Response Criteria
tumor, enlargement of any existing lesion(s, NED, Cancer
ADVERSE EVENT, TUMOR, RECURRENCE, PROGRESSIVE DISEASE, ADVERSE EVENT, DISEASE, REGRESSION, CANCER
Complete response (CR) was defined as the total disappearance of all radiologic evidence of tumor, determined by 2 observations not less than 4 weeks apart, and no evidence of malignant cells in the CSF. No evidence of disease (NED) was defined as no recurrence or appearance of new lesions and no malignant cells in the CSF in a patient with complete resection and no measurable disease after surgery, with NED continuing for at least 6 months. Partial response (PR) was defined as regression of at least 50% of all tumor size (the sum of the products of all measured lesions), determined by 2 observations not less than 4 weeks apart. No simultaneous progression of any lesion or the appearance of new lesions may have occurred. Nonmeasurable lesions (eg, diffuse leptomeningeal spread) must have remained stable or regressed for this category. Patients whose CSF results were negative for disease were required to continue to test negative. Stable disease was regression of less than 50% of tumor size or progression less than 25% of at least 4 weeks’ duration, without appearance of new lesions. Progressive disease was worsening of disease, evidenced by enlargement of any existing lesion(s) of 25% or more or appearance of new lesions or the manifestation of new CSF-positive disease.Health-related quality of life (QOL) data were collected using the KINDL questionnaire in the respective national language at study enrollment and after 6 months. The questionnaire consists of 24 Likert scale items, with 4 items each representing 1 of the following 6 scales: physical well-being, emotional well-being, self-esteem, family, friends, and everyday functioning (school or nursery school or kindergarten). Age-specific self-report versions for children and adolescents and a proxy version for parents were applied. The scale scores and the total score were compared with reference scores of a norm sample of the same age groups.Patients were followed up for survival after completion or discontinuation of study treatment. Safety was evaluated and graded according to the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Adverse events were recorded at study visits and for at least 28 days after the last dose of study treatment.