Written by: Jonas Congelli, RPh Hematology Oncology Associates of CNY
Download Here

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.

 

Read More

Written By: Neal Dave, PharmD, and Natasha Khrystolubova, RPh, BCOP
Download Here

Description: Management of adverse effects related to regorafenib treatment in metastatic colorectal cancer. Optimal dosing and follow up are essential to help patients benefit fully while taking this medication.

Background: Regorafenib is a multikinase inhibitor that has shown an overall survival benefit (6.4 months, regorafenib + supportive care versus 5.0 months, placebo + supportive care; CORRECT Trial) in the third line setting.  Keeping patients on therapy can be challenging due to the adverse effect profile* of multikinase inhibitors. The ReDOS trial evaluated the dose escalation strategy in regorafenib patients and efficacy. A strategy with weekly dose escalation of regorafenib from 80 mg to 160 mg/day (Arm A) was found to be superior to a starting dose of 160 mg/day (Arm B). A trend for improved OS was seen in the dose escalation arm. The dose escalation strategy did not appear to compromise QOL. Patients started on 80mg for the first week with weekly dose escalations in the absence of significant drug-related toxicities. Median Overall Survival (OS) was improved in Arm A vs. Arm B (9.8 months vs. 6.0 months; HR 0.72, 95% CI, p=0.12). Median Progression Free Survival (PFS) was 2.8 months for Arm A vs. 2.0 months for Arm B (HR 0.84, CI 95%, p=0.38).

PQI Process: Upon receipt of a new prescription for regorafenib:

  • If the typical starting dose of 160 mg by mouth once daily is written, exercise clinical judgement and contact prescriber to discuss and potentially start patient on a dose escalation schedule such as the one described (ReDOS trial strategy):
    • Document follow up schedule and dose escalation in EMR
    • Initiate patient at 80 mg for the first week of cycle 1
    • If no significant drug-related toxicities, escalate to 120 mg for the second week of cycle 1, otherwise hold therapy at current dose
    • If no significant drug-related toxicities, escalate to 160 mg for the third week of cycle 1, otherwise hold therapy at current dose
    • For following cycles, start therapy at current tolerated dose (no dose escalation)
  • Coordinate and establish a weekly follow up call with the patient or caregiver for the first 8 weeks
  • Monitor LFTs at baseline, every 2 weeks (for first 2 months), and then at least monthly thereafter
  • Educate patients on side effects and report adverse effects to prescriber and recommend dose adjustments in 40 mg increments as tolerated2

Patient Centered Activities:

  • Provide Oncology Chemotherapy Education (OCE) sheet
  • Provide patient starter kit
  • Ensure patient knows dosing schedule (once daily for 3 weeks on and 1 week off)
  • Ensure patient knows to take dose with a low-fat meal (<600 calories and 30% fat)
  • Only open 1 bottle of Regorafenib at a time. Medication expires 7 weeks after bottle is opened
    • Packaging now available in 21 count bottle
  • Ensure patient or caregiver is able to take and record blood pressure at home weekly
  • Consider Anti Diarrheal and Moisturizing cream ex. Urea 20%
  • Copay Assistance
  • Commercial patients can enroll in a $0 copay card assistance program (online enrollment) 

Supplemental Information:

*Dose limiting side effects include (percentage refers to all grades)1:

Skin and subcutaneous tissue adverse events, including palmar-plantar erythrodysesthesia (Hand and Foot syndrome) 72%, diarrhea 43%, hypertension 30%, fatigue 64%, increased LFTs (AST-65%, ALT-45%, Bilirubin-45%).  The median time to first adverse event was 2 weeks with worst incidences occurring at 3 weeks. The worst severity of diarrhea occurred at 4 weeks. Increases in LFTs usually occur within the first 8 weeks of therapy.

References:

  1. Grothey A, Van Cutsem E, Sobrero A, et al. Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT): an international, multicentre, randomised, placebo-controlled, phase 3 trial. Lancet 2013;381(9863):303-312.
  2. NCCN Clinical Practice Guidelines in Oncology (NCCN guidelines®) for colon cancer v.2.2018. © Page COL-D 9 of 10. National Comprehensive Cancer Network 2018. All rights reserved. Accessed May 10, 2018.
  3. STIVARGA® (Regorafenib) [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, April 2017.
  4. Bekaii-Saab TS, Ou F-S, Ahn DH, et al. Regorafenib dose-optimisation in patients with refractory metastatic colorectal cancer (ReDOS): a randomised, multicentre, open-label, phase 2 study [published online June 28, 2019].Lancet Oncol. doi: 10.1016/S1470-2045(19)30272-4.
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.

