Written by: Jonas Congelli, RPh Hematology Oncology Associates of CNY
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Description: To discuss prevention and management of Hand-Foot Syndrome.

Background: Palmar-plantar erythrodysesthesia, also known as hand-foot syndrome (HFS) is a widely recognized dose-limiting toxicity of certain chemotherapy agents. A comprehensive list can be found in the supplemental information section. Typically, HFS occurs within the first six weeks of starting targeted therapy and after two months for chemotherapy. Preventative measures should be taken to prevent HFS. Effective education and preventative measures, like the use of 10-20% urea cream, has been shown to reduce the severity and time to developing HFS.

PQI process: Upon receipt of a new prescription known to cause HFS:

  • Educate patients on signs and symptoms of HFS
  • Provide urea cream
  • Follow up with the patient within seven days of initial dispense and with every refill
    • Inform provider if symptoms develop and document in the EMR
    • Topical and systemic pain relievers may be needed for the treatment of HFS related pain

Patient Centered Activities:

  • Provide Oral Chemotherapy Education (OCE) Supplemental Sheet
  • Educate patient on signs and symptoms of HFS
    • Numbness
    • Tingling
    • Burning
    • Itching
    • Redness
    • Swelling
    • Tenderness
    • Rash
    • Cracked Skin
    • Flaking Skin
    • Blistered Skin
    • Sores
  • Counsel patient on non-medical interventional strategies including
    • Limit use of hot water and sources of heat to hands and feet
    • Use of lotion within three minutes of bathing
    • Avoid activities that cause excessive rubbing to hands and feet (ex. Jogging)
    • Use of cotton gloves or socks at bedtime or throughout the day
    • Increased water intake and limiting diuretics and dehydrating agents (ex. alcohol, caffeine)
    • Importance of good nail care
    • Importance of wearing shoes/avoiding going barefoot
  • Provide urea cream and counsel on importance of use
  • Ensure patient knows when and who to call regarding onset of HFS symptoms

References:

  1. Hofheinz RD, Gencer D, Schulz H, et. Al Mapisal Versus Urea Cream as Prophylaxis for Capecitabine-Associated Hand-Foot Syndrome: A Randomized Phase III Trial of the AIO Quality of Life Working Group DOI: 10.1200/JCO.2014.60.4587 Journal of Clinical Oncology 33, no. 22 (August 01, 2015) 2444-2449.

 

Supplemental Information:

Medications That Commonly Cause Hand-Foot Syndrome

  • Axitinib (Inlyta®)
  • Cabozantinib (Cabometyx®, Cometriq®)
  • Capecitabine (Xeloda®)
  • Cytarabine
  • Docetaxel (Taxotere®)
  • Doxorubicin
  • Fluorouracil (5FU®)
  • Floxuridine
  • Idarubicin (Idamycin®)
  • Paclitaxel (Taxol®)
  • Pazopanib (Votrient®)
  • Regorafenib (Stivarga®)
  • Sorafenib (Nexavar®)
  • Sunitinib (Sutent®)
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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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).

Continue reading Niraparib (Zejula): Dose Modifications Based on Weight and Platelet Counts

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Written by: Jeff Engle, PharmD, MS
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Description: This PQI will discuss effective management of adverse effects of sorafenib in the treatment of hepatocellular carcinoma and discuss data supporting the sequencing of patients to second-line therapy with regorafenib for increased survival benefit.

Background: Hepatocellular carcinoma (HCC) is associated with a high mortality rate and historically the treatment options have been limited. Prior to 2018, sorafenib was the only Food and Drug Administration approved targeted therapy for the initial treatment of unresectable HCC in patients diagnosed with late stage or metastatic disease.7 Second-line treatment options, though growing in number, have limited and at times conflicting survival data; and all factors of options should be considered.14, 18 A retrospective study of the RESORCE trial ascertained median time from start of sorafenib to death in patients receiving sequential therapy to regorafenib.  Exploratory analysis revealed time from sorafenib initiation to death as 26 months for regorafenib patients vs. 19.2 months for placebo patients.16

PQI Process: Upon receipt of a prescription for sorafenib:

