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  • 1
    Digitale Medien
    Digitale Medien
    Adding adjuvant CMF chemotherapy to either radiotherapy or tamoxifen: Are all CMFs alike? (1998)
    Springer
    Annals of oncology 9 (1998), S. 489-493 
    Details
    ISSN: 1569-8041
    Schlagwort(e): adjuvant chemotherapy ; breast cancer ; CMF ; radiotherapy ; tamoxifen
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Notizen: Abstract The first reported effective adjuvant combination regimen for patients withoperable breast cancer comprised oral cyclophosphamide (C) days 1–14with intravenous methotrexate (M) and fluorouracil (F) on days 1 and 8,repeated every 28 days (’classical‘ CMF). These drugs have since beenextensively used with or without endocrine therapies and/or other cytotoxics,as well as with radiation therapy to the chest wall yielding conflictingresults. Although doses and schedules have varied widely, the combination ofthese three drugs has been generically referred to as CMF. Evidence existsthat reducing the dose and/or altering the schedule of CMF (’modified‘ CMF)have compromised its efficacy in metastatic breast cancer. Reduction belowstandard dose of a similar regimen also gave inferior results in the adjuvantsetting. In fact, the recently reported improved outcome of adding radiationtherapy to CMF was only demonstrated in comparisons with a ’modified‘ CMF.Furthermore, trials in women with estrogen receptor-positive breast cancer,which did not demonstrate any significant benefit for the addition of adjuvantCMF to tamoxifen compared with tamoxifen alone, also used ’modified‘ CMF.Therefore, adherence to the ’classical‘ dose and schedule is recommended whenCMF is used in adjuvant therapy.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1023/A:1008236502420
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  • 2
    Digitale Medien
    Digitale Medien
    New treatments for breast cancer: Breakthroughs for patient care or just steps in the right direction? (1998)
    Springer
    Annals of oncology 9 (1998), S. 973-976 
    Details
    ISSN: 1569-8041
    Schlagwort(e): adjuvant paclitaxel ; breast cancer ; Herceptin™ ; prevention ; Raloxifene ; Tamoxifen
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Notizen: Abstract Three areas of clinical research in breast cancer treatment led to news breaking presentations at the American Society of Clinical Oncology (ASCO) meeting, 1998, in Los Angeles. All three subjects represent important advances in cancer medicine. Prevention: Two related drugs, tamoxifen and raloxifene, were found in placebo controlled trials to significantly reduce the incidence of breast cancer for women at increased risk of developing the disease. Patterns of relapse showed that the reduced rate of breast cancer was exclusively observed for tumors expressing estrogen receptors, while the rate of tumors classified as estrogen-receptor negative was similar for the treatment and the control groups. This may indicate that the observed reduction in breast cancer incidence is due to a treatment effect on occult disease rather than its prevention. We certainly have no adequate information on mortality prevention. Adjuvant therapies: Taxol given every three weeks for four courses following an adjuvant treatment with four courses of doxorubicin and cyclophosphamide (AC) combination was found to be superior to not adding treatment after the four courses of AC in a trial involving 3170 patients. At 22 months of median follow-up, the quoted P-values were P = 0.0077 for disease-free survival and P = 0.039 for overall survival, but these did not cross the prospectively defined interim analysis boundaries for statistical significance at the 0.05 level. The difference was observed early during follow-up, and was exclusively seen in the 40% of patients who had ER-negative primaries and, therefore, did not receive tamoxifen following chemotherapy. One may thus argue that the early difference observed was primarily due to differences in the duration of the treatment regimens in the two groups and the early entry into the trial of patients with particularly aggressive neoplasia (e.g., ER-negative primaries) who would have benefited from a longer duration treatment. Treatment of advanced disease: The use of monoclonal antibodies to c-erb-B2 was found to induce responses in metastatic breast cancer. Patients with tumors expressing c-erb-B2 responded to weekly infusions of this biological agent. It was particularly impressive that the response rate for patients receiving infusion of the monoclonal antibodies together with the cytotoxics was superior to that with chemotherapy alone in a randomized trial. It is important to note that only patients with tumors overexpressing c-erbB-2 (the overall incidence is about 20%) were tested. It must still be demonstrated that the effect of these monoclonal antibodies is indeed confined to cells overexpressing c-erbB-2. Treatment related cardiac toxicity remains a problem, and the effects of treatment in various subsets of patients need to be defined before starting investigations in the adjuvant setting, which is a clear further objective of this specific research. The significant findings from clinical research opened several new questions, which must be answered before allowing them to be employed in routine patient care.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1023/A:1008436810268
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  • 3
    Digitale Medien
    Digitale Medien
    Quality of life assessment in patients receiving adjuvant therapy for breast cancer: The IBCSG approach (1997)
    Springer
    Annals of oncology 8 (1997), S. 825-835 
    Details
    ISSN: 1569-8041
    Schlagwort(e): adjuvant therapy ; breast cancer ; cross-cultural issues ; linear analogue self-assessment (LASA) scales ; quality of life ; randomized controlled trials
