The objective of this phase III global study was to compare the efficacy of gemcitabine plus paclitaxel (GT) versus paclitaxel in patients with advanced breast cancer. It was designed as a pivotal ...study for the approval of G for a breast cancer treatment indication.
Patients who relapsed after adjuvant anthracyclines were randomly assigned to gemcitabine,1,250 mg/m(2) days 1 and 8 plus paclitaxel, 175 mg/m(2) on day 1; or, to paclitaxel at same dose on day 1 (both arms administered every 21 days, unblinded). The primary end point was overall survival (OS) and secondary end points were time to progression (TTP), response rate (RR), progression-free survival, response duration, and toxicity. This final OS analysis was planned at 380 deaths.
A total of 266 patients were randomly assigned to GT and 263 to paclitaxel. Median survival on GT was 18.6 months versus 15.8 months on paclitaxel (log-rank P = . 0489), with an adjusted Cox hazard ratio of 0.78 (95% CI, 0.64 to 0.96; P = .0187). The TTP was longer (6.14 v 3.98 months; log-rank P = .0002) and the RR was better (41.4% v 26.2%; P = .0002) on GT. There was more grade 3 to 4 neutropenia on GT and grade 2 to 4 fatigue and neuropathy were slightly more prevalent on GT.
This phase III study documents a role for gemcitabine in advanced breast cancer after anthracycline-based adjuvant therapy. The results establish GT as a reasonable choice for women who require cytoreduction with manageable toxicities and validate ongoing testing of GT in the adjuvant setting.
The ability to determine the fragility of agribusiness value chains is valuable to agribusines management practitioners and scholars in a context where risk and uncertainty are increasingly ...pervasive, consequential and unpredictable. The paper argues for determining the fragility of a chain to adverse events rather than trying to predict the probability and impact of such events. The paper specifically proposes a framework to detect and quantify non-linear consequences in response to progressively deteriorating chain fragility factors. The paper’s approach is a novel alternative to the traditional value chain ‘risk assessment’. Application of the framework to the South African lamb chain reveals that a number of specific factors, like quality and safety performance and cash flow position, have consistently high fragility scores throughout the chain while some factors are uniquely localized to a specific role-player or activity, which highlights the techno-economic uniqueness of individual activities in a chain.
Background
Trichoepithelioma (TE) is a benign adnexal neoplasm derived from basal cells in the hair follicle. Solitary TE occurs sporadically as opposed to the multiple familial variant that presents ...as an autosomal dominant genodermatosis. The solitary variant can be confused with basal cell carcinoma both clinically and histologically. Multiple familial TEs are a cosmetically disfiguring condition with limited satisfactory treatment options.
Method
Skin biopsies diagnosed as TE from January 1, 2001, to December 31, 2011, were retrieved from the archives of the Division of Anatomical Pathology (University of Stellenbosch and National Health Laboratory Service, Cape Town, South Africa). Clinical and demographic data were retrieved from the patient records at Tygerberg Academic Hospital. Data of patients with solitary TE and multiple TE were compared.
Results
Thirty‐three biopsy specimens were collected from 30 patients. Twenty patients had solitary TE, nine patients had multiple TEs, and one patient had multiple linear TEs. Multiple TEs started to develop in patients at an average age of 17.3 years. Three patients in the study had tumoral TE with a diameter greater than 20 mm. One patient had TE associated with a basal cell carcinoma. Multiple TEs were commonly misdiagnosed clinically as tuberous sclerosis and showed a cribriform histopathological tumor pattern in 80% of cases as compared to only 10% of solitary TEs.
Conclusion
The current study was confined to a cohort of patients, in the Western Cape Province of South Africa, whose ethnic and geographic origins were not available. The extrapolation of findings from this study to the rest of the South African population may not be valid. A cribriform growth pattern occurs in the majority of cases of multiple TEs.
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