FLAG-Ida for Acute Myeloid Leukaemia (AML)
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FLAG-Ida for Acute Myeloid Leukaemia (AML) A Guide for Patients Introduction FLAG-Ida is a combination chemotherapy regimen made up of fludarabine, high dose cytarabine (Ara-C0), idarubicin and granulocyte-colony stimulating factor (G-CSF) used in the treatment of acute myeloid leukaemia (AML). This booklet has been compiled by Saloua Najjam, PhD (Haematology) and peer reviewed by one of our medical professionals, Nurse Advisor Fiona Heath. We are also grateful to Julie Quigley, AML patient reviewer, for her valuable contribution. This booklet has then been updated by our Patient Information Writer, Isabelle Leach. If you would like any information on the sources used for this booklet, please email [email protected] for a list of references. Version 2 Printed: 01/2020 2 www.leukaemiacare.org.uk Review date: 01/2022 In this booklet Introduction 2 In this booklet 3 About Leukaemia Care 4 What is FLAG-Ida? 6 Who receives FLAG-Ida? 10 How is FLAG-Ida administered? 11 What are the side effects of FLAG-Ida? 13 What happens if FLAG-Ida doesn’t work? 16 Glossary 17 Useful contacts and further support 19 Helpline freephone 08088 010 444 3 About Leukaemia Care Leukaemia Care is a national charity dedicated to ensuring that people affected by blood cancer have access to the right information, advice and support. Our services has been affected by a blood cancer. A full list of titles – both Helpline disease specific and general Our helpline is available 8:30am information titles – can be – 5:00pm Monday - Friday and found on our website at www. 7:00pm – 10:00pm on Thursdays leukaemiacare.org.uk/support- and Fridays. If you need someone and-information/help-and- to talk to, call 08088 010 444. resources/information-booklets/ Alternatively, you can send Support Groups a message via WhatsApp on Our nationwide support groups 07500068065 on weekdays are a chance to meet and talk 9:00am – 5:00pm. to other people who are going Nurse service through a similar experience. For more information about a We have two trained nurses on support group local to your area, hand to answer your questions go to www.leukaemiacare.org. and offer advice and support, uk/support-and-information/ whether it be through emailing support-for-you/find-a-support- [email protected] or group/ over the phone on 08088 010 444. Buddy Support Patient Information Booklets We offer one-to-one phone We have a number of patient support with volunteers who have information booklets like had blood cancer themselves this available to anyone who or been affected by it in some 4 www.leukaemiacare.org.uk way. You can speak to someone Website who knows what you are going You can access up-to-date through. For more information information on our website, on how to get a buddy call www.leukaemiacare.org.uk. 08088 010 444 or email [email protected] Campaigning and Advocacy Online Forum Leukaemia Care is involved in campaigning for patient well- Our online forum, being, NHS funding and drug www.healthunlocked.com/ and treatment availability. If you leukaemia-care, is a place would like an update on any of for people to ask questions the work we are currently doing or anonymously or to join in the want to know how to get involved, discussion with other people in a email advocacy@leukaemiacare. similar situation. org.uk Patient and carer conferences Patient magazine Our nationwide conferences Our magazine includes provide an opportunity to inspirational patient and carer ask questions and listen to stories as well as informative patient speakers and medical articles by medical professionals: professionals who can provide www.leukaemiacare.org.uk/ valuable information and support. communication-preferences/ Helpline freephone 08088 010 444 5 What is FLAG-Ida? FLAG-Ida is the abbreviation for Cytarabine a combination of drugs which has shown to be effective for Cytarabine (also called cytosine the treatment of AML. FLAG- arabinidose or Ara-C) is also an Ida consists of fludarabine, antimetabolite chemotherapy cytarabine (Ara-C), granulocyte- drug that has been used for the colony stimulating factor (G-CSF) treatment of AML for over 40 and idarubicin. years. Cytarabine is used in combination Fludarabine with other chemotherapies for Fludarabine is a type of the treatment of AML, acute chemotherapy drug called an lymphoblastic leukaemia antimetabolite. Antimetabolites and crises in chronic myeloid interfere with the synthesis leukaemia. of DNA, and therefore prevent the growth or reproduction of Cytarabine is available as leukaemia cells. a concentrated solution for injection or infusion. Fludarabine is indicated for the treatment of adult patients with Idarubicin chronic lymphocytic leukaemia Idarubicin is a drug that belongs (CLL) in combination with to a group of anti-cancer cyclophosphamide and rituximab drugs called anthracyclines. (FCR), but when used as part of These drugs were originally the FLAG-Ida combination, it has used as antibiotics, but it was been very useful