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Risk of keratinocyte carcinomas with vitamin D and calcium supplementation: a secondary analysis of a randomized clinical trial.
Passarelli, MN, Karagas, MR, Mott, LA, Rees, JR, Barry, EL, Baron, JA
The American journal of clinical nutrition. 2020;(6):1532-1539
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Abstract
BACKGROUND It is unknown whether dietary supplementation with vitamin D or calcium prevents keratinocyte carcinomas, also known as nonmelanoma skin cancers. OBJECTIVES This study aimed to determine whether daily vitamin D or calcium supplementation alters the risk of basal cell carcinoma (BCC) or invasive cutaneous squamous cell carcinoma (SCC). METHODS The Vitamin D/Calcium Polyp Prevention Study is a completed multicenter, double-blind, placebo-controlled, partial 2 × 2 factorial, randomized clinical trial of vitamin D, calcium, or both for the prevention of colorectal adenomas. During 2004-2008, a total of 2259 men and women, 45-75 y of age, recently diagnosed with a colorectal adenoma, were randomly assigned to 1000 IU/d of vitamin D3 or placebo and 1200 mg/d of calcium carbonate or placebo for 3 or 5 y, and followed after treatment ended. Reports of incident BCC or SCC were confirmed from pathology records. RESULTS During a median follow-up of 8 y, 200 (9%) participants were diagnosed with BCC and 68 (3%) participants were diagnosed with SCC. BCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.96; 95% CI: 0.73, 1.26), calcium compared with no calcium (HR: 1.01; 95% CI: 0.74, 1.39), and both agents compared with neither (HR: 0.99; 95% CI: 0.65, 1.51). SCC incidence was unrelated to treatment with vitamin D compared with no vitamin D (HR: 0.79; 95% CI: 0.49, 1.27), but there was suggestive evidence of beneficial treatment effects for calcium compared with no calcium (HR: 0.60; 95% CI: 0.36, 1.01) and both agents compared with neither (HR: 0.42; 95% CI: 0.19, 0.91). CONCLUSIONS Calcium alone or in combination with vitamin D may reduce the risk of SCC, but not BCC. This trial was registered at clinicaltrials.gov as NCT00153816.
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Therapeutic effects of anterolateral thigh flap transfer in repairing oral and maxillofacial defects after ablative surgery of neoplasms.
Zhao, F, Chen, W, Zhao, H, Zhang, H, Chen, Z, Luo, Y, Chen, T
Minerva chirurgica. 2019;(6):452-457
Abstract
BACKGROUND To investigate the therapeutic effects of anterolateral thigh flap transfer in repairing oral and maxillofacial defects after ablative surgery of neoplasms and to discuss perioperative psychological care. METHODS A total of 80 patients who received oral and maxillofacial surgery for tumor resection in Nanfang Hospital from October 2014 to August 2016 were selected. Patients were randomly divided into control group and observation group, 40 patients in each group. Patients in control group received forearm flap transfer, while patients in observation group were treated with anterolateral thigh flap transfer. RESULTS The survival rate of flap, food intake ability, quality of life and incidence of complication were compared between groups. There was no significant difference in survival rate of the flaps between two groups (P>0.05). No significant difference in food intake was found between groups at 3 months after operation (P>0.05). The UW-QOL scores of the two groups at 1 year after operation were significantly higher than those before operation (P<0.05), and no significant differences in UW-QOL scores were found between two groups at 1 year after operation (P>0.05). Incidence of temporary dysfunction, hyperplastic scar, permanent dysfunction, pigmentation and pruritus was significantly lower in observation group than in control group (P<0.05). There was no significant difference in the incidence of necrosis between two groups (P>0.05). CONCLUSIONS The results showed that anterolateral thigh flap transfer has similar therapeutic effects to those of forearm flap transfer in repairing oral and maxillofacial defects after ablative surgery of neoplasms and improving food intake and quality of life. But Anterolateral thigh flap transfer can reduce the incidence of postoperative complications, so this treatment should be popularized.
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A randomized controlled trial of corticosteroids for pain after transoral robotic surgery.
