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"Katz, David B"
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The Development of a Multimedia Teaching Program for Fiberoptic Intubation
Current training methods in fiberoptic intubation entail a trial and error process in which trainees acquire skills by practicing this technique in mannequins or patients. These training methods are not efficient and may expose patients to unnecessary instrumentation. An interactive software program is described which uses Director, a commercially available multimedia authoring tool, to (1) familiarize trainees with video images of the upper airway, (2) permit operator controlled progress through a normal fiberoptic intubation, (3) simultaneously display (side by side) two-dimensional or three-dimensional computer tomographic images with a fiberscope in place and the corresponding endoscopic video images, and (4) demonstrate some of the obstacles which occur in clinical practice (e.g. \"white-out\" and saliva). The intent of this package is to simulate fiberoptic intubation techniques as well as help one create a mental image of the path a fiberscope takes within the lumen of the upper airway. The potential for improving operator immersion (virtual reality) by using a more sophisticated input device is discussed.[PUBLICATION ABSTRACT]
Journal Article
Letters
Sir, - While I have in the past - as a religious- Zionist Jew and based upon my experiences doing reserve duty in Gush Katif - respectfully debated my support of Prime Minister Ariel Sharon's disengagement plan with Rabbi Shlomo Riskin, I wholeheartedly applauded Rabbi Riskin's articulate and responsible essay \"The observant soldier and disengagement\" (UpFront, March 4) in which he questioned our government's decision to disengage from the Gaza Strip - yet unequivocally voiced his opposition to those rabbinic pronouncements calling on IDF soldiers to refuse military orders of evacuation. Sir, - The turnout for Sheikh Hassan Nasrallah's pro- Syrian demonstration (\"Beirut throng rallies for Assad,\" March 9) was impressive. How many Syrians did Caroline Glick, in another of her excellent articles only the day before (\"Pyromaniac fireman\"), say lived and worked in Lebanon - 1.4 million? This made Nasrallah's rallying call - \"Lebanon is Lebanon!\" - a bit illogical. Shouldn't it have been \"Lebanon is Syria\"? Sir, - In many years of reading The Jerusalem Post I have never seen such a release of pent-up animosity to Jews and their religion as \"The real dictators\" (UpFront, March 4), in which Mati Golan professes himself a victim of a religious minority.
Newspaper Article
A phase III randomized crossover trial of plerixafor versus G-CSF for treatment of WHIM syndrome
BACKGROUNDWarts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome is a primary immunodeficiency disorder caused by heterozygous gain-of-function CXCR4 mutations. Myelokathexis is a kind of neutropenia caused by neutrophil retention in bone marrow and in WHIM syndrome is associated with lymphopenia and monocytopenia. The CXCR4 antagonist plerixafor mobilizes leukocytes to the blood; however, its safety and efficacy in WHIM syndrome are undefined.METHODSIn this investigator-initiated, single-center, quadruple-masked phase III crossover trial, we compared the total infection severity score (TISS) as the primary endpoint in an intent-to-treat manner in 19 patients with WHIM who each received 12 months treatment with plerixafor and 12 months treatment with granulocyte CSF (G-CSF, the standard of care for severe congenital neutropenia). The treatment order was randomized for each patient.RESULTSPlerixafor was nonsuperior to G-CSF for TISS (P = 0.54). In exploratory endpoints, plerixafor was noninferior to G-CSF for maintaining neutrophil counts of more than 500 cells/μL (P = 0.023) and was superior to G-CSF for maintaining lymphocyte counts above 1,000 cells/μL (P < 0.0001). Complete regression of a subset of large wart areas occurred on plerixafor in 5 of 7 patients with major wart burdens at baseline. Transient rash occurred on plerixafor, and bone pain was more common on G-CSF. There were no significant differences in drug preference or quality of life or the incidence of drug failure or serious adverse events.CONCLUSIONPlerixafor was not superior to G-CSF in patients with WHIM for TISS, the primary endpoint. Together with wart regression and hematologic improvement, the infection severity results support continued study of plerixafor as a potential treatment for WHIM syndrome.TRIAL REGISTRATIONClinicaltrials.gov NCT02231879.FUNDINGThis study was funded by the Division of Intramural Research, National Institute of Allergy and Infectious Diseases.
