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Sequential Doxorubicin and Docetaxel Less Toxic and as Effective as Concomitant Therapy: Presented at ASCO

By Rabiya S. Tuma

CHICAGO, IL -- June 3, 2003 -- Sequential treatment with doxorubicin and docetaxel is as effective as concurrent therapy in patients with metastatic breast cancer, but is significantly less toxic, according to results presented here June 1^st at the 39^th Annual Meeting of the American Society of Clinical Oncology.

The combination of doxorubicin and docetaxel has good efficacy but its use is limited by the febrile neutropenia associated with this regimen, said Emilio Alba, MD, from the Hospital Virgen de la Victoria, in Málaga, Spain. He presented the results on behalf of the Spanish Breast Cancer Research Group (GEICAM).

Dr. Alba and colleagues at other Spanish centres conducted a multicentre, randomised, controlled, phase III trial to see if the 2-drug combination was as effective when administered sequentially as when given concurrently.

They enrolled 144 women with metastatic breast cancer. A subgroup of 108 women had no prior anthracycline treatment and was randomised into 2 groups: 54 were treated with a sequential regimen and 54 with a concurrent regimen. Among the 36 women with history of anthracycline treatment, 21 were randomised to sequential treatment and 15 to concurrent treatment.

Among patients with no anthracycline history, the sequential arm consisted of 3 cycles of doxorubicin 75 mg/m² every 3 weeks followed by 3 cycles of docetaxel 100 mg/m² every 3 weeks. Patients receiving concurrent therapy were treated with 50 mg/m² doxorubicin plus 75 mg/m² docetaxel every 3 weeks for 6 cycles.

For patients with prior anthracycline treatment, the regimens involved fewer doxorubicin cycles. The sequential arm received doxorubicin 75 mg/m² every 3 weeks followed by docetaxel 100 mg/m² every 3 weeks. The concomitant arm received doxorubicin 50 mg/m² plus docetaxel 75 mg/m² every 3 weeks for 3 cycles, followed by 3 cycles of docetaxel 100 mg/m² every 3 weeks.

For both arms, regardless of prior anthracycline history, the primary toxicity was febrile neutropenia, but there were significantly fewer patients per cycle in the group treated with sequential therapy (6.9%) than in the concurrent therapy group (14.8%). The occurrence of severe asthenia, diarrhoea, and fever were also more frequent in the patients treated with concurrent therapy.

With a median follow-up time of 17 months, the time to progression, duration of response, and overall survival were not statistically different between the 2 treatment arms.

Thus, with the lower toxicity and similar efficacy, Dr. Alba concluded, the sequential therapy was a preferred option and improved compliance.


[Study title: Multicenter Phase III Randomized Trial Comparing Sequential Versus Concomitant Administration of Doxorubicin (A) and Docetaxel (T) as First-Line Treatment of Metastatic Breast Cancer (MBC). GEICAM 9903 Study. Abstract 27]

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