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Oncology Vol. XVI • Issue No. 5 • July 2020 WWW.PHYSICIANSWEEKLY.COM

[ MEDLAW ] New research was presented The Impact of Hypofractionated RT in this year’s ASCO20 Virtual COVID-19 on for Early Breast Cancer Scientific Program, the annual Physician Practices Improves Care meeting of the American Society of here’s no denying the significant impact utilization management policy promoting the COVID-19 pandemic has made on hypofractionated radiotherapy (RT) ap- Clinical Oncology, from May 29-31. PART 2 Tmedicine. “We’re practically developing new A pears to be associated with the improve- protocols every day,” says PW Editor-in-Chief ment of evidence-based cancer care for women Medicolegal CONFERENCE Linda Girgis, MD. “We now are conducting with early breast cancer, according to a study many visits by telemedicine to limit contact published in JAMA Oncology. The retrospec- Issues During the between people and sterilize every surface of the tive economic analysis determined a higher up- office—for those patients who do come in— take of hypofractionated radiotherapy among COVID-19 Pandemic like we’ve never done before.” To get a better women who were either directly subject, or This three-part series—Part 1 in the June issue sense of the impact, we conducted a survey of indirectly exposed, to the policy. However, covered patient confidentiality—reviews a few our physician eNewsletter recipients, during the Ravi B. Parikh, MD, MPP, Perelman School of topics giving physicians concern during the ASCO2020 latter half of 2020. Among the approximately Medicine, University of Pennsylvania, and col- HIGHLIGHTS COVID-19 pandemic. 1,500 recipients representing 15 specialties, we leagues found that the utilization management found striking, but understandable, differences policy did not result in measurable cost savings. by specialty in response to two key questions Maintaining Office Safety According to Dr. Parikh and his colleagues, that reveal and overall trend. PATIENTS l You retain the right to refuse a Breast Cancer Brain Mets while utilization management strategies have patient who will not cooperate with require- Consultant Palliation Improves AML Quality of Life Treated With of offices are been associated with cost savings and uptake of ments to wear a facemask. If they refuse and 90% evidence-based practice in some clinical settings, Referring a patient diagnosed with acute myeloid weeks—a period recognized as most difficult for Nearly using Telemedicine can be safely seen later, they should be given an The risk of death or progression of brain metasta- there is little evidence of their effectiveness in (AML) to the palliation service at the patients who are in the midst of long-term hos- appointment past the expected isolation period. ses was reduced in patients with HER2-positive 11.6% 75%-100% oncology care. In this study, the authors inves- time grueling therapy begins appears to offer pitalization—the quality of life among patients However, you cannot summarily deny care advanced disease who received prior / 50%-75% tigated a utilization management policy devel- psychological benefits down the road, including who received palliation department consultation <50% to someone under active treatment without and T-DM1 when they added tucati- 14.8% Do not use oped by a larger commercial payer in 2016 and improvements in the patients’ perceived quality did not deteriorate, while patients who received 42.4% telemedicine adequate notice to permit them to set up care nib to a regimen of trastuzumab and capecitabine, its association with the uptake of hypofraction- of life, researchers found. For the study, patients standard of care experienced a decline of 8 points study investigators said. Patients who were treated WhatW percentage of elsewhere. 31.2% your appointments ated radiotherapy for patients with early-stage with high-risk AML and admitted to receive in- in the FACT-Leukemia scale. At 24 weeks, the with trastuzumab and capecitabine alone achieved do you conduct via telemedicine? breast cancer, as well as its associated costs. You should also keep the issue of constructive tensive were randomized to inte- quality of life improved in both arms of the trial, a median overall survival of 12.0 months, but abandonment in mind. Actual termination grated palliative and oncology care or usual care. but by 25 points from baseline in patients who According to the authors, under the utilization that survival was increased to 18.1 months with [ TELEMEDICINE APPOINTMENT PERCENTAGES BY SPECIALTY ] from your practice because of how a patient Those