Oncology Update

Transcription

Oncology UpdateSpring2021M. Sitki Copur, MD FACPThomas Zusag, MDCarlene Springer, APRNAnne Roberts, PA-CA quarterly newsletter from Mary Lanning Healthcare’sMorrison Cancer CenterLocal and national cancer authorityThe definition of excellence in a comprehensive, academic,community cancer program.Coming soon: MCC-Grand IslandM. Sitki Copur, MD FACP, Medical DirectorThe Morrison CancerCenter plans to open a15,000-square-foot cancerMorrison Cancer Centercenter on the campus ofGrand Island RegionalM. Sitki Copur, MD FACP,hospital sometime thisMedical Directorsummer. M. Sitki Copur, MDFACP, is the Medical Director of this venture.Dr. Copur attributes the opening to the success of theMCC team in serving both Hastings and Grand Island.“With our academic/community-basedapproach and 24/7 inpatient/outpatient,comprehensive and passionate care, we haveaccomplished our goal of providing excellent service tothe central Nebraska population,” Dr. Copur said.The Morrison Cancer Center, located in Hastings, hasbeen offering patient appointments with Dr. Copur inGrand Island since December 2018. These appointments have taken place at Central NebraskaSpecialty Clinic.mer, MCC — under the medical direction of Dr. Copur— will be able to offer the same consults and follow-upsplus chemotherapy, biologic therapy, immunotherapy,radiation therapy, PED/CT imaging, lab services anda state-of-the-art infusion center for administration offluids and blood products.With the opening of the new space in the Prairie Commons Medical Office Building in Grand Island this sum-Please watch for details on the grandopening later this summer.This issue Increasing care New employees Publication milestones Buffet Advisory Board DeVita Chapter NEJM publications ASCO 2021 submission GI Independent &Lincoln Journal Star Ask the Expert Coronavirus talk Member highlights Publications

Oncology UpdateSpring 2021New employees join MCCCourtney Woita recently joinedthe MCC staff as a front desk receptionist and Chianne Rodriguezadds to our army of skilled chemotherapy certified nurses.Courtney WoitaWoita was born and raised in Hastings. She grew up as part of theMary Lanning Healthcare familybecause her mother, Meg Woita,has worked in Engineering for many years. Woita started asa Department Assistant in the Emergency Department whilefinishing college to earn her bachelor’s degree. Since then,she worked as dialysis technician and scheduler.“I love the relationships I am able to form with patients, andhave not been able to find thatbond in any other setting thanhealthcare,” Woita said. “Healthcare really is my calling. I am soexcited to be a part of the Morrison Cancer Center team.”Chianne RodriguezRodriguez was born and raisedin Cozad. After graduating fromnursing school in 2019, sheworked as oncology coordinator at the Henderson Hospital.“I love the MCC staff I get to work with, as well as the patientI get to care for,” Rodriguez said. “My favorite part of the jobis the ongoing relationship I get to build with our patientsthroughout their cancer journey.”MCC represented in 72 publicationsBy April 2021, articles by Morrison Cancer Center staff members will have been published in 72 peer-reviewed scientificpublications.Publications include the New England Journal of Medicine,Journal of Clinical Oncology, Nature Reviews, Clinical Cancer Research and Oncology. Sixteen are original articles, 14are case studies, 14 are commentaries and 14 are abstractpresentations for large hematology/oncology meetings(ASH, ASCO, SABCS and AACR). Thirteen are book chaptersin popular oncology textbooks (De Vita, Chu-DeVita).“This is very unusual for a community-based oncology program. The publications set us apart from other programs,”said Dr. M. Sitki Copur, MCC Medical Director of Oncology.“Morrison Cancer Center will continue to excel in not onlyproviding the best hematology/oncology care but also willcontinue to publish and share its knowledge and experience with the oncology world.”For a detailed list of all publications, please see our previousnewsletters at cations/2

