Abstract Background: In premenopausal women with breast cancer any treatment that causes abrupt, premature ovarian failure increases the risk of sexual problems. Randomized-controlled trials in this population reported a worsening in sexual functioning over time irrespective of adjuvant endocrine treatment. We investigated key symptoms related to endocrine therapy, depression and age as predictors of sexual problems in premenopausal women with early breast cancer treated in the IBCSG TEXT/SOFT trials over the first two years of endocrine therapy. Methods: A subset of patients (pts) enrolled by centers with English as primary language to TEXT (1027 of 2672 pts) and SOFT (1260 of 3066 pts) completed a questionnaire consisting of global and symptom-specific quality of life indicators, the CES-Depression (CES-D) and the MOS- Sexual Problems (MOS-SP) measures at baseline, 6, 12 and 24 months. The analysis considered 5 cohorts of pts according to chemotherapy use (yes/no), trial (SOFT/TEXT) and endocrine treatment assignment (tamoxifen alone [T], T or exemestane [E] with ovarian function suppression [OFS]). Mixed modeling was used to test the effect of the following on changes in sexual problems (MOS-SP total score) over two years: changes in treatment-induced symptoms (hot flushes, vaginal dryness, sleep disturbances, bone/joint pain, troubled by weight gain, tiredness, nausea/vomiting) from baseline to 6 months; depression at 6 months; and age at randomization. The model included severity groups of symptoms, depression (all dichotomized by median) and age (< 40 vs ≥40 years), 5 cohorts, time points (6, 12, 24 months), baseline covariates, and interactions of symptoms, timepoints and cohorts. Results: Overall across cohorts, pts with more severe worsening of vaginal dryness and sleep disturbances at 6 months reported a greater increase in sexual problems at all timepoints (p<.0001). The effect of vaginal dryness on sexual problems was most pronounced in the cohort of pts who received T+OFS or E+OFS without chemotherapy; the effect of sleep disturbances was most pronounced in the cohort with prior chemotherapy and T alone. All other symptoms had a smaller impact on differences in changes of sexual problems. Significant effects were only seen in the short-term and varied according to cohort. Severity of depression at six months did not predict sexual problems at the later timepoints in the overall population. In the cohort that received T+OFS or E+OFS without chemotherapy, pts who had more severe depression scores at 6 months reported significantly worse sexual problems at all timepoints (p<.05). No differences were found for younger vs. older pts with respect to sexual problems at any timepoint. Conclusion: Among several key symptoms related to endocrine therapy, only vaginal dryness and sleep disturbances significantly predicted sexual problems during the first two years in pts who received adjuvant endocrine therapy with or without chemotherapy. Depression predicted sexual problems only in the cohort of pts who received combined endocrine treatment without chemotherapy. Early identification of vaginal dryness, sleep disturbances and depression is important for timely and tailored interventions. Citation Format: Ribi K, Luo W, Burstein HJ, Naughton MJ, Chirgwin J, Ansari RH, Walley BA, Salim M, van der Westhuizen A, Abdi E, Francis PA, Budman DR, Kennecke H, Harvey VJ, Giobbie-Hurder A, Fleming GF, Pagani O, Regan MM, Bernhard J. The effects of treatment-induced symptoms, depression and age on sexuality in premenopausal women with early breast cancer receiving adjuvant endocrine therapy [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P2-09-09.
