A.A. te Velde

The construction and testing of the EORTC colorectal cancer-specific quality of life questionnaire module (QLQ-CR38)

The objectives of the current study were to construct a colorectal cancer-specific quality of life (QL) questionnaire module to be used in conjunction with the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and to test its reliability and validity in The Netherlands. Module construction took place following the EORTC guidelines for module development. The module--the QLQ-CR38--consists of 38 items covering symptoms and side-effects related to different treatment modalities, body image, sexuality and future perspective. This module was tested among 117 colorectal cancer patients on several occasions. The timing was prior to treatment with radiotherapy or chemotherapy, during treatment and 3 months following the second assessment. For purposes of test-retest reliability, a subsample of patients completed the QLQ-CR38 1 week following the third assessment. Multitrait scaling analysis confirmed the hypothesised scale structure of the function scales but not of the symptom scales. Cronbachs alpha coefficients for seven of the nine scales exceeded the 0.70 criterion at one or both assessments. The test-retest reliability for all scales and one single item was 0.78 or higher. The stability of the two remaining single items was lower. On the basis of known-groups comparisons, selective scales distinguished clearly between patients differing in disease stage, initial and on-treatment performance status and the presence of a stoma. Additionally, selective scales detected change over time as a function of change in performance status and treatment-induced change. These results lend support to the clinical validity of the QLQ-CR38 as a supplementary questionnaire for assessing specific QL issues relevant to patients with colorectal cancer. Additional efforts to test the modules cross-cultural validity are needed.

Modification of the EORTC QLQ-C30 (version 2.0) based on content validity and reliability testing in large samples of patients with cancer

A revision of the Quality of Life Questionnaire (QLQ-C30) of the European Organization for Research and Treatment of Cancer (EORTC) was undertaken to improve low internal consistency estimates (Cronbachs alpha) and content validity for the role functioning scale and a conceptual difficulty (undue emphasis on physical functioning) in the global quality of life (QOL) scale. The role functioning items were reworded and a four-category response format was substituted for the previous dichotomous format. A new item asking about ‘overall health’ was substituted for the ‘overall physical condition’ item in the global QOL domain. The original and new versions were tested at three time points in a total of 1,181 patients with cancer in Canada (n=696) and the Netherlands (n=485). In both samples there was a marked improvement in internal consistency for the role functioning scale (Cronbachs alphas ranging from 0.78-0.88) in the new version. In the global QOL scale, the substitution of the new item for the previous one did not alter internal consistency (Cronbachs alphas ranging from 0.81-0.92). The revised versions of the role functioning and global QOL domains have been incorporated into the QLQ-C30 (version 2.0).

EO9 phase II study in advanced breast, gastric, pancreatic and colorectal carcinoma by the EORTC Early Clinical Studies Group

In a phase II trial, the activity of EO9, a new bioreductive alkylating agent, was assessed. EO9 was used as second-line chemotherapy in breast cancer patients and as first-line chemotherapy for patients with gastric, pancreatic and colorectal cancer. EO9 was given as a 5 min i.v. infusion at a weekly dose of 12 mg/m2. 92 patients were entered; 22 with breast cancer, 26 with colon cancer, 24 with pancreatic cancer and 20 with gastric cancer. In general, the drug was well tolerated with nausea and vomiting occurring in 26.42 and 13.3% of courses, respectively. Reversible proteinuria was the main toxicity occurring in 45% of courses. Antitumour activity was not observed. At this dose and schedule, EO9 is not an active drug in the type of tumour studied.

Rapid densitometric determination of cell migration and cell adhesion in a microchemotaxis chamber

A new rapid staining and measuring method has been developed for the quantification of migrated cells in a microchemotaxis chamber. The migrated cells were, after staining, evaluated by a transmission densitometer. The method introduced here is more accurate and faster than those described previously. In addition the technique can be used to determine the adherent capacity of cells.

Adjustment of the interface detector (location 71) to the absolute number of mononuclear cells in the peripheral blood: No improvement of the collection efficiency of the Fenwal CS3000 plus during progenitor cell harvests

Improvement of the collection efficiency (CE) of the Fenwal CS3000 plus in collecting circulating progenitor cells (CPC) might diminish the number of leukapheresis procedures (LP) required to obtain the CPC required to assure engraftment.

Modulation of phenotypic and functional properties of human peripheral blood monocytes by interleukin-4 (IL-4)

IL-4, which was first described as B-cell stimulating factor-1 (BSF-1), has been shown to have important pleiotropic biologic effects in the mouse as well as in the human system [1]. In the present study we investigated the effect of rIL-4 on human peripheral blood monocytes. These cells were isolated by means of centrifugal elutriation, which prevented activation of the cells, and thus provided an excellent source of highly purified monocytes for functional and phenotypical studies upon culture with IL-4 [2].