for the treatment subsequently found that they of AML. were effective anti-cancer drugs. Fludarabine is available as Anthracyclines work by damaging a concentrated solution for DNA of the leukaemia cells. injection or infusion, or as a Idarubicin is indicated for the tablet. treatment of patients with AML and relapsed/refractory acute 6 www.leukaemiacare.org.uk lymphoblastic leukaemia (ALL). treatments. Idarubicin is available as a freeze- G-CSFs are available as solutions dried powder to be made into a for injection or infusion. It solution for injection or infusion, is included in the FLAG-Ida or as a tablet, if an injection or regimen from the day before the infusion is not possible. chemotherapy drugs start to try to bring the leukaemic cells G-CSF into cycle and increase their G-CSF is a growth factor which sensitivity to the chemotherapy stimulates the bone marrow to agents. produce granulocyte white blood cells, mainly the neutrophils. FLAG-Ida Granulocytes (white blood cells The aim of treatment for AML is that are characterised by small to cure the majority of patients granules in their cells) include who are able to tolerate intensive the neutrophils, eosinophils and chemotherapy, as well as improve basophils. Neutrophils protect supportive care and availability of against bacterial infections and allogeneic stem cell transplants. inflammation. Eosinophils protect FLAG-Ida is a chemotherapy against parasites and allergens, regimen widely used in patients and basophils create the with relapsed or refractory AML. inflammatory reactions during an It is often used in patients with immune response. refractory or relapsed AML who are G-CSFs are indicated for the awaiting an allogeneic stem cell improvement of neutropenia transplant. (a decrease in the number FLAG-Ida has also been shown to of neutrophils) caused by achieve complete remission in chemotherapy. G-CSFs are not newly diagnosed patients. One cancer treatments, but supportive course of FLAG-Ida resulted in care medicines for patients more remissions and reduced with bone marrow suppression relapse compared with the secondary to cancer and its Helpline freephone 08088 010 444 7 What is FLAG-Ida? (cont.) standard care treatment for AML (e.g. FLT3-ITD in the absence of cytarabine with daunorubicin of an NPM1 mutation, p53 in younger patients with AML. mutations, ASXL1 or RUNX1 Daunorubicin is an anthracycline mutations) drug like idarubicin. Patients Patients with secondary treated with FLAG-Ida require • AML (following previous more supportive care than haematological conditions patients receiving daunorubicin like MDS, MPNs) or therapy- and cytarabine. The duration of related AML following previous neutropenia is slightly longer, chemotherapy. they need more transfusions and antibiotics, on average spend Many high-risk patients now slightly longer in hospital, and receive CPX-351 (Vyxeos) as their they experienced bone marrow initial therapy. suppression which can prevent some of them completing the full course of treatment. The FLAG-Ida regimen is given for two cycles and includes fludarabine for four days, cytarabine for four days, idarubicin for three days and G-CSF for six days. Sometimes idarubicin is omitted from the second cycle. High-risk AML includes a number of groups of patients: • Those with high-risk cytogenetic abnormalities, or those with high-risk molecular features 8 www.leukaemiacare.org.uk Helpline freephone 08088 010 444 9 Who receives FLAG-Ida? Patients with AML who may benefit from the FLAG-Ida If you wish to have further combination therapy are the information on AML or APL, following: please view our collection of patient information • Patients with relapsed or booklets that are available refractory AML, who may or may on our website at www. not be awaiting an allogeneic leukaemiacare.org.uk stem cell transplant • Newly diagnosed patients with AML as an induction of remission (particularly those with high-risk disease features) • Patients whose induction therapy with cytarabine and daunorubicin or daunorubicin with cytarabine and etoposide has not worked (refractory AML) Patients with acute promyelocytic leukaemia (APL), which is a subtype of AML, should not be treated with FLAG-Ida as the combination of differentiating agents all-trans retinoic acid (ATRA) and arsenic trioxide (ATO) achieves excellent cure rates of 85% (for high-risk patients) to over 90% (for low- to intermediate- risk patients) in these patients. 10 www.leukaemiacare.org.uk How is FLAG-Ida administered? Before starting FLAG-Ida to your partner or unborn baby. treatment, the following clinical You will then need to read and assessments will be carried out: sign a consent form regarding • Measurement of your weight the receipt of verbal and written and height. information in relation to your disease, treatment and potential Full blood count and urea and • side effects. electrolyte levels as a measure of kidney function. These tests For part of your induction therapy, will be performed before each you will be treated in the hospital treatment cycle.