eceivingr the intervention met with pal- received an intervention, compared with 10 tucatinib on board. The median central nervous management policy, claims for extended-course conducted themselves is something to deal with liative care clinicians at least twice weekly. At 2 points in the patients receiving standard care. Allergy radiotherapy were not reimbursed for fully in- system progression-free survival was 9.9 months in Cardiology when the isolation regimen has ended. the tucatinib-treated patients compared with 4.2 Dermatology sured women who were eligible for hypofraction- months among the patients getting trastuzumab Endocrinology ated radiotherapy. The policy did not apply to EMPLOYEES l The EEOC has specifically Larotrectinib Produces Durable Responses Gastroenterology women in self-insured or Medicare supplemen- and capecitabine alone. The combined primary Internal Medicine said that nothing in the ADA should be taken tal insurance plans, which allowed these groups Patients diagnosed with a variety of advanced prior systemic therapy and 68% had undergone endpoint of death or progression of brain metas- Nephrology to interfere with employers following public cancers appear to have durable responses when two or more lines of therapy. More than 70% tases was a 68% reduction in favor of tucatinib. Neurology to serve as a comparison group in the study. health recommendations. As an employer un- Ob/Gyn treated with larotrectinib, an agent that attacks achieved either a complete (10%) or objective Intracranial objective responses were observed in der OSHA obligations to maintain a safe work- Oncology The percentage of fully insured patients and tropomyosin receptor kinase (TRK) fusion path- partial response. Overall, about 60% of patients 47.3% of the patients on tucatinib compared with place and a physician with a fiduciary duty to Ophthalmology self-insured patients who received hypofraction- ology, researchers reported. Across three studies, also had an objective response and another 16% 20.0% on trastuzumab/capecitabine. At 1 year, Pediatrics safeguard the health of your patients, you may ated radiotherapy increased significantly during patients were treated with 17 types of cancer, in- experienced disease stabilization with larotrec- 70% of patients randomized to tucatinib were Primary Care therefore take steps that you would normally be Psychiatry the study period, from 22.4% in 2012 to 82.3% cluding thyroid (22%), salivary gland (19%), soft tinib. The median duration of response for all alive, compared with 47% randomized to more limited in. Pulmonology in 2018, and from 20.3% to 79.8%, respectively. tissue sarcoma (16%), lung (12%), colon (7%), adults in the study was 35.2 months, with some placebo. About 48% of patients had brain meta- Compared with self-insured patients who were Current employees can be denied access to your melanoma (5%), breast (5%), gastrointestinal patients having responses that were durable More of physicians are concerned stases at baseline, and among them, 60% had than 2/3 about the future of their practice. not subject to the policy, there was an increase premises if they place others at a significant risk. stromal tumors (3%), and nine other types (≤ 2% through 51 months of therapy. Median active brain metastases, meaning untreated brain 64.2% Yes 35.8% No in hypofractionated radiotherapy among fully You can require that employees self-report any each). About 78% of the patients had received progression-free survival was 25.8 months. metastases or progressing brain metastases. [ PERCENTAGES OF CONCERN BY SPECIALTY ] insured patients subject to the policy (adjusted exposure, answer questions about symptoms, Yes No percentage point difference-indifference, 4.2%). and be tested with sufficient medical basis. Allergy 63.0% 37.0% You can require temperature checks, should Progression Free Survival Improved with Survival Benefit Emerges Cardiology 69.6% 30.4% And spillover analyses showed a higher uptake Dermatology 84.6% 15.4% of hypofractionated radiotherapy among self- counsel employees to be mindful of how they Endocrinology 32.3% 67.7% for ES-SCLC But Not Overall Survival in ARAMIS insured patients who were indirectly exposed to feel generally and to immediately report any Gastroenterology 77.4% 22.6% changes, and remind all that hygiene and PPE Data from the phase III KEYNOTE-604 trial pembrolizumab combination was 15.9% versus Men diagnosed with non-metastatic castration- Internal Medicine 87.5% 12.5% the policy (but whose physicians were exposed to Nephrology 52.5% 47.5% precautions apply fully. All employees should showed that although