503 Background: In animal models of hormone receptor positive (HR+) breast cancer, acquired resistance to continued letrozole was shown to be reversed by estrogen-induced apoptosis. Sensitization to reintroduction of estrogen withdrawal by letrozole was hypothesized to improve treatment outcome. SOLE tested the hypothesis that 3 mos treatment-free intervals during extended adjuvant therapy will improve disease-free survival (DFS). Methods: SOLE enrolled 4884 postmenopausal women with HR+ lymph node-positive BC who had completed 4-6 yrs of adjuvant endocrine therapy (19% SERM, 43% AI, 38% both; stratification factor). Pts were randomly assigned to an additional 5 yrs continuous letrozole (2.5 mg daily; n = 2441) vs 5 yrs intermittent letrozole (taken for the first 9 mos of yrs 1-4, and 12 mos in yr 5; n = 2443). The primary endpoint was DFS (randomization until invasive local, regional, distant recurrence or contralateral BC; 2nd malignancy; death). Final analysis was at 665 DFS events, after 2 interim analyses. SOLE required 4800 pts for 80% power to detect a 20% DFS hazard reduction with 2-sided α = 0.05 using a stratified log rank test. Analysis is by intention-to-treat. Results: At 60 mos median follow-up, 5 yr DFS from randomization was 85.8% vs 87.5% for patients assigned intermittent vs continuous letrozole (HR = 1.08; 95% CI 0.93-1.26; P = 0.31). Similar outcome was observed for breast cancer-free interval (HR = 0.98; 95% CI 0.81-1.19), distant recurrence-free interval (HR = 0.88; 95% CI 0.71-1.09), and overall survival (HR = 0.85; 95% CI 0.68-1.07). AEs of grade > 3 were reported for 43.5% vs 41.6% of pts assigned intermittent vs continuous letrozole. Overall 24% pts discontinued letrozole early in both groups. Conclusions: Among postmenopausal women with HR+ BC, extended intermittent letrozole did not improve DFS vs continuous letrozole. The similar observed outcomes and incidence of AEs provides clinically relevant information on the intermittent administration of extended letrozole for patients who could benefit from temporary treatment breaks. Clinical trial information: NCT00553410.
Caregivers have been largely neglected in health literacy measurement. We assess the construct validity, and internal consistency of the Health Literacy of Caregivers Scale–Cancer (HLCS-C), and present a revised, psychometrically robust scale. Using data from 297 cancer caregivers (12.4% response rate) recruited from Melbourne, Australia between January–July 2014, confirmatory factor analysis (CFA) was conducted to evaluate the HLCS-C's proposed factor structure. Items were evaluated for: item difficulty, unidimensionality and overall item fit within their domain. Item-threshold-ordering was examined though one-parameter Item Response Theory models. Internal consistency was assessed using Raykov's reliability coefficient. CFA results identified 42 poorly performing/redundant items which were subsequently removed. A 10-factor model was fitted to 46 acceptable items with no correlated residuals or factor cross-loadings accepted. Adequate fit was revealed (χ2 WLSMV = 1463.807[df = 944], p < .001, RMSEA = 0.043, CFI = 0.980, TLI = 0.978, WRMR = 1.00). Ten domains were identified: Proactivity and determination to seek information; Adequate information about cancer and cancer management; Supported by healthcare providers (HCP) to understand information; Social support; Cancer-related communication with the care recipient (CR); Understanding CR needs and preferences; Self-care; Understanding the healthcare system; Capacity to process health information; and Active engagement with HCP. Internal consistency was adequate across domains (0.78–0.92). The revised HLCS-C demonstrated good structural, convergent, and discriminant validity, and high internal consistency. The scale may be useful for the development and evaluation of caregiver interventions.
