Clinical Trial of the Week: Study of radiotherapy added to chemotherapy for certain metastatic GI cancers

By Donna Loyle, communications specialist, LIMR

Clinical trial EA2183 is a new, phase III trial that seeks to establish superiority of consolidative radiation therapy over continuation of chemotherapy alone in patients with oligometastatic esophageal and gastric adenocarcinoma that does not progress on first-line therapy.

During the induction phase (Step 1), participants are assigned to either Arm A or B, and then during Step 2 are randomized into other groups as noted below:

Arm A: Patients receive oxaliplatin IV over 1.5 hours, leucovorin IV over 1.5 hours, and 5-fluorouracil IV over 46-48 hours on days 1 and 15. Treatment repeats every 28 days for up to 4 cycles.

  • Arm C: One week post induction in Arm A, patients undergo radiotherapy for up to 15 days. Within 2-4 weeks post radiotherapy, patients receive oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years.
  • Arm D: Post induction in Arm A, patients continue oxaliplatin, leucovorin, and 5-fluorouracil as in Arm A for 2 years.

Arm B: Patients receive oxaliplatin IV over 2 hours on day 1 and capecitabine PO twice daily on days 1-14. Treatment repeats every 21 days for up to 6 cycles.

  • Arm E: One week post induction in Arm B, patients undergo radiotherapy for up to 15 days. Within 2-4 weeks post radiotherapy, patients receive oxaliplatin and capecitabine as in Arm B for 2 years.
  • Arm F: Post induction in Arm B, patients continue oxaliplatin and capecitabine as in Arm B for 2 years.

Patients undergo follow-up care for up to 5 years.

Study EA2183 is approved for Lankenau, Bryn Mawr Hospital and Paoli Hospital. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit www.mainlinehealth.org/research/clinical-trials/ea2183

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Clinical Trial of the Week: Treatment trial for patients with ALK-positive NSCLC

By Donna Loyle, communications specialist, LIMR

Main Line Health is participating in a new phase II clinical trial that seeks to determine how well a combination of different biomarker/ALK inhibitors work in treating patients with stage IV, ALK-positive, non-squamous, non-small cell lung cancer. Eligible participants are those who’ve already been treated with a second-generation ALK inhibitor, but their disease has progressed.

The study is comparing several ALK inhibitors, including lorlatinib, ceritinib, alectinib, brigatinib, ensartinib and crizotinib. It also is comparing pemetrexed plus cisplatin and/or carboplatin to determine if chemotherapy may work equal, better or worse in these patients.

Tumors are biopsied for genetic mutations, and participants are placed into appropriate study arms.

Study #NRG-LU003 is approved for all MLH acute care hospitals. The principal investigators are Albert DeNittis, MD, and Paul Gilman, MD. For more, email cancertrials@mlhs.org or visit https://www.mainlinehealth.org/research/clinical-trials/nrg-lu003

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Intravascular lithotripsy shown to be safe and effective in treating calcified arterial stenosis of the lower extremities

Use of intravascular lithotripsy (IVL) to treat severe calcifications of peripheral artery disease showed low residual stenosis, marked acute gain, and few complications despite increased disease complexity, according to the initial results of DISRUPT PAD III registry, an ongoing multicenter clinical study in which Main Line Health is participating.

IVL uses sonic pressure waves that pass harmlessly through soft tissue but fracture the calcified blockage. This nonrandomized, single-arm, observational clinical trial is testing the safety and effectiveness of the FDA-approved Shockwave Medical Peripheral Lithoplasty® system used in combination with adjunctive devices in a real-world clinical setting.

The newly published study examined the initial interval of trial enrollment between November 2017 and August 2018. At that time, about 1,300 patients from 18 sites in the United States and Europe were enrolled in the study and followed through hospital discharge. Eligible participants were those who had claudication or chronic limb-threatening ischemia and moderate or severe arterial calcification. To date, Main Line Health has been the second-leading enroller in the study, collecting data on more than 125 participating patients.