 

Read More

Written by: Latha Radhakrishnan, PharmD, BCPS, BCOP
Download Here

Description: The granisetron transdermal system is a 5-HT3 Receptor Antagonist (5-HT3 RA) that allows for an alternate medication delivery compared to oral or parenteral administration. The purpose of this PQI is to review appropriate patient identification and discuss clinical considerations for the use of granisetron in chemotherapy induced nausea and vomiting (CINV).

Background: The granisetron transdermal system is approved for the prevention of nausea and vomiting in patients receiving moderately and/or highly emetogenic chemotherapy (MEC and/or HEC) for up to 5 consecutive days.1 Current practice guideline include granisetron transdermal system/patch as a 5-HT3 RA option for use in the prevention of acute and delayed intravenous MEC and HEC chemotherapy. It is also a choice in high to moderate chemotherapy emesis prevention.2 The pharmacokinetic profile of the formulation reveals continuous delivery of granisetron through the skin for over 6 days.3

PQI Process: Based on clinical practice experience, consider using the granisetron transdermal system in the following situations:

  1. Moderate to highly emetogenic multi-day chemotherapy
  2. Difficulty swallowing tablets due to oral mucositis, tumor location, vomiting
  3. Combination radiation + chemotherapy (head and neck regimens, etc.)
  4. No intravenous access
  5. Limited gut motility and absorption due to opioids or tumor location
  6. Difficulty remembering to take oral medications
  7. Refractory nausea and vomiting despite receiving appropriate preventative anti-emetics

Upon receipt of an order for granisetron transdermal system:

  • Ensure appropriateness of use in either MEC/HEC intravenous or high/moderate oral chemotherapy
  • Check start date of chemotherapy cycle
    • Apply 1 patch (3.1mg) 24-48 hours on clean, dry, intact skin on the upper outer arm prior to the start of chemotherapy (or on the last day of multi-day intravenous chemotherapy) (do not cut)
    • Wear throughout chemotherapy treatment up to 7 days total
    • Remove at least 1 day (24 hours) after chemotherapy completed
  • Discuss the use of surgical bandages/medical adhesive tape at the edges of the transdermal system to keep in place
    • Provide a prescription for a rescue medication (ex. prochlorperazine, metoclopramide) to assist with breakthrough nausea and vomiting. Other 5-HT3 RA such as ondansetron should not be used as rescue medications to avoid QT prolongation, constipation, and headache

Patient Centered Activities:

  • Application Instructions
    • Ensure that patients understand where to apply the patch
    • Educate on avoiding sunlight and heating sources (heating pads, tanning beds)
  • Patient Education
    • Review common side effects which include constipation and headache
      • Constipation – provide recommendations for a stimulant laxative (bisacodyl, sennosides) PLUS a stool softener
    • Explain when to apply and remove the patch – a calendar would assist
    • Remind to keep patch area covered under clothing and for another 10 days after the patch is removed to avoid potential skin reactions from natural or artificial sunlight

Financial Assistance

  • Patient Rx Solutions online or 1-800-676-5884
    • Coverage option for uninsured patients
    • Co-pay Assistance Cards
    • Sancuso® Patch Replacement Program – If chemotherapy is delayed or reschedule

References:

  1. Sancuso® [package insert, Bedminster, NJ: ProStrakan, Inc.; 2015.
  2. National Comprehensive Cancer Network. Antiemesis (Version 1.2021). https://wnccn.org/professionals/physician_gls/pdf/antiemesis.pdf Accessed September 9,2021.
  3. Howell J, Smeets J, Drenth H, et al. Pharmacokinetics of a granisetron transdermal system for the treatment of chemotherapy-induced nausea and vomiting. J Oncol Pharm Practice. 2009; 15: 223-231.
  4. Boccia RV, Gordan LN, Clark G et al. Efficacy and tolerability of transdermal granisetron for the control of chemotherapy-induced nausea and vomiting associated with moderately and highly emetogenic multi-day chemotherapy: a randomized, double-blind, phase III study. Support Care Cancer. 2011; 19: 1609-1617.

 

 

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.
Read More