Docetaxel and capecitabine in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction: a phase II study from the North Central Cancer Treatment Group.

BACKGROUND: Previous studies suggest that the combination of docetaxel and capecitabine are worthy of further testing in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. We therefore undertook this phase II study to test this combination in a multi-institutional, first-line clinical trial. PATIENTS AND METHODS: Forty-four eligible patients with histologic or cytologic confirmation of the above malignancy were recruited. The cohort had Eastern Cooperative Oncology Group performance scores of 0, 1 and 2 in 59%, 39% and 2% of patients, respectively. Median age was 57 years (range 32-77 years). Adequate organ function was a requirement for study entry. All patients were prescribed docetaxel 75 mg/m2 intravenously on day 1 and capecitabine 825 mg/m2 orally twice a day on days 1-14 of a 21-day cycle. RESULTS: The tumor response rate was 39% [95% confidence interval (CI) 23% to 55%]. There were two complete responses and the rest were partial. Median survival was 9.4 months (95% CI 6.3-10.7 months) and median time-to-tumor progression was 4.2 months (95% CI 3.6-5.6 months). There was one treatment-related death from a myocardial infarction and dysrhythmia. Commonly occurring grade 3 adverse events included neutropenia (11 patients), infection (five patients), constipation (three patients), thrombosis (three patients), dyspnea (three patients) and hand-foot syndrome (three patients). In addition, 24/45 patients developed grade 4 neutropenia. CONCLUSIONS: The regimen docetaxel and capecitabine shows activity in patients with metastatic adenocarcinoma of the stomach and gastroesophageal junction. This regimen merits further study.

A statistical model for predicting the outcome in breast cancer malpractice lawsuits.

OBJECTIVE: To analyze specific medical, legal, and cost factors that predict the probability of successfully defending lawsuits filed because of failure to diagnose breast cancer. METHODS: Seventy-six malpractice cases handled by the Massachusetts Medical Professional Insurance Association between June 29, 1983 and December 30, 1993 were abstracted and analyzed using univariate analysis, multivariate stepwise logistic and least-square regression analysis, and the Cox proportional hazards model to identify statistically significant associations between clinical factors and medicolegal outcomes. RESULTS: Obstetrician-gynecologists were defendants in the largest number of cases (38) and incurred the highest total indemnity ($7,629,570). The probability of defending a suit successfully increased with smaller tumor size and younger patients (less than 40 years of age). The failure to perform a biopsy was associated with a decreased probability of successful defense. Variables predicting high case cost included younger patient age, an increased length of delay in diagnosis, and the failure to perform a biopsy. The presence of metastasis at diagnosis was associated with an increased interval from diagnosis to the initiation of a suit. CONCLUSION: Statistical models that use medicolegal and cost factors can predict both the probability of a successful defense and the total cost of a breast cancer malpractice case.

An analysis of 9,918 consecutive perioperative autotransfusions.

The efficacy of perioperative autotransfusion (PAT) can be evaluated by the reduction in homologous transfusion accompanying its use. An alternative approach is to evaluate the amount of blood salvaged and retransfused. An analysis of 9,918 consecutive PAT procedures in various surgical specialties revealed that the average return of autologous blood salvaged was equivalent to 2.61 units of erythrocytes ("packed cells"). Cardiac operation had the greatest average number of units recovered (4.65), while orthopedic operation had the least (1.05). This method of analysis demonstrates that significant quantities of blood can be salvaged during PAT procedures.