A phase II study of sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin in patients with operable breast cancer: prediction of response using molecular profiling
2008

Neoadjuvant Chemotherapy for Breast Cancer

Sample size: 65 publication 10 minutes Evidence: moderate

Author Information

Author(s): Julka P K, Chacko R T, Nag S, Parshad R, Nair A, Oh D S, Hu Z, Koppiker C B, Nair S, Dawar R, Dhindsa N, Miller I D, Ma D, Lin B, Awasthy B, Perou C M

Primary Institution: All India Institute of Medical Sciences, New Delhi

Hypothesis

Can sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin improve response rates in operable breast cancer?

Conclusion

The study found that sequential neoadjuvant gemcitabine plus doxorubicin followed by gemcitabine plus cisplatin was effective in treating operable breast cancer, with a notable pathological complete response rate.

Supporting Evidence

  • 13 out of 53 patients who had surgery showed a pathological complete response.
  • Overall clinical response rate was 81.5%.
  • Gene expression patterns predicted clinical complete response with 73% accuracy.
  • Patients receiving a specific dosing sequence experienced higher toxicity.
  • Four drug-related deaths occurred during the study.

Takeaway

This study tested a new way to give chemotherapy to women with breast cancer and found that it worked well to shrink tumors before surgery.

Methodology

Patients received four cycles of gemcitabine plus doxorubicin followed by four cycles of gemcitabine plus cisplatin, with tumor biopsies collected for gene expression analysis.

Potential Biases

Potential bias due to the non-randomized design and the specific population studied.

Limitations

The study had a small sample size and was not randomized, which may affect the generalizability of the results.

Participant Demographics

Indian women aged 18 and older with operable breast cancer, primarily with large or locally advanced tumors.

Statistical Information

P-Value

0.01

Confidence Interval

95% CI: 0.57–0.85

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604322

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication