Validation of the Croatian and Lebanese Revised Illness Perception Questionnaires for Healthy People (IPQ‐RH)

The absence of Croatian‐ and Arabic‐language measures to assess illness representations has contributed to lack of research among Croatian and Lebanese populations. Utilising the robust confirmatory factor analysis (CFA) approach, this study aimed to validate Croatian and Arabic versions of the Revised Illness Perception Questionnaire for Healthy People (IPQ‐RH) in the breast and cervical cancer contexts, and compared these illness perceptions among Croatian and Lebanese women living in Australia. Forward and back‐translated versions of the IPQ‐RH were administered in Croatian to Croatian‐born (n = 238), and Arabic to Lebanese‐born (n = 240) women. The IPQ‐RH illness perceptions were assessed for each cancer type, and the Negative Affect (NA) subscale of the Positive and Negative Affect Schedule (PANAS) assessed discriminant validity. The CFA method demonstrated acceptable models across the Croatian and Lebanese IPQ‐RH measures. The internal reliabilities for the IPQ‐RH subscales were adequate and the subscales had low correlations with the NA subscale of the PANAS, indicating that the IPQ‐RH measures are largely distinguishable from negative affective dispositions. These findings demonstrate that the Croatian and Lebanese IPQ‐RH breast and cervical cancer measures have a factor structure similar to the originally developed IPQ‐RH scale and provide further support for the theoretically developed illness representations.     

Validation of the Chinese version of the short-form Supportive Care Needs Survey Questionnaire (SCNS-SF34-C)

Background: There is no instrument available in Chinese for assessing psychosocial needs. This study aimed to assess the validity and reliability of the Chinese version of the Supportive Care Needs Survey short form (SCNS‐SF34‐C) in Chinese women with breast cancer (BC). Methods: The Chinese version of the 34‐item SCNS‐SF34‐C, a self‐report measure for assessing psychosocial unmet needs, was administered to 348 Chinese women with BC at the outpatient oncology unit. Exploratory factor analysis (EFA) tested the factor structure. The internal consistency, convergent, divergent, and discriminant validity of the identified factor structure were assessed. Results: In contrast to the five‐factor structure identified in the original 34‐item SCNS‐SF34, our EFA produced a 33‐item solution accounting for 54% of score variance comprising four‐factors: (1) Health system, information, and patient support, (2) Psychological needs, (3) Physical and daily living, and (4) Sexuality needs. Separate dimensions for Health system and information, and the Patient care and support domains were not supported. Cronbach alphas ranged from 0.75 to 0.92. Correlations of psychological and physical symptom distress measures indicated acceptable convergent validity. No correlation with optimism and positive affect measures indicated divergent validity. Discriminant validity was demonstrated by effective differentiation between clinically distinct patient groups (no active treatment versus active treatment; advanced BC versus localized BC). Discussion: The Chinese version of the Supportive Care Needs Survey has suitable factor structure and psychometric properties for use in assessing psychosocial needs among Chinese women with BC. Further validation is needed for other cancer types. Copyright © 2010 John Wiley & Sons, Ltd.     

A prospective,randomized study on hepatotoxicity of anastrozole compared with tamoxifen in women with breast cancer

Tamoxifen and anastrozole are widely used as adjuvant treatment for early stage breast cancer, but their hepatotoxicity is not fully defined. We aimed to compare hepatotoxicity of anastrozole with tamoxifen in the adjuvant setting in postmenopausal breast cancer patients. Three hundred and fifty‐three Chinese postmenopausal women with hormone receptor‐positive early breast cancer were randomized to anastrozole or tamoxifen after optimal primary therapy. The primary end‐point was fatty liver disease, defined as a liver–spleen ratio <0.9 as determined using a computed tomography scan. The secondary end‐points included abnormal liver function and treatment failure during the 3‐year follow up. The cumulative incidence of fatty liver disease after 3 years was lower in the anastrozole arm than that of tamoxifen (14.6% vs 41.1%, P < 0.0001; relative risk, 0.30; 95% CI, 0.21–0.45). However, there was no difference in the cumulative incidence of abnormal liver function (24.6% vs 24.7%, P = 0.61). Interestingly, a higher treatment failure rate was observed in the tamoxifen arm compared with anastrozole and median times to treatment failure were 15.1 months and 37.1 months, respectively (P < 0.0001; HR, 0.27; 95% CI, 0.20–0.37). The most commonly reported adverse events were ‘reproductive system disorders’ in the tamoxifen group (17.1%), and ‘musculoskeletal disorders’ in the anastrozole group (14.6%). Postmenopausal women with hormone receptor‐positive breast cancer receiving adjuvant anastrozole displayed less fatty liver disease, suggesting that this drug had a more favorable hepatic safety profile than tamoxifen and may be preferred for patients with potential hepatic dysfunction.     

