GSK Medicine: Study No.: Title: Rationale: before initiation of treatment, every 4-6 weeks during treatment

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1 GSK Medicine: Lapatinib Study No.: WWE115270/WEUKSTV4275 Title: Assessment of Physician Compliance to Recommend Liver Function Test (LFT) Monitoring for Lapatinib Patients Rationale: Lapatinib (Tykerb ) is a dual TKI inhibitor, and in combination with capecitabine (Xeloda) or letrozole, is approved for the treatment of hormone-receptor-positive metastatic breast cancer with HER2 over-expression. On July 9, 2008, following a review of the Lapatinib clinical program, Tykerb Prescribing Information (label) was updated (Version 4) to include a boxed warning that reads, Liver function tests (transaminases, bilirubin, and alkaline phosphatase) should be monitored before initiation of treatment, every 4-6 weeks during treatment, and as clinically indicated. If changes in liver function are severe, therapy with Tykerb should be discontinued and patients should not be retreated with Tykerb. For patient safety, it is of interest to know the extent to which providers are adherent with these guidelines for hepatic monitoring of lapatinib users as well as the rates of safety events in the target population. Objectives: The study aimed to 1) determine if physicians conduct liver function testing (LFT) prior to prescribing lapatinib (baseline), 2) describe the prevalence of LFT elevations at baseline, 3) determine if physicians conduct LFTs at regular intervals during lapatinib exposure, 4) describe the incidence of LFT elevations during lapatinib exposure and 5) determine if physicians withdraw lapatinib, and do not retreat, among patients who demonstrate severe liver enzyme elevations while exposed. Study aims 1, 3 and 5 were tested in the (prior to boxed warning) and (after boxed warning) periods to determine physician adherence to the guidelines changed as a result of the warning. Indication: Cancer Study Investigators/Centers: US Oncology Electronic Medical Records (EMR) database Research Methods: Data Source: US Oncology iknowmed electronic medical records database. The US Oncology network includes community cancer practices and cancer centers (including 90+ radiation oncology facilities) in 39 US states and comprises more than 850,000 patients or 12% of the US cancer population. Geographic dispersion is good, with all regions of the country receiving some coverage of the system. Due to the severity of the disease, longitudinality of care is fairly high for breast cancer and these patients have a fairly low level (typically <20%) of loss to follow-up. Study Design: Retrospective cohort study Study Population: This study included 396 female metastatic breast cancer patients (age >19 years) with a documented order/prescription for lapatinib from January 1, 2007 December 31, 2009 and who received care at an oncology practice utilizing the full US Oncology EMR capabilities. All included patients had at least one documented LFT test in their entire EMR to ensure that laboratory tests were captured. Patients were excluded if they participated in a clinical trial, received care for another cancer during the study period, or received lapatinib in an adjuvant or neoadjuvant setting. Study Exposures, Outcomes: The exposure was lapatinib oral medication. The index date was the date of initiation of lapatinib, and the (pre- and post-label) exposure period was defined as the index date through end of study period as follows: Pre Label : Initiated lapatinib between January 1, 2007 and December 31, Follow-up time for this group continued until June 30, 2008 to allow these patients to have at least six months of followup time prior to the label change. Post Label : Initiated lapatinib between July 9, 2008 and December 31, Follow-up time for this group continued until June 30, 2010 to allow these patients to have at least six month of follow-up. Patients that initiated lapatinib between January 1, 2008 and July 8, 2008 were not included since it was not possible for them to have a complete six months of follow-up before the label change went into effect. 1

