Tuesday, September 27, 2011

Afinitor, T-DM1 and Xeloda for Metastatic Breast Cancer

Today we'll share the latest news and research on Afinitor, T-DM1 and Xeloda for metastatic breast cancer.

Afinitor plus Aromasin (phase III)

The big story this week was a phase III trial of Afinitor (everolimus) plus Aromasin (exemestane) for post-menopausal women with advanced breast cancer presented at the 2011 European Multidisciplinary Cancer Congress (EMCC). Links to the EurekAlert!, Reuters and Bloomberg articles may be found on the Afinitor page of our website.

The trial, known as BOLERO 2, involved 724 hormone-receptor positive women whose cancer had become resistant to the aromatase inhibitors Femara (letrozole) or Arimidex (anastrazole). 485 received Afinitor plus Aromasin. 239 received Aromasin alone. Progression-free survival was almost 11 months in the Afinitor group, compared to about 4 months in the Aromasin alone group.

Afinitor is also being studied in combination with other drugs for advanced breast cancer. Novartis plans to file worldwide regulatory submissions for the Afinitor/Aromasin combination by the end of 2011.

TDM-1 (phase II)

Another EMCC presentation made headlines this week. The phase II study, TDM4450g, of trastuzumab emtansine (T-DM1) as first-line therapy in women with advanced HER2 positive breast cancer was covered by Medical News Today, Bloomberg and The Telegraph (UK).

The 137 patients were treated with either T-DM1 alone or Herceptin (trastuzumab) plus Taxotere (docetaxel). The median progression-free survival was 14.2 months with T-DM1 compared to 9.2 months with Herceptin plus Taxotere. In addition, the T-DM1 group suffered fewer side effects with less hair loss and hospitalization.

Larger, phase III trials are needed before regulatory approval. Last week, The Seattle Times shared an interesting story about Jeanne Sather, a breast cancer blogger whose efforts led to a geographic expansion of a T-DM1 trial. The story may be found on our T-DM1 page.

Navelbine/Gemzar vs. Xeloda alone (phase III)

Not all research on metastatic breast cancer involves brand new drugs. Some studies experiment with combinations of existing drugs.

A September 21 phase III study from Greece in the Annals of Oncology compared Navelbine (vinorelbine) plus Gemzar (gemcitabine) to oral Xeloda (capecitabine) alone for women with metastatic breast cancer previously treated with anthracyclines and taxanes.

Progression-free survival, overall survival and overall response were similar for both groups. The authors concluded, "Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients."

At LATESTBreastCancer.com, we'll continue to follow research on treatments for metastatic breast cancer. New developments will be added to our website and database and highlighted here. Please stay tuned.

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