Abstract Background: SOLE efficacy results presented at ASCO 2017 showed that extended intermittent vs continuous letrozole for 5 years did not improve disease-free survival in postmenopausal women who had received 4-6 years of adjuvant endocrine therapy for hormone-receptor positive (HR+), lymph-node positive breast cancer. Previous studies showed that the burden by symptoms related to endocrine therapy can be substantial. Even if symptoms improve during the treatment course, extending treatment implies continuation of symptoms. We compared differences in patient-reported symptoms (PRS) and quality of life (QoL) between extended continuous and intermittent letrozole over the first two years of trial treatment. Methods: From Nov 2007 to Dec 2010, 956 postmenopausal women who were disease-free following 4-6 years of prior adjuvant endocrine therapy for HR+, node-positive breast cancer were enrolled in the QoL substudy of the randomized phase III trial SOLE at selected centers. Patients receive extended continuous letrozole (2.5 mg daily) for 5 years or intermittent letrozole, taken for the first 9 months of years 1-4, and 12 months in year 5. 955 patients completed the 18-item Breast Cancer Prevention Trial (BCPT) Symptom Scales and further symptom-specific and global QoL indicators at baseline, and at 6, 12, 18 and 24 months after randomization. Differences in change of PRS and QoL from baseline between the two administration schedules were tested at 12 and 24 months for 8 symptom scales, 4 additional symptom and 4 global QoL indicators using mixed models with repeated measures. Results: Small changes in PRS and QoL scores were observed between baseline and 12 months after randomization, i.e. at the end of the first treatment-free interval in the intermittent arm. These changes showed a consistent pattern of greater worsening for patients receiving continuous compared to patients receiving intermittent letrozole. Patients receiving continuous letrozole reported a significantly greater worsening in vaginal problems (p<.02), musculoskeletal pain (p<.03), sleep disturbance (p<.01), physical wellbeing (p<.01) and mood (p<.03). At 24 months (after 2nd treatment-free interval) patients with intermittent letrozole reported a greater improvement in hot flushes (p<.03) than those with continuous letrozole. Changes in the other outcomes did not significantly differ between arms at 24 months. Conclusion: Although changes in PRS and QoL were small, there was a consistent pattern favoring the intermittent arm. For several symptoms and global QoL indicators, significantly less worsening was observed with the intermittent administration, mainly during the first year of extended treatment, due to small improvements during the treatment-free interval. Froma QoL perspective, women who suffer from endocrine side-effects in the extended setting may benefit from an intermittent administration. Citation Format: Ribi K, Luo W, Colleoni M, Karlsson P, Chirgwin J, Aebi S, Jerusalem G, Neven P, Di Lauro V, Gomez HL, Ruhstaller T, Abdi E, Di Leo A, Müller B, Maibach R, Gelber RD, Goldhirsch A, Coates AS, Regan MM, Bernhard J. Extended continuous vs intermittent adjuvant letrozole in postmenopausal women with lymph node-positive, early breast cancer (IBCSG 37-05/BIG 1-07 SOLE): Impact on patient-reported symptoms and quality of life [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P5-18-01.
Abstract Objectives Industry‐supported decision impact studies demonstrate that Oncotype Dx (ODX) changes treatment recommendations (TR) in 24–40% of hormone receptor+/HER2− patients. ODX is not reimbursed by third‐party payers in Australia, potentially resulting in more selective use. We sought to evaluate the impact of self‐funded ODX on TRs. Methods Data collected included demographics, tumor characteristics, indication for ODX and pre‐ and post‐recurrence score (RS) TR. Primary endpoint was frequency of TR change and associations with TR change were sought. Results Eighteen physicians contributed 382 patients (median age 54). A total of 232 (61%) of tumors were T1 and were grade 1, 2 and 3 in 49 (13%), 252 (66%) and 79 (21%). A total of 257 (67%) were node negative. Assay indications were: confirm need for chemotherapy (CT) (36%), confirm omission of CT (40%) and genuine equipoise (24%). RS was low (≤17) in 55%, intermediate (18‐31) in 36% and high (≥32) in 9%. Thirty‐eight percent of patients had TR change post‐ODX. Sixty‐five percent of patients recommended CT pre‐ODX changed to hormone therapy alone (HT)—more likely if lower grade and if ER and/or PR > 10%. Fourteen percent of patients with pre‐ODX TR for HT added CT—more likely if ER and/or PR ≤10% and if Ki67 > 15% Overall, TR for CT decreased from 47% to 24%. Conclusion Patient‐funded ODX changed TRs in 38% of patients, de‐escalating 65% from CT to HT and adding CT to 14% of those recommended HT. These changes were greater than an industry‐funded study suggesting that physicians can identify situations where the assay may influence decisions.
