Taxol based chemotherapy increases survival by 31% in women with metastatic breast cancer

First line chemotherapy containing Taxol is an independent predictive factor for survival

New data presented for the first time today adds to existing evidence that Taxol? offers women with metastatic breast cancer (MBC) a 31% improvement in overall survival compared to standard treatment and a 33% chance of improved progression free survival, the largest improvements ever seen. The data collected from 640 patients treated in a consecutive series of studies between 1994 and 2001 also showed an improvement in tumour shrinkage when treated with Taxol-based chemotherapy.

“This study in effect demonstrates treatment outcomes before and after the advent of paclitaxel because we have analysed data over an extensive period of time. These results clearly show the dramatic impact that paclitaxel has had on improving the quality of care for our patients,” comments Professor Pier Franco Conte, lead investigator of the study, Division of Medical Oncology, St Chiara University Hospital, Pisa, Italy,

He added, “These highly significant survival results must surely lead us to adopt paclitaxel as a first line treatment for women with metastatic breast cancer.”

Analysis of data collected from six studies involving 640 women with MBC showed that the 291 patients receiving epirubicin plus Taxol (ET) as first line treatment had a 31% reduction in the hazard of death (hazard ratio = 0.69 p 0.003) and a 33% reduction in the hazard of disease progression (hazard ratio = 0.67 p 0.0001) on top of that seen with the 349 patients who received 5-fluorouracil, epirubicin, cyclophosphamide (FEC), the standard combination currently used to treat women with MBC.

The median survival of patients treated with ET was 24 months compared to 18 months with the FEC regimen, which meant that ET offered a six month gain on top of that seen with FEC.

The 291 patients receiving the ET combination had an overall response rate to this therapy of 66% (and complete response of 16%). The remaining 349 patients who received FEC showed a 50% overall response rate (complete response 15%). Therefore the difference in response rates was in favour of the ET regimen with a 16% higher response than that seen with FEC, yet the survival gain in this group of patients was much higher at 31%. The affect of ET on survival was not entirely accounted for by its effect on response which indicates that Taxol-based therapy is an independent predictive factor of survival.

The strength of this new data lies in the fact that all six studies included in the analysis were originally conducted by the same investigators at St Chiara University Hospital, Pisa, Italy over an 18 year period that started in 1983 with recruitment of the first patients. The ensuing retrospective analysis therefore allowed for comparable inclusion criteria and the same study endpoints of response rates, progression free survival and overall survival. The pooling of equivalent information for analysis offers robust data that provide new information important to today’s clinicians and to the treatment choices available to women.

On examining the impact this may have on the patient Professor Conte comments, “Women with breast cancer, and particularly those with disease spread are extremely frightened and concerned for their future but do not want to be thought of as near death, with little or no time to live. These new data offer women some kind of hope of survival outside the regularly quoted statistics. Let’s hope these data will be used wisely and that women will be given the chance to choose more life.”

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