gms | German Medical Science

Xeloda as a monotherapy achives an objective response rate of 15-36% and a TTP between 3 and 4.9 months in the therapy of metastatic breast cancer with prior treatment [1-7]. The response rate is raised to 42-68% and the TTP to 6.1-10.6 months by a combination with a Taxan [8 -10] or Vinorelbin [11].

In the context of quality assurance projects female patients who got a palliative chemotherapy containing Xeloda were documented and evaluated since July, 2003. 27 medical practices specialized in oncology were involved.

Patient characteristics: 37 patients were administered Taxotere/Xeloda, 24 Navelbine/Xeloda and 38 Xeloda as a monotherapy. The median age was 52 and 56 respectively 59 years. The relapse-free interval was specified with 32, 34 or 38 months. The performance status of the patients had a median of 1 (0-2.) The majority of the patients had received prior treatment (Tbl. 1 [Tab. 1]). 44.6%, 40.8% resp. 31.2% of the patients had a visceral metastatic disease.

Therapy (Tbl. 2 [Tab. 2]): The patients were administered a median of 5-6 cycles. In 21% of the cycles the dose of Xeloda was reduced.

The objective response rates (CR+PR) were at 48.6% (8.1% + 40.5%), 41.7% (0% + 41.7%) and 29.0% (7.9% and 21.1%). When administered as first-line therapy in the metastatic stage the treatment achieved the following response rates: 41.2%; 55.6% and 50.0%.The progression-free interval had a median of 8, 10 and 11 months in the total population, the overall survival was at 11-12 months.

Due to a progression of the disease or present toxicities 35,1/27,0%; 58,3/12,5% and 36,8/15,8% of the patients withdrew from therapy.

Side effects: The following grade 3/4 toxicities (> 15%) occurred: neutropenia (27.0%; 29.2%; 0%); hand-and-foot syndrome 10.8% (16.7%; 18.4%).

Conclusions: It turned out that a Xeloda monotherapy administered as first-line therapy produces an objective response rate that is comparable to a combination. The progression-free interval with a Xeloda-monotherapy is also longer than that of the combination therapies. Therefore, it should be considered if an intermittent therapy of monotherapies would be more reasonable in the treatment of metastatic breast cancer.

[1]Talbot 2002, [2]Blum 1999, [3]Reichardt 2003, [4]Fumoleau 2004, [5]Blum 2001, [6]Wist 2004, [7]O'Shaugnessy 2001, [8]Gradishar 2004, [9]Batista 2004, [10]O'Shaugnessy 2002, [11]Ghosn 2003