If no patient had experienced an objective tumor response, the study would have been terminated.

The endpoint of the study was objective tumor response.

Of the nine patients enrolled in the trial, six could be evaluated for objective tumor response in accordance with the protocol.

Only patients with measurable disease at baseline should be included in protocols where objective tumor response is the primary endpoint.

Therefore, the utilization of such techniques for objective tumor response should be restricted to validation purposes in specialized centers.

The baseline sum LD will be used as reference by which to characterize the objective tumor response.

Statistical Methods This study was planned to recruit 50 evaluable patients, allowing us to estimate objective tumor response to within +/- 15% with 95% confidence.

Several trials comparing 5-fluorouracil alone with combinations based on biochemical modulation have indicated better objective tumour response with the combination treatment.

In addition, no differences were noted in objective tumor response between the hydrazine sulfate group and the placebo group.

After tumor progression on one form of hormonal manipulation develops, an objective tumor response to any other form is uncommon.

Also, the objective tumor response rate of 50 per cent compared favorably to the 25 per cent rate reported in the historical control group.

No differences in survival, objective tumor response, anorexia, weight gain or loss, or nutritional status were observed between the hydrazine sulfate group and the placebo group.

Comparison of objective tumour response rate and median survival time in our chemotherapy group in phase II and III studies with conventional 5-fluorouracil and leucovorin regimens suggest that this is not the case.

As of 2005, multiple trials show objective tumor responses and slowed tumor progression but questionable survival benefit compared to supportive care; greatest benefit seen in patients with preserved liver function, absence of vascular invasion, and smallest tumors.

In a separate study based on follow-up data from 43 treated patients, 20 patients (47%) had an objective tumor response based on percent reduction in tumor size and 34 patients (79%) had a tumor response when percent reduction and/or tumor necrosis were used as a composite measure of tumor response.