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Epoetin Alfa Effective for Mild Chemotherapy-Associated Anemia: Presented at ASCO

By Charlene Laino


NEW ORLEANS, LA -- June 8, 2004 -- Epoetin alfa is effective for the treatment of mild chemotherapy-associated anemia, a multicenter randomized trial shows.

"Even when you start treatment at relatively high hemoglobin, earlier than is usually done, epoetin alfa is effective in reducing transfusion requirements and improving quality of life," said Jorien Savonije, MD, a PHD student in medical oncology at the VU University Medical Center in Amsterdam, the Netherlands. Dr. Savonije reported the results here on June 6th at the American Society of Clinical Oncology 40th Annual Meeting.

Epoetin alfa is already known to be effective for the treatment of moderate to severe chemotherapy-associated anemia, but its role in treating mild anemia in cancer patients is less clear, she said.

"ASCO recommends initiating epoetin alfa therapy in patients with hemoglobin levels of 10 g/dL or less, with treatment for patients with hemoglobin levels between 10 g/dL and 12 g/dL determined by clinical circumstances," she said. The National Comprehensive Cancer Network, on the other hand, recommends epoetin alfa therapy for patients with hemoglobin levels between 10 g/Dl and 11 g/dL.

To help clarify the issue, the researchers studied 316 patients on platinum-based chemotherapy; 211 were randomized to 10,000 IU of epoetin alfa 3 times weekly and 105 to best supportive care. If, after 4 weeks of therapy, hemoglobin was less than 12.1 g/dL or hemoglobin increased less than 1 g/dL, the dose was increased to 20,000 IU thrice weekly.

All the patients had hemoglobin levels of 12.1 g/dL or less, an Eastern Cooperative Oncology Group performance status of 0 to 3, and a life expectancy of at least 5 months. The mean baseline hemoglobin level was 10.7 g/dL in the epoetin alfa arm and 10.8 g/dL in the best supportive care arm.

During a mean treatment duration of about 14 weeks, 65% of patients in the best supportive care arm required a transfusion, compared with 36% of those on epoetin alfa (P <.001), the study showed. Also, mean hemoglobin significantly increased in the epoetin alfa group by 1.6 g/dL (P =.0001), while significantly decreasing by 0.4 g/dL in the best supportive care arm (P <.01), Dr. Savonije reported.

As measured by the Functional Assessment of Cancer Therapy-Anemia (FACT-An) and Cancer Linear Analogue Scales, patients receiving epoetin alfa had significantly better quality of life outcomes at the end of the study than those in the control group (P <.05), she said. For example, mean scores on FACT-An increased 4 points in the epoetin alfa arm, while dropping 3.7 points in the best supportive care group, the study showed.

The overall incidence of adverse events was similar among the 2 arms, she added. While 4.3% of patients in epoetin alfa experienced a thrombovascular event versus only 1.0% in the best supportive care group, Dr. Savonije said that only 1 such event -- a case of deep vein thrombosis -- was considered to be possibly related to epoetin alfa by the investigators.


[Presentation title: "Early Intervention With Wpoetin-alfa During Platinum-based Chemotherapy." Abstract #8111]

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