Clinical Trial of the Week: Treatment study for older patients with advanced non-small lung cancer

By Donna Loyle, communications manager, LIMR

 

Researchers seek to determine if there are any side effects of Keytruda® (pembrolizumab) with or without chemotherapy in treating patients aged 70 and older diagnosed with metastatic, stage 4 non-small cell lung cancer.

 

Eligible participants are grouped into two study arms:

  • Group A receives pembrolizumab IV on day 1. Cycles repeat every 21 or 42 days.
  • Group B receives pembrolizumab and the chemotherapies pemetrexed and carboplatin IV on day 1. Cycles for pembrolizumab repeat every 21 or 42 days. Cycles for the chemotherapies repeat every 21 days.

 

Study # A171901 is approved for all MLH acute care hospitals. For more on this clinical trial, email cancertrials@mlhs.org or visit https://www.mainlinehealth.org/research/clinical-trials/a171901

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Latest Clinical Research from LIMR

By Donna Loyle, communications manager, LIMR

 

Research studies with clinical implications for patients with COVID-19, triple negative breast cancer, aortic valve replacement, atrial fibrillation, lung cancer and chronic cough were published in peer-reviewed journals by investigators at the Lankenau Institute for Medical Research (LIMR) in December.

 

Vitamin A as potential anti-viral therapy, including coronavirus

Retinoic acid (RA; vitamin A) may be an effective prophylactic agent in minimizing airway barrier leak and as a potential therapy to prevent cellular leak caused by inflammation. The authors suggest that RA may be a useful adjuvant for anti-viral therapies, including COVID-19 treatments, as cytokine storms caused by inflammation are known to be related to morbidity.

LIMR investigators: James Mullin, PhD, and Sunil Thomas, PhD. The manuscript: “Retinoic acid improves baseline barrier function and attenuates TNF-α-induced barrier leak in human bronchial epithelial cell culture model, 16HBE 14o” in PLoS One.

 

Poorer outcomes seen in TNBC patients with metabolic syndrome

In this study of 177 Main Line Health patients diagnosed with triple negative breast cancer (TNBC) during the time period of 2007 to 2013, metabolic syndrome (obesity, diabetes, hypertension and dyslipidemia) was significantly associated with poorer outcomes. But overall survival was not impacted. The exception was among those TNBC patients with hypertension; these patients had both poorer disease-free and overall survival. “Hypertension management is therefore potentially an important aspect of the multidisciplinary care of the TNBC patient,” the authors noted. LIMR investigators: Kaitlyn Kennard, MD; Meghan Buckley; Sharon Larson, PhD; Ned Carp, MD; and Thomas Frazier, MD. The manuscript: “Metabolic syndrome: does this influence breast cancer outcomes in the triple-negative population?” in the journal Breast Cancer Research and Treatment.

 

Patient outcomes compared after aortic valve replacement

A retrospective review of 68 Lankenau patients who underwent transcatheter valve-in-valve implantation after bioprosthetic valve failure showed they had reduced need for permanent pacemakers, lower rates of atrial fibrillation and shorter hospital stays compared to patients who had minimally invasive reoperative aortic valve replacement. LIMR investigators: Serge Sicouri, MD; Meghan Buckley; and Scott Goldman, MD. The manuscript: “Transcatheter and ministernotomy aortic valve replacement after bioprosthetic valve failure” in Journal of Cardiac Surgery.

 

Biomarkers identified for stroke in afib patients

In patients with atrial fibrillation, the biomarkers most likely to be associated with subsequent ischemic stroke/systemic embolism represent fibrosis/remodeling; cardiac; vascular calcification; metabolism; and mucosal integrity/ischemia. LIMR investigator: Michael Ezekowitz. The manuscript: “Screening of Multiple Biomarkers Associated with Ischemic Stroke in Atrial Fibrillation” in Journal of the American Heart Association.

 

Optimal P-IDL in SBRT for lung cancer patients

The optimal prescription isodose line (P-IDL) range is 75%-80% for stereotactic body radiotherapy (SBRT) with volumetric-modulated arc therapy (VMAT) to treat early-stage lung cancers, according to a new retrospective study. The authors noted that applying optimized approaches can “significantly improve the lung sparing in SBRT VMAT plans with AXB dose calculation algorithm and makes treatment plans more conformal in high, intermediate and low dose regions, while higher dose is delivered to the target.” LIMR investigators: Albert DeNittis, MD; Tracey Evans, MD; and Thomas Meyer, MD. The manuscript: “Optimal prescription isodose line in SBRT for lung tumor treatment with volumetric-modulated arc therapy” in Journal of Radiosurgery and SBRT.