During the initial study period, 200 patients and 220 target lesions were treated with IVL in combination with either drug-coated balloon (DCB) catheters or, less frequently, concomitant atherectomy or stenting, as per the treating physicians’ preferences. The calcified lesions were located in the iliac artery, common femoral artery, superficial femoral artery, popliteal artery, and infrapopliteal vessels. Nearly one-third were chronic total occlusions.

Results showed significant lesion reduction and low residual stenosis across all lesion types. Only three angiographic complications in the complex lesion set were reported: two complex dissections and one perforation that occurred after DCB use unrelated to the IVL procedure. No instances of abrupt closure, reflow, distal embolization or thrombotic events were reported.

“This study shows the benefit of IVL in a real-world setting, assisting clinicians who treat complex peripheral artery disease with endovascular therapy,” said Sarang Mangalmurti, MD, a cardiologist at Bryn Mawr Hospital and the Main Line Health principal investigator of the DISRUPT PAD III trial.

William Gray, MD, Main Line Health’s chief of the Division of Cardiovascular Disease, president of Lankenau Heart Institute and one of the study’s authors, noted: “At Main Line Health we remain committed to offering our patients the most advanced treatments available, which is why we participate in important clinical trials such as this. The knowledge gained from these studies can help to expand our therapeutic armamentarium.”

Dr. Gray also serves as a clinical professor of the Lankenau Institute for Medical Research, the research division of Main Line Health.

The initial results of DISRUPT PAD III trial were published in the manuscript “Intravascular Lithotripsy for Treatment of Calcified Lower Extremity Arterial Stenosis: Initial Analysis of the Disrupt PAD III Study” in the Journal of Endovascular Therapy. Drs. Gray and Mangalmurti coauthored this manuscript along with colleagues from other institutions.

For more on the DISRUPT PAD III clinical trial, which continues to recruit eligible patients, visit www.mainlinehealth.org/research/clinical-trials/disrupt-pad-iii

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COVID-19 Town Hall Medical Staff

The next Town Hall for Medical Staff will be held on Wednesday August 5 at 5:00pm. An invitation will be sent the day of the event.

 

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Calcium Scoring and Lung CT Price Changes

Effective 8/1/2020 the price (gross charge) for the above referenced services will increase.  Calcium Scoring (CPT Code 75571) will increase from $129 to $351.94.  CT Lung (CPT Code G0297) will increase from $315 to $567.  These increases will allow Main Line Health to receive contracted reimbursement from payers who are now covering these tests.  This includes IBC, Aetna, United, Medicare, Medicaid and possibly others.

A detailed review of these fee changes was conducted by an outside consulting firm as part of our annual Charge Master review process.  It was determined that our current fee creates a disadvantage to Main Line Health as the current charge is far less than the ~ $240 we can expect from IBC and Aetna.

Note:  Patients already scheduled for Calcium Scoring will be contacted by Central Scheduling to verify insurance coverage and/or to discuss financial options prior to testing.

Please read below for important information:

  • Calcium Scoring and CT Lung are now covered by insurance (in most instances).
    • We will learn more about specific payer reimbursement behavior by submitting insurance claims when it is determined that the service is covered.
  • Process change:
    • Ordering physician offices should verify that the test is covered by insurance before directing the patient to call Main Line Health Central Scheduling for an appointment.
    • Central Scheduling will be asking patients for the specific CPT and ICD-10 codes when scheduling a patient for this service if an order is not directly placed in Epic.
      •   This is the standard process for scheduling all diagnostic testing.
    • If the insurance will not cover the Calcium Scoring or Lung CT test, the following options are available.
      • Patients can pay for the test out of pocket at the new self-pay discounted rate of $211.20 for Calcium Scoring and 340.20 for CT Lung.
      • If your patient is unable to pay, the scheduler will direct the patient to the Hospital Financial Counselors to discuss assistance. The test will not be scheduled until the patient is financially cleared or until the Financial Assistance application is approved.  The turnaround time for this application is less than 48 hours after obtaining the required documentation from the patient.