Journal Article
Physical activity and exercise during preoperative pancreatic cancer treatment
PurposeGuidelines recommend exercise to cancer survivors, but limited data exists regarding exercise among patients undergoing preoperative cancer treatment. We examined differences in weekly self-reported exercise and accelerometer-measured physical activity among participants in a home-based exercise program administered during preoperative treatment for pancreatic cancer.MethodsParticipants were encouraged to perform at least 60 min/week of moderate-intensity aerobic exercise and at least 60 min/week of full-body strengthening exercises concurrent with chemotherapy, chemoradiation therapy or both sequentially and received resistance equipment, program instruction, and biweekly follow-up calls to encourage adherence. Self-reported aerobic and strengthening exercise minutes were measured using daily logs, and physical activity was measured objectively using accelerometers.ResultsFifty participants (48% female, mean age 66 ± 8 years) participated for an average of 16 ± 9 preoperative weeks. Participants reported overall means of 126 ± 83 weekly minutes of aerobic exercise and 39 ± 33 weekly minutes of strengthening exercise in daily logs. Participants performed 158.7 ± 146.7 weekly minutes of accelerometer-measured moderate-to-vigorous physical activity. There were no significant differences in exercise or physical activity between treatment phases.ConclusionsThese findings suggest that it is feasible to target the entire preoperative course for exercise prescription. Although participants exceeded aerobic exercise recommendations on average, we observed low strengthening exercise adherence and wide variability in self-reported exercise and accelerometer physical activity variables. These findings suggest that additional support, including program adaptations, may be necessary to overcome barriers to exercise or improve motivation when prescribing exercise in this clinical scenario.
Journal Article
Lenalidomide plus high-dose dexamethasone versus lenalidomide plus low-dose dexamethasone as initial therapy for newly diagnosed multiple myeloma: an open-label randomised controlled trial
High-dose dexamethasone is a mainstay of therapy for multiple myeloma. We studied whether low-dose dexamethasone in combination with lenalidomide is non-inferior to and has lower toxicity than high-dose dexamethasone plus lenalidomide.
Patients with untreated symptomatic myeloma were randomly assigned in this open-label non-inferiority trial to lenalidomide 25 mg on days 1–21 plus dexamethasone 40 mg on days 1–4, 9–12, and 17–20 of a 28-day cycle (high dose), or lenalidomide given on the same schedule with dexamethasone 40 mg on days 1, 8, 15, and 22 of a 28-day cycle (low dose). After four cycles, patients could discontinue therapy to pursue stem-cell transplantation or continue treatment until disease progression. The primary endpoint was response rate after four cycles assessed with European Group for Blood and Bone Marrow Transplant criteria. The non-inferiority margin was an absolute difference of 15% in response rate. Analysis was by modified intention to treat. This trial is registered with
ClinicalTrials.gov, number
NCT00098475.
445 patients were randomly assigned: 223 to high-dose and 222 to low-dose regimens. 169 (79%) of 214 patients receiving high-dose therapy and 142 (68%) of 205 patients on low-dose therapy had complete or partial response within four cycles (odds ratio 1·75, 80% CI 1·30–2·32; p=0·008). However, at the second interim analysis at 1 year, overall survival was 96% (95% CI 94–99) in the low-dose dexamethasone group compared with 87% (82–92) in the high-dose group (p=0·0002). As a result, the trial was stopped and patients on high-dose therapy were crossed over to low-dose therapy. 117 patients (52%) on the high-dose regimen had grade three or worse toxic effects in the first 4 months, compared with 76 (35%) of the 220 on the low-dose regimen for whom toxicity data were available (p=0·0001), 12 of 222 on high dose and one of 220 on low-dose dexamethasone died in the first 4 months (p=0·003). The three most common grade three or higher toxicities were deep-vein thrombosis, 57 (26%) of 223 versus 27 (12%) of 220 (p=0·0003); infections including pneumonia, 35 (16%) of 223 versus 20 (9%) of 220 (p=0·04), and fatigue 33 (15%) of 223 versus 20 (9%) of 220 (p=0·08), respectively.
Lenalidomide plus low-dose dexamethasone is associated with better short-term overall survival and with lower toxicity than lenalidomide plus high-dose dexamethasone in patients with newly diagnosed myeloma.
National Cancer Institute, Rockville, MD, USA.
Journal Article
Acute Myocardial Infarction after Laboratory-Confirmed Influenza Infection
Patients who had a positive laboratory test for influenza were six times as likely to be hospitalized for acute myocardial infarction during the 7 days after specimen collection (the “risk interval”) as during the year before and the year after the risk interval.
Journal Article
Characterization of Anthropometric Changes that Occur During Neoadjuvant Therapy for Potentially Resectable Pancreatic Cancer
Background
Little is known about changes in body composition that may occur during neoadjuvant therapy for pancreatic cancer. This study was designed to characterize these changes and their potential relationships with therapeutic outcomes.
Methods
The study population consisted of patients with potentially resectable pancreatic cancer treated on a phase II trial of neoadjuvant chemotherapy and chemoradiation. Skeletal muscle and adipose tissue compartments were measured before and after administration of neoadjuvant therapy using SliceOMatic software (TomoVision, 2012) and protocol-mandated CT scans. Sarcopenia was defined using gender-adjusted norms.
