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Usha Patel Manish Pandey Sadhana Kannan Tanuja A. Samant Poonam Gera Neha Mittal Swapnil Rane Asawari Patil Vanita Noronha Amit Joshi Vijay M. Patil Kumar Prabhash Manoj B. Mahimkar 《British journal of cancer》2020,123(12):1757
Background Anti-EGFR-based therapies have limited success in HNSCC patients. Predictive biomarkers are greatly needed to identify the patients likely to be benefited from these targeted therapies. Here, we present the prognostic and predictive association of biomarkers in HPV-negative locally advanced (LA) HNSCC patients.Methods Treatment-naive tumour tissue samples of 404 patients, a subset of randomised Phase 3 trial comparing cisplatin radiation (CRT) versus nimotuzumab plus cisplatin radiation (NCRT) were analysed to evaluate the expression of HIF1α, EGFR and pEGFR by immunohistochemistry and EGFR gene copy change by FISH. Progression-free survival (PFS), locoregional control (LRC) and overall survival (OS) were estimated by Kaplan–Meier method. Hazard ratios were estimated by Cox proportional hazard models.Results Baseline characteristics of the patients were balanced between two treatment groups (CRT vs NCRT) and were representative of the trial cohort. The median follow-up was of 39.13 months. Low HIF1α was associated with better PFS [HR (95% CI) = 0.62 (0.42–0.93)], LRC [HR (95% CI) = 0.56 (0.37–0.86)] and OS [HR (95% CI) = 0.63 (0.43–0.93)] in the CRT group. Multivariable analysis revealed HIF1α as an independent negative prognostic biomarker. For patients with high HIF1α, NCRT significantly improved the outcomes [PFS:HR (95% CI) = 0.55 (0.37–0.82), LRC:HR (95% CI) = 0.55 (0.36–0.85) and OS:HR (95% CI) = 0.54 (0.36–0.81)] compared to CRT. While in patients with low HIF1α, no difference in the clinical outcomes was observed between treatments. Interaction test suggested a predictive value of HIF1α for OS (P = 0.008).Conclusions High HIF1α expression is a predictor of poor clinical response to CRT in HPV-negative LA-HNSCC patients. These patients with high HIF1α significantly benefited with the addition of nimotuzumab to CRT.Clinical trial registration Registered with the Clinical Trial Registry of India (Trial registration identifier—CTRI/2014/09/004980).Subject terms: Tumour biomarkers, Head and neck cancer, Tumour biomarkers, Head and neck cancer, Predictive markers 相似文献
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Dan Azagury Tara E Mokhtari Luis Garcia Ulysses S Rosas Trit Garg Homero Rivas John Morton 《Surgery》2019,165(3):565-570
Background
Laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and laparoscopic adjustable gastric banding all lead to substantial weight loss in obese patients. Long-term weight loss can be highly variable beyond 1-year postsurgery. This study examines and compares the frequency distribution of weight loss and lack of treatment effect rates after laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and laparoscopic adjustable gastric banding.Methods
A total of 1,331 consecutive patients at a single academic institution were reviewed from a prospectively collected database. Preoperative data collected included demographics, body mass index, and percent excess weight loss. Postoperative BMI and %EWL were collected at 12, 24, and 36 months. Percent excess weight loss was analyzed by the percentiles of excess weight lost, and the distribution of percent excess weight loss was evaluated in 10% increments. Lack of a successful treatment effect was defined as <25% excess weight loss.Results
Of the 1,331 patients, 72.4% (963) underwent laparoscopic Roux-en-Y gastric bypass, 18.3% (243) laparoscopic sleeve gastrectomy, and 9.4%(125) laparoscopic adjustable gastric banding. Mean percent excess weight loss was greatest for laparoscopic Roux-en-Y gastric bypass, followed by laparoscopic sleeve gastrectomy, and then by laparoscopic adjustable gastric banding at every time point: at 2 years mean percent excess weight loss was 77.9± 24.4 for laparoscopic Roux-en-Y gastric bypass, 50.8 ± 25.8 for laparoscopic sleeve gastrectomy, and 40.8± 25.9 for laparoscopic adjustable gastric banding (P < .0001). The rates of a successful treatment effect s for laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, and laparoscopic adjustable gastric banding were 0.9%, 5.2%, and 24.3% at 1 year; 0.3%, 11.1%, and 26.0% at 2 years; and 1.0%, 25.3%, and 30.2% at 3 years. At 1 year, the odds ratio of lack of a successful treatment effect of laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass was 6.305 (2.125–19.08; P?=?.0004), the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic Roux-en-Y gastric bypass was 36.552 (15.64–95.71; P < .0001), and the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic sleeve gastrectomy was 5.791 (2.519–14.599; P < .0001). At 2 years, the odds ratio for laparoscopic sleeve gastrectomy versus laparoscopic Roux-en-Y gastric bypass increased to 70.7 (9.4–531.7; P < .0001), the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic Roux-en-Y gastric bypass increased to 128.1 (16.8–974.3; P < .0001), and the odds ratio for laparoscopic adjustable gastric banding versus laparoscopic sleeve gastrectomy decreased to 1.8 (0.9–3.6; P?=?.09).Conclusion
This study emphasizes the existing variability in weight loss across bariatric procedures as well as in the lack of a treatment effect for each procedure. Although laparoscopic adjustable gastric banding has the greatest rate of a lack of a successful treatment effect, the rate remained stable over 3 years postoperatively. Laparoscopic sleeve gastrectomy showed a doubling in the rate of a lack of a successful treatment effect every year reaching 25% at year 3. The rates for lack of a successful treatment effect for laparoscopic Roux-en-Y gastric bypass remained stable at about 1% for the first 3 years postoperatively. 相似文献5.
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Sameer Arora Kamal Shemisa Muthiah Vaduganathan Arman Qamar Ankur Gupta Sushil K. Garg Dharam J. Kumbhani Helen Mayo Houman Khalili Ambarish Pandey Sandeep R. Das 《Journal of the American College of Cardiology》2019,73(19):2454-2464
Ticagrelor is a cornerstone of modern antithrombotic therapy alongside aspirin in patients with acute coronary syndrome and after percutaneous coronary intervention. Adverse effects such as bleeding and dyspnea have been associated with premature ticagrelor discontinuation, which may limit any potential advantage of ticagrelor over clopidogrel. The randomized trials of ticagrelor captured adverse events, offering the opportunity to more precisely quantify these effects across studies. Therefore, a meta-analysis of 4 randomized clinical trials of ticagrelor conducted between January 2007 and June 2017 was performed to quantify the incidence and causes of premature ticagrelor discontinuation. Among 66,870 patients followed for a median 18 months, premature ticagrelor discontinuation was seen in 25%; bleeding was the most common cause of discontinuation followed by dyspnea. Versus the comparators, the relative risk of dyspnea-related discontinuation during follow-up was 6.4-fold higher, the relative risk of bleeding was 3.2-fold higher, and the relative risk of discontinuation due to any adverse event was 59% higher for patients receiving ticagrelor. Understanding these potential barriers to adherence to ticagrelor is crucial for informed patient-physician decision making and can inform future efforts to improve ticagrelor adherence. This review discusses the incidence, causes, and biological mechanisms of ticagrelor-related adverse effects and offers strategies to improve adherence to ticagrelor. 相似文献
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Manish Gautam Santanu Saha Sarang Bani A. Kaul Sanjay Mishra Dada Patil N.K. Satti K.A. Suri Sunil Gairola K. Suresh Suresh Jadhav G.N. Qazi Bhushan Patwardhan 《Journal of ethnopharmacology》2009