No abstract

This method can achieve safety and en bloc mucosal resection to the submucosal layer. This novel approach may be promising for clinical application as a new form of endoscopic surgery.

Introduction: A previous large-scale phase III study demonstrated that, compared with docetaxel (T) alone, capecitabine (X) and T in combination (XT) offered significantly superior progression free survival (PFS) and overall survival (OS) in metastatic breast cancer (MBC). However, XT increased Grade 3/4 adverse events (AEs) which led to more frequent dose reductions than with T alone. Optimal dose of XT in Japanese was examined in a phase Ib study. Based on the background, we conducted a phase III randomized study in Japanese HER2 negative MBC patients pre-treated with anthracycline to compare efficacy and safety of XT therapy and T therapy. Methods: Eligible pts were HER2-negative MBC pts with anthracycline-pretreatment, a measurable tumor, and ECOG performance status of 0 or 1. Pts were randomly assigned to the XT group or the T→X group. The XT group received concurrent therapy of X (1650 mg/m2/day from day 1 to 14) and T (60 mg/m2) in 3-week cycle. The T→X group received sequential therapy of T (70 mg/m2) in 3-week cycle followed at disease progression by X (2500 mg/m2/day from day 1 to 14 followed by 1-week rest). Primary endpoint was PFS. Secondary endpoints were OS, overall response rate (ORR), time to treatment failure (TTF), safety, and quality of life. The XT group and the T phase of the T→X group (T group) were compared in our evaluation. Results: Of 163 pts enrolled, 156 were eligible. Baseline characteristics of all pts in each group were well balanced. The median delivered dose was 79.0% and 95.1% of the planned dose respectively for X and T in the XT group, and it was 97.2% in the T group. Median PFS in the XT group was 10.5 months compared to 9.8 months in the T group (hazard ratio [HR], 0.62; 95% confidence interval [CI], 0.40–0.97). The ORR was 70% and 61%; the median TTF was 9.6 months and 7.0 months in the XT group and the T group, respectively. Median OS has not been reached yet. Subgroup analysis showed PFS was longer in pts with liver metastasis (HR, 0.39; 95% CI, 0.19–0.84) and in pts with lung metastasis (HR, 0.43; 95% CI, 0.21–0.90) in the XT group. Incidence of treatment related AEs (TR-AEs) ≥Grade 3 was 74.4% (61 pts) in the XT group and 76.3% (61 pts) in the T group. Frequently reported TR-AEs ≥Grade 3 were; decrease in neutrophil count (XT, 57.3%; T, 60.0%), neutropenia (XT, 8.5%; T, 12.5%) and febrile neutropenia (XT, 6.1%; T, 10.0%). TR-AE ≥Grade 3 in the XT group with incidence at least 5% higher than the T group was hand-foot syndrome (XT, 7.3%; T, 0%). On the other hand, TR-AEs ≥Grade 3 in the T group with incidence at least 5% higher than the XT group were fatigue (XT, 2.4%; T, 8.8%) and peripheral edema (XT, 1.2%; T, 6.3%). Conclusion: The concurrent therapy of XT demonstrated significant improvement of PFS compared with T alone. Superior efficacy of XT therapy was reported as same as the previously reported study on XT versus T although the dose was lower in our study. Considering the efficacy and tolerability, we consider concurrent Japanease dose XT therapy is a preferable treatment for MBC pts with liver or lung metastasis. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P1-12-01.

We describe a unique case of a patient who presented with a linear, transverse filling defect in the common bile duct, detected by cholangiography, that was caused by the posterosuperior pancreaticoduodenal artery compressing the common bile duct associated with gallstones. We believe this case to be the first of its kind reported in the literature.

No abstract