Comparison of prognostic factors in patients in phase I trials of cytotoxic drugs vs new noncytotoxic agents
2003

Comparing Prognostic Factors in Cancer Trials

Sample size: 420 publication 10 minutes Evidence: moderate

Author Information

Author(s): Han C, Braybrooke J P, Deplanque G, Taylor M, Mackintosh D, Kaur K, Samouri K, Ganesan T S, Harris A L, Talbot D C

Primary Institution: Cancer Research UK Medical Oncology Unit, Churchill Hospital, Oxford, UK

Hypothesis

Are there differences in outcomes for patients in phase I trials of cytotoxic drugs compared to non-cytotoxic agents?

Conclusion

The study found no significant difference in median overall survival between patients treated with cytotoxic and non-cytotoxic drugs, although cytotoxic drugs showed higher response rates.

Supporting Evidence

  • Patients treated with cytotoxic drugs had a higher objective response rate compared to those treated with non-cytotoxic drugs.
  • Significantly more women were treated with cytotoxic drugs, reflecting a specific study for breast cancer.
  • Patients with liver metastases had poorer survival when treated with non-cytotoxic drugs compared to cytotoxic drugs.

Takeaway

This study looked at cancer patients in trials to see if different types of drugs worked better. It found that while one type of drug had more responses, both types had similar survival rates.

Methodology

The study analyzed data from 420 patients in phase I trials, comparing clinical, biochemical, and haematological factors for toxicity and survival.

Potential Biases

Potential physician bias in patient selection for trials was not fully assessed.

Limitations

The study was retrospective and conducted at a single center, which may limit the generalizability of the findings.

Participant Demographics

The study included 210 males and 210 females, with a median age of 56 years.

Statistical Information

P-Value

0.47

Confidence Interval

1.15–1.92

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601218

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