Patients referred from the Women’s Heart Initiative will follow the same process detailed above.  Insurance will be billed where appropriate.  Patients who are uninsured will be charged the discounted Self Pay rate.  In the event of a financial hardship, the Financial Assistance program will be available.

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Clinical Trial of the Week: Treatment study of patients with blockages of femoropopliteal arteries

By Donna Loyle, communications specialist, LIMR

Researchers seek patients for a multicenter, randomized clinical trial that aims to determine the safety and effectiveness of using a device called Jetstream Atherectomy (JS) followed by treatment with a drug-coated balloon (DCB). JS is a rotational atherectomy device with active aspiration capacity approved in the United States to treat infrainguinal obstructive peripheral arterial disease.

Eligible participants must have been diagnosed with complex lesions in femoropopliteal arteries with claudication (Rutherford Clinical Category) of 2-4. They also must be able to tolerate antiplatelet therapy, anticoagulants, thrombolytic drugs or any other drug anticipated to be used.

One group of patients receives treatment of their lesions with JS followed by DCB. The other group receives treatment with traditional angioplasty (so called, plain old balloon angioplasty) followed by DCB.

The MLH principal investigator for the JET-RANGER study is Vincent DiGiovanni, DO. The trial is approved for Lankenau Medical Center and Riddle Hospital. For more, visit: www.mainlinehealth.org/research/clinical-trials/jet-ranger

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MLHCare physician network provider updates

PRACTICE MERGER:  Effective 7/1/2020

MLHC FM in Westtown & MLHC Chester County PC have become:

MLHC Primary Care in Westtown

Catherine Bergan, DO; Joseph Quintiliani, Jr., DO; Anne Bowen, MD; Lisa Johnson, MD;  and Vicki McLorie, CRNP

+ NEW 7/1/2020 – Lawrence A. Notaro, MD

1601 McDaniel Drive, Suite 50

PHONE:  484.905.8000 / FAX: 484.905.8005

WEBPAGE:  mainlinehealth.org/westtownprimary

 

NEW: Opening  7/1/2020

Main Line Health Integrative & Functional Medicine in King of Prussia
Rachel A. Sugarman, DO

Main Line Health King of Prussia, 120 Valley Green Lane, Suite 670, King of Prussia, PA  19406

PHONE:  484.324.7311 / FAX: 484.324.7696

WEBPAGE:  mainlinehealth.org/kopintegrative

*Note:  As part of this expansion, Robert Denitzio, MD of MLH Integrative & Functional Medicine

in Concordville has an updated webpage:  mainlinehealth.org/concordvilleintegrative

 

MLHC Specialist Physicians Additional Locations

Ana Recober-Montilla, MD & Alisha Amendt, CRNP

Main Line HealthCare Neurology   

Also seeing Headache patients at MLH King of Prussia, Suite 510 – 484.572.6300

 

Main Line HealthCare WELCOMES:

David Chen, DO (7/20/20)

MLHC Family Medicine in Collegeville – 484.565.8440

 

Dana Wallace, CRNP

MLHC Family Medicine in Havertown  – 610.449.9666

 

Kathryn Spillane, CRNP (7/27/20)

MLHC Primary Care in King of Prussia – 484.324.7100

 

Lawrence A. Notaro, MD

MLHC Primary Care in Westtown – 484.905.8000

 

Linda Barrasse, MD

Lankenau Heart Group (King of Prussia) – 484.476.1000

 

Aubrey Okpaku, MD  (7/20/20)

MLH-Jefferson Neurosurgery

Paoli Hospital – 484.527.2229

 

Joseph Li, MD

MLHC Neurology in Paoli –  610.647.8000

 

Rosalie Recto, PA-C

MLHC Pain Management at Lankenau – 610.658.1928

 

Drew L. Kotler, MD

Alison Rhoades, MD

Palliative Care at Bryn Mawr Hospital  – 484.337.2580

Palliative Care at Lankenau Medical Center  – 484.476.2580

 

Sidra Ghafoor, MD

David Halpern, MD

MLH Psychiatric Associates (inpatient)– 1.888.CARE.898 (227.3898)

 