Clayburgh, D, Stott, W, Bolognone, R, Palmer, A, Achim, V, Troob, S, Li, R, Brickman, D, Graville, D, Andersen, P, et al
The Laryngoscope. 2017;(11):2558-2564
Abstract
OBJECTIVE To determine if an extended perioperative course of corticosteroids will improve pain control following transoral robotic surgery (TORS). STUDY DESIGN Randomized, double-blind, placebo-controlled trial. METHODS Patients undergoing TORS for initial treatment of oropharyngeal squamous cell carcinoma received a single intraoperative dose of 10-mg dexamethasone and then were randomized to receive 8-mg dexamethasone every 8 hours, or placebo, for up to 4 days after surgery. Pain, measured by visual analog scale (VAS), was the primary outcome measure. Secondary outcome measures included length of stay, dysphagia assessments, and complications. RESULTS VAS pain scores were similar between steroid and placebo cohorts on postoperative day (POD) 1, 2, and 7 through 21, although they significantly improved in the steroid cohort on POD 3. The steroid cohort also demonstrated a decreased hospital length of stay (median 1 day) and improvement in diet consistency, as measured by the performance status scale on POD 7 through 21. There was no difference in complications between the steroid and placebo cohorts. CONCLUSION Extended perioperative corticosteroids after TORS is safe and may allow earlier improvement in diet consistency and decreased length of hospital stay, although postoperative pain appears minimally affected. LEVEL OF EVIDENCE 1b. Laryngoscope, 127:2558-2564, 2017.
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Weekly versus Three-Weekly Cisplatin-based Concurrent Chemoradiotherapy as definitive treatment in Head and Neck Cancer- Where do we stand?
Rawat, S, Srivastava, H, Ahlawat, P, Pal, M, Gupta, G, Chauhan, D, Tandon, S, Khurana, R
The Gulf journal of oncology. 2016;(21):6-11
Abstract
PURPOSE To compare toxicity, compliance, and early response of weekly and 3-weekly cisplatin administration concurrent with radiotherapy as definitive treatment in locally advanced squamous cell carcinoma head and neck. MATERIALS AND METHODS Patients with histologically proven stage III - IV B head and neck carcinoma presenting from June 2013 to March 2014 were randomly assigned to weekly (35 mg/m2, 6 cycles; arm A) and 3 weekly (100 mg/m2, 3 cycles; arm B) cisplatin with concurrent radiotherapy. RESULTS 60 patients were randomly assigned to treatment, 30 in each arm. Median follow-up was 8 months (range 4-13). There was no significant difference in grade 3 mucositis between the two arms (75.9% vs 70%, p = 0.20). Grade 3 neutropenia was more frequent in arm B (55.2% vs 26.7%, p = 0.01). Hypomagnesemia was the commonest electrolyte imbalance and it was significantly higher in arm B (60% vs 20%, p = 0.001). Completion rate of scheduled chemotherapy cycles was higher for patients receiving weekly regimen. Response at 3 months was similar for all the patients {Complete Response (66.7% vs 62.1%), p = 0.200}. Our data suggested that there is a reduced need of hospitalization and supportive care measures for patients receiving weekly cisplatin with RT (p = 0.05). CONCLUSIONS Weekly cisplatin 35 mg/m2 chemotherapy concurrent with radiotherapy is equally effective and less toxic in terms of neutropenia, hypomagnesemia and need for supportive measures than the conventional 3 weekly cisplatin 100 mg/m2 regimen.
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A phase II randomized controlled trial of nicotinamide for skin cancer chemoprevention in renal transplant recipients.
Chen, AC, Martin, AJ, Dalziell, RA, McKenzie, CA, Lowe, PM, Eris, JM, Scolyer, RA, Dhillon, HM, Vardy, JL, Bielski, VA, et al
The British journal of dermatology. 2016;(5):1073-1075
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Improving Quality of Life With Nabilone During Radiotherapy Treatments for Head and Neck Cancers: A Randomized Double-Blind Placebo-Controlled Trial.
Côté, M, Trudel, M, Wang, C, Fortin, A
The Annals of otology, rhinology, and laryngology. 2016;(4):317-24
Abstract
OBJECTIVES Patients treated for head and neck carcinomas experience a significant deterioration of their quality of life during treatments because of severe side effects. Nabilone has many properties that could alleviate symptoms caused by radiotherapy and improve patients' quality of life. The aim of the present study was to compare the effects of nabilone versus placebo on the quality of life and side effects during radiotherapy for head and neck carcinomas. METHODS Fifty-six patients were randomized to nabilone or placebo. Patients filled the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EORTC QLQ-H&N35; three independent questionnaires assessing appetite, nausea, and toxicity; and a visual analog scale for pain. These data were collected before radiotherapy, each week during radiotherapy, and 4 weeks after radiotherapy. Patients were weighed every week. RESULTS Nabilone did not lengthen the time necessary for a 15% deterioration of quality of life (P = .4279), and it was not better than placebo for relieving symptoms like pain (P = .6048), nausea (P = .7105), loss of appetite (P = .3295), weight (P = .1454), mood (P = .3214), and sleep (P = .4438). CONCLUSION At the dosage used, nabilone was not potent enough to improve the patients' quality of life over placebo.