Oncology UpdateSpring 2021Dr. Copur invited to write part of textbookDr. M. Sitki Copur has been invited towrite the “Miscellaneous ChemotherapyDrugs” chapter in the upcoming 12thedition of “Cancer: Principles & Practiceof Oncology.”Devita, Hellman and Rosenberg’s textbookhas been acclaimed by the worldwidemedical community as a standard-settingoncology reference. Its primary goal isto present the practicing oncologist withpractical and cutting-edge informationto ensure the best possible care for eachpatient.Taking a multidisciplinary approach, theauthors have asked a surgeon, a medicaloncologist and a radiation oncologist tocontribute to each of the major treatmentchapters.MCC featured in two newspapersIn January, Dr. M. Sitki Copur talked about theCOVID-19 mRNA vaccines, explaining theirrelevance to cancer research.The interview as based on an article Dr. Copur wrote on the topic. Dr Copur highlightedthe significance of the first time human useof two mRNA vaccines, which will open thegateway for cancer vaccine research.The Lincoln Journal Star also picked up theGrand Island article.To read the full accines-may-help-with-cancer-treatment/article ogist-says/article 64aacbcd-0ce8-554d-bdc0-3dfaea014b8e.html3

Oncology UpdateSpring 2021MCC contributes to meeting of Buffett CancerCenter Community Advisory BoardA group of Morrison Cancer Center patients andcaregivers recently participated in a virtual meetingof the Buffett Cancer Center Community AdvisoryBoard. Dr. M. Sitki Copur is an inaugural member ofthe board.On March 4, MCC staff and patients shared theirexperiences, views and ideas about cancer care,including barriers to accessing services and screenings. Information gathered during the focus groupswill be shared with state and local health departments, local cancer centers and other partnersthroughout the state, which are working to improvecancer-related services. The report also will be available to the public.The focus groups are part of a Statewide Cancer Community Health Needs Assessment being conducted by the BuffettCancer Center at the University of Nebraska Medical Centerin collaboration with the Nebraska Cancer Coalition andthe state Comprehensive Cancer Program.“MCC is excited to be a part of this importantproject,” Dr. Copur said.The Buffett Cancer Center CAB is made up to patient ad-vocates, clinicians, community members and governmentagency representatives.The Fred and Pamela Buffett Cancer Director choosesthe board members. The board’s mission is to reduce theburden of cancer, promote health equity, eliminate cancerhealth disparities in Nebraska with community, clinical andpublic health partners. The program aims to facilitate development and implementation of cancer research of particular relevance in Nebraska and engage diverse populationsacross the state.Abstract submitted for ASCO 2021The Morrison Cancer Center this yearagain submitted an abstract to the largestoncology convention in the world, ASCO’sJune 2021 meeting.This year, the MLH Pathology Departmentand the Morrison Cancer Center submitted data on pathology diagnoses ofcancer patients.The abstract, “Diagnostic Discrepancies inSecond Opinion Pathology Reviews in aCommunity-Based Cancer Center, represents another example of the academic,community-based approach of the Morrison Cancer Center.4

Oncology UpdateSpring 2021Joint radio show on coronavirus & cancerDr. M. Sitki Copur recently joinedMichelle Beaver, South HeartlandDistrict Health Department director,on a radio talk focused on COVID-19vaccine.Dr. Copur talked about the coronavirusvaccine and cancer patients, including the feasibility of vaccine use forchemotherapy patients. Beaver commented on process, procedures andphases of distribution.The audio is available at onavirus-vaccine-and-cancer.New ‘Ask the Expert’ topics postedThe KHAS radio “Ask the Expert” segments for January, February and March can be found on the Mary Lanning website.Topics for the quarter include a Brain and Spinal Cord Tumors for January and February and Colorectal Cancer in March.The interviews are broadcast on the first Wednesday and third Friday of each month on KHAS (1230 AM) /in-the-news/5

