Written by: Michelle Hoa and Natasha Heimbigner, PharmD – Summit Cancer Centers
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Description: Patients undergoing cancer treatment are more susceptible to infections due to their compromised immune system. This PQI will review which vaccinations cancer patients can or cannot use for the proper protection against preventable infections.

Background: Cancer treatments weaken the immune system rendering it more susceptible to infections.1,2 In order to prevent these infections, cancer patients can either take antimicrobial prophylaxis, get vaccinated, or avoid contact with germs.2 Generally, it is best to get vaccinated prior to the start of cancer therapy. Live vaccines should be administered at least four weeks prior to the start of chemotherapy and/or at least 3 months after completion of treatment.1,3 Inactive vaccines should be administered 2 weeks prior to the start of therapy for maximal effect, however, they can be given during therapy. Patients vaccinated during chemotherapy treatment with an inactive vaccine should consider revaccination at least 3 months after therapy as they could be rendered ineffective.3

 PQI Process:

  • Obtain patient vaccination history and reference with CDC recommendations to ensure they are current
  • Determine type of vaccination chemotherapy patient needs
    • Non-replicating (inactive) vaccines: should be given at least 2 weeks before the initiation of chemotherapy or other immunosuppressive therapy to maximize immune response1
      • Vaccination, 2 weeks prior to chemotherapy, allows for immune response against the targeted pathogen
      • Antibody response is suboptimal if given vaccination during immunosuppressive therapy but is better than not vaccinating; repeat vaccination or boosters may be beneficial in prolonging immunity1,4
    • Replicating live vaccines: should be given at least 4 weeks prior to and at least 3 months after immunosuppressive therapy1
      • Live vaccinations contain a weak live version of the virus; an immunocompromised system will not be able to fight against the pathogen (may cause vaccine-derived infections)
      • An adequate immune response usually occurs 3 to 12 months after the completion of treatment; wait at least 3 months after the completion of therapy to receive live vaccinnes5
      • Vaccination should be delayed for at least 6 months after treatment if the patient is receiving anti-B-cell antibodies2
    • Based on regimen, reference the package insert for all oncolytic specific vaccination suggestions

Patient Centered Activities:

  • If patient has not been vaccinated, counsel patient on the importance of vaccination
  • Immunocompromised patients are at higher risk for certain diseases; additional vaccines are recommended4
    • TIV and polysaccharide-based vaccines (PCV, PPV, MCV4, MPSV, and Hib vaccines)8
    • Flu vaccine:
      • Do NOT get nasal mist flu vaccine since it is a live vaccine
      • Influenza-related hospitalization is 3 to 5 times higher in cancer patients
    • Pneumococcal vaccine (PCV13 and PPV23):
      • Immunocompromised patients should receive PCV13 and are recommended to receive PPV23 vaccine about 8 weeks later;7,8 then receive a second dose of PPV23 5 years after the first PPV238
      • Patients that received at least one dose of PPV23 should receive PCV13 no sooner than 1 year after last PPV23 dose8
      • Help patients fight off serious lung, blood, or brain bacterial infections7
      • Recommended in multiple myeloma, lung cancer, chronic lymphocytic leukemia, and lymphoma1
    • Shingrix:®
      • Shingrix® is an inactivated recombinant vaccine (not recommended due to its lack of research)9
    • COVID-19 Vaccine:
      • Moderna – two doses, 4 weeks apart
      • Pfizer-BioNTech – two doses, 3 weeks apart
      • Johnson and Johnson – one dose
      • Booster – Immunocompromised patients receive a booster 4 weeks after initial immunization
    • Counsel patients who are on immunotherapy on vaccination recommendations and precautions
      • Immunotherapy has variable immunomodulatory or immunosuppressive effects
      • Vaccine may be triggering an exaggerated immune response in certain patients1
        • Reports suggest that influenza vaccines given to patients on certain types of immunotherapies triggered an amplified immune-related adverse reaction10,11
        • Some patients receiving immune checkpoint inhibitors experienced intensified immune response11
      • Consult with prescriber if vaccination is appropriate with current immunotherapy
    • Follow up with patient 3 months after chemotherapy is complete
      • If patient had inactive vaccine during treatment, remind to revaccinate 3 months post-treatment
      • If patient is over 65 or has an altered immune system, the CDC recommends a flu vaccine every year and pneumonia vaccine (PPSV23) every 5 years; PCV13 vaccine should only be given once
      • Booster Tdap vaccination should be considered for patients who have completed chemotherapy1
    • Counsel family on risk of receiving live vaccines around patients undergoing chemotherapy