 

Laryngopharyngeal reflux may contribute to chronic cough

A retrospective chart review of 28 patients presenting with chronic cough found that laryngopharyngeal reflux may be a prevalent contributing or etiologic factor. After three months of reflux treatments, 60% reported improvement in cough. Among the possible contributing causes for non-responders were esophageal dysmotility, mycoplasma and pertussis.

LIMR investigator: Robert Sataloff, MD. The manuscript: “The Relationship Between Chronic Cough and Laryngopharyngeal Reflux” in Journal of Voice.

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Clinical Trial of the Week: Phase II treatment study for breast cancer

By Donna Loyle, communications manager, LIMR

 

In this randomized phase II clinical trial, researchers are studying how well docetaxel or paclitaxel work in reducing chemotherapy-induced peripheral neuropathy in a patient cohort comprised of African American women diagnosed with stages I-III breast cancer.

 

Eligible participants must have had no prior taxane therapy and no prior or concurrent platinum-based chemotherapy. Also, they must have no pre-existing neuropathy.

 

Participants are grouped into two study arms:

  • Arm 1 receives paclitaxel IV once weekly. Treatment repeats every 21 days for 4 cycles.
  • Arm 2 receives docetaxel IV once every 3 weeks. Treatment repeats every 21 days.

 

Patients may also receive other medications at the physician’s discretion.

 

Study #EAZ171 is approved for all four MLH acute care hospitals. For more, email cancertrials@mlhs.org or visit https://www.mainlinehealth.org/research/clinical-trials/eaz171

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Serious drug-induced cardiac side effect accurately detected and scored by LIMR researcher

By Donna Loyle, communications manager, LIMR

 

A new study coauthored by investigators at the Lankenau Institute for Medical Research (LIMR) showed the utility of a scoring system enabled by a LIMR-developed assay in predicting drug-induced torsade de pointes (TdP).

 

TdP, a life-threatening polymorphic ventricular tachycardia, occurs in the setting of QT prolongation. Clinicians have known that certain approved and experimental medications can inadvertently cause QT prolongation. In fact, the U.S. Food and Drug Administration (FDA) now requires all drug candidates in development to be tested to ensure they don’t cause QT prolongation before entering into clinical use. But testing in patients isn’t always possible, so the FDA has called for preclinical testing methods.

 

LIMR Professor Gan-Xin Yan, MD, PhD — along with colleagues at the FDA, Janssen Pharmaceuticals, GlaxoSmithKline and Peking University — demonstrated in a recently published, blinded study that the Normalized TdP Score System they developed successfully predicted the proarrhythmic risk of 34 medications.

 

To complete their study, the team used Dr. Yan’s arterially perfused ventricular wedge preparation (wedge prep for short), an invention previously shown to accurately record all electrical signals in the heart, even in its innermost layers. Previously, scientists could record only the signals sensed on the outside of the heart.

 

In the current study, researchers used Dr. Yan’s wedge prep to detect signals on the inside of animal hearts, each of which had been treated with one of the 34 studied medications. They then assigned scores to those drugs, thus enabling an accurate risk assessment of a medication’s ability to induce TdP.

 

“There has long been a need to reliably predict TdP risk among drug candidates,” said Dr. Yan.   “We’ve now shown that using our normalized TdP score by the wedge prep assay can enable pharmaceutical researchers to readily determine drug-induced TdP risk among their compounds. We think this assay will turn out to be a best-practice preclinical drug-safety solution for pharmaceutical development and may eventually reduce the need for human QT studies.”

 

The study, “Utility of normalized TdP score system in drug proarrhythmic potential assessment: a blinded in vitro study of CiPA drugs,” was published in Clinical Pharmacology and Therapeutics.

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Hepatitis C laboratory test process change

Effective Dec 21st we have started Hepatitis C antibody testing with reflex to Hep C by RNA for both employees and source patients for needle stick/other exposures. This is to comply with new CDC recommendation (July 2020) for reflex testing within 48 hours of exposure. The order sets with reflex testing will be built in EPIC soon for both source patients and employees. This will not be process for any other Hepatitis C antibody testing either as hospital in-patients or outpatients.

 

If you have any questions, please contact Dr. Bhagat at 484-476-3521.

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Clinical Trial of the Week: Diagnostic device trial for patients with metastatic breast cancer

By Donna Loyle, communications manager, LIMR

 

Researchers, including those at MLH, seek to evaluate the performance of fludeoxyglucose F-18 (FDG)-PET/CT response criteria as a binary predictor of progression-free survival in patients with bone-dominant metastatic breast cancer treated with systemic therapy.

 

Participants in this phase II, non-randomized clinical trial receive FDG intravenous solution and undergo PET/CT scan over 15 to 30 minutes within 21 days before start of standard treatment, and then again at 12 weeks after start of standard treatment.

