Gemcitabine, Cisplatin, and Nab-Paclitaxel as a First-Line Therapy for Advanced Biliary Tract Cancers.

INTRODUCTION: Locally advanced, inoperable, or metastatic gallbladder cancers (GBC) are treated with either gemcitabine-platinum combinations or gemcitabine alone based on physician discretion. However, the combination of gemcitabine, cisplatin, and nab-paclitaxel (GCNP) has shown increased response rates and prolonged survival in a phase II trial of biliary tract patients. MATERIALS AND METHODS: Consecutive series of patients diagnosed with locally advanced (liver infiltration > 5 cm, large nodes at porta, abutting duodenum), inoperable, and metastatic biliary tract patients between January 2018 and August 2022 were evaluated for first-line chemotherapy GCNP, in the multidisciplinary joint clinic (MDJC). The primary endpoint was ORR, and the major secondary endpoint was event-free survival (EFS). RESULTS: A total of 142 patients received GCNP during the specified time period. The median age of the cohort was 52 years (range: 21-79), the majority were females (61.3%), and the majority were GB (81.7%). Response rates were available in 137 patients. Complete response, partial response, and stable disease were seen in 9 (6.3%), 87 (61.3%), and 24 (16.9%), respectively, for an ORR of 67.6% and a clinical benefit rate of 84.5%. The median EFS was 9.92 (95% CI, 7.69-12.14) months. Of the 52 patients in whom GCNP was given with NACT intent for locally advanced GBC, 17 patients underwent surgery (34%). CONCLUSION: Our study indicates that GCNP leads to improved response rates, increased chances of resectability, and possibly better survival in patients with GBC.

The use of an obstetric balloon as a pelvic spacer in preventing empty pelvis syndrome after total pelvic exenteration in rectal cancers - A prospective safety and efficacy study for the Bakri balloon.

AIM: Empty pelvis syndrome (EPS) is a source of considerable morbidity following total pelvic exenteration. None of the available methods have been universally successful in mitigating this problem. The aim of this work was to evaluate the safety and efficacy of the obstetric Bakri balloon in preventing empty pelvis syndrome. METHOD: This study was a combined prospective and retrospective study of all total pelvic exenterations for rectal cancers from a single institution performed between October 2013 and May 2022. Since December 2019 the Bakri balloon was used in all patients who provided consent. EPS within 90 days was the primary end point, and included bowel obstruction, pelvic collection and entero-perineal fistula. Comparison with those patients who did not have a Bakri balloon was performed. RESULTS: Seventy-five patients with a Bakri balloon were compared with 96 patients without a balloon placed after pelvic exenteration. No patient experienced an untoward complication from balloon deployment. The incidence of EPS was 13.3% and 22.9% in the Bakri and no Bakri cohorts, respectively (p = 0.110). Every component of EPS was proportionally lower, without statistical significance. Based on point estimates, the number needed to treat to prevent EPS using the Bakri balloon was 10. CONCLUSIONS: Use of the Bakri balloon was safe without serious adverse events. The incidence of EPS after total pelvic exenteration was not statistically different with the use of the Bakri balloon despite a 9.6% reduction. A larger comparative study is needed to evaluate the efficacy of the balloon.