Gregory Cannon, DO  (Concordville)
Danielle Marotta, CRNP  (Exton Square & St. Joe’s U)

MLH Urgent Care  – 484.565.1293

 

Hospitalist Medicine Services

Rachel Bobby, DO  (Lankenau)

Ehren Dancy, MD  – (Lankenau) – Chief Resident 20-21

Daniel Kurz, DO  – (Lankenau) – Chief Resident 20-21

Kayla Titus, MD – (Lankenau)

Anum Siddiqui, DO – (Bryn Mawr)

Katrina Viloria, DO  – (Bryn Mawr)

David Barrese, DO  – (Paoli)

Phillip Choi, MD  – (Paoli) – 7/26/20

Tatiana Parra, MD  – (Riddle)

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Clinical Trial of the Week: Treatment trial for patients diagnosed with high-risk GI cancer

By Donna Loyle, communications specialist, LIMR

Main Line Health is participating in a randomized phase II treatment study for patients diagnosed with high-risk anal cancer. Researchers seek to determine if the immunotherapy drug nivolumab (Opdivo®) can help these patients.

Once participants complete their chemotherapy and radiation, they are randomized into one of two study arms. One receives nivolumab intravenously every four weeks for six cycles. Those in the other study arm receive standard care, which is generally no further treatment but with close observation (i.e., follow-up care and imaging).

Inclusion criteria:

  • Must already have received combined modality therapy
  • Must have stage II (T3N0 only), IIIA, or IIIB invasive anal squamous cell carcinoma (includes tumors of non-keratinizing histology, e.g., basoloid, transitional cell, or cloacogenic)
  • No prior treatment of an immune checkpoint inhibitor for any type of cancer
  • HIV+ patients with CD4 >200 and serum HIV viral load of <200 copies/mm are permitted
  • No active autoimmune disease that has required systemic treatment in past two years

The principal investigators for trial #EA2165 are Albert DeNittis, MD, and Paul Gilman, MD. This trial is available at all Main Line Health acute care hospitals.

More information is available at

https://www.mainlinehealth.org/research/clinical-trials/ea2165

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COVID-19 Town Hall Medical Staff

The next Town Hall for Medical Staff will be held on Wednesday July 22 at 5:00pm. An invitation will be sent the day of the event.

 

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“Helping the Helpers”: COVID Frontline Support Group

Attention physicians, nurses, first responders and long term care staff. You are invited to a weekly video conference support group. The purpose of this group is to provide free emotional support, encouragement and compassionate self-care strategies to medical providers who are on the “front lines” of this unprecedented crisis. Please see the dates and registration information below.

 

Physicians: Thursday, July 23, July 30, August 6, August 13: 7:00PM-8:15PM To attend, we ask you to please register at this zoom link: https://us02web.zoom.us/j/88051518905?pwd=V3c1Rk1kUjdRSTMzdG44VVVlekV6QT09

Meeting ID: 880 5151 8905 Password: 869500

 

Nurses: Wednesday, July 22, July 29, August 5, August 12: 7:00PM-8:15PM To attend, we ask you to please register at this zoom link:

https://us02web.zoom.us/meeting/register/tZ0sc-ihqzgoGdDLNzCUbHtwgKK5_5d50GAX After registering, you will receive a confirmation email containing information about joining the meeting.

 

First Responders: Wednesday, July 22, July 29, August 5, August 12: 7:00PM-8:15PM To attend, we ask you to please register at this zoom link: https://us02web.zoom.us/j/81800511076?pwd=OXB6MkU2ZURkbkVzc21rUTlpditkQT09

Meeting ID: 818 0051 1076 Password: 122823

 

Long Term Care Staff: Wednesday, July 22, July 29, August 5, August 12: To attend, we ask you to please register at this zoom link: https://us02web.zoom.us/j/86546043008?pwd=UWluVm1rY2lJN3NDQ0wrUmVKaGlNdz09

Meeting ID: 865 4604 3008 Password: 4Uwbbg

 

For registration questions, contact Valerie Ferri at Vaferri@pmhcc.org .

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