Abstract Background: An Australian industry-funded decision impact study demonstrated that Oncotype Dx (ODX) changed treatment recommendations (TR) in 24% of hormone receptor+/HER2- patients. ODX is available in Australia, but is self-funded by patients (∼USD 4175), so its use is limited. We sought to evaluate the impact of self-funded ODX on TRs. A high proportion of TR changes would imply a benefit to the broader community if ODX testing were available to all appropriately selected patients. Methods: All Australian physicians who had ordered >5 ODX were invited to participate. Data collected included demographics, tumor characteristics, indication for ODX (confirm need for chemotherapy (CT), confirm omission of CT, or genuine equipoise). Pre- and post Recurrence Score (RS) TRs (CT recommended versus hormone therapy alone (HT)) were also collected. The primary endpoint was the frequency and predictors of TR change. Relationships between categorical variables were assessed using Chi2 test and logistic regression analysis determined factors associated with TR change post-ODX. Results: 382 patients with median age 54 (range 31-76) were included. 18 physicians contributed a median of 17 (5-87) patients. Tumor characteristics were: T1 232 (61%); ≥T2 150 (39%); grade 1 49 (13%), grade 2 252 (66%) and grade 3 79 (21%) and Ki67>15% in 131/231 (49%). 257 (67%) were node negative (N0). Assay indications were: confirm need for CT in 36%, confirm omission of CT in 40% and genuine equipoise in 24%. RS was low in 55%, intermediate in 36% and high in 9%. Of 355 patients with a TR recorded pre-ODX, 38% had TR change post-ODX. 109/168 patients (65%) recommended CT pre-ODX changed to HT alone, and this was more likely if lower grade (82.1% vs 50.8% p<0.001) and less likely if ER and/or PR≤10% (12% vs 25% p=0.03). 27/187 (14%) with pre-ODX TR for HT alone changed to CT, and this was more likely if ER and/or PR≤10% (27.6% vs 11.5% p=0.02) and if Ki67 >15% (27.5% vs 9.8% p=0.015). Overall, TR for CT decreased from 47% to 24%. Influence of adverse prognostic factors (defined as ≥T2, grade 3, ER and/or PR <10%, nodal macrometastasis) on TR is tabulated. In 348 patients with complete data, TR changed in 31% (72/234) of N0 and 53% (60/114) of node positive (N+) patients. Number of "adverse factors"01234N0 (n=234)Number of patients90116244 RS median (range)16 (0-40)17 (0-41)26 (5-52)31 (22-40) TR change19/90 (21%)45/116 (39%)6/24 (25%)2/4 HT to CT7/71 (10%)10/61 (16%)2/11 (18%)1/2 CT to HT12/19 (63%)35/55 (64%)4/13 (31%)1/2 N+ (n=114)Number of patients22424181 RS median (range)14 (5-34)16 (0-38)14 (0-32)24 (12-50)39 TR change11/22 (50%)21/42 (50%)25/41 (42%)3/8 (38%)0/1 HT to CT3/13 (23%)3/14 (21%)0/12NANA CT to HT8/9 (89%)18/28 (64%)25/29 (86%)3/7 (43%)0/1 Conclusions: Patient self-funded ODX changed TRs in 38%. 65% who would have been recommended CT pre-ODX were spared CT post-ODX, suggesting that traditional histopathological indications for CT in ER+ patients has led to many receiving CT unnecessarily. Where the pre ODX TR was HT alone, only 14% changed to adding CT, suggesting that the indication was reassurance that CT could be omitted. Consideration could be made for third party funding in select patient groups. Citation Format: Chin-Lenn L, Segelov E, De Boer R, Marx G, Hughes TM, McCarthy N, White S, Foo S, Rutovitz J, Della Fiorentina S, Jennens R, Antill Y, Tsoi D, Cronk M, Lombard J, Kiely BE, Chirgwin J, Gorelik A, Mann GB. Indications for, and impact of oncotype DX on adjuvant treatment recommendations when third party funding is unavailable. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr P5-15-02.
