Research Spotlight

Posted July 15th 2017

Prior season vaccination and risk of influenza during the 2014-2015 season in the U.S.

Manjusha Gaglani M.D.

Manjusha Gaglani M.D.

Chung, J. R., B. Flannery, R. K. Zimmerman, M. P. Nowalk, M. L. Jackson, L. A. Jackson, J. G. Petrie, E. T. Martin, A. S. Monto, H. Q. McLean, E. A. Belongia, M. Gaglani and A. M. Fry (2017). “Prior season vaccination and risk of influenza during the 2014-2015 season in the U.S.” J Infect Dis: 2017 Jun [Epub ahead of print].

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The US Flu VE Network conducts annual studies of VE using the test-negative study design that is also used in Canada. In the Canadian study, current and prior-season vaccination status is based on a combination of patient self-report and sentinel practitioner documentation. In the US Flu VE Network, current season vaccination status is also based on a combination of patient self-report and electronic immunization records; however, prior-season vaccination is based on immunization records only. Misclassification of vaccine history may result from inaccurate self-report or incomplete immunization records. One study that compared self-reported influenza vaccination to an immunization registry found that patients overreported vaccination by approximately 10% [5]; recall of prior seasons’ vaccination may be less accurate. To minimize misclassification of vaccination history in 2 prior seasons, we considered documented doses only among patients aged ≥9 years with medical records available for at least 2 years prior to enrollment, and excluded patients who reported 2014–2015 influenza vaccination that was not documented. After adjusting for age and other potential confounding variables, we found no statistically significant association between vaccination in 3 consecutive seasons and A(H3N2)-related illness during 2014–2015 (Table 1). However, we observed the highest point estimate among persons vaccinated in 2014–2015 only. A sensitivity analysis restricted to the main genetic group (clade 3C.2a) of antigenically drifted A(H3N2) and influenza negatives resulted in similar estimates (data not shown). Although the higher point estimate for vaccination only in 2014–2015 is consistent with potential negative interference from prior vaccination [1], our results do not support evidence of increased likelihood of influenza due to A(H3N2) viruses among repeatedly vaccinated individuals compared to those unvaccinated in 3 consecutive seasons.


Posted July 15th 2017

Prolonged survival in patients with breast cancer and a history of brain metastases: Results of a preplanned subgroup analysis from the randomized phase iii beacon trial.

Joyce O'Shaughnessy M.D.

Joyce O’Shaughnessy M.D.

Cortes, J., H. S. Rugo, A. Awada, C. Twelves, E. A. Perez, S. A. Im, P. Gomez-Pardo, L. S. Schwartzberg, V. Dieras, D. A. Yardley, D. A. Potter, A. Mailliez, A. Moreno-Aspitia, J. S. Ahn, C. Zhao, U. Hoch, M. Tagliaferri, A. L. Hannah and J. O’Shaughnessy (2017). “Prolonged survival in patients with breast cancer and a history of brain metastases: Results of a preplanned subgroup analysis from the randomized phase iii beacon trial.” Breast Cancer Res Treat.

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PURPOSE: Conventional chemotherapy has limited activity in patients with breast cancer and brain metastases (BCBM). Etirinotecan pegol (EP), a novel long-acting topoisomerase-1 inhibitor, was designed using advanced polymer technology to preferentially accumulate in tumor tissue including brain metastases, providing sustained cytotoxic SN38 levels. METHODS: The phase 3 BEACON trial enrolled 852 women with heavily pretreated locally recurrent or metastatic breast cancer between 2011 and 2013. BEACON compared EP with treatment of physician’s choice (TPC; eribulin, vinorelbine, gemcitabine, nab-paclitaxel, paclitaxel, ixabepilone, or docetaxel) in patients previously treated with anthracycline, taxane, and capecitabine, including those with treated, stable brain metastases. The primary endpoint, overall survival (OS), was assessed in a pre-defined subgroup of BCBM patients; an exploratory post hoc analysis adjusting for the diagnosis-specific graded prognostic assessment (GPA) index was also conducted. RESULTS: In the trial, 67 BCBM patients were randomized (EP, n = 36; TPC, n = 31). Treatment subgroups were balanced for baseline characteristics and GPA indices. EP was associated with a significant reduction in the risk of death (HR 0.51; P < 0.01) versus TPC; median OS was 10.0 and 4.8 months, respectively. Improvement in OS was observed in both poorer and better GPA prognostic groups. Survival rates at 12 months were 44.4% for EP versus 19.4% for TPC. Consistent with the overall BEACON population, fewer patients on EP experienced grade >/=3 toxicity (50 vs. 70%). CONCLUSIONS: The significant improvement in survival in BCBM patients provides encouraging data for EP in this difficult-to-treat subgroup of patients. A phase three trial of EP in BCBM patients is underway.