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Notizen: Abstract Background and purpose: The International Breast Cancer Study Group (IBCSG) has developed an approach for assessing the impact of adjuvant therapy on quality of life (QL) within the framework of international, multilingual clinical trials. The major steps are summarized. Conceptual, methodological and practical issues are discussed with reference to results of two trials closed to accrual (IBCSG VI, VII) and one subsequent ongoing trial (IBCSG IX). Patients and methods: QL was assessed in pre- and postmenopausal patients with operable breast cancer. Various single-item linear analogue self-assessment (LASA) scales were used as indicators of components of QL, including global indicators of well-being, functioning and health perception, and specific indicators of symptoms of disease and treatment. In trials VI and VII, QL was assessed at baseline, during adjuvant treatment and follow-up, and at recurrence. Based on this experience, the QL form was revised for subsequent trials and further investigated in a subsample of patients randomized into trial IX. Results: In trials VI and VII, the QL indicators were responsive to the impact of biomedical factors at baseline, various adjuvant treatments, changes over the first 18 months, and recurrence. In trial IX, the revised QL form was well accepted by patients and staff. Completing this form did not exceed five minutes. QL differences between on and off cytotoxic treatment strengthen the claim that these measures are responsive. Correlations and logistic regression analyses show the expected relationship among the various global and specific indicators. Conclusion: Results from two trials closed to accrual and an ongoing trial confirm the feasibility, validity and clinical relevance of the IBCSG approach for studying the impact of adjuvant breast cancer therapy on QL in international clinical trials.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1023/A:1008269715091
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  • 4
    Digitale Medien
    Digitale Medien
    Menstrual cycle and timing of breast surgery in premenopausal node-positive breast cancer: Results of the International Breast Cancer Study Group (IBCSG) Trial VI (1997)
    Springer
    Annals of oncology 8 (1997), S. 751-756 
    Details
    ISSN: 1569-8041
    Schlagwort(e): adjuvant chemotherapy ; breast cancer ; menstrual cycle ; premenopausal ; surgery
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Notizen: Abstract Purpose: It has been postulated that breast cancer surgery performedduring the follicular phase of the menstrual cycle is associated with pooreroutcome. Patients and methods: We tested this hypothesis by evaluatingdisease-free survival (DFS) for 1033 premenopausal patients who receiveddefinitive surgery either during the follicular phase (n = 358) or theluteal phase (n = 675). All patients were enrolled in a randomized trialconducted between July 1986 and April 1993. All had node positive breastcancer and randomization was stratified by estrogen receptor (ER) status.All patients received at least three cycles of adjuvant cyclophosphamide,methotrexate, and 5-fluorouracil (CMF). The median follow-up was 60 months. Results: Patients who underwent definitive surgery for breast cancer inthe follicular phase had a slightly worse disease-free survival than thoseoperated on during the luteal phase (five-year DFS percentage: 53%versus 58%; hazard ratio, 1.13; 95% confidence interval (CI),0.94–1.38; P = 0.20). The effect was significantly greater for thesubpopulation of 300 patients with ER-negative primaries (P = 0.02interaction effect; five-year DFS percentages 42% vs. 59%;hazard ratio 1.60; 95% CI, 1.12–2.25; P = 0.008). The effect oftiming of surgery diminished for analyses based on lesser surgicalprocedures, e.g., excisional biopsies. In particular, no effect of timingwas observed for fine needle aspiration procedures. Conclusions: Surgical procedures which are more extensive than a fineneedle aspiration biopsy might be associated with worse prognosis if conductedduring the follicular phase of the menstrual cycle. This phenomenon was seenpredominantly for high risk breast cancer with low levels or no estrogenreceptors in the primary tumor.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1023/A:1008220301866
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  • 5
    Digitale Medien
    Digitale Medien
    The Q-TWiST approach to assessing health-related quality of life in epilepsy (1995)
    Springer
    Quality of life research 4 (1995), S. 135-141 
    Details
    ISSN: 1573-2649
    Schlagwort(e): outcomes ; quality of life ; neurological disease ; epilepsy ; patient perspective ; Q-TWiST
    Quelle: Springer Online Journal Archives 1860-2000
    Thema: Medizin
    Notizen: Abstract We propose to develop a methodology for evaluating clinical interventions for epilepsy in terms of their effects on disease-related outcomes, social cost and quality of life, while incorporating patient preference. The technique represents an extension of the ‘quality-adjusted time without symptoms and toxicities’ (Q-TWiST) method, which has been previously used to evaluate treatments for cancer and AIDS with respect to their costs in terms of toxicities, and benefits in terms of improved progression-free and overall survival. The extensions we propose to develop allow additional dimensions of quality of life relevant to epilepsy to be included in the analysis. We demonstrate a possible application of the proposed Q-TWiST method with a hypothetical example comparing surgeryvs antiepileptic medication management alone for seizure control. The trade-offs between these alternative treatments are highlighted, along with patient importance weightings regarding various dimensions of quality of life. We describe further research needed to develop the methodology fully and comment on its potential usefulness.
    Materialart: Digitale Medien
    URL: http://dx.doi.org/10.1007/BF01833607
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