Results
Among 89 eligible patients, 46 (52 %) patients met anthropometric criteria for sarcopenia prior to the initiation of neoadjuvant therapy. Further depletion of skeletal muscle, visceral adipose tissue, and subcutaneous adipose tissue occurred during neoadjuvant therapy, but these losses did not preclude the performance of potentially curative surgery. Degree of skeletal muscle loss correlated with disease-free survival while visceral adipose loss was associated with overall and progression-free survival. However, completion of all therapy, including pancreatectomy, was the only independently significant predictor of outcome in a multivariate analysis of overall survival.
Discussion
These data suggest that body composition analysis of standard CT images may provide clinically relevant information for patients with potentially resectable pancreatic cancer who receive neoadjuvant therapy. Anthropometric changes must be considered in the design of preoperative therapy regimens, and further efforts should focus on maintenance of muscle and visceral adipose tissue in the preoperative setting.
Journal Article
Prognostic Value of Lymph Node Status and Extent of Lymphadenectomy in Pancreatic Neuroendocrine Tumors Confined To and Extending Beyond the Pancreas
Background
The impact of lymph node (LN) status and lymphadenectomy (LA) on survival in pancreatic neuroendocrine tumors (pNETs) remains controversial. We evaluated the impact of tumor extension and grade on nodal metastasis and survival.
Methods
Surgical pNET patients were queried in the Surveillance Epidemiology and End Results (SEER) database (1998–2012,
N
= 981). Factors associated with LN status were analyzed by logistic regression and by Cox analyses.
Results
For T1–T2 tumors, N status was associated only with tumor size. N status (
p
= 0.001), grade (
p
< 0.001), age (
p
= 0.001), and sex (
p
= 0.007) predicted overall survival (OS). For T3–T4, grade (
p
< 0.001), sex (
p
= 0.004), size (
p
= 0.013), and age (
p
= 0.007) but not N status (
p
= 0.789) predicted OS. For T1–T2, disease-specific survival (DSS;
p
= 0.003) and OS (
p
= 0.008) were longer for N0 vs N1, while N0 vs NX had similar OS (
p
= 0.59) and DSS (
p
= 0.80). While a difference was seen in DSS for NX vs N1 (
p
= 0.04), no significant difference in OS was seen (
p
= 0.08). For T3–T4, N status did not affect DSS (
p
= 0.365) or OS (
p
= 0.454). For all T groups and any N status, extended LA (≥10 nodes resected) was not associated with OS.
Conclusion
While in T1–T2 pNET N1 status is a predictor of negative OS, similar outcome between NX and N0 supports limited LN resection in selected patients. Extended LA is unlikely to be helpful in T3–T4.
Journal Article
Home-Based Exercise Prehabilitation During Preoperative Treatment for Pancreatic Cancer Is Associated With Improvement in Physical Function and Quality of Life
Purpose: To investigate relationships among physical activity, changes in physical function, and health-related quality of life (HRQOL) among patients with pancreatic adenocarcinoma enrolled in a home-based exercise prehabilitation program. Methods: Patients with resectable pancreatic adenocarcinoma receiving preoperative chemotherapy and/or chemoradiation were enrolled on this prospective, single-arm trial and were advised to perform ≥60 minutes each of moderate-intensity aerobic exercise and strengthening exercise weekly. Activity was measured via self-report and accelerometers, including moderate-to-vigorous physical activity (MVPA), light physical activity (LPA), and sedentary activity (SA). Physical function measures at baseline and restaging follow-up included 6-minute walk test (6MWT), 5 times sit-to-stand (5×STS), handgrip strength (HGS), 3-m walk for gait speed (GS), and the PROMIS Physical Function Short Form. HRQOL was measured via the FACT-Hep questionnaire. Results: Fifty participants with mean age 66 years (standard deviation = 8 years) were enrolled. The 6MWT, 5×STS, and GS significantly improved from baseline to restaging follow-up (P=.001, P=.049, and P=.009, respectively). Increases in self-reported aerobic exercise, weekly MVPA, and LPA were associated with improvement in 6MWT (β=.19, P=.048; β=.18, P=.03; and β=.08, P=.03, respectively) and self-reported physical functioning (β=.02, P=.03; β=.03, P=.005; and β=.01, P=.02, respectively). Increased weekly LPA was associated with increased HRQOL (β=.03, P=.02). Increased SA was associated with decreased HRQOL (β=-.02,P=.01). Conclusions: Patients with potentially resectable pancreatic cancer exhibit meaningful improvement in physical function with prehabilitation; physical activity was associated with improved physical function and HRQOL. These data highlight the importance of physical activity during treatment for pancreatic cancer.
Journal Article