References:

  1. Ariza-Heredia, Ella J, and Roy F Chemaly. “Practical Review of Immunizations in Adult Patients with Cancer.” Human Vaccines & Immunotherapeutics 11.11 (2015): 2606–2614.
  2. nccn.org/patients/resources/life_with_cancer/managing_symptoms/infections.aspx
  3. https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5515a1.htm
  4. Centers for Disease Control and Prevention. Recommendations of the advisory committee on immunization practices (ACIP): Use of vaccines and immune globulins in persons with altered immunocompetence. Morbidity and Mortality Weekly Report. 1993;42(RR-4). Available from: https://dosinghealth.com/wp-content/uploads/2017/09/rr4204.pdf
  5. https://www.medscape.com/viewarticle/413557
  6. http://chemocare.com/
  7. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/infections/vaccination-during-cancer-treatment.html
  8. https://www.pharmacytimes.com/news/cdc-committee-high-risk-adults-should-get-2-pneumococcal-vaccines
  9. https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/faqs.html
  10. https://www.cancernetwork.com/oncology-journal/immunizing-cancer-patients-which-patients-which-vaccines-when-give
  11. https://www.pharmaceutical-journal.com/news-and-analysis/news/influenza-vaccine-may-cause-exaggerated-immune-response-in-patients-on-cancer-immunotherapy/20202682.article?firstPass=false

Supplemental Information:

Table 1: Types of Vaccines

Type of ImmunizationPrinciple of ActionExamplesComments
Non-replicating vaccinesBased on toxoid, protein subunits, bacterial, antigens, or immunogenic proteins obtained with recombinant, technology.Tetanus, diphtheria, pertussis, poliomyelitis, hepatitis B, influenza, varicella zoster (shingles) (Shingrix®), Haemophilus influenza, pneumococcus, meningococcus, COVID-19Usually requires 3–5 doses; antibody titers diminishes with time
Replicating live vaccinesProduced by disabling the virulent properties of a disease-producing virus or bacteriumMeasles-mumps-rubella, varicella (chicken pox), varicella zoster (shingles) (Zostavax®)  intranasal influenza, yellow fever, oral polio, oral typhoidSevere reactions are possible; transmission of live pathogen may occur; most provide immunity with 1 dose
Passive immunizationAntibodies are infused to provide short-term protectionVaricella Immunoglobulin, hepatitis B immunoglobulinProtection diminishes after weeks or months

 

Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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Written by Isabel Houlzet, PharmD, BCPS, BCOP, Miami Cancer Institute
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Description: This PQI will review patient identification and clinical considerations for this treatment option for gastric cancer.

Background: Trifluridine and Tipiracil is approved for use in patients with gastric or gastroesophageal junction (GEJ) cancer who have failed at least two prior lines of chemotherapy including a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy. This approval is based on results from the TAGS trial, a Phase III, multinational, randomized, double-blind trial that compared trifluridine/tipiracil plus best supportive care vs. placebo plus best supportive care in metastatic GEJ/gastric cancer patients previously treated with at least 2 prior regimens.  Median overall survival was 5.7 months (95% CI 4.8–6.2) in the trifluridine/tipiracil group and 3.6 months (3.1–4.1) in the placebo group.1 Sequencing of treatment in advanced gastric cancer is still not well defined, but trifluridine/tipiracil serves as a viable option for 3rd and subsequent lines of treatment and is currently NCCN category 1 recommended for 3rd line (or later) therapy.2

PQI Process:

  • Identify patients with metastatic gastric or GEJ cancer who have failed at least two prior lines of chemotherapy (including a fluoropyrimidine, a platinum, either a taxane or irinotecan, and if appropriate, HER2/neu-targeted therapy)
  • Consider conversation with care team with trifluridine/tipiracil as potential oral oncolytic option

Upon receiving a prescription for trifluridine and tipiracil:

  • Verify appropriateness of treatment (indication, prior lines of treatment)
  • Verify correct dose: rounded to nearest 5mg (see dosing in Supplemental Information)
  • Check complete blood counts prior to Day 1 and on Day 15 of each cycle
    • Do not initiate cycle until ANC ≥ 1,500/mm3 and platelets ≥ 75,000/mm3
    • Hold treatment for ANC < 500/mm3, febrile neutropenia, or platelets < 50,000 mm3
  • Kidney function
    • CrCl 15-29 mL/min – Dose adjust to 20 mg/m2 BID with food on days 1-5 and 8-12 of 28 day cycle
      • Consider dose reduction to 15 mg/m2 BID if unable to tolerate 20 mg/m2
    • Liver function
      • Do not initiate therapy in patients with moderate to severe hepatic impairment (bilirubin >1.5 ULN and any AST elevation)
    • The most common grade 3 or worse adverse effect is neutropenia (38%)
      • In the TAGS trial, the majority of episodes were managed by delaying the next dose
      • 16% of subjects in that trial were managed with granulocyte colony-stimulating factor
    • Consider antiemetic and antidiarrheal medications to manage potential patient adverse effects

Patient Centered Activities:

  • Provide Oncology Chemotherapy Education (OCE) sheet and counsel on potential side effects
  • Counsel patient on dosing schedule and administration (see Supplemental Information)
  • Consider starting on a Monday to complete days 1-5 from Monday to Friday, break on the weekend (days 6-7), and resume Monday to Friday for days 8-12. Patient does not take therapy for days 13-28
  • Notify the patient that dose delays may be beneficial when managing adverse effects, and should not interfere with their ability to receive treatment or achieve benefit
  • Provide medication and clinic appointments calendar (dosage calculator and calendar creator at http://www.lonsurfhcp.com/dosing/dosage-calculator)
  • Ensure patient has access to at home antiemetic and antidiarrheal medications
  • Counsel patient on safe storage, handling, and disposal of cytotoxic drugs (instruct caregiver to wear gloves)
  • Provide support kit – Lonsurf® Starter Kits contain patient and caregiver brochures, pillboxes, and thermometer

References:

  1. Shitara K. et al. Trifluridine/tipiracil versus placebo in patients with heavily pretreated metastatic gastric cancer (TAGS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2018 Nov;19(11):1437-1448. doi: 10.1016/S1470-2045(18)30739-3.
  2. NCCN Guidelines Gastric Cancer.
  3. Lonsurf® (trifluridine/tipiracil) [package insert]. Princeton, NY: Taiho Oncology, Inc.

Supplemental Information

Dosing and Administration:

  • 35 mg/m2 (based on trifluridine) twice daily on days 1 to 5 and 8 to 12 of a 28-day cycle
  • Round to the nearest 5 mg (available in 15 mg and 20 mg tablets)
  • Maximum dose 80 mg trifluridine/dose (160 mg/day)
  • Administer with food and swallow tablets whole, within 1 hour after completion of morning and evening meals
  • If treatment held for neutropenia, thrombocytopenia, or other Grade 3/4 adverse effect, after recovery, reduce dose by 5 mg/m2/dose if:
    • Patient had febrile neutropenia, uncomplicated Grade 4 neutropenia or thrombocytopenia that resulted in > 1 week delay in start of next cycle
    • Nonhematologic grade 3 or 4 adverse reaction, except for grade 3 or 4 nausea/vomiting controlled by antiemetics or grade 3 diarrhea responsive to antidiarrheal medication
    • Maximum of 3 dose reductions. Permanently discontinue if unable to tolerate 20 mg/m2/dose.
    • Do not escalate dose after it has been reduced

Copay Support

Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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Written by: Michelle Phillips, PharmD, University of Rochester Medical Center
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Description: The purpose of this PQI is to highlight key criteria for appropriate monitoring, dosing, and administration to improve the dispensing and management of patients taking niraparib (Zejula).

Background: Niraparib is indicated for the maintenance treatment of patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy. Additional indication in patients with three or more prior chemotherapy regimens and whose cancer is associated with homologous recombination deficiency (HRD) positive status (BRCA+ or BRCA- with Genomic Instability Positive (GIS+) disease).  Niraparib efficacy is particularly pronounced in patients with BRCA1/2 mutations but also yields therapeutic benefit in those without germline BRCA mutations.