5Oncology UpdateSpring 2021Second NEJM publication for MCCThe Morrison Cancer Center recently receivedacceptance of our second publication in theNew England Journal of medicine.This will be the second time that MCC hashad an article in the NEJM in the past twoyears.The article focuses on adjuvant therapyof hormone receptor positive HER-2 negativebreast cancer.content to physicians, educators, researchersand the global medical community.NEJM is the world’s leading medical journaland website. Published continuously for morethan 200 years, NEJM delivers high-quality,peer-reviewed research and interactive clinicalNEJM is cited more often in scientrific literaturethan any other medical journal and has thehighest journal impact factor (74.699) of allgeneral medical journals.MCC sponsors annual Race for GraceThe Morrison Cancer Center is a proudsponsor of the Race for Grace ButterflyGarden on the bike path for 2021.The Race for Grace virtual event, whichinvolves runners, walkers and bikers,includes the two mile or 10 k, or 20-milebike ride any time during the week ofApril 10-18. Along with a runner’s race bib,participants receive a short-sleeve t-shirt.(The bicycle option is new for 2021.)Publications since our last issue Copur M.S., Bell S., Rodrigues P.,ZusagT.,Wedel W.,Allen J. A 65-Year-Old Man withBack Pain and Imaging Findings of SpinalCord Compression Oncology (Williston Park).March 2021; 35 (Published) Copur, M.S. Adjuvant Therapy for HormoneReceptor–Positive, HER2-Negative Breast Cancer. N Engl J Med 2021. (Published) Copur, M.S. mRNA vaccines and CancerOncology (Williston Park).(Accepted forpublication) Albert Pedroza, Whitney Wedel, Nicholas Lintel, Adam Horn, Mehmet Sitki Copur. Diagnostic discrepancies in second opinion pathologyreviews in a community-based cancer center.Abstract 335971: J Clin Oncol 2021. (Submit-ted for publication) Copur M.S. Safety and Efficacy of theBNT162b2 mRNA Covid-19 Vaccine. N Engl JMedicine. (Accepted for publication) Copur M.S. Efficacy Safety of mRNA-1273SARS-Cov-2 Vaccine- Vaccine or GeneTherapy? N Engl J Medicine. (Submitted forpublication)

Oncology UpdateSpring 2021Dawn Hatch, RN, works with a Morrison Cancer Center patient recently. Hatch is in charge of the Vascular AccessTeam at MLH.Staff highlight: Vascular Access TeamIntravenous access is extremely important in cancer care, and Dawn Hatch,RN, plays an important role at MCC.Cancer patients require not onlychemotherapy but also blood tests,medication administration, contrast fluid and blood products. Not all patientshave intravenous port devices.Hatch helps by using ultrasound imaging systems for peripheral IV insertion.Hatch, who was instrumental in forming the MLH Vascular Access Team sixyears ago, previously worked in theEmergency Room and the PediatricUnit for 13 years. She is board certifiedin vascular access.The team began when she was askedto take PICC placements from anesthesia. She perfected the process andresearched/studied guidelines.The team now has nine members,including nurses from ICU/PCU, Pediatric Unit, Cath Lab, Surgery and InfusionCenter.Hatch and her team are available 8a.m. ot 5 p.m. Monday through Friday,and are on call in the evening and onweekends. The team makes it possibleto place midlines and peripheral IVs atMLH almost anytime for anyone fromnewborns and up.The team takes provider requests forPICCs, midlines, difficult access IVs, labdraws or port access.7

