Xeloda plus paclitaxel is a new, safer first-line treatment option for patients with advanced breast cancer

 BASEL , Switzerland , June 4/PRNewswire/ --

News from the 2006 American Society of Clinical Oncology (ASCO) Annual Meeting, Atlanta , GA , USA

A new randomised phase III study in advanced breast cancer shows the combination of Xeloda (capecitabine) plus paclitaxel is equally as effective and safer than the, recognised as highly potent, combination of epirubicin (an anthracycline) plus paclitaxel.(1) It is well known that anthracyclines (epirubicin and others) are associated with cumulative cardiac toxicity, which can be life-threatening, restricting the number of treatments a patient can receive during her lifetime due to progressive heart failure. Importantly, Xeloda plus paclitaxel (known as 'XP') is safer for patients as it has no cumulative side-effects.

The results support those seen in previous studies, which showed that the Xeloda plus Taxotere (docetaxel) combination, known as 'XT', leads to longer survival compared with docetaxel alone, for women with anthracycline-pretreated breast cancer.(2),(3)

"Women with advanced breast cancer need treatment options that they can rely on to provide powerful benefits early in their treatment course. Anthracyclines have been, and will remain, an effective and important part of breast cancer therapy, but the risk of progressive heart failure after receiving a cumulative dose restricts their use and therefore their effectiveness over the long term. These new study results demonstrate that Xeloda combinations can offer patients all the good of anthracyclines without the bad effects," commented Dr Lueck, of the Horst-Schmidt Clinic, Wiesbaden , Germany , and lead investigator of the AGO Breast Cancer Study Group. "XP is a new, powerful weapon in our fight against breast cancer."

Breast cancer is the primary cause of cancer-related deaths in women worldwide(4) and the second leading cause of death for women in Europe.(5) Statistics show that breast cancer spreads in half of all women diagnosed, and that the average survival time for these patients is only 18 to 30 months.(6)

Study Details

Xeloda plus paclitaxel versus epirubicin plus paclitaxel first-line in metastatic breast cancer:

340 metastatic breast cancer patients were randomised to receive either epirubicin plus paclitaxel (EP), or Xeloda plus paclitaxel (XP). The aim of the study was to show non-inferiority of XP to EP. Key findings were:

-- Efficacy: This study shows similar efficacy between the non-anthracycline regimen XP and the EP combination when given upfront (overall response rate 41.5 percent vs. 41.0 percent; progression-free survival 12.3 months vs. 11.8 months)

-- Safety: The toxicity of XP is relatively low compared with other non- anthracycline-containing combination therapies, and compares favorably with EP. Moreover, Xeloda clearly has safety advantages compared with anthracyclines, such as lack of cumulative cardiotoxicity, neutropenia and hair loss

-- New option: XP is a strong option for patients with anthracycline- pretreated metastatic breast cancer

  About Xeloda

Xeloda is licensed in more than 90 countries worldwide including the EU, USA , Japan , Australia and Canada and has been shown to be effective, safe, simple and convenient oral chemotherapy in treating over 1 million patients to date.

Xeloda is licensed in combination with Taxotere (docetaxel) in women with metastatic breast cancer (breast cancer that has spread to other parts of the body) and whose disease has progressed following intravenous (i.v.) chemotherapy with anthracyclines. Xeloda monotherapy is also indicated for treatment of patients with metastatic breast cancer that is resistant to other chemotherapy drugs such as paclitaxel and anthracyclines. Xeloda is licensed for the first-line treatment of stomach cancer that has spread, in South Korea .

The most commonly reported adverse events with Xeloda include diarrhoea, abdominal pain, nausea, stomatitis and hand-foot syndrome (palmar-plantar erythrodysesthaesia).

References:

1. H. Lueck et al, Epirubicin/paclitaxel (EP) vs. capecitabine/paclitaxel (XP) in first-line metastatic breast cancer (MBC): a prospective, randomized multicentre phase III study of the AGO breast cancer study group. Oral presentation, Abstract 517 presented at ASCO 2006

2. S. Beslija et al, Randomized trial of sequence vs. combination of capecitabine (X) and docetaxel (T): XT vs. T followed by X after progression as first-line therapy for patients (pts) with metastatic breast cancer (MBC). Poster 571 presented at ASCO 2006

3. O'Shaughnessy J et al. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: Phase III trial results. J Clin Oncol 2002; 20:2812-23

4. World Health Organisation: International Agency for Research on Cancer Database no.5 (Globocan 2000); Lyon 2001

5. Mortality Report - UK : Cancer Research UK . February 2003.

6. Perez EA. Current Management of Metastatic Breast Cancer. Seminars in Oncology. 1999; 26(Suppl.12): 1-10

  (5/6/06)