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| |  SABCS: Dose-intense Chemotherapy Regimen Reduces Toxicity By Robert H. Carlson SAN ANTONIO, TX -- December 12, 2001 -- A pilot study using standard anticancer drugs in a continuous "dose intense" regimen showed good responses with lower-than-usual toxicity in intermediate-risk women with node-positive breast cancer. In five years of follow-up, only one of 37 patients has been hospitalized for neutropenic fever, said Georgiana Ellis, MD, Associate Professor of Medicine, University of Washington, in Seattle, Washington. In her presentation here at the 24th Annual San Antonio Breast Cancer Symposium, Dr. Ellis said a dose-intense "(F)AC+G" adjuvant chemotherapy regimen has shown excellent five-year event-free survival in patients who have four to nine involved axillary nodes. The regimen consisted of Adriamycin (A) 18 or 24 mg/m² given intravenously once weekly, cyclophosphamide (C) 60 mg/m² taken orally once a day, plus granulocyte-colony stimulating factor (G-CSF) (G) 5 µg/kg on the days when Adriamycin is not given. The first 17 patients also received fluorouracil (F) but that was stopped because of hand-foot syndrome, and also because AC became a national standard in the U.S. after this study had already begun. The last 20 patients received Adriamycin 24 mg/m². The regimen was given until the cumulative Adriamycin dose reached 480 mg/m². If the patient progressed, she was continued on therapy with taxanes or high-dose chemotherapy. Dr. Ellis said the AC regimen she used is considered dose intense because it employs smaller doses with more frequent administration. This contrasts with another modern strategy in breast cancer chemotherapy, the dose-dense approach, which gives full doses at shorter-than-usual intervals. The dose-dense approach can result in a high hospitalisation rate for neutropenia, Dr. Ellis said. The women in Dr. Ellis' study had a median age of 41 years (range 23-62), and had stage II or IIIA disease. In the total of 37 patients, five-year disease-free survival was 81 percent, with overall survival at 88 percent. Twenty-one patients who did not need additional chemotherapy after the dose-intense regimen had disease-free survival at five years of 90 percent and overall survival of 90 percent, Dr. Ellis said. She pointed out that this compares favorably with studies of dose-dense AC regimens at Memorial Sloan-Kettering Cancer Center, New York, New York, in which absence of relapse at five years was noted in 64 percent and 70 percent of a similar group of patients, respectively (JCO 1999;17:1118-1126). "Our dose-intense approach is to give lower-dose therapy on a relatively continuous basis," Dr. Ellis said. "A lot of the dose intensity is in the daily cyclophosphamide, but we think the bulk of the activity is in the Adriamycin." Novel to this regimen is the G-CSF support overlapping the oral cyclophosphamide dose, she said, which supports the patients' neutrophils and allows the dose intensity to be kept high. "Our hospitalisation rate is less than 10 percent with this out-patient regimen, yet it shows a lot of activity with good long-term results," Dr. Ellis concluded.
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