In aspect of usefulness of IBS-QOL in clinical studies for Paclitaxel NSC 125973 IBS treatment, therefore, it seems to be used as a primary end-point and has a role in support of subjective symptomatic end-point to evaluate and monitor efficacy of certain drug. Additionally IBS-QOL can characterize the patients according to their responsiveness and acts as an indicator for the clinical course of patients with IBS under treatment. This study has limitations since it was not a placebo controlled study and there has been no consensus about the definition of responder in the scoring system. We used p-value < 0.05 or �� 2 point reduction from baseline score as response indicator according to previous study, but p-value or certain reduction of score do not imply whether a particular finding has clinical implications.
Until now, there have been few available data from well-designed studies about the impact of tegaserod on QOL. Therefore, it is necessary to study about the clinically meaningful threshold of scoring system and more clinical trials using IBS-QOL questionnaire for specific culture, nation, and race are needed. In conclusion, current results suggest that tegaserod 6 mg twice daily is effective for improvement of the QOL as well as the bowel symptoms in Korean female patients with IBS whose primary symptom is constipation. In addition, the IBS-QOL can be used as a reliable end-point in IBS clinical study and provide with additional useful information in clinical practice. Acknowledgments We thank Donald L. Patrick for kindly consenting to the use of the IBS-QOL in Korea.
Footnotes Financial support: This work was funded by grants from The Korean Society of Neurogastroenterology and Motility by Novartis Pharmaceuticals Corporation, Korea. Conflicts of interest: None.
AIM: To investigate whether the evaluation of tumor budding can complement K-RAS analysis to improve the individualized prediction of response to anti-epidermal growth factor receptor based therapies in metastatic colorectal cancer (mCRC) patients. METHODS: Forty-three patients with mCRC treated with cetuximab or panitumumab were entered into this study. According to the Response Evaluation Criteria in Solid Tumors criteria, 30 patients had stable or progressive disease (non-responsive), while 13 patients had a partial response.
Tumor buds were evaluated from whole tissue sections stained for pan-cytokeratin, evaluated in the densest region using a 40 �� objective and ��high-grade�� tumor budding was defined as 15 buds/high-power field. RESULTS: Tumor buds and K-RAS mutation both correctly classified 68% of patients. All patients with K-RAS mutation (n = 7) or high-grade tumor budding (n = 11) were non-responsive, of which 4 patients had both features. All 13 partial responders were K-RAS wild-type with low-grade tumor budding. Combined, the predictive value of K-RAS Dacomitinib and tumor budding was 80%.