Posted July 15th 2017

Cryopreserved venous allograft is an acceptable conduit in patients with current or prior angioaccess graft infection.

James Kohn M.D.

James Kohn M.D.

Harlander-Locke, M. P., P. F. Lawrence, A. Ali, E. Bae, J. Kohn, C. Abularrage, M. Ricci, G. W. Lemmon, S. Peralta and J. Hsu (2017). “Cryopreserved venous allograft is an acceptable conduit in patients with current or prior angioaccess graft infection.” J Vasc Surg: 2017 Jun [Epub ahead of print].

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OBJECTIVE: The durability of cryopreserved allograft has been previously demonstrated in the setting of infection. The objective of this study was to examine the safety, efficacy, patency, and cost per day of graft patency associated with using cryopreserved allograft (vein and artery) for hemodialysis access in patients with no autogenous tissue for native fistula creation and with arteriovenous graft infection or in patients at high risk for infection. METHODS: Patients implanted with cryopreserved allograft for hemodialysis access between January 2004 and January 2014 were reviewed using a standardized, multi-institutional database that evaluated demographic, comorbidity, procedural, and outcomes data. RESULTS: There were 457 patients who underwent placement of cryopreserved vein (femoral: n = 337, saphenous: n = 11) or artery (femoral: n = 109) for hemodialysis access at 20 hospitals. Primary indications for allograft use included high risk of infection in 191 patients (42%), history of infected prosthetic graft in 169 (37%), and current infection in 97 (21%). Grafts were placed more frequently in the arm (78%) than in the groin, with no difference in allograft conduit used. Mean time from placement to first hemodialysis use was 46 days (median, 34 days). Duration of functional graft use was 40 +/- 7 months for cryopreserved vein and 21 +/- 8 months for cryopreserved artery (P < .05), and mean number of procedures required to maintain patency at follow-up of 58 +/- 21 months was 1.6 for artery and 0.9 for vein (P < .05). Local access complications occurred in 32% of patients and included late thrombosis (14%), graft stenosis (9%), late infection (9%), arteriovenous access malfunction (7%), early thrombosis (3%), and early infection (3%). Early and late infections both occurred more frequently in the groin (P = .030, P = .017, respectively), and late thrombosis occurred more frequently with cryopreserved artery (P < .001). Of the 82 patients (18%) in whom the cryopreserved allograft was placed in the same location as the excised infected prosthetic graft, 13 had infection of the allograft during the study period (early: n = 4; late: n = 9), with no significant difference in infection rate (P = .312) compared with the remainder of the study population. The 1-, 3-, and 5-year primary patency was 58%, 35%, and 17% for cryopreserved femoral vein and 49%, 17%, and 8% for artery, respectively (P < .001). Secondary patency at 1, 3, and 5 years was 90%, 78%, and 58% for cryopreserved femoral vein and 75%, 53%, and 42% for artery, respectively (P < .001). Mean allograft fee per day of graft patency was $4.78 for cryopreserved vein and $6.97 for artery (P < .05), excluding interventional costs to maintain patency. CONCLUSIONS: Cryopreserved allograft provides an excellent conduit for angioaccess when autogenous tissue is not available in patients with current or past conduit infection. Cryopreserved vein was associated with higher patency and a lower cost per day of graft patency. Cryopreserved allograft allows for immediate reconstruction through areas of infection, reduces the need for staged procedures, and allows early use for dialysis.


Posted July 15th 2017

If We Don’t Ask, Our Patients Might Never Tell: The Impact of the Routine Use of a Patient Values Assessment.