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Is a Central Venous Catheter Necessary for the Perioperative Management of Esophagectomy? A Prospective Randomized Pilot Study Comparing Two Different Perioperative Regimens.
Saito, K, Nakajima, Y, Kawada, K, Tokairin, Y, Kawano, T
Digestive surgery. 2016;(6):478-87
Abstract
BACKGROUND/AIMS: Our prospective randomized study examined the possibility of perioperative management of esophagectomy without a central venous catheter (CVC). METHODS Forty patients who underwent esophagectomy for esophageal cancer were divided into the total parenteral nutrition (TPN; receiving conventional perioperative management via a CVC) and peripheral parenteral nutrition (PPN; receiving perioperative management without a CVC) groups. Albumin and retinol-binding protein (RBP) levels were used as measurements of the nutritional status. Early postoperative complications and catheter-related complications were also evaluated. RESULTS The actual calories administered per kg of body weight and the albumin and RBP levels did not significantly differ between the groups. Additionally, there was no significant difference in the morbidity of early postoperative complications between the groups. Catheter-related complications were observed in 4 patients in the TPN group (2 catheter infections, 1 case of thrombosis, and 1 case of iatrogenic pneumothorax), and 4 cases of peripheral phlebitis occurred in the PPN group. The incidence of catheter-related complications did not significantly differ between the groups. CONCLUSIONS Perioperative management without a CVC can be safely performed in esophagectomy patients, and the decision to insert a CVC should be made based on the patient's perioperative condition.
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Afatinib versus methotrexate as second-line treatment in patients with recurrent or metastatic squamous-cell carcinoma of the head and neck progressing on or after platinum-based therapy (LUX-Head & Neck 1): an open-label, randomised phase 3 trial.
Machiels, JP, Haddad, RI, Fayette, J, Licitra, LF, Tahara, M, Vermorken, JB, Clement, PM, Gauler, T, Cupissol, D, Grau, JJ, et al
The Lancet. Oncology. 2015;(5):583-94
Abstract
BACKGROUND Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck (HNSCC) progressing after first-line platinum regimens have a poor prognosis and few treatment options. Afatinib, an irreversible ERBB family blocker, has shown efficacy in a phase 2 study in this setting. We aimed to assess the efficacy and safety of afatinib compared with methotrexate as second-line treatment in patients with recurrent or metastatic HNSCC progressing on or after platinum-based therapy. METHODS In this open-label, phase 3, randomised controlled trial conducted in 101 centres in 19 countries, we enrolled patients aged 18 years or older with histologically or cytologically confirmed HNSCC that was recurrent, metastatic, or both who had progressed on or after first-line platinum-based therapy, were not amenable for salvage surgery or radiotherapy, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Previous treatment with more than one systemic regimen in this setting was not allowed; previous treatment with EGFR-targeted antibody therapy (but not EGFR-targeted tyrosine-kinase inhibitors) was allowed. We randomly assigned eligible patients in a 2:1 ratio to receive oral afatinib (40 mg/day) or intravenous methotrexate (40 mg/m(2) per week), stratified by ECOG performance status and previous EGFR-targeted antibody therapy for recurrent or metastatic disease. Randomisation was done centrally with an interactive voice or web-based response system. Clinicians and patients were not masked to treatment allocation; independent review of tumour response was done in a blinded manner. The primary endpoint was progression-free survival as assessed by an independent, central imaging review committee. Efficacy analyses were done in the intention-to-treat population and safety analyses were done in patients who received at least one dose of study drug. This ongoing study is registered with ClinicalTrials.gov, number NCT01345682. FINDINGS Between Jan 10, 2012, and Dec 12, 2013, we enrolled 483 patients and randomly assigned 322 to afatinib and 161 to methotrexate. After a median follow-up of 6·7 months (IQR 3·1-9·0), progression-free survival was longer in the afatinib group than in the methotrexate group (median 2·6 months [95% CI 2·0-2·7] for the afatinib group vs 1·7 months [1·5-2·4] for the methotrexate group; hazard ratio [HR] 0·80 [95% CI 0·65-0·98], p=0·030). The most frequent grade 3 or 4 drug-related adverse events were rash or acne (31 [10%] of 320 patients in the afatinib group vs none of 160 patients in the methotrexate group), diarrhoea (30 [9%] vs three [2%]), stomatitis (20 [6%] vs 13 [8%]), fatigue (18 [6%] vs five [3%]), and neutropenia (1 [<1%] vs 11 [7%]); serious adverse events occurred in 44 (14%) of afatinib-treated patients and 18 (11%) of methotrexate-treated patients. INTERPRETATION Afatinib was associated with significant improvements in progression-free survival and had a manageable safety profile. These findings provide important new insights into the treatment of this patient population and support further investigations with irreversible ERBB family blockers in HNSCC. FUNDING Boehringer Ingelheim.
