10715 Background: Docetaxel has become a standard of care in BC, initially as salvage therapy, then as front line therapy for advanced disease and now in the adjuvant setting. Patients and Methods: A survey of the use of docetaxel in advanced BC in the community setting included 129 patients (128 females; 1 male) treated by 29 oncologists from 27 centers in South Africa from August 2002 until October 2003. Median age was 51 years (range 25–82 years). Median time between initial diagnosis and treatment was 27 months (range 6 days - 22 years). Although the survey was planned for advanced disease, 10 patients received adjuvant therapy; 59 received 1 st line docetaxel and the rest 2 nd line or more; major metastatic sites were bone (n = 57), liver (n = 45) and lung (n = 37); 47% patients were ER+, 30% ER- and 23% ER unknown; most had good PS (63 ECOG PS 0, 53 PS 1); 19 patients had no prior chemotherapy, 58 prior adjuvant therapy and 52 prior non-taxane chemotherapy for advanced disease. 62% patients received single agent docetaxel including 75–100mg/m 2 3–4 weekly (38%) and 20–50mg/m 2 weekly (19%) with 38% receiving docetaxel plus another drug. Results: At 1 year, 88 patients (68.8%) were alive. Log rank analysis showed age >40 years (p = 0.025) and PS 0 (p = 0.0000) were prognostic factors for survival, while post docetaxel chemotherapy (p = 0.062), 1 st line vs more advanced disease (p = 0.3557), weekly vs 3–4 weekly docetaxel (p = 1.00), ER status (p = 0.1527) and menopausal status (p = 0.997) were not. Of 59 1 st line patients, 40 (67.8%) were alive at 1 year. Age >40 years (p = 0.0015) and PS 0 (p = 0.031) as well as ER status (p = 0.011) and post docetaxel chemotherapy (p = 0.0436) were prognostic factors for survival, while menopausal status (p = 0.0609) and weekly vs 3–4 weekly docetaxel (p = 0.248) were not. 115 patients had 655 adverse events (AEs) including 111 serious AEs (SAEs) in 55 patients. 470 AEs were drug related with 54 SAEs including neutropenia (8), diarrhea (6) febrile neutropenia (5), emesis (5), cellulitis (3) and pneumonia (3). There were no treatment related deaths. Conclusions: Docetaxel alone or in combination is effective and well tolerated therapy in advanced BC especially in patients over 40 years of age with good PS (ECOG 0). Sponsored by Aventis Pharma (South Africa). No significant financial relationships to disclose.
The International Breast Cancer Study Group (formerly the Ludwig Group) has conducted nine clinical trials since 1978 (see the Appendix for participants and authors). Biologic hypotheses related to the combined use of chemotherapy and endocrine therapy in women with operable breast cancer were tested. Questions of timing of chemotherapy with respect to tumor surgery and late introduction of chemotherapy were also evaluated. Ongoing and future trials continue in this tradition to investigate combinations of available endocrine therapies and cytotoxic agents.
PURPOSE: Information on the tolerability and efficacy of adjuvant chemoendocrine therapy for older women is limited. We studied these issues using the data collected as part of the International Breast Cancer Study Group Trial VII. PATIENTS AND METHODS: Postmenopausal women with operable, node-positive breast cancer were randomized to receive either tamoxifen alone for 5 years (306 patients) or tamoxifen plus three consecutive cycles of classical cyclophosphamide (100 mg/m 2 orally days 1 to 14), methotrexate (40 mg/m 2 intravenous days 1 and 8), and fluorouracil (600 mg/m 2 intravenous days 1 and 8) every 28 days (CMF; 302 patients). The median follow-up was 8.0 years. RESULTS: Among the 299 patients who received at least one dose of CMF, women 65 years of age or older (n = 76) had higher grades of toxicity compared with women less than 65 years old (n = 223) (P = .004). More women in the older age group compared with the younger women experienced grade 3 toxicity of any type (17% v 7%, respectively), grade 3 hematologic toxicity (9% v 5%, respectively), and grade 3 mucosal toxicity (4% v 1%, respectively). Older patients also received less than their expected CMF dose compared with younger postmenopausal women (P = .0008). The subjective burdens of treatment, however, were similar for younger and older patients based on quality-of-life measures (performance status, coping, physical well-being, mood, and appetite). For older patients, the 5-year disease-free survival (DFS) rates were 63% for CMF plus tamoxifen and 61% for tamoxifen alone (hazards ratio [HR], 1.00; 95% confidence interval [CI], 0.65 to 1.52; P = .99). For younger patients, the corresponding 5-year DFS rates were 61% and 53% (HR, 0.70; 95% CI, 0.53 to 0.91; P = .008), but the test for heterogeneity of CMF effect according to age group was not statistically significant. The reduced effectiveness of CMF among older women could not be attributed to dose reductions according to dose received. CONCLUSION: CMF tolerability and effectiveness were both reduced for older patients compared with younger postmenopausal node-positive breast cancer patients who received tamoxifen for 5 years. The development and evaluation of less toxic and more effective chemotherapy regimens are required for high-risk elderly patients.
