Post-marketing surveillance (PMS) was performed in Japan to obtain information on the safety and efficacy of crizotinib.
Target patients included almost all patients with anaplastic lymphoma ...kinase-positive non-small cell lung cancer who were administered crizotinib. The observation period was 52 weeks. In the present study, we focused on the treatment status and safety of crizotinib therapy and analyzed the real-world data obtained by this PMS (ClinicalTrials.gov: NCT01597258).
The safety analysis set included 2028 Japanese patients, and more than half of the patients (56.4%) were nonsmokers. The incidence of adverse drug reactions (ADRs) was 91.6%, and common ADRs (incidence ≥15%) were nausea (32.2%), diarrhea (24.3%), photopsia (18.9%), vomiting (17.5%) and dysgeusia (16.8%). Many patients (623 patients) discontinued treatment of crizotinib because of adverse events within 12 weeks after therapy initiation, which tended to frequently occur in the following cases: (1) elderly, (2) body weight <40 kg, (3) body surface area <1.2 m2 (4) ECOG PS 2-4, (5) higher Brinkman index and (6) history of occupational/environmental exposure such as asbestos/pneumoconiosis. The proportions of patients remaining on crizotinib therapy were 68.2% for 3 months, 55.2% for 6 months and 36.1% for 12 months, with a median duration of 7.9 months. Multivariate analysis with a Cox proportional hazard model identified 10 statistically significant patient background factors influencing the duration of crizotinib therapy.
No new safety concerns were observed in this PMS study. Our results provide useful information regarding the status of crizotinib therapy in the clinical setting.
Although colonic diverticular bleeding (CDB) often ceases spontaneously, re-bleeding occurs in about 30%. Bleeding diverticulum can be treated directly by endoscopic hemostasis; however, it is ...difficult to perform colonoscopy in all cases with limited medical resource and certain risks. The aim of this study was to clarify who should undergo colonoscopy as well as appropriate methods of initial management in CDB patients.
A total of 285 patients who were diagnosed as CDB and underwent colonoscopy from March 2004 to October 2015 were retrospectively analyzed. First, the association between re-bleeding and various factors including patients' background and initial management were analyzed. Second, the examination conditions that influenced bleeding point identification were analyzed.
Of 285 patients, 187 were men and 98 were women. Median age was 75 years, and the median observation period was 17.5 months. Re-bleeding was observed in 79 patients (28%). A history of CDB (OR 2.1, p = 0.0090) and chronic kidney disease (CKD; OR 2.3, p = 0.035) were risk factors, and bleeding point identification (OR 0.20, p = 0.0037) was a preventive factor for re-bleeding. Bleeding point identification significantly reduced approximately 80% of re-bleeding. Furthermore, extravasation on CT (OR 3.7, p = 0.031) and urgent colonoscopy (OR 5.3, p < 0.001) were predictors for identification of bleeding point. Compared to bleeding point identification of 11% in all patients who underwent colonoscopy, identification rate in those who had extravasation on CT and underwent urgent colonoscopy was as high as 70%.
Contrast-enhanced CT upon arrival is suggested, and patients with extravasation on CT would be good candidates for urgent colonoscopy, as well as patients who have a history of CDB and CKD.
Abstract
Background and study aims
We developed a new endoscopic closure technique using just conventional endoclips. The feasibility of endoscopic mucosa-submucosa clip closure method was evaluated ...in this clinical pilot study.
Patients and methods
This study involved consecutive 25 patients who underwent colorectal endoscopic submucosal dissection. Endoclips were placed at the edge of the mucosal defect. Each arm of the endoclip gripped the mucosa and submucosa, respectively. The direction in which the endoclip grips were placed was parallel to the short axis of the defect. Several endoclips were applied in this way. As a result, the mucosal defect was significantly reduced in size. Additional clips were placed to achieve complete closure.
