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Herceptin Suitable Second- or Third-Line Treatment for Metastatic Breast Cancer: Presented at SABCS

By Robert H. Carlson

SAN ANTONIO, TX -- December 17, 2001 -- Women whose metastatic breast cancer tumors overexpress the human epidermal growth factor receptor 2 (HER2) gene can benefit from treatment with Herceptin (trastuzumab) even after they have failed to respond to several previous chemotherapy drugs.

Researchers say Herceptin is especially suited for palliative treatment in this heavily pretreated population because of its favorable safety profile.

Holger Eidtmann, MD, Senior Physician-in-Charge, Department of Obstetrics and Gynecology, University of Kiel, in Kiel, Germany, presented the data on use of Herceptin as second- or third-line therapy at the 24^th Annual San Antonio Breast Cancer Symposium, in San Antonio, Texas.

"This study confirms the earlier study of Dr. Melody Cobleigh reported in 1998," Dr. Eidtmann said. "We found the same response rate and time to progression as she did, showing that Herceptin works in second- or third-line monotherapy."

The 70 women in this trial (mean age 55 years) had HER2-positive breast cancer as assayed by the DAKO HercepTest, with 92 percent of them having 3+ status. All were enrolled after failure to respond to at least one chemotherapy regimen for metastatic disease. Forty-three percent of the patients had received previous adjuvant chemotherapy, and the group as a whole had received a median of two chemotherapy regimens for advanced disease, while 44 percent had received palliative endocrine pretreatment.

Two-thirds of the women suffered from visceral metastasis, half of those being in the liver, and half of the women had bone tumors. The overall mean number of organ systems involved was 1.5. Two patients had evidence of cardiac disease at baseline but this was considered to be clinically insignificant so they were entered into the trial.

Treatment consisted of an initial dose of 4 mg/kg trastuzumab in week 1 and 2 mg/kg weekly thereafter, continued until the disease progressed.

Dr. Eidtmann reported on 67 patients evaluable for treatment results. At the time these data were collected, duration of treatment with Herceptin ranged from one to 66 weeks, with a median of 12 weeks.

Objective responses were seen in 12 of 67 patients who were evaluable for response, a rate of 18 percent, he said, and included two patients who had a complete response and 10 others who had partial responses. Another 18 patients showed stabilization of disease. Median duration of response was 44 weeks, and median time to progression was 12 weeks. About 10 percent of patients were alive and progression free after one year on therapy.

Patients with liver metastases had significantly shorter times to progression, Dr. Eidtmann noted.

Among the 47 patients who were evaluable for safety, toxicities attributable to Herceptin were reported in less than 18 percent of patients and these were generally mild, Dr. Eidtmann said. Significant cardiac problems were detected in three cases -- all patients who had anthracycline pretreatment. Other severe adverse effects included elevation of liver enzymes, cholestasis and vomiting (one case each), but no treatment cycle was delayed due to toxicity.

There were three severe cardiac events, Dr. Eidtmann said, two patients with grade 4 cardiac insufficiency and one with grade 3 edema.

"Abnormal cardiac findings were reported in 29 percent of patients, but considering that these patients are very ill, that's not bad," he concluded.

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