Background 'Taste' changes are commonly reported during chemotherapy. It is unclear to what extent this relates to actual changes in taste function or to changes in appetite and food liking and how these changes affect dietary intake and nutritional status. Patients and methods This prospective, repeated measures cohort study recruited participants from three oncology clinics. Women (n = 52) prescribed adjuvant chemotherapy underwent standardised testing of taste perception, appetite and food liking at six time points to measure change from baseline. Associations between taste and hedonic changes and nutritional outcomes were examined. Results Taste function was significantly reduced early in chemotherapy cycles (p<0.05) but showed recovery by late in the cycle. Ability to correctly identify salty, sour and umami tastants was reduced. Liking of sweet food decreased early and mid-cycle (p<0.01) but not late cycle. Liking of savory food was not significantly affected. Appetite decreased early in the cycle (p<0.001). Reduced taste function was associated with lowest kilojoule intake (r = 0.31; p = 0.008) as was appetite loss with reduced kilojoule (r = 0.34; p = 0.002) and protein intake (r = 0.36; p = 0.001) early in the third chemotherapy cycle. Decreased appetite early in the third and final chemotherapy cycles was associated with a decline in BMI (p = <0.0005) over the study period. Resolution of taste function, food liking and appetite was observed 8 weeks after chemotherapy completion. There was no association between taste change and dry mouth, oral mucositis or nausea. Conclusion The results reveal, for the first time, the cyclical yet transient effects of adjuvant chemotherapy on taste function and the link between taste and hedonic changes, dietary intake and nutritional outcomes. The results should be used to inform reliable pre-chemotherapy education.
e20536 Background: "Taste changes" are commonly reported by people receiving chemotherapy. It is unclear to what extent this relates to altered taste function or changes to other aspects of the eating and drinking experience such as food liking or appetite. Methods: Women (n = 52) prescribed adjuvant chemotherapy underwent testing of taste perception, appetite and food liking before, during and after chemotherapy. Taste sensitivity was measured by correct or incorrect identification of prototypical tastants sweet, salt, sour, bitter and umami. Perceived intensity of each tastant was measured on a 10cm Visual Analogue Scale. Liking of standard sweet and savory foods was measured on the 9-point hedonic scale. Appetite was measured on a 10-point scale. McNemar’s test was used to determine whether proportion of correctly identified tastants changed significantly from baseline at follow-up assessments. Mixed-effects models were used to estimate and test change in mean taste intensity, food liking and appetite from baseline at follow-up assessments. Results: Significant adverse effects were observed for taste identification, liking of sweet food and appetite close to chemotherapy administration. Notably different patterns of change were observed for identification of individual tastants. Conclusions: The demonstrated changes in taste function and food hedonics could be used to guide pre-chemotherapy education and have implications for dietary choice and nutritional outcomes. [Table: see text]
Abstract Background Smartphone technology represents an opportunity to deliver practical solutions for people affected by cancer at a scale that was previously unimaginable, such as information, appointment monitoring, and improved access to cancer support services. This study aimed to determine whether a smartphone application (app) reduced the unmet needs among people newly diagnosed with cancer. Methods A single blind, multisite randomized controlled trial to determine the impact of an app‐based, 4‐month intervention. Newly diagnosed cancer patients were approached at three health service treatment clinics. Results Eighty‐two people were randomized (intervention; n = 43 and control; n = 39), average age was 59.5 years (SD: 12.9); 71% female; 67% married or in a de facto relationship. At baseline, there were no differences in participants’ characteristics between the groups. No significant effects, in reducing unmet needs, were demonstrated at the end of intervention (4‐month) or 12‐month follow‐up. Overall, 94% used the app in weeks 1‐4, which decreased to 41% in weeks 13‐16. Mean app use time per participant: Cancer Information, 6.9 (SD: 18.9) minutes; Appointment Schedule, 5.1 (SD: 9.6) minutes; Cancer Services 1.5 minutes (SD: 6.8); Hospital Navigation, 1.4 (SD: 2.8) minutes. Conclusions Despite consumer involvement in the design of this smartphone technology, the app did not reduce unmet needs. This may have been due to the study being underpowered. To contribute to a meaningful understanding and improved implementation of smartphone technology to support people affected by cancer, practical considerations, such as recruitment issues and access to, and confidence with, apps, need to be considered. Australian New Zealand Clinical Trials Registration (ACTRN) Trial Registration: 12616001251415; WEF 7/9/2016.
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