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A Walk-and-Eat Intervention Improves Outcomes for Patients With Esophageal Cancer Undergoing Neoadjuvant Chemoradiotherapy.
Xu, YJ, Cheng, JC, Lee, JM, Huang, PM, Huang, GH, Chen, CC
The oncologist. 2015;(10):1216-22
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Abstract
BACKGROUND Preserving functional walking capacity and nutritional status is important for patients with esophageal cancer, but no effective intervention is available, particularly during active treatment. METHODS This pilot randomized controlled trial tested the effects of a walk-and-eat intervention for patients with esophageal cancer undergoing neoadjuvant chemoradiotherapy. Participants with locally advanced esophageal cancer stage IIB or higher (n = 59) were randomly assigned to receive the walk-and-eat intervention (n = 30; nurse-supervised walking three times per week and weekly nutritional advice) or usual care (n = 29; control group) during 4-5 weeks of chemoradiotherapy. Primary endpoints were changes in distance on the 6-minute walk test, hand-grip strength, lean muscle mass, and body weight between initiation and completion of intervention. RESULTS Participants (mean age: 59.6 years) were mostly male (92.9%) with squamous cell carcinoma (96.4%). During chemoradiotherapy, participants who received the walk-and-eat intervention had 100-m less decline than controls in walk distance (adjusted p = .012), 3-kg less decrease in hand-grip strength (adjusted p = .002), and 2.7-kg less reduction in body weight (adjusted p < .001), regardless of age. The intervention group also had significantly lower rates of need for intravenous nutritional support and wheelchair use. CONCLUSION The nurse-led walk-and-eat intervention is feasible and effective to preserve functional walking capacity and nutritional status for patients with esophageal cancer undergoing neoadjuvant chemoradiotherapy.
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Randomized study of antiinflammatory and immune-modulatory effects of enteral immunonutrition during concurrent chemoradiotherapy for esophageal cancer.
Sunpaweravong, S, Puttawibul, P, Ruangsin, S, Laohawiriyakamol, S, Sunpaweravong, P, Sangthawan, D, Pradutkanchana, J, Raungkhajorn, P, Geater, A
Nutrition and cancer. 2014;(1):1-5
Abstract
Concurrent chemoradiotherapy (CCRT) induces toxicities from inflammation and immunological suppression. Omega-3 fatty acids, glutamine, and arginine are therapeutic factors that can attenuate such inflammation and promote cellular immunity. The question is whether immunonutrition (IN) during CCRT reduces inflammation and improves the immune function in patients with esophageal squamous cell carcinoma (ESCC). Seventy-one locally advanced ESCC patients being treated with CCRT (5-FU and cisplatin) were randomized into 2 groups. The IN group received a combination of omega-3 fatty acids, glutamine, and arginine, whereas the control group received standard formula. The levels of C-reactive protein (CRP), tumor necrosis factor (TNF), interferon-gamma (IFN), interleukin (IL-6, IL-10), CD3, CD4, CD8, white blood cells, neutrophils, and total lymphocytes were measured before and during treatment. The levels of CRP (P = 0.001) and TNF (P = 0.014) increased more during treatment in the control group than the treatment group, whereas IFN, IL-6, and IL-10 were similar but not significantly. CD3, CD4, CD8, white blood cells, neutrophils, and total lymphocytes decreased more in the control group than in the treatment group, but not significantly. Enteral IN during CCRT reduced the increase of inflammatory cytokine levels.