Presentation on theme: "The Benefits of Soltamox® (tamoxifen citrate) Oral Solution in Breast Cancer Patients Speaker Program Supported by DARA BioSciences Inc., Leaders in Oncology."— Presentation transcript:
1 The Benefits of Soltamox® (tamoxifen citrate) Oral Solution in Breast Cancer Patients Speaker ProgramSupported by DARA BioSciences Inc., Leaders in Oncology Supportive CareOpen with informal audience survey. Sample questions:Who in the room is directly involved in the diagnosis and treatment of women with breast cancer?Are you:A medical oncologist?A radiation oncologist?An oncology/radiology nurse or NP/PA?None of the above?Who in the room is involved in diagnosing and managing swallowing difficulties in breast cancer patients?Do you believe swallowing difficulties are a potential issue among your breast cancer patients?Lastly, who actively seeks to understand if your patients have some degree of swallowing difficulty, via use of a simple assessment tool or probing/counseling?
2 Agenda Breast Cancer and the use of tamoxifen citrate Soltamox® (tamoxifen citrate) oral solutionImproving Patient Outcomes
3 DISCLAIMERSThis program was developed by DARA BioSciences Inc. and I presenting on behalf of DARA BioSciences Inc.I have received compensation from DARA BioSciences Inc. to make this presentation.The information I am presenting is consistent with the full prescribing information for Soltamox® (tamoxifen citrate) oral solution as required under applicable Food and Drug regulations.Copies of the full prescribing information for Soltamox® (tamoxifen citrate) oral solution are available at this presentation and at
4 Breast Cancer US Prevalence* Tamoxifen citrate** 2.6M women with a history of breast cancer~290K new cases each year230K invasive and 58K in-situTamoxifen citrate**Used to treat estrogen receptor + breast cancer (~80% all cases), to reduce the risk of recurrencePrevention in high-risk patientsUsed in up to 40% of patients (~1.8 M Rx written per year)Treatment period up to 5 yearsTamoxifen widely used in treating hormone receptor-positive breast cancerAlso used to prevent breast cancer in high-risk patientsTamoxifen a chronic treatment: patients on therapy many years* American Cancer Society - Facts and Figures ; ** Tamoxifen citrate US Package Insert; Symphony Rx data 2012
5 Adjuvant Endocrine Therapy NCCN Guidelines (BINV-J) Pre-menopausalTamoxifen 5 yrsPost-menopausalConsider tamoxifen +5 yrs or No further endocrine treat.Aromatase inhibitor 5 yrsAI to complete 5 yrs or up to 5 yrs AIAI contra-indicatedTamoxifen4.5-6 yrsAI 5 yrs or Tamoxifen 2-3 yrs orAI 2-3 yrsTamoxifen 5 yrs or consider tamoxifen up to 10 yrsAI 5 yrs or consider tamoxifen for +5 yrsTamoxifen to complete 5 yrsNCCN Treatment Guidelines Version (AI = Aromatase Inhibitor)
6 Tamoxifen Efficacy - DCIS* NSABP B-24 TrialDouble-blind, randomized, placebo-controlled trial1,804 women randomized to tamoxifen 20mg/day or placebo (in addition to lumpectomy and radiation)For the primary endpoint, the incidence of invasive breast cancer was reduced by 43% among women assigned to tamoxifen44 cases tamoxifen vs. 74 cases placebo; p=0.004*DCIS = Ductal Carcinoma in Situ; NSABP B-24 Trial (Tamoxifen citrate Package Insert)
7 Tamoxifen - Breast Cancer Prevention Tamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer*Defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥ 1.67%, as calculated by the Gail Model*Tamoxifen citrate Package Insert
8 Tamoxifen Efficacy in High Risk Women NSABP P-1 TrialDouble-blind, randomized, placebo controlled trial13,388 women at least 35 yrs, randomized to tamoxifen 20mg/day or placebo for 5 yrsAfter a median follow-up of 4.2 years, the incidence of invasive breast cancer was reduced by 44%86 cases tamoxifen vs. 156 cases placebo; p<NSABP P-1 trial; Tamoxifen citrate Package Insert