  • Obtain CBC with differential, metabolic panel including magnesium and phosphorus, liver function tests, lipase and amylase prior to starting therapy and then monthly until labs have stabilized
  • Consider obtaining thyroid stimulating hormone level at baseline, every 4 weeks for 4 months, and then every 2-3 months thereafter
  • Monitor blood pressure at baseline and weekly during the first 6 weeks of sorafenib, and then monitor blood pressure, utilizing clinic appointments and treatment any developing hypertension as needed
  • Treatment associated hypertension and dermatologic toxicity are managed with dose interruptions and reductions.8 Grade 1 dermatologic toxicity may not require dosage adjustments (see table 3 for dose reductions due to toxicity)
  • Consider proactively discussing 2nd line treatment options following progression or intolerance

If regorafenib is considered for 2nd line tyrosine kinase inhibitor transitioning

  • Ensure recovery from sorafenib mediated adverse effects and that patient did not permanently discontinue sorafenib due to toxicity or inability to tolerate doses
    • RESORCE trial required that patients be able to tolerate at least 400 mg a day of sorafenib for 20 days of the last 28 days prior to withdrawal to be eligible
  • Determine Child-Pugh Class status and make appropriate recommendation for therapy
  • If underlying hypertension exists or developed while on sorafenib, ensure appropriate blood pressure control prior to starting regorafenib
  • Refer to Regorafenib (Stivarga®) In the Treatment of Hepatocellular Carcinoma PQI for managing adverse effects

Patient Centered Activities:

Counseling for sorafenib

  • Provide patient Oral Chemotherapy Education (OCE) sheet
  • Counsel patient on the signs and symptoms of hand-foot syndrome and other dermatologic side effects
  • Counsel on appropriate management of chemotherapy induced diarrhea
  • Counsel on measuring blood pressure weekly at home (first 6 weeks) and instruct to report blood pressures > 140/90 mmHg
  • Dose adjustments for baseline hepatic and renal dysfunction have been recommended based on a phase I pharmacokinetic study and are included in Table 1 and 215

Counseling for regorafenib

 

Supplemental Information:

Table 1: Dose Adjustments for Baseline Hepatic Dysfunction15*

Degree of Hepatic ImpairmentCriteriaSorafenib Dose
MildBilirubin >1 to ≤1.5 times ULN and/or AST >ULN400 mg twice daily
ModerateBilirubin >1.5 to ≤3 times ULN; any AST200 mg twice daily
SevereAlbumin <2.5 g/dL with any bilirubin/AST200 mg once daily
Bilirubin >3 to 10 x ULN with any ASTNo tolerable dose identified

*Reference used differs slightly from sorafenib prescribing information reference

 

Table 2: Dose Adjustments for Baseline Renal Dysfunction15

Baseline Creatinine ClearanceSorafenib Dose
40-59 mL/min400 mg twice daily
20-39 mL/min200 mg twice daily
< 20 mL/minUnable to define dose
Hemodialysis200 mg once daily

 

Table 3: Dose Reduction Levels for Adverse Effects*

Dose ReductionSorafenib Dose
Starting400 mg twice daily
1200 mg twice daily
2200 mg once daily or 400 mg every other day
3Discontinue

 

Patient Assistance

Sorafenib patients can utilize the REACH support program while on therapy

  • Nurse counselors are available for answering questions and providing patient education including Patient Starter Kits
  • Service counselors are available to discuss patient access services including co-pay assistance

References:

  1. Siegel RL, Miller KD, Jemal A. Cancer statistics, 2019. CA Cancer J Clin. 2019 Jan;69(1):7-34.
  2. Cronin KA, Lake AJ, Scott S, et al. Annual report to the nation on the status of cancer, part I: National cancer statistics. Cancer. 2018 Jul 1;124(13):2785-2800.
  3. Morgan TR, Mandayam S, Jamal MM. Alcohol and hepatocellular carcinoma. Gastroenterology. 2004; 127: S87–96.
  4. El-Serag HB. Epidemiology of viral hepatitis and hepatocellular carcinoma. Gastroenterology. 2012;142:1264–73.e1.
  5. Marrero JA, Kulik LM, Sirlin CB, et al. Diagnosis, staging, and management of hepatocellular carcinoma: 2018 practice guidance by the American Association for the Study of Liver Diseases. Hepatology. 2018 Aug;68(2):723-750.
  6. National Comprehensive Cancer Network. Hepatobiliary cancers version 1.2019. https://www.nccn.org/professionals/physician_gls/pdf/hepatobiliary.pdf. Accessed February 10, 2019.
  7. Llovet JM, Ricci S, Mazzaferro V, et al. Sorafenib in advanced hepatocellular carcinoma. N Engl J Med. 2008;359:378-390.
  8. Nexavar (sorafenib) [prescribing information]. Wayne, NJ: Bayer Healthcare Pharmaceuticals Inc; October 2010.
  9. Bruix J, Qin S, Merle P, et al. Regorafenib for patients with hepatocellular carcinoma who progressed on sorafenib (RESORCE): a randomized, double-blind, placebo-controlled, phase 3 trial. Lancet. 2017;389:56-66.
  10. El-Khoueiry AB, Sangro B, Yau T, et al. Nivolumab in patients with advanced hepatocellular carcinoma (CheckMat 040): an open-label, non-comparative, phase 1/2 dose escalation and expansion trial. Lancet. 2017;389:2492-2502.
  11. Zhu AX, Finn RS, Edeline J, et al. Pembrolizumab in patients with advanced hepatocellular carcinoma previously treated with sorafenib (KEYNOTE-224): a non-randomised, open-label phase 2 trial. Lancet Oncol. 2018;19(7):940-952.
  12. Abou-Alfa GK, Meyer T, Cheng AL, et al. Cabozantinib in patients with advanced and progressing hepatocellular carcinoma. N Engl J Med. 2018;379:54-63.
  13. Zhu AX, Kang YK, Yen CJ, et al. Ramucirumab after sorafenib in patients with advanced hepatocellular carcinoma and increased α-fetoprotein concentrations (REACH-2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2019 Feb;20(2):282-296.
  14. Merck Provides Update on KEYNOTE-240, a Phase 3 Study of KEYTRUDA® (pembrolizumab) in Previously Treated Patients with Advanced Hepatocellular Carcinoma. Merck. Published February 19, 2019. https://bit.ly/2SQ6J45. Accessed March 18, 2019.
  15. Miller AA, Murry DJ, Owzar K, et al. Phase I and pharmacokinetic study of sorafenib in patients with hepatic or renal dysfunction: CALGB 60301. J Clin Oncol. 2009 Apr 10;27(11):1800-5.
  16. https://www.ncoda.org/chemotherapy-induced-diarrhea/
  17. https://www.ncoda.org/regorafenib-in-the-treatment-of-hepatocellular-carcinoma/
  18. Finn RS et. Al Outcomes of sequential treatment with sorafenib followed by regorafenib for HCC. J Hepatol.2018 Aug;69(2):353-358. doi: 10.1016/j.jhep.2018.04.010.
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: 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. Accessed July 17, 2019.
  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; May 2018.
  13. Lynparza® (olaparib) tablets [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; December 2018.
  14. Rubraca® (rucaparib) [prescribing information]. Boulder, CO: Clovis Oncology; April 2018.
  15. Talzenna® (talazoparib) [prescribing information]. New York, NY: Pfizer Inc; October 2018.

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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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) following 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.  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. 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.

PQI Process:

  • Identify patients with 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 if ANC < 500/mm3, febrile neutropenia, or platelets < 50,000 mm3
  • Check 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
    • Check liver function
      • Do not initiate therapy in patients with moderate to severe hepatic impairment (bilirubin >1.5 ULN and any AST elevation)

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 available online
  • 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
  • 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. Lonsurf® (trifluridine/tipiracil) [package insert]. Princeton, NY: Taiho Oncology, Inc.; 2019.
  3. NCCN Guidelines Gastric Cancer Version 2.2019. 3 Jun 19. Accessed 16 July 2019.

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); refer to dosing calculator available
  • Maximum dose 80 mg/dose (160 mg/day)
  • Administer with food and swallow tablets whole, within 1 hour after completion of morning and evening mealsAfter recovery, reduce dose by 5mg/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

Co-pay 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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