Discontinuation due to thrombocytopenia, anemia, and neutropenia occurred, respectively, in 3%, 1%, and 2% of patients. Retrospective analysis of the pivotal phase III NOVA clinical trial reveals most dose adjustments occurred within 3 months and did not appear to compromise efficacy.

PQI Process:

  • Verify dose on initial fill—labeled starting dose is 300 mg once daily
    • Consider starting at 200 mg daily for patients with baseline weight < 77 kg or baseline platelets < 150K.
    • In practice, it has been seen at starting doses of 100 mg once daily as well
  • Ensure patients should start treatment with niraparib no later than 8 weeks after their most recent platinum-containing regimen
  • Consider bevacizumab discontinuation before initiation of treatment with niraparib
  • Ensure appropriate monitoring:
    • CBC weekly x 4 weeks, monthly x 11 months, then periodically
    • Heart rate and BP monthly x 12 months, then periodically

Dose Adjustments:

  • Discontinue for any adverse effect that has not resolved within 28 days or grade ≥ 3 while on 100 mg/day.

Dose Adjustments for hematologic toxicity: **MINIMUM dose 100 mg/day**

Platelets < 100 K

(Monitor CBC weekly until resolved)

1st Occurrence: HOLD* until platelets ≥ 100 K

Resume same dose

However, if < 75K, reduce dose by 100 mg

2nd Occurrence: HOLD* until platelets ≥ 100K

Reduce by 100 mg/day

ANC < 1.0 or

Hg < 8 g/dL

(Monitor CBC weekly until resolved)

HOLD* until ANC ≥ 1.5 or Hg ≥ 9 g/dL

Reduce dose by 100 mg/day

* Hold for maximum of 28 days. Discontinue if not resolved within 28 days or if dose reduction needed beyond 100 mg/day.

Patient-Centered Activities

  • Provide Oral Chemotherapy Education (OCE) Sheet
  • Take once daily, with or without food
  • Taking at bedtime may minimize nausea
    • Moderate to high emetogenic risk per NCCN guidelines
  • Advise patients of warnings:
    • Myelodysplastic syndrome/Acute myeloid leukemia
    • Bone marrow suppression
    • Cardiovascular effects (hypertension, tachycardia)
    • Embryo-fetal toxicity
  • Consider weekly home blood pressure and heart rate monitoring
  • Recommend stool softeners/laxatives as needed for constipation
  • Recommend home antiemetic as needed for nausea/vomiting
    • 5HT-3 such as: Ondansetron

Financial Assistance

  • Quick start and bridge program
  • Commercially insured patients

References:

  1. Mirza MR, Monk BJ, Herrstedt J, et al. Niraparib maintenance therapy in platinum-sensitive, recurrent ovarian cancer. NEJM. 2016; 375 (22): 2154 – 64.
  2. Moore KN, Mirsa MR, Matulonia UA. The poly (ADP ribose) polymerase inhibitor niraparib: Management of toxicities. 2018; 149: 214 – 220.
  3. National Comprehensive Cancer Network. Antiemesis (Version 2.2018). https://www.nccn.org/professionals/physician_gls/pdf/antiemesis.pdf Accessed May 17, 2018.
  4. National Comprehensive Cancer Network. Ovarian cancer (Version 2.2018). https://www.nccn.org/professionals/physician_gls/pdf/ovarian.pdf Accessed May 15, 2018.
  5. Niraparib incidence and management of thrombocytopenia. TESARO Response letter; 2018.
  6. Retrospective analaysis of the NOVA trial to assess potential predictors for early dose modification. TESARO Response Letter; 2018.
  7. Gonzalez A, Mirza MR, et al. A Prospective Evaluation of tolerability of niraparib dosing based upon baseline body weight and platelet count. Annals of Oncology (2018) 29 (suppl_8): vii332-vii358.10.1093/annonc/mdy285
  8. ZEJULA [Package Insert]. Waltham, MA: Tesaro, Inc.

