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BACKGROUND. ImRx for CML is a long-term treatment. Patterns and prevalence of NA to ImRx remain largely unknown. Short-term NA trends may be indicative of long-term NA. Methods for clinical NA assessment vary in reliability. A multimethod approach is indicated. OBJECTIVE. Multimethod estimation of patterns and prevalence of ImRx NA in CML pts at baseline (BL) and follow-up (FU) at 90 days (90d), incl. BL to 90d changes. DESIGN AND PATIENTS. Data subset from prospective, 90d observational, open-label, multicenter study. 169 evaluable pts on ImRx for minimum 30d at enrollment [1]. METHODS OF NA ASSESSMENT. At BL (NA with prior ImRx) and 90d (NA during study): visual analog scale (VAS) for physicians (phs; mVAS), pts (pVAS), cos (cVAS); Basel Assessment of Adherence Scale for pts (pBAAS; structured interview re NA in past 4 weeks [4wks]); pts reported persistence (pPST); % clinic appointments (%CAPPTS) kept (if any scheduled). At 90d also: % of ImRx taken per pill count (%pts@ImRx). RESULTS. See Table 1. CONCLUSIONS. Intuitive adherence ratings (VAS) by phs, pts, and cos are very high and differ from those from structured interview, where about one-third of patients exhibited NA behavior in 4wks prior to BL and FU - despite high persistence. Pill count suggests patterns of under- and overtaking, with only 1 out 7 patients being perfectly adherent. Rate of clinic appointments may be affected by physician scheduling practices and collateral input is a function of availability of collateral person. Consenting to participate in the ADAGIO study did not reduce NA. Though patient self-reports in structured interview (pBAAS) and pill counts have inherent biases, both indices suggest that NA with ImRx may be similar to NA rates in other disease categories. Especially pBAAS and pill count may be useful rapid clinical assessment tools, with pBAAS having the benefit of validated categorical assessment (vs. continuous in other methods). Determinants of NA and the impact of NA on treatment outcomes must be examined. Table 1 - Multimethod Assessment of Non-Adherence with Imatinib Method BL 90d n M±SD/Min-Max M±SD/Min-Max P mVAS 164 95.0±7.6/60–100 94.9±9.9/0–100 ns pVAS 169 95.3±8.5/25–100 95.7±6.1/75–100 ns cVAS 56 97.1±5.1/80–100 97.4±5.1/75–100 ns %pts@ImRx 162 - 91.0±21.1/29.5–2002.2 71.0% @ < 100% ImRx 14.2% @ 100% ImRx n % NA % NA P pBAAS 163 36.2% 32.5% ns %CAPPTS 51 94.1% 88.2% 0.001 pPST 163 98.8% 100.0% ns

BACKGROUND. ImRx for CML is a long-term treatment potentially compromised by NA. Identifying APVs may assist in reducing NA and optimizing treatment outcomes. OBJECTIVE. To model the relationships between two NA measures and selected APVs using CCA, a multivariate analog of multiple regression to accommodate multiple criterion variables. DESIGN AND PATIENTS. Data subset from prospective, 90d observational, open-label, multicenter study. 169 evaluable pts on ImRx for minimum 30d at enrollment [1]. MEASUREMENTS. NA at 90d vector: Basel Assessment of Adherence Scale for pts (pBAAS; 0/1 with 1=NA); and % of ImRx taken per pill count (%ImRx, subtracted from 100 to reflect NA). APVs at BL vector: age; months since CML diagnosis (mCML); months since ImRx initiation (mImRx); knowledge of CML disease, treatment, and ImRx (KCMLRx); and general health (SF-8). RESULTS. The criterion (dependent) vector of NA indicators included pBAAS and %ImRX. The predictor (independent) vector of APVs included: age, mCML, mImRx, KCMLRx, and SF-8. Two canonical correlations were generated: 0.389 (Bartlett Chi-squared=23.564, P=0.009) and 0.170 (Bartlett Chi-squared= 3.590, P=0.464); the second correlation was deleted due to nonsignificance from zero. The canonical loadings (or structure coefficients) for the retained model were: age 0.951, mCML 0.205, mImRx 0.145, SF-8 0.016, and KCMLRx -0.367. Redundancy analysis showed that 22.1% of variance in the predictor set was explained by variables within that set. CONCLUSIONS. The patient NA vector (composed of a binary assessment of NA per pBAAS 0/1 with 1=NA) and continuous quantification of % of ImRx not taken was related to the APV vector as follows: NA increased as patients were older, had been diagnosed with CML for a longer period of time, had been on imatinib treatment for a longer period time, and were in slightly better health at enrollment. These may be considered warning signs for NA for clinicians to consider in practice, given the long-term nature of ImRx. Importantly, better patient knowledge of disease and treatment, a clinically modifiable APV, was associated with a decrease in NA. The initial insights in patient NA with ImRX provided by these findings, though some are counterintuitive to the NA literature at large, must be studied further to better understand the dynamics of NA in the CML population.