Development,confirmation, and validation of a measure of coping with colorectal cancer: a longitudinal investigation

Objective: This longitudinal study developed and confirmed the factor structure of the 32‐item Coping with Colorectal Cancer (CCRC) measure. Reliability and validity of the measure were also assessed. Methods: Participants were 1800 individuals diagnosed with colorectal cancer (CRC). A written questionnaire and a telephone interview were completed at 5 (Time 1) and 12 months post‐diagnosis (Time 2). Results: Exploratory and confirmatory factor analyses revealed eight mostly empirically distinct subscales: Positive Perceptual Change, Religion/Spirituality, Rumination, Acceptance, Humour, Palliative, Seeking Social Support, and Lifestyle Reorganisation. Internal reliabilities were adequate and comparable to other coping measures, and test–retest analyses showed moderate temporal stability of the subscales. Cross‐sectional and longitudinal regression analyses were conducted to establish criterion‐related validity. As hypothesised, after controlling for demographics, disease/treatment, and stress/coping variables, regression analyses showed that CCRC subscales uniquely predicted Time 1 quality of life (QOL) outcomes (positive affect, cancer‐related QOL, psychological distress). After controlling for Time 1 QOL, Seeking Social Support coping continued to predict Time 2 positive affect. Conclusions: Results demonstrated the preliminary validity and reliability of the CCRC subscales, and have extended the cancer coping research by revealing new relations between coping subscales and QOL in a mixed‐gender, older population with CRC. Copyright © 2008 John Wiley & Sons, Ltd.     

Exploring global meaning in Greek breast cancer patients: validation of the Life Attitude Profile--Revised (LAP-R)

Objective: The aim of this study was to examine the factor structure and the psychometric properties of the Life Attitude Profile—Revised (LAP‐R) among a sample of Greek breast cancer patients, and to test the fit of a structural equation model with one latent factor underlying the measured LAP‐R dimensions. Methods: A total of 153 patients with breast cancer completed the LAP‐R. Convergent validity was assessed by examining the correlations between the LAP‐R subscales and measures of perceived stress, intrusiveness, mental health, and coping styles. Known‐groups validity was also assessed. Results: Principal axis factor analysis with promax rotation yielded four factors: purpose–coherence–vacuum, choice, death acceptance, and goal seeking. Internal consistency reliability of the subscales and convergent validity of LAP‐R were satisfactory. LAP‐R was able to detect differences in meaning between different age groups. Confirmatory factor analysis provided support for a single‐factor model including a latent meaning‐variable indicated by the observed subscales. Conclusions: The LAP‐R is a reliable and valid measure of global meaning in life, when administered to breast cancer patients. The use of LAP‐R in evaluating meaning‐centered psychotherapy interventions for patients with cancer is emphasized. Copyright © 2010 John Wiley & Sons, Ltd.     

The Posttraumatic Growth Inventory: an examination of the factor structure and invariance among breast cancer survivors

Objective: The present study tested the proposed five‐factor structure and invariance of the Posttraumatic Growth Inventory (PTGI; Tedeschi & Calhoun, 1996) in a sample of physically active breast cancer survivors. Methods: A sample of breast cancer survivors (N=470, Mage=57.3, SD=7.8 years) completed the PTGI and a demographic questionnaire. The factor structure, factorial invariance, and latent mean invariance were tested using maximum likelihood structural equation modeling. Results: Preliminary analyses showed acceptable reliability for the PTGI subscales (α<0.83). Confirmatory factor analysis (CFA) supported the five related factors corresponding to: relating to others, new possibilities, personal strength, spiritual change, and appreciation of life (χ² (179)=822.53, CFI=0.97, NNFI=0.96, SRMR=0.05, RMSEA=0.09). Multigroup CFA supported the invariance of the PTGI across age groups, treatment type, time since diagnosis, and time since last treatment. Conclusions: These findings provide support for (1) the multidimensional nature and factorial validity of the PTGI, and (2) the use of the PTGI in future research examining posttraumatic growth within samples of physically active breast cancer survivors. Copyright © 2009 John Wiley & Sons, Ltd.     

