Clinical Research Paper

Purpose: Because of the high cost of hepatic Overall Survival Is Not a Realistic End Point for Clinical Trials of New Drugs in Advanced Solid Tumors: A Critical Assessment Based on Recently Reported Phase III Trials in Colorectal and Breast Cancer... Memorial Sloan-Kettering Cancer Center, New York, NY. University of California San Francisco, San Francisco, CA. Four phase III clinical trials comparing a fluorouracil-based regimen with the same regimen plus either CPT-11 or oxaliplatin in advanced colorectal cancer patients were reviewed.

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The primary aim of the critical assessment was to explain the lack of OS advantage observed in two of the four trials, despite the presence of increased response rate (RR) and time to progression (TTP).

Four possible reasons for the lack of OS benefit (i.e.

But recent studies demonstrate significant improvement in disease-free survival and overall survival for patients with advanced colon and rectal cancer who receive adjuvant therapy.

Surgery alone is inadequate therapy in as many as 50% of patients.

While several phase II studies have been finalized or are in progress, no...

more Clinical investigation of autologous hematopoietic stem cell transplantation (HSCT) as therapy for multiple sclerosis (MS) has been ongoing for over a decade.

Objective Our primary goal was to design and test the feasibility of a clinical trial protocol that would address the main critiques of MT trialspreviously reported in the literature.

Methods We conducted a literature review guided by the questions: (1) What is the set of indicators and tools that can be used to measureeffectiveness of MT for seniors in palliative care and EOL settings?

Three of the four trials had roughly the same statistical power to detect 1-year OS differences, while the fourth trial was underpowered to detect realistic OS differences.

The lack of OS advantage observed in the two oxaliplatin trials is therefore likely fortuitous, and due to lack of statistical power.