9 Soltamox® (tamoxifen citrate) Oral Solution Launched in the US, Nov. 2012Bioequivalent to tamoxifen tabletsSame indications as tamoxifen tabletsWith free Co-pay assistance, same low monthly cost ($10) as generic tabletsRecommended dosageTamoxifen 20-40mg per day20mg Soltamox = 10 mLMeasuring cup suppliedFor patients with breast cancer, the recommended daily dose of tamoxifen is mg.Dosages greater than 20mg per day should be given in divided doses (morning and evening).A 20 mg dose of SOLTAMOX® is administered as 10 mL (equivalent to 2 teaspoons) of the oral solution.Soltamox (tamoxifen citrate) oral solution Package Insert
11 Soltamox® Bioequivalent to Tamoxifen Tablets ParameterSoltamoxliquid(n=30)Mean (SD)Tamoxifen Citrate tablet (n=33)AUC (ng.hr/mL)( )( )AUCT (ng.hr/mL)(847.38)(900.86)Cmax (ng/mL)53.38 (14.03)55.94 (13.63)Tmax (hour) a4.5 ( )4.5 ( )t½ (hour)(69.58)(58.88)One pharmacokinetic study has been performed in healthy perimenopausal and postmenopausal female subjects to evaluate the bioavailability of Soltamox® in comparison with the commercially available tamoxifen citrate tablets under fasting condition and also to determine the drug absorption from Soltamox® under fed conditions. The rate and extent of absorption of Soltamox® was found to be comparable to that of tamoxifen citrate tablets under fasting condition as shown in the table.Soltamox (tamoxifen citrate) oral solution Package Insert
12 Soltamox® The Same Indications as tamoxifen citrate Metastatic Breast CancerTamoxifen citrate is effective in the treatment of metastatic breast cancer in women and men.Adjuvant Treatment of Breast CancerTamoxifen citrate is indicated for the treatment of node-positive breast cancer in postmenopausal women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. In some tamoxifen citrate adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes.Tamoxifen citrate is indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. The estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen citrate therapy is likely to be beneficial.Tamoxifen citrate reduces the occurrence of contra lateral breast cancer in patients receiving adjuvant tamoxifen citrate therapy for breast cancer.Ductal Carcinoma in Situ (DCIS)In women with DCIS, following breast surgery and radiation, tamoxifen citrate is indicated to reduce the risk of invasive breast cancer (see BOXED WARNING at the beginning of the Prescribing Information). The decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy.Reduction in Breast Cancer Incidence in High Risk WomenTamoxifen citrate is indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. (see BOXED WARNING at the beginning of the Prescribing Information). Tamoxifen citrate is indicated only for high-risk women. "High risk" is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer = 1.67%, as calculated by the Gail Model.Dosage and administrationFor patients with breast cancer, the recommended daily dose is mg. Dosages greater than 20 mg per day should be given in divided doses (morning and evening). A 20 mg dose of SOLTAMOX™ is administered as 10 mL (equivalent to 2 teaspoons) of the oral solution (Please see the Full Prescribing Information for complete dosage instructions.)Please see full Prescribing Information and complete Black Box Warning contained within your presentation folder.Soltamox (tamoxifen citrate) oral solution Package Insert
13 Soltamox® (tamoxifen citrate) oral solution The Same Important Safety Information Serious and life-threatening events associated with tamoxifen medications such as Soltamox (tamoxifen citrate) in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.Soltamox (tamoxifen citrate) oral solution Package Insert
14 Soltamox® (tamoxifen citrate) oral solution The Same Black Box Warning In Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events were associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.Soltamox (tamoxifen citrate) oral solution Package Insert
15 Improving Patient Outcomes Important considerations:Patient preferenceLong term adherence
16 Preference – The Importance of Offering Patients a Choice Some patients prefer a liquid to tablets/pillsPsychological factors, anxietyCan address/identify underlying pathologiesAge related swallowing difficultiesCo-existing conditions (e.g. neurological, acid-reflux)Effect of other medications (e.g. that cause dry mouth,have anticholinergic or CNS-depressing effects)Consistent with good practices
