Pegylated liposomal doxorubicin and gemcitabine in the front-line treatment of recurrent/metastatic breast cancer: a multicentre phase II study
2008

Pegylated Liposomal Doxorubicin and Gemcitabine for Breast Cancer

Sample size: 71 publication Evidence: moderate

Author Information

Author(s): Adamo V, Lorusso V, Rossello R, Adamo B, Ferraro G, Lorusso D, Condemi G, Priolo D, Di Lullo L, Paglia A, Pisconti S, Scambia G, Ferrandina G

Primary Institution: University Hospital G Martino, Messina, Italy

Hypothesis

The study aimed to investigate the activity and safety of pegylated liposomal doxorubicin (PLD) and gemcitabine (GEM) as front-line therapy in chemotherapy-naïve recurrent/metastatic breast cancer patients.

Conclusion

The combination of PLD and GEM is effective and safe for treating chemotherapy-naïve recurrent/metastatic breast cancer patients, with a significant overall response rate and manageable toxicity.

Supporting Evidence

  • The overall response rate was 39.1%, with 12.5% complete responses and 26.6% partial responses.
  • Median time to progression was 11 months, and median overall survival was not reached.
  • The clinical benefit rate was 85.9%, including stable disease.

Takeaway

This study tested a new medicine combination for breast cancer and found it works well and is safe for patients who haven't had chemotherapy before.

Methodology

This multicentre phase II study evaluated the efficacy and safety of PLD and GEM in chemotherapy-naïve recurrent/metastatic breast cancer patients.

Potential Biases

Potential biases may arise from the non-randomized nature of the study and the selection criteria for participants.

Limitations

The study's findings may be limited by the non-randomized design and the specific patient population studied.

Participant Demographics

Median age was 63 years, with 43.7% of patients aged 65 or older.

Statistical Information

P-Value

0.039

Confidence Interval

95% CI for overall response rate: 27.1, 50.9

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604409

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