2 Treatment duration for each prescription was determined as the standardized quantity dispensed divided by the standardized dose, and the time interval (i.e. gaps) between consecutive prescriptions was calculated as the start date of the current prescription minus the last date of the preceding prescription. A gap of >60 days was considered a drug interruption. For patients with complete or temporary (i.e. resume after interruption) discontinuation, the last administration date of lapatinib that precedes the interruption was used as the discontinuation date. The outcomes for the five objectives were: 1) Proportion of patients that received LFTs within 30 days prior to (and including) the day lapatinib was initiated. The LFTs considered were alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP) and total bilirubin (BILI). 2) Prevalence of LFT elevations within 30 days prior to (and including) the day of lapatinib initiation. LFT elevations were defined as an occurrence of an elevation greater than or equal to a defined upper limit of normal (ULN) threshold value for each type of LFT during the baseline periods of 30 days prior to (and including) the index date. Multiple increasingly severe ULN thresholds were explored. 3) Proportion of patients that had LFTs performed routinely (at least every 6 weeks) while exposed to lapatinib. 4) Cumulative incidence (%) and incidence rate (IR) of LFT elevation for each type of LFT during lapatinib exposure follow-up. Multiple increasingly severe ULN thresholds were explored, including selected combinations of tests that identifies potentially significant liver injury, including ALT>3x ULN + BILI>2x ULN and possible Hy s Law combination (ALT or AST>3x ULN + ALP<2x ULN + BILI>2x ULN). 5) Proportion of patients with severe LFT elevations that have lapatinib discontinued within 30 days of elevation. Severe elevation was defined as a) ALT>8x ULN or b) possible Hy s Law combination. Data Analysis Methods: All individuals were categorized into Pre-Label or group. A Chi-square test for categorical data or t-tests / Kruskul-Wallis for continuous variables were conducted to determine if there were any statistically significant differences in patient demographics, and clinical and treatment characteristics, by pre- and post-label status. Total exposure time to lapatinib, by pre- and post-label status, was also calculated. All analyses were stratified by pre- and post-label status. Wider baseline time periods and discontinuation periods, including 60 and 90 days, were explored; however, only analyses using the 30-day timeframe are presented, as it is the most relevant, and furthermore, the findings were consistent across the different periods. 1) Frequency and proportion of patients tested for LFTs within 30 days prior to and including the index date were calculated among those receiving lapatinib. Chi-square test was used to compare proportions across preand post-label groups. 2) Prevalence proportions of LFT elevations at various threshold levels within 30 days prior to the index date was calculated as the number of patients who had an LFT elevation during the baseline time period that was greater or equal to a defined ULN threshold value for each type of LFT divided by the total number of patients tested for that LFT within that time period x 100%. 3) Frequency and proportion that were tested at least once during each 6 week interval post index date among those with at least one exposure day within that 6-week time period. 4) Incidence of LFT elevation while exposed to lapatinib include: a) Cumulative incidence was calculated as the number of patients who reached an LFT elevation during the exposure period that was greater than or equal to a defined ULN threshold for each LFT (or combination) divided by the total number of patients with at least one follow-up LFT. b) Incidence rate was similarly calculated, except the denominator was the sum of person-time for all patients with at least one follow-up LFT. Person-time was defined from the index date until either the date the patient reached threshold while exposed or the date of last visit during which LFT was conducted while exposed to lapatinib, and was expressed per 1000 person-months (PM). 5) Frequency and proportion of patients that experienced a severe LFT elevation, and among those with severe 2

3 elevation, the frequency and percentage that have temporary or complete discontinuation of lapatinib in the 30 days following the elevation. Limitations: Exposure assessment The method of defining exposure period using prescription information only (supply in days) may overestimate true exposure if ordered prescriptions are not filled or taken by the patient (we have no indication of compliance with taking the medication). Alternatively, the exposure period may be under-estimated if a lapatinib refill is not documented in the EMR. Brief rests from lapatinib are difficult to capture when using prescription information only. If patients were directed to stop taking lapatinib for a brief time in the middle of a cycle of medication, they will appear to still be using the drug and considered as exposed. Similarly, an exact date for drug cessation is difficult to measure when using prescription information only. While a patient may in reality discontinue lapatinib at any point during a particular cycle, we will use the final date of the patient s final cycle as the discontinuation date. For patients with multiple lapatinib exposure periods