7

October

Trifluridine / Tipiracil for Treatment of Gastric Cancer

Written by Isabel Houlzet, PharmD, BCPS, BCOP, Miami Cancer Institute
Download Here

To increase awareness and management of adverse effects related to trifluridine/tipiracil treatment in metastatic colorectal cancer.

Background: Trifluridine/Tipiracil (Lonsurf) 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. It is currently the only oral option available.  Clinical guidelines recommend utilizing this agent in patients who have low-volume gastric cancer with minimal or no symptoms, and are able to swallow.

PQI Process:

  • Identify 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)
  • Consider conversation with care team with trifluridine/tipiracil as potential oral oncolytic option

Upon receiving a prescription for Trifluridine/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 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 at lonsurfhcp.com/dosing/dosage-calculator
  • 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

  1. Private/commercial insurance:
    1. Consider patient enrollment in Taiho Oncology Patient Support Co-pay Assistance Program to reduce out-of-pocket expenses to $0
        1. www.taihopatientsupport.com
    2. Public/government insurance, (ex. Medicare, Medicaid)
      1. Consider utilizing Extra-Help, the Low-Income Subsidy (LIS) from Medicare program
        1. Financial assistance for patients who may otherwise be unable to afford the costs associated with their Medicare Part D plan
        2. To learn more visit https://secure.ssa.gov/i1020/start

Refer to nonprofit foundations or Patient Assistance Program (PAP)

 

 

Victoria

Victoria has blogged 670 posts

View all PQI