, and provided written informed consent to participate in the study. Patients with nausea and vomiting requiring antiemetic drugs, ascites requiring therapeutic puncture, gastrointestinal obstruction, diabetes requiring use of insulin or oral hypoglycemic agents, a hemoglobin AIn addition to standard antiemetic therapy for HEC (palonosetron: 0.75 mg on day 1; aprepitant: 125 mg on day 1 and 80 mg on days 2 to 3; dexamethasone: 12 mg on day 1 and 8 mg on days 2 to 4), the study drugs (5 mg of olanzapine or placebo) were administered after dinner on days 1 to 4. Patients recorded the degree of nausea (using a 4-point categorical scale: none, mild, moderate, or severe), the presence and frequency of vomiting, and rescue medication in their symptom diary every 24 hours from the start of cisplatin-based chemotherapy administration to 120 hours later. Additionally, patients described 3 risk factors that are typical for nausea and vomiting, such as history of motion sickness, drinking habit (defined as alcoholic drinks consumption in excess of occasional drinking), and history of morning sickness during pregnancy (only for females), in their symptom diary.The primary end point was CR in the delayed phase (24-120 hours after cisplatin-based chemotherapy initiation). Secondary end points were CR in the acute (from cisplatin-based chemotherapy initiation to 24 hours) and overall (from cisplatin-based chemotherapy initiation to 120 hours) phases; complete control (CC, defined as no more than mild nausea under CR); total control (TC, defined as no nausea under CR) in the acute, delayed, and overall phases; and time to treatment failure (TTF, defined as time from cisplatin-based chemotherapy initiation to the first emesis or use of rescue medication), among other outcomes.