 

Inclusion criteria:

  • Must have been diagnosed with metastatic breast cancer that is hormone-receptor positive and with known HER2 status and whose cancer has spread only or predominantly to the bones
  • Must be able to undergo FDG-PET imaging
  • Must be undergoing a systemic therapy such as endocrine therapy, chemotherapy or an HER2-targeted treatment
  • Other inclusion and exclusion criteria apply

 

Study #EA1183 is approved for all MLH acute care hospitals. The principal investigator is Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit https://www.mainlinehealth.org/research/clinical-trials/ea1183.

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Dr. Ali Keramati’s Honor – American College of Cardiology

Cardiac electrophysiologist Ali R. Keramati, MD, a member of the Lankenau Heart Institute at Lankenau Medical Center, has been appointed to serve as a Member of the NCDR EP Registry Steering Committee, part of the American College of Cardiology.

 

The American College of Cardiology (ACC) has the privilege to select outstanding members of the College to serve on its task forces, workgroups, councils, and committees. Aligned with ACC’s governance principles, the ACC Nominating Committee works together to identify the best candidates, based upon College needs and skillsets. The National Cardiovascular Data Registry (NCDR®) is the ACC’s suite of cardiovascular data registries helping hospitals and private practices measure and improve the quality of care they provide.

 

As a Member of the NCDR EP Registry Steering Committee, Dr. Keramati will help govern the organization, be a driving force behind the development of educational programming, products and guidelines, and shape ACC positions on both state and federal legislation.

 

In a note to Dr. Keramati notifying him of his appointment, ACC President Athena Poppas, MD, FACC and Chair of the ACC Nominating Committee  Richard J. Kovacs, MD, MACC wrote: “Thank you for the time and effort in putting forth your application. We are grateful for your commitment and hope you will agree to serve the College and your fellow ACC members in this important capacity.”

 

Dr. Keramati’s term will begin in April 2021 and last for three years.

 

Congratulations, Dr. Keramati, on this well-deserved accomplishment!

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Vaccination Update: What you need to know

Sent on behalf of Barbara Wadsworth and Jon Stallkamp, MD

 

Colleagues,

 

Following the FDA’s issuance of an EUA for the Pfizer COVID vaccine, Main Line Health and other hospitals across the country are expecting to receive shipment of the first COVID vaccines this week. With this in mind, we would like to provide you an update on our vaccine distribution and planning.

 

Vaccination eligibility and categories 

 

Employees and medical staff have been carefully reviewed and organized into categories in accordance with the distribution recommendations from the CDC and the PA Department of Health. At Main Line Health, the vaccine will be administered in five categories based on risk of exposure to COVID-19:

 

  • Category 1: Hospital staff who have significant risk of exposure to COVID-unknown patients
  • Category 2: Staff who work with COVID-positive patients in COVID units
  • Category 3: Other patient-facing staff
  • Category 4: Staff who work in a hospital, but are not patient-facing
  • Category 5: Work-from-home staff

 

Categories were assigned based on the individual’s primary worksite or department. Ultimately, our goal is to vaccinate all employees and medical staff who are in patient-facing roles. Employees without patient-facing jobs will receive their vaccines at a later date. ​While the vaccine is not mandatory, we do encourage you to be vaccinated for your safety and the safety of our patients and community. Your manager should have received your category assignment late last week. Please reach out to your manager if you are unsure as to which category you are in.

 

We have received many questions about individuals who should not take the vaccine. At this time, we will allow staff who are pregnant or breastfeeding to be vaccinated, but strongly encourage that you consult with your health care provider before scheduling a vaccination. If you were unable to schedule your appointment previously due to the pregnancy and breastfeeding question and would like to schedule your vaccination, please try again tomorrow.

 

As previously mentioned in COVID communications and town halls, we will continue to work with our pregnant staff members who wish to be reassigned because of exposure to COVID-positive or COVID unknown patients.

 

Scheduling your vaccination 

 

For some employees in Categories 1 and 2, vaccination scheduling has already begun. If you have scheduled a vaccination for December 16th or 17th please be advised that you will need to reschedule your vaccination. We do not expect to be able to begin vaccinations on those days, as previously suspected, and appreciate your flexibility to find a new vaccination day and time.

 

Regardless of when you are expected to receive the vaccine, please remember: All employees and medical staff who wish to be vaccinated will be required to register for a Main Line Health MyChart account, if they have not done so already. You will not be eligible to receive the vaccine until you have an MLH MyChart account.

 

By opening an MLH MyChart account, you will be able to:

  • Receive notifications when you have been identified as eligible to get the vaccination
  • Schedule your vaccine slots
  • Sign vaccine consents
  • Have a record of the immunization

 

Signing up for MLH MyChart is easy and can be done at any time. Go to www.mainlinehealth.org  and click on the MLH MyChart link. If you need assistance, please call our 24/7/365 portal help desk at 484.580.1080 or send a message securely using our support form. You will receive a MyChart notification when scheduling is available for you, based on your role.