Assessment and management of bone health in women with early breast cancer receiving endocrine treatment in the DATA study

The phase III DATA study investigates the efficacy of adjuvant anastrozole (6 vs. 3 year) in postmenopausal women with breast cancer previously treated with 2–3 years of tamoxifen. This planned side-study assessed patterns of care regarding detection and treatment of osteopenia/osteoporosis, and trends in bone mineral density (BMD) during and after therapy. We registered all BMD measurements and bisphosphonate-use. Time to osteopenia/osteoporosis was analysed by Kaplan Meier methodology. For the trend in T-scores we used linear mixed models with random patients effects. Of 1860 eligible DATA patients, 910 (48.9%) had a baseline BMD measurement. Among patients with a normal baseline BMD (n = 417), osteopenia was observed in 53.5% and 55.4% in the 6- and 3-year group respectively (p = 0.18), during follow-up. Only two patients (3-year group) developed osteoporosis. Of the patients with osteopenia at baseline (n = 408), 24.4% and 20.4% developed osteoporosis respectively (p = 0.89). Three years after randomisation 18.3% and 18.2% used bisphosphonates in the 6- and 3-year groups respectively and 6 years after randomisation this was 23.7% and 20.9% respectively (p = 0.90) of which the majority used oral bisphosphonates. The yearly mean BMD-change during anastrozole in the lumbar spine showed a T-score decline of 0.075. After bisphosphonate addition the decline became less prominent (0.047 (p < 0.001)) and after anastrozole cessation, while continuing bisphosphonates, the mean BMD yearly increased (0.047 (p < 0.001)). In conclusion, extended anastrozole therapy was not associated with a higher incidence of osteoporosis. Anastrozole-use was associated with a BMD decrease; however, the decline was modest and partially reversible after anastrozole cessation.     

Health-related quality of life,psychological distress,and adverse events in postmenopausal women with breast cancer who receive tamoxifen,exemestane, or anastrozole as adjuvant endocrine therapy: National Surgical Adjuvant Study of Breast Cancer 04 (N-SAS BC 04)

Health-related quality of life (HRQOL), symptoms of depression, and adverse events (AEs) were compared between Japanese postmenopausal patients with hormone-sensitive breast cancer (BC) who received adjuvant tamoxifen, exemestane, or anastrozole in an open-labeled, randomized, multicenter trial designated as the National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04 substudy of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. During the first year of treatment, HRQOL and symptoms of depression were analyzed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and its Endocrine Symptom Subscale (ES), and the Center for Epidemiologic Studies Depression Scale (CES-D), respectively. In addition, predefined AEs were analyzed. A total of 166 eligible patients were randomly assigned to receive adjuvant tamoxifen, exemestane, or anastrozole. FACT-B scores increased after treatment began and remained significantly higher in the tamoxifen group than in the exemestane group or anastrozole group during the first year (P = 0.045). FACT-B scores were similar in the exemestane group and anastrozole group. ES scores and CES-D scores were similar in all treatment groups. Arthralgia and fatigue were less frequent, but vaginal discharge was more frequent in the tamoxifen group than in the exemestane group or anastrozole group. HRQOL was better in Japanese postmenopausal women treated with tamoxifen than those treated with exemestane or anastrozole. HRQOL and AEs were similar with exemestane and anastrozole. Given the results of the TEAM trial, upfront use of tamoxifen followed by an aromatase inhibitor (AI) may be an important option for adjuvant endocrine therapy in Japanese postmenopausal women.     

Confirmatory factor analysis of the Sexual Adjustment and Body Image Scale in women with gynecologic cancer

BACKGROUND:

There is evidence that treatment of gynecologic cancer (GC) negatively affects body image and sexuality. The Sexual Adjustment and Body Image Scale (SABIS‐G) was developed to assess disturbances after diagnosis of GC. The objective of this study was to confirm the factor structure using a confirmatory factor analysis (CFA).

METHODS:

Women with a history of GC completed the SABIS‐G, a 9‐item self‐report measure. Ninety randomly selected participants were used for the exploratory factor analysis (EFA). CFA was performed on the remaining participants (n = 204) to confirm the factor structure developed in the EFA against a one‐factor model. Test‐retest reliability between baseline and follow‐up scores was assessed using the intraclass correlation coefficient.

