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A study reported initially at the 25th San Antonio Breast Cancer Symposium (December 2002) has recently had publicity in the Australian press and prompted questions from my patients. (Citron M, et al. Superiority of dose-dense (DD) over conventional scheduling (CS) and equivalence of sequential (SC) vs. combination adjuvant chemotherapy (CC) for node-positive breast cancer (CALGB 9741, INT C9741). Program and abstracts of the 25th San Antonio Breast Cancer Symposium; December 11-14, 2002; San Antonio, Texas. Abstract 15.) The study enrolled 2005 women with primary breast cancer that had spread to the lymph nodes, and with no other metastases. Patients in the trial were randomized to receive concurrent AC followed by Taxol in two- or three-week cycles. Because frequent administration of chemotherapy can result in a condition called neutropenia--the decline in the number of certain white blood cells--those on the dose-dense regimens received granulocyte colony stimulating factor (G-CSF or Filgrastim or Neupogen®) to permit administration of the drugs every two-weeks rather than at the conventional three-week intervals. After four years of follow-up, researchers found that the dose-dense regimens, whether sequential or concurrent, were significantly better than the conventionally-timed three-week regimens in improving both disease-free survival and overall survival. Among patients on the dose-dense regimens, disease-free survival was 82 percent compared to 75 percent for those who received conventional therapy at four years from the start of the study. In terms of overall survival, after three years 92 percent of patients on the dose dense therapy were alive, compared to 90 percent of those on the conventionally administered regimens. The differences between the dose dense and the conventional regimens were expected to increase over time with continued patient follow-up. Researchers also found that side effects were no more severe among patients on dose-dense regimens than among those on the conventional treatments, and that patients on the dose-dense regimens suffered fewer cases of neutropenia. So why aren’t I recommending this to all my patients? Trials of this kind are very important pilot studies that indicate directions that we should take as oncologists in further testing chemotherapy for early breast cancer. However, they are generally not regarded as sufficient on their own to indicate widespread change in medical practice. We have discussed this trial at the New South Wales breast Cancer Institute, as we do all major developments in breast cancer treatment, and have determined as a group that so far the evidence is insufficiently strong to indicate that we change our standard protocols for adjuvant chemotherapy. This trial contained just 2005 women, and trials of this size have in the past given false leads. One classic example was in the report that high dose chemotherapy followed by bone marrow transplantation would lead to improved survival. When this experiment was repeated in several other centres, no such benefit was seen. The treatment described in this dose intense chemotherapy trial could not be given in Australia on the Pharmaceutical Benefits Scheme. The drug Taxol is only available in Australia to women who have had prior A C Chemotherapy and who have lymph node positive, oestrogen receptor negative breast cancer. The drugs Figrastim and Neupogen are available only for women who have had one episode of prior febrile neutropenia. All these drugs are extremely expensive if not prescribed under the PBS scheme. Whilst, of course, many people would agree to meet this expense if the evidence for increased effectiveness was strong, at present, none of us at Westmead currently believes that this evidence warrants such action. As always, we will continue to be personally represented as a group at all the major international breast cancer meetings (including the forthcoming A S C O Meeting in Chicago in June)and I will update this information whenever necessary. | AC | CMF | Dose-intense Chemotherapy | Paclitaxel ('Taxol') | Vinorelbine ('Navelbine') | Capecitabine ('Xeloda') | FAC | FEC | Docetaxel ('Taxotere') | Taxotere, Adriamycin and Cyclophosphamide 'TAC' | | Tamoxifen | Chemotherapy for Breast Cancer | After Treatment - What Now? | Causes of Breast Cancer | Breast Cancer Myths | Family History | Herceptin | Femara, Arimidex, Aromasin | Adjuvant Chemotherapy | Zoladex and Stopping the ovaries | Stage, Grade, Receptors | Zometa, XGeva | Alopecia from Hormonal Therapy | New treatments | Lapatinib 'Tykerb' | Avastin | Pertuzumab | | What's New | FAQ Page | Living with chemotherapy | Dietary Advice | Exercise | The Flu Vaccine | Insomnia | Marijuana | Alternative Medicine | Managing Menopause | Advice to Carers | Breast Cancer | Pain | Useful Tips | Chemotherapy: The What and How | MRI Screening | | Your Cancer Information | | Return Home | New Patients | Services and Clinics | Useful Links | Contact Us | Download Page | Cancer Information | |
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