J. Russell Hoverman M.D.

J. Russell Hoverman M.D.

Hoverman, J. R., C. Taniguchi, K. Eagye, S. Mikan, A. Kalisiak, S. Ash-Lee and R. Henschel (2017). “If we don’t ask, our patients might never tell: The impact of the routine use of a patient values assessment.” J Oncol Pract: 2017 Jun [Epub ahead of print].

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PURPOSE: Good communication can be associated with better end-of-life outcomes. The US Oncology Network developed and tested a Values Assessment (VA) for facilitating advance care planning (ACP). The results of the first 1,268 patients are reported. METHODS: The VA consists of 10 questions of the format “How valuable is it to me to…” (eg, “…know that I am not a burden to my family, friends, or helpers?”). Responses were on a four-point scale from unsure to very valuable. VA data on 1,286 patients with metastatic cancer from April 1, 2013, to July 31, 2015, were extracted from the electronic health record, including demographics, diagnosis, stage, chemotherapy, and outcomes (hospice enrollment, place of death). These demographics were compared by using the chi2 or Fisher’s exact test or the Wilcoxon rank sum test for continuous variables. RESULTS: A total of 1,268 patients completed the VA (56.7% were >/= 65 years of age, 57.8% completed advance directives [ADs]). There were 438 deaths of which 308 had a place of death or a hospice enrollment recorded. Of these, 78% died at home or inpatient hospice; 14.6% died in the hospital. Hospice enrollment with ADs was 76.1% and without, 60.9%. Median length of stay in hospice was 21 days with ADs versus 12.5 days without. Chemotherapy in the last 14 days of life was 8.8% with ADs and 15.5% without. The VA was well accepted by patients. CONCLUSION: A VA as a routine part of practice is feasible and scalable. It facilitates ACP discussions that lead to ADs. The results suggest that VA and ACP lead to less-aggressive care at the end of life.


Posted July 15th 2017

Holmium Laser Enucleation of the Prostate After Prostatic Urethral Lift Surgery: Feasibility and Technical Considerations from a Multi-Institutional Case Series.

Andrew F. Navetta M.D.

Andrew F. Navetta M.D.

McAdams, S. B., J. Funk, A. Navetta, M. El Tayeb and M. R. Humphreys (2017). “Holmium laser enucleation of the prostate after prostatic urethral lift surgery: Feasibility and technical considerations from a multi-institutional case series.” J Endourol: 2017 Jun [Epub ahead of print].

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INTRODUCTION AND OBJECTIVE: Prostatic urethral lift (PUL) is gaining popularity for the treatment of symptomatic benign prostatic hyperplasia (BPH). We describe the feasibility and considerations of performing holmium laser enucleation of the prostate (HoLEP) as a salvage therapy after previous PUL. METHODS: Men who have undergone HoLEP after PUL were retrospectively identified from three institutions with surgeons experienced in HoLEP. Subjects were characterized by age, time from PUL procedure (months) to HoLEP surgery, indication for retreatment, and pre-operative prostate volume by ultrasound. Outcomes of interest included enucleation time, morcellation time, morcellator type, weight of tissue resected, and Clavien complications. We also summarize findings related to location of PUL device implants, and the effect of the implants on the enucleation and morcellation portions of the procedure. RESULTS: From 12/15/2015 to 10/31/2016 seven men age 51-78 years underwent HoLEP at a median of 8.6 months (range 3-18) after PUL. In each case PUL had been performed with a variable number of UroLift (NeoTract Inc.) device implants. In several cases implants were found to reside in areas other than where intended by usual PUL technique. In one case performed for refractory pain the device implant was not identified during HoLEP, but was subsequently removed from the outer bladder wall via a robotic trans-abdominal procedure, resulting in improvement of pain at six weeks. The reciprocating morcellator system (Lumenis Versacut) tended to jam with each implant requiring a pause for withdrawal of the morcellator and manual removal from the blade, whereas the oscillating system (Wolf Piranha) tended to morcellate around the device components, and required grasper retrieval of device components. There were no complications. CONCLUSIONS: HoLEP can be performed safely and effectively post PUL, however morcellation of the adenoma tissue is complicated by metallic implants of the PUL dev.