Results
Mean size of resected specimen was 31.2 ± 11 mm. The success rate was 96 % (24/25). Mean procedure time was 9.6 ± 4.4 minutes. Mean number of endoclips was 9.3 ± 3.7. No complications were observed in any of the patients after the procedure.
Conclusion
Endoscopic mucosa-submucosa clip closure method could close mucosal defect of size around 2 – 4 cm completely using just conventional endoclips, and it seems easy, simple and low cost.
Atrial fibrillation (AF) is the most common cardiac arrhythmia, and cryoballoon ablation was developed as a new treatment modality for symptomatic AF. Gastroparesis is rarely reported as a transient ...complication of ablation, and its frequency and risk are not clear. We experienced a rare case of gastroparesis after cryoballoon ablation followed by medication-induced recovery within 6 months.
Abstract
Background and study aims
Although cold polypectomy (CP) is widely used for colorectal polyps < 10 mm, appropriateness of indications for CP or endoscopic mucosal resection (EMR) are still ...unclear. The aim of this study was to validate the endoscopic treatment algorithm based on the Japan NBI Expert Team (JNET) classification.
Patients and methods
Consecutive patients with at least one colorectal non-pedunculated polyp < 10 mm between July 2014 and October 2016 were included in this retrospective study. During the period, EMR was performed for JNET ≥ 2B lesions and CP for JNET < 2A. Among a total of 3966 lesions, 3368 lesions with JNET ≤ 2A were resected by CP in compliance with the treatment algorithm but 565 resections for JNET ≤ 2A were not compliant (by EMR), while all 24 JNET > 2B lesions were removed by EMR in compliance with the algorithm. Polypectomy outcomes were compared between the compliant and non-compliant groups. Histological outcomes were analyzed in accordance with JNET classification.
Results
Post-polypectomy bleeding rate in the compliant group (0 %) was lower than that in the non-compliant group (0.53 %,
P
< 0.01). Proportion of lesions diagnosed as cancer (38 % vs 0.36 %,
P
< 0.01) or submucosal cancer (4.2 % vs 0.03 %,
P
= 0.012), and the lesion with free resection margin (91 % vs 64 %,
P
< 0.01) was higher in the JNET ≥ 2B than JNET ≤ 2A.
Conclusion
This study indicated our algorithm would be valid: CP is suitable for most polyps < 10 mm as incidence of post-polypectomy bleeding is low, whereas EMR is recommended for JNET ≥ 2B lesions for histological complete removal.
The study objective was to determine the incidence and characteristics of drug-induced interstitial lung disease (ILD) associated with an orally available small-molecule tyrosine kinase inhibitor, ...crizotinib, in a real-world clinical setting.
Post-marketing surveillance was performed in Japan to obtain information on the safety and efficacy of crizotinib. Target patients included all patients with anaplastic lymphoma kinase-positive NSCLC who received crizotinib during the enrollment period between May 2012 and December 2014. The observation period was 52 weeks. Expert analysis of the ILD incidence was performed by an ILD independent review committee composed of five medical specialists.
The safety analysis set included 2028 patients, and more than half of the patients (56.4%) were nonsmokers. The incidence of ILD associated with crizotinib therapy was 5.77%; and 3.45% patients showed grade 3 or greater. Pulmonary edema-like shadows with or without diffuse alveolar damage pattern were observed in crizotinib-associated ILD (incidence: 0.39%), but a causal relationship with the prognosis could not be identified. ILD developed within 4 weeks from initiation of crizotinib administration in 41.9% and within 8 weeks in 69.2% of the patients. Age 55 years or older, Eastern Cooperative Oncology Group performance status 2-4, smoking history, previous or concomitant ILD, and comorbid pleural effusion were statistically determined as significant risk factors for crizotinib-induced ILD.
Crizotinib therapy should be applied to the NSCLC patients with any of above risk factors under a cautious monitoring for ILD occurrence, and clinicians should pay attention to the risks of severe ILD.
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