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Education of patients taking capecitabine EORTC 10041 BIG 3-04 Intergroup Study MINDACT (Microarray In Node-negative Disease may Avoid ChemoTherapy): A.

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Presentation on theme: "Education of patients taking capecitabine EORTC 10041 BIG 3-04 Intergroup Study MINDACT (Microarray In Node-negative Disease may Avoid ChemoTherapy): A."— Presentation transcript:

1 Education of patients taking capecitabine EORTC BIG 3-04 Intergroup Study MINDACT (Microarray In Node-negative Disease may Avoid ChemoTherapy): A prospective, randomized study comparing the 70-gene signature with the common clinical-pathological criteria in selecting patients for adjuvant chemotherapy in node-negative breast cancer

2 Oral capecitabine = chemotherapy at home Treatment with capecitabine is home-based The patient takes an active role in treatment administration The patient must take an active role in the management of toxicity The patient must receive proper education to manage home-based chemotherapy

3 Treatment interruptions prevent worsening toxicity Studies show that –if capecitabine is interrupted at onset of toxicity, it usually resolves quickly (2-3 days) –capecitabine can be re-started at same dose –if capecitabine is not interrupted in time, toxicity worsens and may lead to permanent treatment discontinuation Blum JL et al. J Clin Oncol 1999; 17: Cassidy J et al. Ann Oncol 2002;13:566–75

4 Patients need to understand importance of early capecitabine interruption Patients –may not easily accept the idea of interrupting capecitabine –are often prepared to experience toxicities and do not want to interrupt treatment for fear it may decrease efficacy Not accepting short interruptions is counter- productive as it may lead to increased toxicity and treatment discontinuation or low dose intensity

5 Patients must be reassured that protocol compliant dose modifications will not compromise efficacy

6 No. of patients BeforeAfterBeforeAfterBeforeAfter Hand-foot syndrome DiarrheaStomatitis Grade 2 Grade 3 Grade 4 Capecitabine dose modification reduces the recurrence of adverse events Cassidy J et al. Ann Oncol 2002;13:566–75

7 Capecitabine dose modification does not compromise efficacy Decreased risk of disease progression Increased risk of disease progression No difference in risk of disease progression capecitabine HR=0.97 p= FU/LV HR=1.12 p=NS HR = hazard ratio for disease progression in patients with versus without dose reduction Cassidy J et al. Ann Oncol 2002;13:566–75

8 Detailed instructions should be given to patients If patients experience any of the following –moderate diarrhea (increase of 4 to 6 stools a day) and/or diarrhea at night –2-5 vomiting episodes in 24 hours –pain, redness and/or swelling of the mouth –pain, swelling and redness of the hands or feet

9 If grade 2 non-hematologic toxicity, patient should stop capecitabine and call you They should –STOP taking capecitabine –TELEPHONE their investigator / study nurse immediately –Begin treatment if available –Drink plenty of water ( 2L/day)

10 Phone contact permits investigator / study nurse to advise patient on further management The investigator / study nurse can advise on –treatment at home –set appointment for further phone follow-up –re-starting capecitabine –need to come to the clinic for further assessment –possibly hospitalization

11 Proactive patient contact may further improve patient management Sites contacting patients on a regular basis proactively between clinic visits might discover potential adverse events earlier, resulting in –earlier treatment, decreased duration of treatment and/or less aggressive treatment of adverse event –reduction in number of adverse events reaching grade 3 / 4 severity –decreased possibility that capecitabine dose will have to be held or reduced in order to manage the event –increased patient comfort and confidence in taking a home-based chemotherapy

12 Grade 2, 3, or 4 non-hematologic toxicity Diarrhea Nausea / vomiting * Stomatitis / mucositis Hand-foot syndrome Interrupt capecitabine for grade 2 non-hematologic toxicities INTERRUPT CAPECITABINE IMMEDIATELY * Occuring under adequate antiemetic treatment Note per MINDACT protocol: sites should follow local guidelines – antiemetics and/or corticoids

13 GI toxicity requires prompt management The most common problem is GI toxicity: diarrhea, nausea, vomiting In case of diarrhea grade 2 patients should be instructed to STOP taking capecitabine and START taking loperamide If diarrhea is not properly managed it may worsen, leading to life-threatening dehydration and even death

14 Supportive management of diarrhea in MINDACT: loperamide and fluids Loperamide (patient should have at home) –4 mg first onset, then 2 mg every 2 hours until 12 hours after last loose stool (total treatment duration should not exceed 48 hrs) –Do not re-start capecitabine until diarrhea has resolved to < grade 1 with the last loperamide dose given at least 24 hours beforehand –prophylaxis not recommended –laxatives should not be used Note: under Capecitabine monotherapy 2mg Loperamide every 6 hrs is usually enough to successfully treat diarrhea

15 Supportive management of diarrhea cont.: loperamide and fluids Tell patient to drink at least 2 L water per day Hospitalization with fluid and electrolyte support when clinically indicated or diarrhea persists after 48 hrs of recommended Loperamide treatment

16 Management of other non-hematological adverse events grade 2 In case of grade 2 Patients should STOP taking capecitabine and start Nausea/vomiting *Anti-emetics, suitable food & drink Mucositis/StomatitisMouth washes, suitable food & drink Hand-foot-syndromeSkin emollients, avoid putting pressure on palms and soles * Note per MINDACT protocol: sites should follow local guidelines – antiemetics and/or corticoids

17 Dose-reduction tables If dosereductions are necessary please use the following dose reduction tables

18 Pill combinations to be taken based on a 25% dosereduction for capecitabine (620 mg/m 2 bid) Body Surface Area (m 2 ) Total dose per administration (mg) Morning pillsEvening pills 150 mg500 mg150 mg500 mg < – – – > % dose level

19 Pill combinations to be taken based on a 50% dosereduction for capecitabine (412.5 mg/m 2 bid) Body Surface Area (m 2 ) Total dose per administration (mg) Morning pillsEvening pills 150 mg500 mg150 mg500 mg < – – > % dose level

20 Patient education must be clear and face-to-face The educator should take enough time to inform patients A longer initial information session is a good investment Avoid fragmentation of information (several persons giving pieces of information without coordinating their efforts) Repeat information during treatment Establish clear communication lines

21 Use the available tools Patients should have written information leaflets at home as a reminder of the information received at the site Educators should use the provided check lists for patient education

22 Patient education is an integral part of capecitabine treatment


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