RESULTS:

A total of 614 eligible patients were approached to participate: 398 (65%) consented to the study and 294 (74%) completed the SABIS‐G. The median age was 53 years (range, 27‐80 years) and the primary site of disease was: 120 (41%) uterine, 85 (29%) ovary, 82 (28%) cervix, and 7 (2%) other. A 2‐factor structure was favored in the EFA, and the CFA fit indices indicated an excellent fit for the 2‐factor measurement model (standardized root‐mean‐square residual = 0.05, non‐normed fit index = 0.97, comparative fit index = 0.98). Internal consistency reliability was high for the Body Image (0.88) and Sexual Adjustment (0.91) subscales, as was test‐retest reliability (0.89).

CONCLUSIONS:

These results confirm the 2‐factor structure of the SABIS‐G and provide evidence that this is a valid and reliable instrument to measure changes in body image and sexuality in women after a diagnosis of GC. Cancer 2012;118: 3095–104. © 2011 American Cancer Society.     

Molecular characterization of anastrozole resistance in breast cancer: Pivotal role of the Akt/mTOR pathway in the emergence of de novo or acquired resistance and importance of combining the allosteric Akt inhibitor MK‐2206 with an aromatase inhibitor

Acquisition of resistance to aromatase inhibitors (AIs) remains a major drawback in the treatment of estrogen receptor alpha (ERα)‐positive breast cancers. The Res‐Ana cells, a new model of acquired resistance to anastrozole, were established by long‐term exposure of aromatase‐overexpressing MCF‐7 cells to this drug. These resistant cells developed ER‐independent mechanisms of resistance and decreased sensitivity to the AI letrozole or to ERα antagonists. They also displayed a constitutive activation of the PI3K/Akt/mTOR pathway and a deregulated expression of several ErbB receptors. An observed increase in the phospho‐Akt/Akt ratio between primary and matched recurrent breast tumors of patients who relapsed under anastrozole adjuvant therapy also argued for a pivotal role of the Akt pathway in acquired resistance to anastrozole. Ectopic overexpression of constitutively active Akt1 in control cells was sufficient to induce de novo resistance to anastrozole. Strikingly, combining anastrozole with the highly selective and allosteric Akt inhibitor MK‐2206 or with the mTOR inhibitor rapamycin increased sensitivity to this AI in the control cells and was sufficient to overcome resistance and restore sensitivity to endocrine therapy in the resistant cells. Our findings lead to us proposing a model of anastrozole‐acquired resistance based on the selection of cancer‐initiating‐like cells possessing self‐renewing properties, intrinsic resistance to anastrozole and sensitivity to MK‐2206. Altogether, our work demonstrated that the Akt/mTOR pathway plays a key role in resistance to anastrozole and that combining anastrozole with Akt/mTOR pathway inhibitors represents a promising strategy in the clinical management of hormone‐dependent breast cancer patients.     

Quality of Life of Postmenopausal Women in the ATAC (“Arimidex”, Tamoxifen, Alone or in Combination) Trial after Completion of 5 years' Adjuvant Treatment for Early Breast Cancer

The impact of treatment on health-related quality of life (HRQoL) is an important consideration in the adjuvant treatment of operable breast cancer. Here we report mature HRQoL outcomes from the ATAC trial, comparing anastrozole with tamoxifen as primary adjuvant therapy for postmenopausal women with localized breast cancer. Patients completed the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire plus endocrine subscale (ES) at baseline, 3 and 6 months, and every 6 months thereafter. Baseline characteristics in the HRQoL sub-protocol were well balanced between the anastrozole (n = 335) and tamoxifen (n = 347) groups in the primary analysis population. As with previously published results at 2 years, there was no statistically significant difference in the Trial Outcome Index of the FACT-B, the primary endpoint of the study, between treatments at 5 years. There were no statistically significant differences between treatment groups in ES total scores. Consistent with the 2-year analysis, there were differences between treatment groups in patient-reported side effects: diarrhea (anastrozole 3.1% vs. tamoxifen 1.3%), vaginal dryness (18.5% vs. 9.1%), diminished libido (34.0% vs. 26.1%), and dyspareunia (17.3% vs. 8.1%) were significantly more frequent with anastrozole compared to tamoxifen. Dizziness (3.1% vs. 5.4%) and vaginal discharge (1.2% vs. 5.2%) were significantly less frequent with anastrozole compared to tamoxifen. In this, the first report of HRQoL over 5 years of initial adjuvant therapy with an aromatase inhibitor, we conclude that anastrozole and tamoxifen had similar impacts on HRQoL, which was maintained or slightly improved during the treatment period for both groups.     

