A randomised factorial trial of sequential doxorubicin and CMF vs CMF and chemotherapy alone vs chemotherapy followed by goserelin plus tamoxifen as adjuvant treatment of node-positive breast cancer
2005

Comparing Chemotherapy Regimens for Breast Cancer

Sample size: 466 publication Evidence: moderate

Author Information

Author(s): Sabino De Placido, Michele De Laurentiis, Angelo Raffaele Bianco, Rossella Lauria, Clorindo Pagliarulo, Alfredo Marinelli, Chiara Carlomagno, Giuseppe Petrella, Gennaro Limite, Francesca Caputo, Antonio Farris, Maria Giuseppina Sarobba, Giovanni Sanna, Maria Grazia Alicicco, Giovanna Fois, Modesto D'Aprile, Giorgio Pistillucci, Maurilio Natali, Susanna Busco, Francesco Angelini, Francesco Ferraù, Giuseppe Failla, Salvatore Palazzo, Virginia Liguori, Antonio Roviti, Sergio Palmeri, Marina Vaglica, Cristina Raimondi, Luigi Manzione, Domenico Bilancia, Rosangela Romano, Vincenzo Adamo, Giuseppe Altavilla, Claudia Garipoli, Ettore Greco, Rosalia Carroccio, Francesco Cognetti, Guido Francini, Tonino Pedicini, Antonio Febbraro, Claudia Corbo, Stefano Iacobelli

Primary Institution: University Federico II

Hypothesis

The sequential doxorubicin and CMF regimen is superior to CMF alone and the addition of goserelin plus tamoxifen after chemotherapy improves outcomes.

Conclusion

The sequential doxorubicin followed by CMF regimen significantly improved disease-free survival compared to CMF alone, and adding goserelin plus tamoxifen after chemotherapy also improved disease-free survival.

Supporting Evidence

  • The sequential doxorubicin regimen improved disease-free survival compared to CMF.
  • Adding goserelin and tamoxifen after chemotherapy significantly improved disease-free survival.
  • The study included 466 premenopausal node-positive patients.
  • Median follow-up was 72 months.

Takeaway

This study looked at different treatments for breast cancer and found that one treatment worked better than another, helping patients stay cancer-free longer.

Methodology

Patients were randomly assigned to four treatment groups and followed for a median of 72 months to assess disease-free and overall survival.

Potential Biases

Potential bias due to the imbalance in the number of chemotherapy cycles between treatment arms.

Limitations

The trial was underpowered due to lower than expected patient accrual, which may affect the precision of the results.

Participant Demographics

Median age was 44 years; 79% had estrogen receptor-positive or unknown tumors.

Statistical Information

P-Value

0.040

Confidence Interval

0.556–0.986

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602355

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