17 Consistent with Good Practices “The 8 Rights of Medication Administration” Right PatientRight MedicationRight DoseRight Routecheck the order and appropriateness of the route orderedconfirm that the patient can take or receive the medication by the ordered routeRight TimeRight DocumentationRight ReasonRight Response*Nursing Center.com May 27, 2011 Lisa Bonsall, MSN, RN, CRNP
18 Good Administration Practices CMS* policies and procedures require the correct route, to ensure that the method of administration is the appropriate one for that particular medication and patientStandards for Medicines Management** recommend that dosage, method of administration, route and timing be considered during the administration of medicines*CMS Guidance on Medication Administration, Hospital Appendix A P.10 (2011)**Standards for Medicines Management NMC pg.6 (UK)
20 Age Related - 40% patients on tamoxifen >65yrs Approx. 40% >65yrsPatient GenderFemale = 99.9%Male = 0.1%Source: Catalina Retail Pharmacy data base (N = 27,315 pts.)20
21 Improving Patient Outcomes - Better Long Term Adherence “We’re doing well with women taking endocrine therapy, but there’s work to do. If guidelines begin to shift so that some women at high risk of breast cancer recurring need 10 years of endocrine therapy, then the number of women who persist with treatment will likely worsen. We need better ways of supporting women through this therapy”Christopher Friese. Assistant Professor, University of Michigan School of Nursing*Lead study author, Adjuvant endocrine therapy initiation and persistence in a diverse sample of patients with breast cancer.Breast Cancer Res Treat Friese C et al Apr;138(3): doi: /s
22 Adherence – University of Michigan Study (2013) Study of 743 women eligible for endocrine therapy (tamoxifen or aromatase inhibitors)Women surveyed in Detroit and Los AngelesReported to SEER (Surveillance, Epidemiology and End Results) registry11 % never initiated therapy15% stopped early26%Breast Cancer Res Treat Friese C et al Apr;138(3): doi: /s
23 University of Michigan Study The most common reason patients discontinue or never start therapy is side effectsmenopause-like symptoms, joint painWomen who expressed more worry about cancer recurring were more likely to complete their endocrine therapy.Women who reported receiving less information about endocrine therapy were less likely to begin taking it.Breast Cancer Res Treat Friese C et al Apr;138(3): doi: /s
24 Tamoxifen Adherence A Systematic Review of 30 Studies At the end of 5 years treatment:Adherence: 41% - 72%Discontinuation: 31% - 73%Murphy C et al.Breast Cancer Research and Treatment 2012Prevalence of adherence ranged from 41% to 72% and discontinuation (i.e., non-persistence) ranged from 31% to 73%, measured at the end of 5 yrs of treatment.Extremes of age (older or younger), increasing out-of- pocket costs, follow-up care with a general practitioner (vs. oncologist), higher CYP2D6 activity, switching from one form of therapy to another, and treatment side effects were negatively associated with adherence and/or persistence.Murphy et al Adherence to adjuvant hormonal therapy among breast cancer survivors in Clinical practice: a systematic review. Breast Cancer Research Treat Pub. Online 12 June 201224
25 Tamoxifen Adherence“Patients who are prescribed adjuvant tamoxifen… have a lower risk of death” “Cumulative non-persistence with tamoxifen therapy occurs in nearly half of patients….”Full quotes:“Patients who are prescribed adjuvant tamoxifen in the community have a lower risk of death, with increased duration of use further reducing the risk.”“Cumulative non-persistence with tamoxifen therapy occurs in nearly half of patients prescribed tamoxifen. Conversely, in those who continue to take tamoxifen adherence is generally high, but there is a significant proportion of women with low adherence who are at greater risk of death.”McCowan et al. British Journal Cancer, 2008McCowan C et al. Cohort study examining tamoxifen adherence and its relationship to mortality in women with breast cancer British Journal of Cancer (2008) 99, 1763–1768. doi: /sj.bjc Published online 4 November 200825
