Objectives: To assess the efficacy and tolerability of gemcitabine and paclitaxel as first-line treatment in advanced breast cancer. Methods: Patients with histologically confirmed metastatic or metastatic plus locally advanced breast cancer received gemcitabine 1,200 mg/m² on days 1 and 8 and paclitaxel 175 mg/m² on day 1 every 21 days for 8 cycles. Results: From December 1999 to August 2001, 45 patients, with a median age of 53.5 years (range, 22–77), received a total of 260 cycles. All were assessable for response and toxicity. Twenty-seven patients had prior adjuvant therapy. Hormonal receptor status was positive in 31.1% and negative in 40.0% of patients. Main metastatic sites included soft tissue (62.2%) and lung (53.3%). The objective response rate was 66.7%; complete response, 22.2%; partial response, 44.4%; stable disease, 15.6%; progressive disease, 17.8%. Median duration of response was 18 months and median time to tumor progression was 11 months. Grade 3/4 leukopenia, neutropenia, and thrombocytopenia developed in 13.3% of patients, and 15.5% developed grade 3/4 mucositis. No treatment-related deaths occurred. Median overall survival was 19 months. Conclusion: Gemcitabine plus paclitaxel is an active combination with a favorable toxicity profile as first-line treatment for patients with advanced breast cancer.

This CEF regimen safely provides significantly better tumor control than CMF, manifest as a higher response rate, and longer TTP and TTF, but not survival, when used as first-line chemotherapy for metastatic breast cancer.

The treatment of colorectal cancer continues to pose major challenges for oncologists throughout the world. Uracil and tegafur (UFT), as an oral agent, represents a new patient-focused approach to managing a malignancy with few treatment alternatives other than an intravenous fluorouracil (5-FU)-based regimen. The ability of UFT to achieve equivalent clinical outcomes compared with continuous 5-FU infusion, along with its oral formulation and mild toxicity profile, provide a compelling backdrop for fiscal analysis. An economic assessment of therapy attributes and effects would, therefore, be prudent and necessary when deliberating the adoption of this chemotherapy regimen. We developed a pharmacoeconomic model in Brazil and Argentina identifying clinical practices associated with chemotherapy administration and adverse event management practices from a panel of physicians assembled in each country. Practice patterns and clinical events were then evaluated for resource utilisation trends. The perspective of this pharmacoeconomic analysis was that of the healthcare payor. Country-specific charge data were applied to the identified resources to arrive at an average cost per patient receiving a 6-cycle course of 5-FU with either levamisole and/or leucovorin as a modulator vs a modelled oral UFT/leucovorin regimen. As a comparator, the oral UFT/leucovorin regimen was modelled based on the expert panel's input. Adverse events and incidence data were derived from clinical trial data for both agents. Both agents were analysed in the treatment of metastatic disease and as adjuvant therapy. The principal findings of a cost-minimisation analysis in Brazil revealed approximately equivalent treatment costs for both regimens in the adjuvant setting. When analysing the metastatic treatment arm, costs diverged by $R335/per patient ($R = Reals - the currency of Brazil) in favour of a UFT regimen. The profile in Argentina yielded more dramatic differences, with a UFT regimen costing $P782/per patient ($P = Pesos - the currency of Argentina) less than a 5-FU regimen in the adjuvant setting. In the treatment of metastatic disease, a UFT regimen provided $P1188/per patient in savings over a 5-FU regimen. These differences are predominantly driven by the mild toxicity profile of UFT and its corresponding less severe adverse event management practice patterns. In addition, the oral formulation of UFT versus intravenous 5-FU provides for ease of administration, lowering the total cost of care as well as likely impacting on the patient's quality of life. The pharmacoeconomic results suggest that a UFT regimen is a useful and economical alternative to the standard 5-FU regimen in the treatment of colorectal cancer in Brazil and Argentina.

e22214 Background: Triple negative breast cancer (BC) is a distinct group of tumors that show common but heterogeneous morphologic, genetic, and immunophenotypic features. Despite differences in the definition and prevalence, it comprises 8% to 20% of all breast cancers and is associated with an aggressive clinical course with significant risk of either local or systemic relapse and subsequent increased risk of death on short term follow up (particularly in the first 5 years).We study the pathological characteristics and the clinical outcome of a cohort of 77 triple negative BC patients (pts) diagnosed at our Institution. Methods: Between January 1999 and September 2008, 77 (stage I to III) triple negative BC pts. were retrospectively analyzed. All pts had their receptor status, Her neu, ck-5, ck-6 and staining for EGFR by the same pathologist. Pathological parameters (Pp) analyzed were: status of axilary lymph nodes (LN), nuclear grade, histologic grade, mitotic index and vascular invasion and the use of antraciclins in the adjuvant setting. Univariate and multivariate analysis (proporcional hazard regression Cox model) for the Pp associated with relapse, and the log rank test to compare two curves of each Pp for disease free survival (DFS), and overall survival (OS) were performed. Results: The median age was 57.8 years (range 30–86 years).The median follow up time was 57.7 months (range, 4- 241). From 77 Pts. analized, 65 (84.4%) were basal-like and 43 (64.6%) of those were GH3. Stage at the time of presentation was: 16 (20,7%) stage I; 40 (51,9%) stage II; 21 (27,7%) stage III. Pre-menopausal status was 29,48% (23 pts.), and 61% (47 pts) were LN negative. Overall, relapse rate was 38.5 % (n= 30), 63 Pts (81.8%) are still alive. Median DFS was not reached. Global DFS and OS were 59% and 79% respectively, and status of LN was the only prognostic factor. LN- vs LN+ DFS (p< 00.02) and OS p (< 0.02).All others Pp analyzed were not statistically significative. Conclusions: Despite previous studies have demonstrated that triple negative is an independent marker of poor prognosis in BC as a whole, in the LN-negative, and LN-positive groups, in this basal like population only positive LN was an independent poor prognostic factor for DFS and OS. No significant financial relationships to disclose.