throughout follow-up, we assessed the frequency of testing and incidence of LFT elevations only during the first exposure period. While this created a more homogenous new users population, it does decrease the overall length of follow-up exposure time evaluated. Though we excluded patients that initiated lapatinib between January 1, 2008 and July 8, 2008 since these months represent a time of transition while GSK finalized the label change wording and initiated communication activities (such as Dear Doctor letters) to educate physicians about the impending label change, patients initiating lapatinib very late in the pre-label period may contribute some follow-up time after their treating physician began to learn about the new LFT recommendations. Overall, this is likely to be a small proportion of the overall pre-label group. Outcome assessment Any liver function tests occurring outside of the US Oncology participating clinics and cancer centers were not captured in this study. For example, patients who experienced a mid to high level elevation may be referred to hepatologists for follow-up. As well, testing performed as part of in-patient hospital care would not be included. The inability to observe person time after hepatologist referral or during hospitalization may cause some underestimation in the incidence rate, especially of elevations at higher ULN thresholds. Missing ULN values for lab data occurred in about 4% of patients, however this was rectified in all cases by using the average ULN of overall labs as a referent. Study Results for LFT analysis Demographics/Baseline Characteristics: A total of 396 female metastatic breast cancer patients: 128 (32%) pre-label and 268 (68%) post-label with a median age at diagnosis of 56.4 years. Nine percent of patients who received lapatinib were HER2-negative, and 14% were missing HER2 status. The only clinical characteristic that differed significantly between the two groups was stage at initial diagnosis, with more post-label patients initially diagnosed with Stage IV cancer than pre-label patients (38% vs. 30%, respectively). Although not statistically significant, there was a trend towards physicians using lapatinib earlier in the metastatic experience, with 17% of post-label vs. 8% of pre-label patients receiving lapatinib as part of their 1 st line metastatic regimen. patients had longer median lapatinib exposure time than post-label patients (73 days vs. 53 days). Furthermore, 28% of pre-label patients compared to 38% of post-label patients were exposed to lapatinib for <6 weeks. Results of Objective 1: Determine if physicians perform LFTs prior to prescribing lapatinib (baseline) patients were statistically significantly more likely than pre-label patients to be tested within 30 days prior to initiating lapatinib (82% vs 63%) (Table 1). 3

4 Table 1. Proportion of patients tested within 30 days prior to initiating lapatinib (index date) LFT Labs (n=128) (n=268) p-value ALT (U/L) 63% 81% <.0001 AST (U/L) 64% 82% ALP (U/L) 63% 82% <.0001 BILI (mg/dl) 63% 82% <.0001 Results of Objective 2: Describe prevalence of LFT elevations at baseline The prevalence of LFT elevation was extremely rare, with no pre-label patients and only 4(1.8%) post-label patients having an ALT>3x ULN (Table 2). One post-label patient had a severe ALT elevation above 8x ULN. Table 2. Prevalence of liver function elevations within 30 days prior to index date Elevated LFT n (%) (95% CI) n (%) (95% CI) ALT > 3x ULN 0-4 (1.8%) 0.5%-4.6% ALT > 5x ULN 0-2 (0.9%) 0.1%-3.3% ALT > 8x ULN* 0-1 (0.5%) 0.0%-2.5% * This threshold was used to define severe elevation Results of Objective 3: Determine if physicians perform LFTs routinely after prescribing lapatinib The frequency of screening in the initial 6-week exposure period was high, with about 68% of pre-label patients and 81% of post-label patients tested (Table 3). Table 3. Proportion* of patients tested at least once for ALT during each 6 week interval after lapatinib prescription 6-wk exposure time interval after start of lapatinib prescription 0 to <6 weeks 68% 81% 6 to <12 weeks 73% 81% 12 to <18 weeks 73% 82% 18 to <24 weeks 62% 83% 24 to <30 weeks 63% 88% 30 to <36 weeks 61% 86% 36 to <42 weeks 82% 93% 42 to <48 weeks 86% 89% 48+ weeks 100% 88% * Identical pattern for other LFTs: AST, ALP, and BILI Results of Objective 4: Describe cumulative incidence and incidence rate of LFT elevations among lapatinib users Across all thresholds, the cumulative incidence and incidence rates were approximately similar between pre- and postlabel groups, including severe elevation classified as ALT>8x ULN (Table 4). However, the post-label group had a higher rate of the ALT>3x ULN plus BILI>2x ULN combination (2.3% vs. 1.1%) and a lower rate of possible Hy s Law combination (0.5% vs. 2.1%). Table 4. Cumulative incidence and incidence rate of LFT elevations while exposed to lapatinib (among patients with at least one test during follow-up) Elevated LFT n (%) IR a (95% CI) n (%) IR a (95% CI) ALT > 3x ULN 3 (3.2%) 8.0 (0.2, 2.3) 9 (4.1%) 12.5 (5.7, 23.8) ALT > 5x ULN 2 (2.1%) 5.3 (0.06, 1.9) 4 (1.8%) 5.5 (1.5, 14.1) ALT > 8x ULN* 0-1 (0.5%) 1.4 (0.03, 7.7) Possible Hy s Law combination b * 2 (2.1%) 5.1 (0.6, 18.5) 1 (0.5%) 1.4 (0.03, 7.7) 4