Systemic treatment for breast cancer is given as neoadjuvent therapy to reduce tumour bulk before surgery, and as adjuvant therapy after surgery to control micrometastatic disease, reduce tumour bulk and improve quality of life in metastatic disease. Systemic therapy is divided into endocrine therapy, chemotherapy and biological response modifier therapy. All therapies will cause a higher rate of anxiety and depression, and loss of libido, which for many is a major problem. In pre-menopausal patients fertility issues should be discussed as the agents used can cause a decrease in or, in some cases, loss of fertility.
PURPOSE: To identify patient populations at high risk for bone metastases at any time after diagnosis of operable breast cancer, because these patients are potential beneficiaries of treatment with bisphosphonates. PATIENTS AND METHODS: We evaluated data from 6,792 patients who were randomized in International Breast Cancer Study Group clinical trials between 1978 and 1993. Median follow-up was 10.7 years. A total of 1,275 patients (18.7%) presented with node-negative disease, whereas 3,354 patients (49.4%) had one to three and 2,163 patients (31.9%) had four or more involved axillary lymph nodes. We also assessed the incidence of subsequent bone metastases in the cohort of 1,220 patients who had a first event in local or regional sites or soft tissue alone. Median follow-up for this cohort was 7.7 years from first recurrence. RESULTS: For the entire population with operable disease, the cumulative incidence of bone metastases at any time was 8.2% at 2 years from randomization and 27.3% at 10 years. The highest cumulative incidences of bone metastases at any time were among patients who had four or more involved axillary nodes at the time of diagnosis (14.9% at 2 years and 40.8% at 10 years) and among patients who had as their first event a local or regional recurrence or a recurrence in soft tissue, without any other overt metastases (21.1% at 2 years from first recurrence and 36.7% at 10 years). CONCLUSION: Treatments to prevent bone metastases may have a major impact on the course of breast cancer and may be most efficiently studied in populations with several involved axillary nodes at the time of presentation and in populations with local or regional recurrence or recurrence in soft tissue.
Lateral internal sphincterotomy has been the standard treatment for chronic anal fissure, but fissure healing rates of up to 80% with topical glyceryl trinitrate (GTN) treatment have suggested that this operation may become redundant. We evaluated the results of topical treatment of chronic anal fissures with 0.2% GTN for 6 weeks in the outpatient clinical setting, outside the confines of a randomized clinical trial. The role of lateral internal sphincterotomy in the GTN era was also assessed. GTN induced fissure healing in 21 of 49 consecutive patients. Fissures healed spontaneously in 2 patients who discontinued GTN because of headache. Lateral internal sphincterotomy was performed in 26 patients who had persistent symptoms after 6 weeks of GTN therapy. At the 6-week post-sphincterotomy review, all fissures had healed and there were no complications. In this study topical GTN for treatment of chronic anal fissure in the outpatient setting was not as effective as demonstrated in controlled clinical trials. Lateral internal sphincterotomy is still a good therapeutic option, especially in patients not responding to GTN.
To describe the patterns of use of injectable progestogen contraceptives (IPCs) among coloured and black women in the Western Cape. These data are part of an ongoing study in the Western Cape, the main aim of which is to explore the relationship between IPCs and breast cancer.A population-based case-control study of breast cancer risk in relation to the use of IPCs among coloured and black women.The Western Cape, including the Cape metropole and surrounding rural areas.All coloured and black women with newly diagnosed breast cancer, resident in the study area and below age 55 years, who present at either of the two tertiary care hospitals in the Western Cape are recruited. Controls are a sample of hospitalised patients representative of the populations from which the patients are drawn. Cases are frequency-matched to controls according to cross-tabulation of age, ethnic group and residential area in a ratio of approximately 1:3.Questionnaires are administered by trained nurse interviewers, information is elicited on a wide range of variables, including sociodemographic variables, medical history, family history of breast disease, lifetime history of all methods of contraception and use of non-contraceptive female steroids, reproductive variables, cigarette smoking, alcohol consumption and other potentially confounding variables.Between January and December 1994, 122 incident cases and 389 controls were enrolled. Ever-use of IPCs among the controls was 72% (N = 280) and use for 5 years or more was 30% (N = 117). Use of IPCs in the distant past was common, with 61% (N = 232) of all controls having initiated use 10 or more years previously. Current use was also high (19%). Other contraceptive methods were used far less commonly.Coloured and black women in South Africa have been using and continue to use IPCs for more commonly and for longer periods than women anywhere else in the world. It is therefore especially important to evaluate the risk of breast cancer and other health effects of IPCs. The rates of use identified in this study ensure that there will be adequate statistical power to evaluate long-term use, use in the distant past and current use of IPCs.
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