There were more objective responses at the lower doses than at the higher doses (Table 2).
If 16 or more objective responses were observed, the regimen would be considered worthy of additional evaluation in this disease.
If 10 or more objective responses were observed among the 30 assessable patients, the treatment would be considered worthy of further consideration.
If 5 or more objective responses were observed among these initial patients, an additional 13 assessable patients had to be entered.
Initial analysis was planned after 16 patients had been treated, and there was a further accrual to a total of 25 patients if one or more objective responses were seen in the first 16.
However subsequent studies applying more rigorous objective response criteria report response rates between 6 and 45% for pancreatic NETs (Eriksson et al, 1990; Cheng and Saltz, 1999; Kouvaraki et al, 2004) and 15 30% for non-pancreatic NETs (Engstrom et al, 1984; Bukowski et al, 1987; Sun et al, 2005).
Recently, two proof-of-concept studies revealed that prostate-specific antigen (PSA) responses can be detected in 38 46% of patients treated with docetaxel every 3 weeks (q3w) and, more importantly, measurable objective responses are also reported in 24 29% of patients.
The regimen would be considered for further evaluation if more than four objective responses were seen in evaluable patients, suggesting a true response rate of at least 30%.
Radiological assessment by mammography and/or ultrasound has been used as a more objective measurement of response, but correlation with long-term survival has not been widely studied.
This resulted in tumor sizes that were almost always less than those obtained by palpation, but permitted a more objective monitoring of response, according to the RECIST recommendations, because real tumor shrinkage is evaluated in this way and is not confounded by the response to therapy of the peritumoral inflammatory reaction.
Likewise, to get a more objective measure of physiological responses to taste stimuli, some investigators have studied heart rate changes or other responses not under voluntary control, such as sweating [ 71].