Illness perceptions in Greek patients with cancer: a validation of the Revised‐Illness Perception Questionnaire

Objective: The Revised‐Illness Perception Questionnaire (IPQ‐R) assesses illness perceptions according to Leventhal's self‐regulatory model. The aim of this paper is to present findings on the reliability and validity of the IPQ‐R in a population of Greek cancer patients. Methods: A total of 206 patients completed a Greek translation of the IPQ‐R and the Greek version of the Beck Depression Inventory (BDI). The scale's reliability was investigated by examining its internal consistency (Cronbach's alpha) and its test–retest reliability. Structural validity was examined through factor analyses. Predictive validity was tested by regressing BDI scores on IPQ subscale scores. Inter‐relationships between IPQ‐R dimensions were also examined by computing Pearson's Correlation Coefficients. Results: Cronbach's alpha showed satisfactory internal consistency for the IPQ‐R subscales. Paired samples' t‐test showed good test–retest reliability. Factor analysis of the IPQ‐R items revealed that the Greek version reflects the structure of the original with the only difference being that the ‘Consequences’ and ‘Emotional Representations’ subscales loaded on one factor. Factor analysis of the causal dimension items revealed a different structure of Causal Representations than that of the original questionnaire yielding three main factors: Psychological Attributions, Behavioral, and External Factors. Multiple regression analyses showed that Consequences, Emotional Representations, Illness Identity, and Psychological Attributions were the best predictors for depression. Conclusions: Translation of the IPQ‐R has good reliability and similar structure to that of the original. Difficulties to confirm the structure of Causal Representations may represent cultural differences in understanding illness causation. Copyright © 2009 John Wiley & Sons, Ltd.     

A contribution to the validation of the Needs Evaluation Questionnaire (NEQ): a study in the Italian context

Background and object: An accurate assessment of patients' needs is a core point in improving treatment adherence, satisfaction, and quality of life of care receivers. The Needs Evaluation Questionnaire (NEQ) is a practical and short instrument designed to record hospitalized patients' necessities. The present paper is a contribution to its factorial definition, useful in enhancing the understanding of NEQ psychometric properties and in supporting its use in research as well as in current practice. Method: Six hundred consecutive hospitalized cancer patients completed the NEQ together with a form for the collection of personal identification and clinical data. The initial sample was randomly split into two subsamples, and we then conducted: (1) an exploratory factor analysis (EFA) on Subsample 1; (2) a confirmatory factor analysis (CFA) of the factor structure resulting from EFA on Subsample 2; (3) a comparison between the factor structure resulting from CFA and a unidimensional factor solution. Results and conclusions: EFA revealed the presence of five factors (i.e. informative needs, needs related to assistance/care, relational needs, needs for psychoemotional support, and material needs) explaining a total of 50.5% of the variance. CFA confirmed the validity of the correlated five‐factor solution emerging from EFA, demonstrating how the theoretical model provided a good fit to the observed data. Finally, we demonstrated that the five‐factor solution was more appropriate in the reconstruction of the observed data than the unidimensional factor solution. According to the present data and despite the limitations raised, using NEQ as a five‐factor questionnaire is functional and recommendable. Copyright © 2008 John Wiley & Sons, Ltd.     

Plasma Levels of Tamoxifen, N-Desmethyl Tamoxifen and Anastrozole in a Patient with Metastatic Breast Cancer and Chronic Hemodialysis

Endocrine therapy for hormone-sensitive breast cancer is a well-established treatment option, both in adjuvant and palliative settings. For patients undergoing chronic hemodialysis, only scant pharmacokinetic data have been published for tamoxifen, and no data have been published for anastrozole. We therefore measured plasma levels of tamoxifen, its major metabolite, N-desmethyl tamoxifen, and anastrozole in a breast cancer patient undergoing chronic hemodialysis. Clinical tolerability was good. The blood levels for tamoxifen, N-desmethyl tamoxifen and anastrozole were within the expected therapeutic ranges. From this study, we can conclude that endocrine therapy for breast cancer with tamoxifen or anastrozole seems feasible and safe for patients undergoing chronic hemodialysis.     

COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial,assessing the incidence of arthralgia,and compliance within the first year of adjuvant anastrozole therapy

BackgroundThis prospective study evaluated the relationship between arthralgia and compliance during the first year of adjuvant anastrozole therapy in postmenopausal women with hormone receptor-positive early breast cancer.Patients and methodsCOMPliance and Arthralgia in Clinical Therapy (COMPACT) was an open-label, multicenter, noninterventional study conducted in Germany. Patients had started adjuvant anastrozole 3–6 months before the study start. The primary end points were arthralgia, compliance, and the relationship between compliance and arthralgia, assessed at specific time points.ResultsOverall, 1916 patients received upfront anastrozole. Mean arthralgia scores were increased from baseline at each visit up to 9 months. Compliance with anastrozole therapy gradually decreased over time from baseline to 9 months (P < 0.001). At 9 months, investigators estimated that >95% of patients were compliant versus patient reports of <70%. There was a significant association between arthralgia mean scores and noncompliance at 6 months (P < 0.0001), 9 months (P < 0.0001), and overall (P < 0.0001). Over time, new events or impairment of existing arthralgias were reported in 14% (3 months), 11% (6 months), and 9% (9 months) of patients.ConclusionArthralgia is important in the clinical management of women with early breast cancer and may contribute to noncompliance and clinical outcomes.ClinicalTrials.gov identifierNCT00857012.     

Validity of the Psycho-Oncology Screening Tool (POST)

Identifying cancer patients who are experiencing psychosocial challenges during the early phase of oncology treatment can prevent escalating patient distress. Standardized screening methods allow the medical team to identify those at high risk for poor adjustment. The purpose of this study was to provide preliminary psychometric evidence for a brief, self-administered screening instrument, the Psycho-Oncology Screening Tool (POST), designed to evaluate emotional and physical distress, depressive symptoms, and social concerns. Participants included 944 radiation oncology patients who completed the POST prior to their treatment appointment and a subgroup of 516 patients who completed the POST and one of six concurrent validity measures. Psychometric analysis included construct validity evidence provided through confirmatory factor analysis (CFA), internal reliability estimates, and concurrent validity estimates assessed with bivariate correlations between POST subscales scores and conceptually similar established measures. A three-factor CFA model was found to produce acceptable model fit, supporting the three domain structure of the POST. Furthermore, the three subscales—emotional and physical distress, depressive symptoms and social concerns—were found to produce acceptable internal reliability estimates (α = .73–.88). Concurrent validity evidence was observed with significant, moderate to large correlations between the POST subscales and all relevant measures (i.e., Profile of Mood States, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy Fatigue, Beck Depression Inventory, Pain Disability Index, and the Interpersonal Support Evaluation List) with correlations ranged from 0.42 to 0.83, p < 0.01. Patients and clinic staff reported no problems administering or completing the POST. Results of this study support the psychometric soundness as well as the feasibility and acceptability of the POST as a brief screening tool for oncology patients receiving outpatient services.     

Analysis of Ki‐67 expression with neoadjuvant anastrozole or tamoxifen in patients receiving goserelin for premenopausal breast cancer

BACKGROUND:

The increasing costs associated with large‐scale adjuvant trials mean that the prognostic value of biologic markers is increasingly important. The expression of nuclear antigen Ki‐67, a marker of cell proliferation, has been correlated with treatment efficacy and is being investigated for its value as a predictive marker of therapeutic response. In the current study, the authors explored correlations between Ki‐67 expression and tumor response, estrogen receptor (ER) status, progesterone receptor (PgR) status, and histopathologic response from the STAGE study (S_ tudy of T_ amoxifen or A_ rimidex, combined with G_ oserelin acetate to compare E_ fficacy and safety).

METHODS:

In a phase 3, double‐blind, randomized trial (National Clinical Trials identifier NCT00605267), premenopausal women with ER‐positive, early stage breast cancer received either anastrozole plus goserelin or tamoxifen plus goserelin for 24 weeks before surgery. The Ki‐67 index, hormone receptor (ER and PgR) status, and histopathologic responses were determined from histopathologic samples that were obtained from core‐needle biopsies at baseline and at surgery. Tumor response was determined by using magnetic resonance imaging or computed tomography.

