A phase I/II study of 4 monthly courses of high-dose cyclophosphamide and thiotepa for metastatic breast cancer patients
2002

High-Dose Chemotherapy for Metastatic Breast Cancer

Sample size: 28 publication 10 minutes Evidence: moderate

Author Information

Author(s): Bachelot T, Gomez F, Biron P, Ray-Coquard I, Soler-Michel P, Philip I, Guastalla J P, Rebattu P, Dumortier A, Droz J P, Blay J Y

Primary Institution: Centre Léon Bérard

Hypothesis

Can high-dose cyclophosphamide and thiotepa improve outcomes for hormone-refractory metastatic breast cancer patients?

Conclusion

The study found that high-dose chemotherapy with cyclophosphamide and thiotepa is manageable and can lead to promising survival outcomes in some patients.

Supporting Evidence

  • Eighteen patients completed the study, and the maximum tolerated dose was determined.
  • Median time to treatment failure was 11 months, and median overall survival was 26 months.
  • Three patients were alive and free of disease 30 months after treatment.

Takeaway

This study tested a strong cancer treatment for women with advanced breast cancer, and while it was tough on their bodies, some patients did really well.

Methodology

Patients received four courses of high-dose cyclophosphamide and thiotepa with support from stem cell reinfusion and granulocyte-colony stimulating factor.

Potential Biases

Potential bias due to the small sample size and the specific patient selection criteria.

Limitations

Only 18 out of 28 patients completed the study, and the sample size was small.

Participant Demographics

Median age was 42 years, with most patients having visceral localization and 24 having measurable lesions.

Statistical Information

P-Value

p<0.001

Confidence Interval

95% CI: 7–15 for TTF; 95% CI: 15–37 for overall survival

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600631

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