Oncology UpdateSpring 2021FDA hematology/oncology drug approvals since last issue FDA approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.),a kinase inhibitor, for adult patients with relapsed or refractoryadvanced renal cell carcinoma (RCC) following two or more priorsystemic therapies. March 10, 2021 FDA granted accelerated approval to axicabtagene ciloleucel(Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemictherapy. March 5, 2021 FDA granted regular approval to lorlatinib (Lorbrena, Pfizer Inc.) forpatients with metastatic non-small cell lung cancer (NSCLC) whosetumors are anaplastic lymphoma kinase (ALK)-positive, detected byan FDA-approved test. March 3, 2021 FDA granted accelerated approval to melphalan flufenamide(Pepaxto, Oncopeptides AB) in combination with dexamethasonefor adult patients with relapsed or refractory multiple myeloma whohave received at least four prior lines of therapy. February 26, 2021 FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced nonsmall cell lung cancer whose tumors have high PD-L1 expression(Tumor Proportion Score [TPS] 50%). February 22, 2021 FDA approved cemiplimab-rwlc for locally advanced and metastatic basal cell carcinoma. February 9, 2021 FDA approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed orrefractory large B-cell lymphoma after two or more lines of systemictherapy. February 5, 2021 FDA granted accelerated approval to umbralisib (Ukoniq, TGPotentiallyPracticeChangingDATATherapeutics), a kinase inhibitor including PI3K-delta and caseinkinase CK1-epsilon, for the adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at leastone prioranti-CD20-basedregimen, adult patients with relapsed orrefractory follicular lymphoma (FL) who have received at least threeprior lines of systemic therapy. February 5, 2021 FDA granted accelerated approval to tepotinib (Tepmetko, EMDSerono Inc.) for adult patients with metastatic non-small cell lungcancer harboring mesenchymal-epithelial transition (MET) exon 14skipping alterations. February 3, 2021 FDA approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-linetreatment for patients with advanced renal cell carcinoma (RCC).January 22, 2021 FDA granted accelerated approval to daratumumab plus hyaluronidase (Darzalex Faspro, Janssen Biotech Inc.) in combinationwith bortezomib, cyclophosphamide and dexamethasone for newlydiagnosed light chain (AL) amyloidosis. January 15, 2021 FDA approved fam-trastuzumab deruxtecan-nxki (Enhertu, DaiichiSankyo) for adult patients with locally advanced or metastaticHER2-positive gastric or gastroesophageal (GEJ) adenocarcinomawho have received a prior trastuzumab-based regimen. January15, 2021 FDA approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma that is ALK-positive.January 14, 2021Randomized Phase II Study of Bevacizumab in combinationwith Carboplatin plus Paclitaxel in patients with previouslyuntreated Advanced Mucosal MelanomaMucosal melanoma is a highly vascularized tumor with an extremely poor prognosis. The efficacy and safety of bevacizumab in combination with carboplatinplus paclitaxel was evaluated in patientswith previously untreated advancedmucosal melanoma.Patients were randomly assigned in a 2:1ratio to receive carboplatin (area underthe curve, 5) plus paclitaxel (175 mg/m2) once every four weeks in combination with 5 mg/kg) or without bevacizumab once every two weeks.Progression-free survival (PFS) was theprimary end point. Secondary endpoints included overall survival (OS),objective response rate, and adverseevents. The median PFS was significantlylonger in the bevacizumab arm (4.8months; 95% CI, 3.6 to 6.0 months) versusno bevacizumab arm (3.0 months;95% CI, 1.7 to 4.3 months) (hazard ratio,0.461; 95% CI, 0.306 to 0.695; P .001).Objective response rates were 19.7%and 13.2%, respectively (P .384). Themedian OS was also significantly longerin the bevacizumab arm (13.6 v 9.0months; hazard ratio, 0.611; 95% CI, 0.407to 0.917; P .017). No new safety signalswere observed. A phase III study shouldbe performed to confirm these benefits.Reference: Xieqiao Yan, Xinan Sheng,Zhihong Chi, et al. Randomized PhaseII Study of Bevacizumab in Combination with Carboplatin plus Paclitaxel inPatients with Previously Untreated Advanced Mucosal Melanoma. Journal ofClinical Oncology 2021 39:8, 881-889.8