 

When you receive the notification that vaccination scheduling is available to you, please take the time to schedule your vaccination and complete the pre-visit check-in process. If you do not intend to be vaccinated, we ask that you please designate this during the scheduling process. A demo is now available on MLH To Go and Wellspring on how to schedule and complete your pre-visit check-in.

 

Vaccination time slots will be available from 5:00 AM-12:00 AM. We ask that you consider scheduling your vaccine for the end of your shift.

 

Day of vaccination: What to know 

 

All vaccinations will take place at the Lankenau Medical Center Annenberg Auditorium. This is because Lankenau has ultra-low temperature freezers that will allow us to store the vaccinations safely. If you are not familiar with the Lankenau campus, please know that signage will be in place to direct you to parking on the day of your vaccination. When you come to Lankenau, please ensure that you have:

 

  • Your MLH ID badge
  • A second form of photo ID
  • Completed your pre-visit check-in on MyChart

 

Once you’ve received your vaccine, you will be asked to remain in the Auditorium for 15 minutes so that a member of our vaccination team can monitor you for any reactions to the vaccine. A physician will be on hand during every vaccination day, and EpiPens will be available in the event of an allergic reaction.

 

If you have questions, please consult our COVID Vaccine FAQs, available on the COVID Vaccine Wellspring page. If you have questions that are not answered here, please email COVIDVaccine@MLHS.org. As always, we thank you for your patience, cooperation and support during this time.

 

Barbara Wadsworth, DNP, RN
Chief Operating Officer | Chief Nursing Officer

 

Jon Stallkamp, MD
Interim Chief Medical Officer

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GC/Chlamydia, HPV lab update

Effective Friday, Dec 11th Main Line Health labs will convert GC/Chlamydia/HPV testing from Roche Cobas instruments to Hologic Panther instruments. The Aptima Combo 2® Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal disease using the Panther® System. These tests will be offered only as combo test, will be build in EPIC as combo test and will require a new collection kits-Aptima kits rather than Roche Cobas kits.

 

The Aptima HPV assay is an in vitro nucleic acid amplification test for the qualitative

detection of E6/E7 viral messenger RNA (mRNA) from 14 high-risk types of human

papillomavirus (HPV) in cervical specimens. The high-risk HPV types detected by the assay

include: 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68. The Aptima HPV assay

does not discriminate between the 14 high-risk types. Cervical specimens in ThinPrep Pap

Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula

collection devices may be tested with the Aptima HPV assay.

 

If Aptima HPV is positive, Aptima HPV 16 18/45 genotype assay will be performed. Aptima genotype assay is an in vitro nucleic acid amplification test for the qualitative detection of E6/E7 viral messenger RNA (mRNA) of human papillomavirus (HPV) types 16, 18, and 45 in cervical specimens from women with positive HPV results. The Aptima HPV 16 18/45 genotype assay can differentiate HPV 16 from HPV 18 and/or HPV 45, but does not differentiate between HPV 18 and HPV 45. Cervical specimens in ThinPrep Pap Test vials containing PreservCyt Solution and collected with broom-type or cytobrush/spatula are acceptable specimens.

 

If you have any questions, contact Daniel Lindao at 476-8424 or Dr. Bhagat at 476-3521.

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Clinical Trial of the Week: Device trial to treat left atrial appendage closure in atrial fibrillation ablation patients

By Donna Loyle, communications manager, LIMR

 

The OPTION clinical trial is a randomized, multicenter study to determine if left atrial appendage closure with the WATCHMAN FLX device is a reasonable alternative to oral anticoagulation following percutaneous catheter ablation for high-risk patients with non-valvular atrial fibrillation (AF).

 

Participants are randomized into two study groups:

  • Arm 1 receives the WATCHMAN FLX implant, including a modified post-implant drug regimen
  • Arm 2 receives oral anticoagulants for the trial’s duration

 

Inclusion criteria:

  • Must have a CHA2DS2-VASc score of 2 or greater for males and 3 or greater for females
  • Must be deemed suitable for the protocol’s drug regimen
  • Must not require long-term anticoagulation therapy for reasons other than AF-related stroke-risk reduction

Other significant inclusion and exclusion criteria apply.

 

The primary outcomes being measured are stroke, all-cause death, systemic embolism, and non-procedural bleeding within 36 months.

 

The MLH principal investigator is Sheetal Chandhok, MD. The trial is approved for Bryn Mawr Hospital and Lankenau Medical Center. For more: https://www.mainlinehealth.org/research/clinical-trials/option

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