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BackgroundEverolimus in combination with exemestane is indicated for the treatment of hormone receptor-positive, HER 2-neg endocrine resistant advanced breast cancer in postmenopausal women. This study investigated treatment adherence, tolerability, satisfaction and efficacy. MethodsA prospective, non-interventional, non-controlled, multicentric observational study assessed adherence by means of a validated questionnaire (‘Morisky Medication Adherence Scale’) and ‘Medication Event Monitoring System’ (MEMS®) data. The level of adherence was calculated per patient as percentage of days on which the medicine was taken as prescribed during the total treatment period, referred to as ‘unadjusted adherence rate’ (UAR). Second, MEMS® data were adjusted for treatment interruptions according to the CRF and questionnaire data, approved by the treating physician (‘adjusted adherence rate’ (AAR)). Successful adherence was defined as ≥ 95% – ≤ 105%. Validated questionnaires (‘Patient Satisfaction with Cancer Treatment Education’, ‘Cancer Treatment Satisfaction Questionnaire’ (CTSQ) and ‘Functional Assessment of Cancer Therapy – General’ (FACT-G) were used to report patients experience and satisfaction with the treatment and perceived care, questioned at initial visit and after approximately 1, 3, 6 and 12 months. The efficacy was primary analyzed through progression free survival (PFS). ResultsBetween Dec 2015 and Nov 2017, a total of 58 women (median age 65 yrs) from 7 oncology centers were included after a mean of 34m ± 36.9 (SD) of being diagnosed with stage IV disease; most (62.1%) had ≥3 organs involved and 84.5% had ≥2 prior metastatic treatment lines. The mean follow-up duration was 185.5 ± 100.0 days. The mean UAR for exemestane, everolimus and the combination were 92.9 %, 84.8 % and 81.7 % respectively. For everolimus and the combination therapy these rates differ significantly from the mean AAR, with p &lt; 0.05 (see table 1). For the AAR of the combination therapy, 13.8 % of the patients showed optimal adherence (100 %). Six patients (10.3%) interrupted their treatment with exemestane with a mean time of treatment pause of 34.3 ± 19.1 days. The treatment with everolimus was interrupted by 36 (62.1%), with a mean interruption time of 24.3 ± 16.5 days, which corresponds with a mean of 19.6 % ± 17.6% of the total follow-up duration. Some patients interrupted their treatment multiple times. The most common side effect was mucositis (n=26 at 1 month, of whom 8 patients grade 3 and 15 patients grade 2)). Six (10.4 %) of the 58 patients stopped treatment with everolimus and exemestane due to side effects. The median PFS was 170 days. With regard to quality of life, patients scored lowest on emotional and functional well-being. However, there were no significant differences measured for the mean FACT-G score between Day0, M1 and M3 (P = 0.273). Also, patients scored overall low on the ‘CTSQ’. Conclusion Despite close monitoring and preventive measures to overcome side effects, adherence to everolimus and exemestane was rather low. Many patients needed to interrupt the treatment due to side effects; treatment is perceived as intensive. Nevertheless, median PFS is 170 days, even when used late in the therapeutic journey of breast cancer patients. Table 1. UAR and AAR for Exemestane, Everolimus and the combinationExemestaneEverolimusCombination therapyUAR (%)mean ± SD92.97 ± 13.1784.86 ± 19.4081.74 ± 20.98AAR (%)mean ± SD93.07 ± 13.1491.81 ± 15.0487.55 ± 18.17Significance differenceP-value0.277&lt; 0.001&lt; 0.001 Citation Format: Veerle Foulon, Carrie Visser, Sandra De Coster, Lise-Marie Kinnaer, Ellen Reynders, Anne Deblander, Patrick Berteloot, Kevin Punie, Hans Wildiers, Véronique Cocquyt, Hannelore Denys, Ahmad Awada, Eric Strobbe, Andrea Gombos, Isabelle Spoormans, Ximena Elzo-Kraemer, Christof Vulsteke, Marleen Borms, Philip Debruyne, Wim Wynendaele, Patrick Neven. Adherence to and patient satisfaction with the combination therapy of exemestane and everolimus in postmenopausal women with HR+ HER2- advanced breast cancer: Results from the IPSOC-mamma study [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PS9-06.