Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · Dec 2005
Randomized Controlled Trial Multicenter StudyDose-dense adjuvant chemotherapy in early breast cancer patients: results from a randomized trial.
To determine whether a dose-dense regimen improves outcome in early breast cancer patients, we compared outcomes with the same fluorouracil, epirubicin, and cyclophosphamide (FEC) chemotherapeutic regimen administered every 3 weeks (FEC21) or administered every 2 weeks (FEC14 including support with filgrastim, a granulocyte colony-stimulating factor) in a multicenter phase III randomized trial. ⋯ Our results support the long-term safety of FEC14 chemotherapy as an adjuvant treatment of breast cancer. However, this therapy was not associated with improved outcome, but because of the limited statistical power of our study, we cannot rule out a modest improvement in outcome associated with FEC14 therapy.
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J. Natl. Cancer Inst. · Nov 2005
Randomized Controlled TrialTamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study.
Initial findings from the National Surgical Adjuvant Breast and Bowel Project Breast Cancer Prevention Trial (P-1) demonstrated that tamoxifen reduced the risk of estrogen receptor-positive tumors and osteoporotic fractures in women at increased risk for breast cancer. Side effects of varying clinical significance were observed. The trial was unblinded because of the positive results, and follow-up continued. This report updates our initial findings. ⋯ Despite the potential bias caused by the unblinding of the P-1 trial, the magnitudes of all beneficial and undesirable treatment effects of tamoxifen were similar to those initially reported, with notable reductions in breast cancer and increased risks of thromboembolic events and endometrial cancer. Readily identifiable subsets of individuals comprising 2.5 million women could derive a net benefit from the drug.
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J. Natl. Cancer Inst. · Sep 2005
Randomized Controlled Trial Clinical TrialRandomized trial of letrozole following tamoxifen as extended adjuvant therapy in receptor-positive breast cancer: updated findings from NCIC CTG MA.17.
Most recurrences in women with breast cancer receiving 5 years of adjuvant tamoxifen occur after 5 years. The MA.17 trial, which was designed to determine whether extended adjuvant therapy with the aromatase inhibitor letrozole after tamoxifen reduces the risk of such late recurrences, was stopped early after an interim analysis showed that letrozole improved disease-free survival. This report presents updated findings from the trial. ⋯ Letrozole after tamoxifen is well-tolerated and improves both disease-free and distant disease-free survival but not overall survival, except in node-positive patients.
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J. Natl. Cancer Inst. · Jul 2005
Randomized Controlled Trial Clinical TrialFlexible sigmoidoscopy in the PLCO cancer screening trial: results from the baseline screening examination of a randomized trial.
The Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial is a randomized clinical trial to test the effectiveness of cancer screening, including the effect of flexible sigmoidoscopy screening on colorectal cancer mortality. Here we report findings from the baseline screening flexible sigmoidoscopy examination. ⋯ Acceptance of screening flexible sigmoidoscopy was high. Diagnostic follow-up varied according to polyp size, yet cancer or adenoma detection rates met expectations.
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J. Natl. Cancer Inst. · Jun 2005
Randomized Controlled Trial Multicenter Study Clinical TrialRandomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases.
Radiation therapy is effective in palliating pain from bone metastases. We investigated whether 8 Gy delivered in a single treatment fraction provides pain and narcotic relief that is equivalent to that of the standard treatment course of 30 Gy delivered in 10 treatment fractions over 2 weeks. ⋯ Both regimens were equivalent in terms of pain and narcotic relief at 3 months and were well tolerated with few adverse effects. The 8-Gy arm had a higher rate of re-treatment but had less acute toxicity than the 30-Gy arm.