 

Important notice: National Community Oncology Dispensing Association, Inc. (NCODA), has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional. This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented. NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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Written by: Martina Fraga, PharmD
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Description: The purpose of this PQI is to highlight effective practices to ensure ovarian cancer patients are identified, tested, tracked, and offered a PARP inhibitor when appropriate.

Background: In gynecologic cancer patients, PARP inhibitors (PARP-I), have shown increased progression free survival (PFS) and, in some cases, overall survival. Misconceptions may exist around which patients are eligible for PARP inhibitors and when these therapies should be utilized.  Patients should be educated upfront about the anticipated therapy journey including the role of maintenance treatment. In ovarian cancer, maintenance therapy is rapidly becoming the new standard of care and it is imperative to identify and appropriately offer maintenance therapy to eligible patients.3 Data presented at a 2018 ESMO conference showed that the majority of eligible patients were not on maintenance therapy.4 A real-world data analysis by Garofalo and colleagues found that maintenance therapy was used in 49% of eligible patients; 47% of those on maintenance therapy received a PARP-I as the maintenance agent. A study done by Randall and colleagues found 50% of women with epithelial ovarian cancer underwent BRCA1/2 testing, while Buchanan and colleagues found testing rates in this patient population to be close to around 75%. Use of a PARP-I was higher in those with a BRCA mutation at 61%, vs 45% with wild-type or unknown status.5 This study looked at maintenance after second line or greater therapy; newer data shows progression free survival (PFS) benefit of maintenance after first line therapy, highlighting the need to accurately identify patients up front.6,7

PQI Process:  Upon diagnosis of ovarian cancer stage II, III or IV

  • Identify and track all ovarian cancer patients by utilizing the Electronic Medical Record (EMR)
  • Determine patient’s BRCA mutation status (consider genetic testing if not already completed)
    • Utilize EMR Pathways, Regimens or Patient Management Software when available
  • Work with your EMR vendor to ensure PARP-I are listed as a treatment option
  • Track all current or upcoming first-line platinum therapy patients with estimated completion date:
    • Consider use of a calendar reminder system for dates of treatment milestones
      • The treatment plan should be reviewed with the treating oncologist. A calendar should be maintained to mark the end of systemic therapy
      • Work closely and proactively with provider to determine each unique patient’s anticipated treatment plan (rather than reactive after a prescription is ordered)
    • As completion date approaches, assess treatment plan regarding maintenance therapy
      • Consider re-discussing options with provider
      • Consider monthly follow-up in the EMR during surveillance
      • When appropriate, ensure prescription for a PARP inhibitor is submitted
    • Consider PARP-Inhibitor utilization:
      • For patients in relapsed platinum sensitive ovarian cancer maintenance therapy following partial or complete response to platinum based chemotherapy (niraparib or rucaparib)
      • For first line or relapsed platinum sensitive maintenance therapy in BRCA associated advanced ovarian cancer (olaparib)
    • BRCA1 and BRCA2-positive patients have historically been more responsive to PARP-I therapy than BRCA-negative patients
  • Ensure the entire MIP team is educated about the importance of consistent tracking in the EMR (as described above) to ensure critical appointments and calls are done, accordingly
    • Consider creating a standard treatment plan and inform all potential professionals of the anticipated path and timing (genetic counselors, schedulers, assistants, pharmacists, providers, technicians, financial counselors, administrators, and more)

Patient Centered Activities:

References:

  1. Online Breast Cancer 1 Gene, OMIM®. Johns Hopkins University, Baltimore, MD. MIM Number: 113705. 06/28/2019. https://omim.org/entry/113705#contributors
  2. Helleday T. The underlying mechanism for the PARP and BRCA synthetic lethality: clearing up the misunderstandings. Mol Oncol 2011; 5(4):387-93.
  3. Randall LM, Birrer MJ, Herzog TJ. Ovarian cancer maintenance: practice-changing data calls for changing practice. The Oncologist 2019;24:1-4.
  4. Mahner S. Proceedings of ESMO Educational Symposium. Presented October 22, 2018. Available at https://cslide.ctimeetingtech.com/library/esmo/browse/search/262N#2Ea4M.
  5. Garofalo D, Verma-Kurvari S, Aydin E, et al. Real world data analysis of ovarian cancer maintenance utilization among maintenance eligible patients. Presented at the American Society of Clinical Oncology Annual Congress; Chicago, IL: 2019.
  6. Moore K, Colombo N, Scambia G, et al. Maintenance olaparib in patients with newly diagnosed advanced ovarian cancer. N Engl J Med. 2018;379(26):2495-2505. doi: 10.1056/NEJMoa1810858.
  7. GSK announces positive headline results in Phase 3 PRIMA study of ZEJULA (niraparib) for patients with ovarian cancer in the first line maintenance setting [press release]. London, UK: GlaxoSmithKline plc; July 15, 2019. https://bit.ly/2YTFO6h. Accessed July 15, 2019.
  8. Childers CP, Childers KK, Maggard-Gibbons M, Macinko J. National estimates of genetic testing in women with a history of breast or ovarian cancer. J Clin Oncol 2017;35(34):3800-3806.
  9. Randall LM, Aydin E, Louie-Gao M, Hazard S, Westin SN. A retrospective analysis of real-world tumor BRCA (tBRCA) testing trends in ovarian cancer before and after PARP inhibitor approvals. Presented at the 17th Biennial Meeting of the International Gynecologic Cancer Society; Kyoto, Japan: 2018.
  10. Buchanan TR, Griffin NE, Leon C, et al. Maintaining adherence rates for genetic testing in an era with fewer in-office counselors. Gynecologic Oncology 2019; 154(1):204.
  11. Daly MB, Pilarski R, Berry M, et al. NCCN guidelines insights: Genetic/familial high-risk assessment: Breast and ovarian, version 3.2019. J Natl Compr Canc Netw 15:1-18-2019.
  12. Zejula® (niraparib) [prescribing information]. Waltham, MA: Tesaro Inc.
  13. Lynparza® (olaparib) tablets [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; December 2018.
  14. Rubraca® (rucaparib) [prescribing information]. Boulder, CO: Clovis Oncology.
  15. Talzenna® (talazoparib) [prescribing information]. New York, NY: Pfizer Inc.

Supplemental Information:

Current NCCN guidelines for genetic testing describe recommendations for BRCA testing in all ovarian cancer patients and in breast cancer patients that meet specific criteria.11 Please refer to the NCCN guidelines or consulting a genetic counselor for specifics on testing recommendations within that group of patients.

 BRCA Testing Populations in Breast and Ovarian Cancer5
·     Individual from family with known BRCA1/2 variant

·     History of breast cancer + one of the following

o  45 years or younger

o  46-50 years with additional breast cancer primary OR 1 or more close blood relative with either breast cancer or high-grade prostate cancer

o  Unknown or limited family history

·     60 or younger with triple negative breast cancer

·     Any age + one of the following

o  45 years or younger

o  1 or more blood relative with breast cancer diagnosed at 50 years or younger, ovarian carcinoma, male breast cancer, metastatic prostate cancer or pancreatic cancer

o  2 or more diagnoses of breast cancer at any age in patient or close blood relatives

·     Ashkenazi Jewish ancestry

·     History of ovarian cancer

·     History of male breast cancer

·     History of pancreatic cancer

·     History of metastatic prostate cancer

·     Regardless of family history, NCCN guidelines recommend BRCA testing in those that may benefit from targeted therapy

Important notice: NCODA has developed this Positive Quality Intervention platform. This platform represents a brief summary of medication uses and therapy options derived from information provided by the drug manufacturer and other resources. This platform is intended as an educational aid and does not provide individual medical advice and does not substitute for the advice of a qualified healthcare professional.  This platform does not cover all existing information related to the possible uses, directions, doses, precautions, warning, interactions, adverse effects, or risks associated with the medication discussed in the platform and is not intended as a substitute for the advice of a qualified healthcare professional. The materials contained in this platform are for informational purposes only and do not constitute or imply endorsement, recommendation, or favoring of this medication by NCODA, which assumes no liability for and does not ensure the accuracy of the information presented.  NCODA does not make any representations with respect to the medications whatsoever, and any and all decisions, with respect to such medications, are at the sole risk of the individual consuming the medication. All decisions related to taking this medication should be made with the guidance and under the direction of a qualified healthcare professional.
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