26 Tamoxifen Discontinuation Women ≥ 65 yrs Of 961 women ≥65 years who were prescribed tamoxifen, 49% discontinued tamoxifen before the completion of 5 years.Of 961 women ≥65 years prescribed tamoxifen,49% discontinued treatment before 5 years.Cynthia Owusu et al. Predictors of Tamoxifen Discontinuation among Older Women with Estrogen Receptor–Positive Breast Cancer. Journal of Clinical Oncology. Volume 26 Number , February26
27 US Tamoxifen Prescribers Believe Patients Have Adherence Issues Patient adherence(Percentage of tamoxifen prescribers)Patients with issues taking medicationlong-term as prescribed(Percentage of tamoxifen prescribers)My patients on Tamoxifen…3%frequently miss a dosesometimes miss a doseYes42%Norarely miss a dose45%never miss a dose55%51%On average, respondents believe that 15% of their breast cancer patients stop taking their Tamoxifen prior to the prescribed duration4%US Market Research (on-line) Gelclair and Soltamox; Conducted Jan 2013 N=103
28 Reason Why Patients Stop Taking Tamoxifen Reasons patients stop taking Tamoxifentablet therapy earlyPercentage of writersRanked 1Ranked 2Ranked 3Not rankedDrug side effects51%11%11%Patient feels better and stops taking medication12%24%15%Multiple conditions/pills - forget to take12%10%25%Lack of understanding regarding importance9%34%17%Too expensive/can’t afford to pay for prescription8%9%16%Have difficulty swallowing tablets as a result ofchemotherapy or radiation therapy5%4%Lack of follow-up by primary care provider4%6%3%Have difficulty swallowing in general4%6%Other2%US On-line Market Research among oncologists and oncology nurses; Jan 2013 (N=103)
29 Possible Ways to Improve Long Term Adherence to Tamoxifen Educate pts. regarding the importance of long term tamoxifen therapyEducate pts. regarding the management of tamoxifen side effectsMonitor pt. adherenceAssess pts. ability to swallowOffer pts. a choice of a liquid vs. a tabletPatients who have a say in their “choice” of medicine may be more compliant on a daily basis
30 Simple Questions Do you prefer a liquid medication or pills? Do you find itdifficult toswallowcertain things?Do you take yourtamoxifen tabletsevery day?How do you take your tablets? Do you use applesauce or crush them?Do you think taking a liquid form oftamoxifen will help you take your therapyover the long term?
31 Summary - Patients Who May Benefit From Soltamox Tamoxifen Patients whoprefer a liquid vs. a pillOffering patientsa choicebetween a pill and asolution maysupport long termadherence.Patients who have underlying “pathology”(e.g., cancer treatment, co-existing disease, concomitant meds, physical orpsychological issues)Patients with tabletadherence issues whomay benefit from a change
32 ConclusionsTamoxifen has proven efficacy, yet treatment remains sub-optimal due to poor adherenceTwo dose forms (tablets, liquid) are now availableSoltamox has the same indications and is bioequivalent to tamoxifen citrate tabletsOffering patients a choice may improve adherencePatients who have a say in their “choice” of medicine may be more compliant on a daily basisDifficulty swallowing occurs in the general population but is under-diagnosedBreast cancer patients are at increased risk of swallowing difficultiesSimple assessment tools (e.g., EAT-10) and proactive counseling can identify affected breast cancer patientsA variety of options exist to help manage the issue, including substitution of solid/tablet medications with liquid (Soltamox, tamoxifen citrate)
33 Discussion TopicsTo what extent do your breast cancer patients have adherence issues with tamoxifen?Main reasons?Impact on treatment outcomes?Ways to monitor?Ways to address?Does it make sense to offer patients a choice between tablets and liquid tamoxifen?Do you see a role for Soltamox in certain populations?Patient types?How to keep Soltamox top-of-mind?
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