Effectiveness,safety and quality of life of trifluridine/tipiracil in pretreated patients with metastatic colorectal cancer: Real-world data from the noninterventional TACTIC study in Germany

The prospective, multicenter, noninterventional TACTIC study assessed effectiveness and safety of trifluridine/tipiracil (FTD/TPI) in patients with metastatic colorectal cancer (mCRC) in a real-world setting in Germany, thus evaluating the external validity of the findings from the pivotal RECOURSE trial. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS), safety, and quality of life (QoL). Subgroups comprised patients with good (<3 metastatic sites at inclusion, ≥18 months from diagnosis of first metastasis to inclusion) or poor (remaining patients) prognostic characteristics (GPC/PPC). GPC without liver metastases was considered best prognostic characteristics (BPC). In total, 307 eligible patients (pretreated or not suitable for other available therapies) were treated with FTD/TPI. Overall, median [95%-CI] OS was 7.4 months [6.4-8.6], median PFS was 2.9 months [2.8-3.3]. In BPC (n = 65) and GPC (n = 176) compared to PPC (n = 124) subgroup, median OS (13.3 [9.1-17.6] vs 8.9 [7.6-9.8] vs 5.1 [4.4-7.0] months) and median PFS (4.0 [3.3-5.3] vs 3.4 [3.0-3.7] vs 2.6 [2.4-2.8] months) were longer. Patient-reported QoL, assessed by validated questionnaires (EQ-5D-5L, PRO-CTCAE), was stable throughout FTD/TPI treatment. Predominant FTD/TPI-related adverse events of grades 3 or 4 were neutropenia (13.0%), leukopenia (7.5%), and anemia (5.2%). Altogether, palliative FTD/TPI therapy in patients with pretreated mCRC was associated with prolonged survival, delayed progression, maintained health-related QoL, and manageable toxicity. Low metastatic burden and indolent disease were favorable prognostic factors for survival. TACTIC confirms the effectiveness and safety of FTD/TPI, highlighting its value in routine clinical practice.     

Anal Canal Pressure After Ileal Pouch–Anal Anastomosis with Strengthened Internal Anal Sphincter

INTRODUCTION The aim of sphincter-saving operative techniques and creation of intestinal reservoirs is to improve the quality of life for patients with restorative proctocolectomy.METHODS In this study, 48 consecutive patients (19 males and 29 females of ages between 19 and 55 years; mean age, 35.52 years) with ulcerative colitis and familial adenomatous polyposis underwent ileal pouch–anal anastomosis after proctocolectomy in 1986 to 2002. In 26 patients (54.17 percent of the cases), 10 males and 16 females, ileal pouch–anal anastomosis was performed after a modified surgical technique for strengthening the internal anal sphincter by creation of a smooth muscle cuff through plication of a mucosectomized segment of residual rectum. Basal resting anal canal pressure and pressure after voluntary contraction were recorded preoperatively, one month after surgery, and every six months for two years.RESULTS One month after the operation manometric results showed significantly higher values of resting pressure in patients with a plicated rectal segment than values measured preoperatively (P < 0.001). This effect was absent after the standard ileal pouch–anal anastomosis. With the rectal plication technique, basal pressure increased from a preoperative value of 69 ± 6 mmHg up to 80 ± 6 mmHg at the end of the second postoperative year (P < 0.001).CONCLUSIONS We concluded that ileal pouch–anal anastomosis with rectal plication perhaps improved sphincter function. The operative technique did not affect anal squeeze pressure. Patients quality of life was improved for those undergoing the modified ileal pouch–anal anastomosis.