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Addition Of Chemotherapy To Herceptin (Trastuzamab) Improves Response Rate In Patients With Advanced Breast Cancer: Presented at ASCO

Taxol Plus Paraplatin Added to Herceptin Also Helps Improve Disease Control

ORLANDO, FL -- May 21, 2002 -- The addition of weekly Taxol (paclitaxel) plus Paraplatin (carboplatin) to Herceptin (trastuzamab) improves patient response and disease control in metastatic, or advanced, breast cancer that overexpresses the HER2 neu oncogene, according to a study released today at the 38th Annual American Society of Clinical Oncology (ASCO) Meeting.

In this trial, among 58 patients who were evaluable for response, 66 percent demonstrated stable disease or better after first-line Herceptin. Patients who responded continued to receive the HER-2 neu antibody alone, prior to receiving weekly Taxol plus Paraplatin administered concurrently with Herceptin. A 71 percent overall response rate was seen for patients who responded to Herceptin and continued to receive weekly Herceptin concurrently with Taxol and Paraplatin. Patients in the study who had discontinued Herceptin after failing to respond (20 patients) experienced a 63 percent response rate to weekly Taxol and Paraplatin. The median time to progression for those patients with 3+ HER2 overexpression was 17 months; the median time to progression was 12 months for the entire group. Overall survival for the entire group was 29.3 months.

"Results of this study show that in patients with advanced breast cancer, the addition of weekly Taxol plus Paraplatin to Herceptin produces improved responses as compared to Herceptin alone," said Denise Yardley, MD, Director of Breast Cancer Research, Sarah Cannon Cancer Center; Associate, Tennessee Oncology, PLLC; and presenter of this trial. "In addition, the combination of Taxol plus Paraplatin is effective in patients who do not respond to first- line Herceptin."

FISH data has been obtained on 49 patients (28 FISH+ and 21 FISH-) to date. FISH is the evaluation of HER2 genes as amplified by fluorescent in situ hybridization. Three FISH- patients demonstrated a 15 percent response rate to induction Herceptin, while six FISH+ patients demonstrated a 23 percent response rate to single-agent Herceptin.

"Patients with metastatic breast cancer with FISH+ HER2 overexpression, a previously poor prognostic factor, may now actually have better treatment outcomes and survival as compared to those patients who demonstrate normal HER2 expression, following the addition of targeted therapy such as Herceptin," according to Dr. Yardley.

This phase II trial evaluated the activity of Herceptin as a single agent and the benefits of adding weekly Taxol plus Paraplatin to Herceptin. All patients received eight weeks of induction Herceptin. Patients with a minor or better response after induction treatment received another eight weeks of Herceptin alone. Patients with stable disease on Herceptin began weekly Taxol (70 mg/m2/week) and Paraplatin (AUC 2.0/week) in combination with Herceptin (2 mg/kg) for six weeks, with cycles repeated every eight weeks. Patients who failed to respond to Herceptin discontinued this therapy and then began weekly Taxol and Paraplatin according to the above dosing schedule.

The use of weekly Herceptin, Taxol and Paraplatin was well tolerated by patients. Patients experienced neither febrile neutropenia (fever induced by a reduction in white blood cells) nor symptomatic cardiac toxicity. In addition, there were no treatment-related deaths. The trial was conducted by the Minnie Pearl Cancer Research Network in Nashville, TN.

According to the American Cancer Society, more than 203,500 new cases of invasive breast cancer and more than 54,300 new cases of in situ breast cancer will be diagnosed in 2002. An estimated 40,000 women will die of breast cancer. Breast cancer is the second leading cause of cancer-related death in women. Advanced or metastatic disease is cancer that has spread beyond the original tumor site. Treatment for metastatic disease remains a challenge for the oncology community with an average survival rate of two years. Therefore, the goal of treatment for advanced breast cancer is usually to palliate (reduce symptoms of the disease) and to prolong survival.

The Sarah Cannon Cancer Center at Centennial Medical Center is part of TriStar Health System based in Nashville, Tenn. Through its outreach efforts, The Sarah Cannon Cancer Center includes nearly 400 community-based oncologists in 22 states. To date, more than 60 cancer research studies have been conducted in the areas of lung cancer, breast cancer, ovarian cancer, lymphoma, bladder cancer, cancers of the head and neck, prostate cancer and carcinoma of unknown primary. The Sarah Cannon Cancer Center is named for the creator of the beloved character Minnie Pearl. For more information about The Sarah Cannon Cancer Center please call 615-342-1919 or 800-242-5662.

SOURCE: The Sarah Cannon Cancer Center

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