Oncology UpdatePotentiallyPracticeChangingDATAFinal results from a phase II study of infigratinib (BGJ398), an FGFRselective tyrosine kinase inhibitor, in patients with previouslytreated advanced cholangiocarcinoma harboring an FGFR2gene fusion or rearrangementTreatment options for cholangiocarcinoma (CCA) after progression onfirst-line gemcitabine-based therapy arelimited. Fibroblast growth factor receptor2 (FGFR2) gene fusions occur in 13–17%of intrahepatic CCA.A single-arm, phase II study(NCT02150967) evaluated infigratinib,an ATP-competitive FGFR1–3-selectiveoral tyrosine kinase inhibitor, in previously-treated advanced CCA with FGFRfusions/rearrangements.Adult patients with advanced/metastatic CCA with progression on 1 lineof systemic therapy received infigratinib125 mg orally for 21 days of each 28day cycle until unacceptable toxicityor disease progression. All patientsreceived prophylaxis with the oral phosphate binder sevelamer.Primary endpoint: objective responserate (ORR) by independent centralreview per RECIST v1.1, with duration ofPotentiallyPracticeChangingDATASpring 2021response (DOR). Secondary endpoints:progression-free survival (PFS), diseasecontrol rate, overall survival, safety, pharmacokinetics. As of 31 March 2020, 108patients, including 83 (77%) with FGFR2fusions, received infigratinib: medianage 53 years (range 23–81 years); 54%had received 2 prior treatment lines.Median follow-up was 10.6 months(range 1.1–55.9 months). 96 patients(88.9%) discontinued treatment (12ongoing). Centrally reviewed ORR was23.1% (95% CI 15.6–32.2) including1 CR and 24 PRs; median DOR was5.0 months (range 0.9–19.1 months).Among responders, 8 (32.0%) patientshad a DOR of 6 months.Median PFS was 7.3 months (95% CI5.6–7.6 months). Prespecified subgroupanalysis: ORR was 34% (17/50) in thesecond-line setting and 13.8% (8/58)in the third-/later-line setting (3–8 priortreatments).Most common treatment-emergentadverse events (TEAEs, any grade) werehyperphosphatemia (76.9%), eye disorders (67.6%, excluding central serousretinopathy/retinal pigment epitheliumdetachment [CSR/RPED]), stomatitis(54.6%), and fatigue (39.8%). CSR/RPEDoccurred in 16.7% of patients (including 1 G3 event; 0 G4). Other commongrade 3/4 TEAEs were stomatitis (14.8%;all G3), hyponatremia (13.0%; all G3),and hypophosphatemia (13.0%; 13 G3,1 G4).Reference: Javle MM, RoychowdhuryS, Kelley RK, et al: Final results from aphase II study of infigratinib (BGJ398),an FGFR-selective tyrosine kinase inhibitor, in patients with previously treatedadvanced cholangiocarcinoma containing FGFR2 fusions/rearrangements.2021 Gastrointestinal Cancers Symposium. Abstract 265. Presented January17, 2021.Radiation therapy for small-cell lung cancer: ASCOguideline endorsement of an ASTRO guidelineThe American Society for RadiationOncology (ASTRO) produced anevidence-based guideline on radiationtherapy (RT) for small-cell lung cancer(SCLC).Because of the relevance of this topicto ASCO membership, ASCO reviewedthe guideline, applying a set of procedures and policies used to criticallyexamine guidelines developed byother organizations.The ASTRO guideline on RT for SCLCwas reviewed for developmental rigorby methodologists. Then, an ASCOExpert Panel reviewed the content andthe recommendations.The ASCO Expert Panel determinedthat the recommendations from ASTROguideline on RT for SCLC, published inJune 2020, are clear, thorough, andbased upon the most relevant scientific evidence. ASCO endorsed ASTROguideline on RT for SCLC with a fewdiscussion points. Recommendationsaddressed thoracic radiotherapy forlimited-stage SCLC, role of stereotactic body radiotherapy in stage I or IInode-negative SCLC, prophylactic cranial radiotherapy, and thoracic consolidation for extensive-stage SCLC.Reference: Daly ME, Ismaila N, DeckerRH, et al. Radiation Therapy for SmallCell Lung Cancer: ASCO GuidelineEndorsement of an ASTRO GuidelineJournal of Clinical Oncology 2021 39:8,931-939.9

Oncology UpdatePotentiallyPracticeChangingDATASpring 2021American College of Gastroenterology clinicalguidelines: Colorectal Cancer Screening 2021Colorectal cancer (CRC) is the thirdmost common cancer in men andwomen in the United States. CRCscreening efforts are directed towardremoval of adenomas and sessile serrated lesions and detection ofearly-stage CRC.Detailed recommendations for CRCscreening in average-risk individualsand those with a family history ofCRC are discussed. The developmentof cost-effective, highly accurate,noninvasive modalities associatedwith improved overall adherence tothe screening process is also a desirable goal.Recommended CRC screening inaverage-risk individuals are: Screening between ages 50 and 75 years toreduce incidence of advanced adenoma, CRC, and mortality from CRC.Strong recommendation; moderate-quality evidence. Suggest CRCscreening in average-risk individuals between ages 45 and 49 years to reduceincidence of advanced adenoma,CRC, and mortality from CRC. Conditional recommendation; very low-qualityevidence.Suggest that a decision to continuescreening beyond age 75 years beindividualized. Conditional recommendation; very low-quality evidence.Recommend colonoscopy and FIT asthe primary screening modalities forCRC screening. Strong recommendation; low-quality evidence.Suggest consideration of the followingscreening tests for individuals unable orunwilling to undergo colonoscopy or FIT:flexible sigmoidoscopy, multitarget stoolDNA test, CT colonography or coloncapsule.Conditional recommendation; verylow-quality evidence. Suggest againstSeptin 9 for CRC screening. Conditionalrecommendation, very low-quality ofevidenceReference: Aasma S, Charles K, BurkeCA et al. Clinical Guidelines: ColorectalCancer Screening 2021. The AmericanJournal of Gastroenterology: March2021 - Volume 116 - Issue 3 - p 458-479.10

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Oncology Update Spring 2021 Oncology Update 3 Dr. Copur invited to write part of textbook Dr. M. Sitki Copur has been invited to write the “Miscellaneous Chemotherapy Drugs” chapter in the upcoming 12th edition of “Cancer: Principles & Practice of Oncology.” Devita, Hellman and Rosenberg’s