Fig. 2
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT). “a”: baseline evaluations (conducted within 2 weeks of the start of the therapy protocol); “b”: every 6 weeks after inclusion (irinotecan was dosed at 100 mg/m2 intravenously on days 1 and 8 of a 3-week cycle); “c”: patients will be monitored for new or existing adverse events for 4 weeks after treatment discontinuation; “d”: follow-up via outpatient appointments and telephone calls will begin after withdrawal of irinotecan and end at patient death. Disease progression information of all patients will be collected and recorded every 3 months beginning 2 months after treatment completion, which will be continued until patient death or the end of PFS follow-up; “e”: laboratory tests will include hematological data (hemoglobin, white blood cell count, blood glucose, blood ketone, neutrophil count, and platelet count), biochemical data (total bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine, total protein, sodium ions, potassium ions, magnesium ions, blood chloride, blood calcium, blood urea, and thyroid function index), pregnancy status (if applicable), tumor-marker data (breast-cancer-associated antigen CA153 and carcino-embryonic antigen), and urinary data (urinary sugar, urinary ketones, urinary protein). Tumor measurements during the study will be conducted using computed tomography scans and/or magnetic resonance imaging, with a bone scan if clinically indicated at the time of baseline screening, every 6 weeks after inclusion and 4 weeks after the end of treatment, and then every 3 months thereafter. Treatment response will be evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) criteria. AJCC American Joint Committee on Cancer, ECOG PS Eastern Cooperative Oncology Group Performance Status Scale, EORTC QLQ-C30, version 3 the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30, PFS progression-free survival, OS overall survival, C/E cost/effectiveness ratio