Although gemcitabine only modestly prolonged survival (median survival 5.65 vs. 4.41 months), the effect on the clinical benefit response, a composite of measurements of pain, performance status, and weight loss was more marked.
Key secondary measures included the Stanford Health Assessment Questionnaire, patient global assessment of pain, and the percentage of patients who achieved ACR20 responder criteria response (a composite of pain, inflammation, function, and global assessments).
Diamide was shown to elicit expression response resembling a composite of responses to heat shock, oxidative stress, and disulfide reducing agent, demonstrating pleiotropic effects [25].
In pancreatic cancer, the endpoint of clinical benefit response (a composite assessment of pain, performance status and weight) was created to provide a way in which the impact of therapy on tumor-related symptoms could be assessed [ 19] and has become a well-accepted outcome parameter.
Objective tumour assessments and evaluation of clinical benefit response, a composite measure of pain (analgesic consumption and pain intensity), performance status, and body weight (Burris et al, 1997), were determined at the end of every 2 cycles during chemotherapy and every 3 months after discontinuation of treatment.
These factors were: mother's age; whether the pregnancy was planned; whether the mother smoked during pregnancy; whether the cohort member was a first born; ethnicity; lone parent family; and a measure of survey response style 17 (a composite of non-response to questions including life satisfaction, relationship quality, social networks).
It should be noted that pretreatment with methylphenidate may have altered the baseline locomotor activity of SHR rats, and thus the augmented locomotor response may be a composite of sensitized baseline locomotor activity and sensitized cocaine-induced locomotion.
Exploratory endpoints were time to first response, duration of response, and clinical benefit consisting of a composite of complete response, partial response, tumor regression of 20 29 %, and stable disease ≥ 6 months).
In conclusion, the overall survival of patients with brain cancers in response to therapy most likely reflects a composite of response of tumour cells and host responses to tumour, and it is clear from this study that tumour cell cytokinetics may play a major role.
For that reason, a definition of clinical response that is both a composite of a percent reduction in symptoms (eg, a 30% improvement in symptom levels from baseline), as well as a second measure of clinical improvement (eg, Clinical Global Impressions-Improvement [CGI-I] [ 13] of 1 [very much improved] or 2 [much improved]) may be considered a more meaningful measure.
The 5HIAA response in WT mice also occurs early, but this is followed by a larger maximal response, consistent with it being a composite of both direct and TNF-mediated effects.