RESULTS:

In total, 197 patients were randomized to receive either anastrozole plus goserelin (n = 98) or tamoxifen plus goserelin (n = 99). The best overall tumor response was better for the anastrozole group compared with the tamoxifen group both among patients who had a baseline Ki‐67 index ≥20% and among those who had a baseline Ki‐67 index <20%. There was no apparent correlation between baseline ER status and the Ki‐67 index in either group. Positive PgR status was reduced from baseline to week 24 in the anastrozole group.

CONCLUSIONS:

In premenopausal women with ER‐positive breast cancer, anastrozole produced a greater best overall tumor response compared with tamoxifen regardless of the baseline Ki‐67 index. Cancer 2013. © 2012 American Cancer Society.     

Psychometric properties of the Dutch version of the Mental Adjustment to Cancer scale in Dutch cancer patients

Objectives: The measurement of adjustment to cancer is relevant for research purposes and daily practice. In this study, the psychometric properties of the original five subscales and the two recently proposed summary scales of the Mental Adjustment to Cancer (MAC) scale were examined in Dutch cancer patients. Methods: Data from 289 cancer patients were assessed with the Dutch version of the MAC scale and the Hospital and Anxiety Depression scale (HADS); 259 patients completed the MAC scale for a second time. Results: In total, 85.5% of the participants completed the full MAC scale. The internal consistency of the five subscales and the summary scales were mostly similar to the original versions. The test–retest reliability of the Fighting Spirit, Helplessness/Hopelessness, Anxious Preoccupation, Summary Positive Adjustment and Summary Negative Adjustment subscales were moderate and the test–retest reliability of the Fatalism and Avoidance subscales were low. Correlations between the original and the two summary scales of the MAC scale and the depression and anxiety subscales of the HADS indicated good convergent validity. The structure of the five original subscales as well as the structure of the two proposed summary scales was adequate as shown by construct validity using confirmatory factor analyses. Conclusion: The Dutch version of the MAC scale is a feasible questionnaire and appeared to have comparable psychometric properties as demonstrated by studies in the UK. The psychometric properties of the summary scales and Fighting Spirit and Helplessness/Hopelessness subscales seem to be acceptable. This supports the cross‐national usefulness of the MAC scale. Copyright © 2009 John Wiley & Sons, Ltd.     

Effects of Switching from Tamoxifen to Anastrozole on Tamoxifen-Related Endocrine Symptoms and Quality of Life

Objective:To determine the effects on menopausal symptoms and quality of life of switching from tamoxifen to anastrozole as adjuvant endocrine treatment for early breast cancer patients. Patients and methods:Forty-four women who had completed primary breast cancer treatment (surgery ± radiotherapy ± chemotherapy), were postmenopausal, and had switched from tamoxifen to anastrozole as adjuvant hormonal treatment because of tolerability issues were enrolled. Endocrine symptoms and health-related quality of life were assessed by the series of Functional Assessment of Cancer Therapy-Breast (FACT-B) and endocrine subscale (ES) questionnaires at the time of the switch and 12 months later, and by the ES alone at 3, 6, and 9 months after switching. Sample size was decided by the effect size method, with a standard deviation fixed at 0.5, the conventionally accepted value representative of an effect of medium value. To evaluate score modifications, one-way ANOVAs were applied. Results:Endocrine symptoms improved between baseline and 3 months and stabilized thereafter. Improvements in mean ES scores from baseline were +3 (95% CI 1, 5), +4 (95% CI 3, 6), +5 (95% CI 3, 7), and +4 (95% CI 3, 6) at 3, 6, 9, and 12 months, respectively. The FACT-ES global score showed a mean improvement over 12 months of 9 points (95% CI 6, 13; p < 0.0005). A statistically significant improvement in Trial Outcome Index scores from baseline to 12 months (+4 points [95% CI 2, 6; p < 0.0005]) and in the physical and breast cancer subscales (+2 [95% CI 1, 2; p < 0.001] and +1 [95% CI 1, 2; p < 0.001]) was also observed. Compared with tamoxifen treatment, patients receiving anastrozole reported significantly higher rates of mild arthritic and bone pain (27%vs 7%; p = 0.021) Conclusion:This study evaluated a small population of 44 patients who had switched from tamoxifen to enastrozole mainly because of gynecologic adverse effects with tamoxifen. However, the results of this study suggest that a change to anastrozole as adjuvant therapy should be considered for patients who develop endocrine symptoms while receiving tamoxifen to minimize those symptoms and improve quality of life.