5 Other LFT combination c 1 (1.1%) 2.6 (0.1, 14.7) 5 (2.3%) 6.9 (2.2, 16.0) a Incidence rate per 1000 person-months b Hy s Law combination: AST or ALT 3x ULN + BILI 2x ULN + ALP<2x ULN c Other LFT combination: ALT>3x ULN + BILI>2x ULN * These thresholds were used to define severe elevations Results of Objective 5: Describe patients that experienced severe LFT elevations during lapatinib exposure and the proportion that have lapatinib discontinued During follow-up, only 4 patients experienced severe LFT elevation: 2 pre-label patients temporarily discontinued lapatinib within 30 days of severe elevation but resumed at a later date and 2 post-label patients with complete discontinuation within 30 days of elevation. Due to small numbers, no statistical testing of differences was conducted. Conclusion: This study provides real world evidence that physician adherence to the guidelines for conducting LFTs prior to prescribing lapatinib, and routinely during lapatinib exposure, improved after the addition of detailed guidance on liver function testing to the Prescribing Information. The post-label group was statistically significantly more likely to be tested within 30 days prior to the initiation of lapatinib than the pre-label group (81-82% vs %), and the fairly high level of testing overall among the two groups suggests that LFT testing may be an integral part of routine oncology care protocols. Likewise, when examining the occurrence of testing within each six week interval after the index date, the frequency of regular testing was higher among postlabel patients compared to pre-label levels, regardless of the length of exposure. Further, the frequency of testing did not diminish substantially with long lapatinib exposure times, again, suggesting that routine screening is likely a routine part of oncology care. With only four patients experiencing severe LFT elevations in this population, it is not possible to draw firm conclusions about whether the Prescribing Information guidance to permanently discontinue lapatinib when severe elevations occur were as closely followed. Also, we cannot be certain that the subsequent discontinuation was due solely to LFT elevation, since detailed information on the reason for discontinuation was not collected. The potential role of other factors may have influenced physician behaviors. Firstly, clinical difference between pre- and post-label groups may play a role. For example, post-label patients were more likely to be diagnosed with Stage IV disease and it is possible that physicians are more diligent about testing patients at advanced stages of the disease. However, stage did not appear as an independent predictor of testing before or during lapatinib use. The presence of liver metastases or liver co-morbidities may also be markers for more frequent testing, however the two groups did not differ with regard to the frequency of these events, and again, they were not significant independent predictors of testing. Secondly, the uptake of tyrosine kinase inhibitors in cancer care was increasing during the study period and information about the efficacy and safety of these drugs was becoming widespread in the literature and at professional congresses. Therefore, physicians may have learned about hepatic related side effects of lapatinib, or other drugs in the class, through these learning opportunities. Despite some limitations in exposure and outcome assessments, this study has several strengths including the use of a large, population based data source of nearly 400 lapatinib users, which allows for the assessment of compliance to LFT testing in the real world, community practice setting. An EMR database can be ideal for this type of study and this specific EMR had known comprehensiveness that resulted in a high capture of relevant clinical and laboratory data. As a cancer specific database, the US Oncology database also allows for the creation of a demographic and cancer profile of real world lapatinib users. This data was useful in determining if any key characteristics are associated with the various compliance steps being evaluated in this study. The pre-label/post-label study design utilized for this study provides an opportunity to assess the impact of inclusion of detailed LFT monitoring recommendations on physician behavior. 5

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