patients with extensive- 5.0% with the placebo combination. Even at 18 resistant prostate cancer live longer if they are the policy) compared with those who were not Neurology 54.8% 45.2% exposed (adjusted percentage point difference- be required to engage in proper hygienic stage small cell lung cancer (ES-SCLC) who months, the PFS rate in the pembrolizumab arm treated with darolutamide than placebo, the final Ob/Gyn 60.5% 39.5% procedures. If an at-will employee is not cooper- received pembrolizumab with backbone che- was higher than the placebo arm at 10.8% ver- results of the phase III ARAMIS trial revealed, Oncology 48.4% 51.6% indifference, 8.5%). This suggests that the use of Ophthalmology 86.4% 13.6% ating with hygienic conduct, you may fire them motherapy etoposide/platinum (EP) compared sus 2.1%. In terms of OS, pembrolizumab/EP adding to previous reports from the study that it hypofractionated radiotherapy extended beyond prolonged OS compared with the control com- Pediatrics 77.5% 22.5% the policy’s target audience, the authors wrote. immediately. with patients who received EP and placebo did met its primary endpoint of metastasis-free sur- Primary Care 69.6% 30.4% not benefit from improved overall survival (OS), bination (10.8 vs 9.7 months; HR: 0.80), but vival and that darolutamide delays radiographic Psychiatry 45.5% 54.5% ©2020 BreakingMed, All Rights Reserved. If an employee was exposed or has tested pos- progression-free survival (PFS) rates with the it did not reach the superiority threshold. The progression, slows time for the need of cytotoxic Pulmonology 70.0% 30.0% itive, you will need to inform co-workers, but Source: 2020 Physicians Weekly COVID-19 Survey combination did reach the threshold for signifi- 12-month OS rate was 45.1% in the pembroli- chemotherapy, and slows progression to pain and ask for permission to reveal their identity. If they cance. The KEYNOTE-604 study aimed to im- zumab arm compared with 39.6% in the placebo skeletal events. For the study, 1,509 men diag- In light of these impacts, Dr. Girgis says “Hang refuse, tell other employees without naming the prove upon the efficacy of immunotherapy in arm. At 24 months, the OS rate was 22.5% in nosed with non-metastatic castration-resistant in there, and don’t forget to take a pause! We need source. Since a sudden absence at this time can newly diagnosed ES-SCLC with the combina- the pembrolizumab arm compared with 11.2% prostate cancer were treated with darolutamide to speak up and let people know the conditions be revealing, firmly instruct in writing that the tion of pembrolizumab and EP. in the placebo arm. The safety analysis showed 600 mg twice daily or placebo. All the patients we are working under and keep pressuring admin- employees who remain not discuss a co-work- that adverse events (AEs) of any-grade occurred continued androgen-deprivation therapy. About istrators to provide a safe work environment.” er’s PHI. While an employee is on self-isolation, The study randomized 453 patients; pembroli- in 100% of patients in the pembrolizumab arm 15.5% of patients who were treated with darolut- ask only the minimum information necessary to zumab 220 mg on day 1 plus EP 100 mg/m2 on and 99.6% of patients in the placebo arm, in amide died, compared with 19.1% of those in make a work-related determination of their safe days 1 and 2 and carboplatin AUC 5 on day 1 or the as-treated population. AEs were grade 3/4 in the placebo group, a 31% relative risk reduction return. You can also require that they provide a cisplatin 75 mg/m2 on day 1 or placebo, matching 76.7% of subjects who received pembrolizumab/ that achieved statistical significance. The drug physician’s note saying that they are fit to return. EP, and carboplatin or cisplatin for up to 31 EP compared with 74.9% of those who received was well tolerated, with some increases in fatigue This article was written by Dr. Medlaw, cycles. The final PFS analysis was significant the placebo combination. Grade 5 AEs/death oc- reported but no increased risk of cognitive a physician and medical malpractice attorney. (4.8 vs 4.3 months; HR: 0.73; 95% CI: 0.60- curred in 6.3% of patients in the pembrolizumab impairment, seizures, falls or fractures, hyper- COVID-19RESOURCE CENTER 0.88). The 12-month PFS rate observed with the arm versus 5.4% in the control arm. tension, or rash. VISIT physiciansweekly.com/covid19 for the latest updates on the pandemic, including breaking news, Scan for points! Join our PW Partner Perks Program. Office personnel visit www.physiciansweekly.com/PWperks. expert-written features and editorials, patient education, and more!