Endocrine Treatment and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer: ASCO Guideline Update.

Purpose: To update recommendations of the ASCO systemic therapy for hormone receptor (HR)-positive metastatic breast cancer (MBC) guideline.

Methods: An Expert Panel conducted a systematic review to identify new, potentially practice-changing data.

Results: Fifty-one articles met eligibility criteria and form the evidentiary basis for the recommendations.

The development and initial evaluation of the Diarrhoea Management Diary (DMD) in patients with metastatic breast cancer.

Purpose: Chemotherapy-induced diarrhoea (CID) is a common, but often underreported problem in patients with breast cancer that has a profound effect on quality of life. It is best measured from a patient's perspective, but tools are limited. The aim of this study was to develop and evaluate the Diarrhoea Management Diary (DMD), a self-report measure to assess CID, use of self-management strategies and treatment adherence.

Sexual functioning in 4,418 postmenopausal women participating in UKCTOCS: a qualitative free-text analysis.

Objective: Sexual well-being can contribute significantly to the overall quality of women's lives. This qualitative study aimed to examine sexual activity, functioning, and satisfaction in a large sample of postmenopausal women from the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) METHODS:: Thematic analysis was used to evaluate the free-text data of the Fallowfield Sexual Activity Questionnaire (FSAQ) completed by UKCTOCS participants at baseline before annual screening.

Results: A total of 24,305 women completed the baseline FSAQ and 4,525 (19%) provided free-text data, with 4,418 comments eligible for analysis.

For the Benefit of Others: Reasons Why Women with Breast Cancer Participate in RCTs.

Background: Appreciation of the barriers and drivers affecting enrolment in randomised clinical trials (RCTs) is important for future trial design, communication and information provision.

Methods: As part of an intervention to facilitate UK multidisciplinary team communication about RCTs, women with breast cancer who discussed trials with doctors or research nurses completed questionnaires examining i) clarity of trial information and ii) reasons for their trial decision.

Results: 152 women completed the questionnaires; 113/152 (74%) consented to RCT enrolment.

Intravenous versus Subcutaneous Drug Administration. Which Do Patients Prefer? A Systematic Review.

Background: Intravenous (IV) drug delivery is commonly used for its rapid administration and immediate drug effect. Most studies compare IV to subcutaneous (SC) delivery in terms of safety and efficacy, but little is known about what patients prefer.

Methods: A systematic review was conducted by searching seven electronic databases for articles published up to February 2014.

Pain and health-related quality of life in patients with advanced solid tumours and bone metastases: integrated results from three randomized, double-blind studies of denosumab and zoledronic acid.

Purpose: This analysis evaluated patient-reported outcomes and analgesic use in patients with bone metastases from solid tumours across three comparative studies of denosumab and zoledronic acid.

Methods: Pooled data were analysed from three identically designed double-blind phase III studies comparing subcutaneous denosumab 120 mg with intravenous zoledronic acid 4 mg monthly in patients with bone metastases from breast cancer (n = 2,046), castration-resistant prostate cancer (n = 1,901) or other solid tumours (n = 1,597). Pain severity, pain interference, health-related quality of life and analgesic use were quantified.

Adjuvant chemotherapy in elderly women with breast cancer: patients' perspectives on information giving and decision making.

Background: Decisions about adjuvant chemotherapy in older women with early stage breast cancer (EBC) are often challenging. Uncertainty about benefits due to limited data about treatment efficacy and outcomes complicates decision making. This qualitative study explored older patients' experiences and preferences towards information giving and ultimate decisions about adjuvant chemotherapy.

Randomized controlled trial of pulmonary metastasectomy in colorectal cancer: PulMiCC International is open in Italy.

Advocates of the Pulmonary Metastasectomy in Colorectal Cancer trial describe trial design and goals, in agreement with others that such a trial is necessary to solve the question of whether or not surgery is beneficial in patients with metastatic colorectal cancer and, ultimately, to assist patients and clinical teams in deciding for or against pulmonary metastectomy.

Evaluation of an educational program to improve communication with patients about early-phase trial participation.

Background: Discussing early-phase cancer trials is challenging; most offer little personal benefit to patients with life-limiting illnesses who frequently have a poor understanding of and misconceptions about the therapeutic aims. We evaluated an evidence-based training program aimed at enhancing communication.

Methods: Prior to and after the intervention, 47 health care professionals (HCPs) experienced in early-phase trial recruitment were audio taped discussing trials with patient simulators who completed postinterview evaluations.

Patient-reported outcome instruments used to assess pain and functioning in studies of bisphosphonate treatment for bone metastases.

Purpose: When treating metastatic bone disease, relief of bone pain is often a key outcome. Because pain cannot be quantified with objective clinical measures, patient-reported outcome (PRO) measures are required to assess patients' subjective experience. The goal of the current review was to examine measures used to assess pain, as well as the impact of pain on functional status and health-related quality of life (HRQL), in trials of bisphosphonates for the treatment of bone metastases.

The value of progression-free survival to patients with advanced-stage cancer.

Progression-free survival (PFS) is frequently used as a primary end point in oncology clinical trials. Employing PFS instead of overall survival as the primary outcome has the advantage that trial completion can be quicker with fewer patients required, and it is cheaper. PFS is sensitive to cytostatic as well as cytotoxic mechanisms of therapeutic intervention and directly measures the effect of the investigational treatment.

The views of patients and the general public about expensive anti-cancer drugs in the NHS: a questionnaire-based study.

Objectives: To determine the views of patients and members of the public about who should pay for expensive new cancer drugs not recommended by the National Institute for Health and Clinical Excellence (NICE).

Design: A study-specific questionnaire was used to elicit the views of patients and the general public between April and June 2010. It examined whether participants thought patients should be told about all possible cancer treatments, if the NHS should always fund non-NICE recommended drugs and attitudes towards self-funding/co-payments.

A UK-wide survey of follow-up practices for patients with high-grade glioma treated with radical intent.

Rationale And Objective: High-grade glioma profoundly affects patients and their families. The best ongoing care for patients completing radical treatment is uncertain. To address this issue a UK-wide audit surveying the follow-up practices of multidisciplinary cancer teams was conducted.

What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions.

Unlabelled: PURPOSE; Evaluation of the communication and informed consent process in phase I clinical trial interviews to provide authentic, practice-based content for inclusion in a communication skills training intervention for health care professionals.

Patients And Methods: Seventeen oncologists and 52 patients from five United Kingdom cancer centers consented to recording of phase I trial discussions. Following each consultation, clinicians completed questionnaires indicating areas they felt they had discussed, and researchers conducted semistructured interviews with patients examining their recall and understanding.

Anastrozole and letrozole: an investigation and comparison of quality of life and tolerability.

Previous studies have demonstrated that both anastrozole and letrozole are well tolerated. Letrozole suppresses estrogen to a greater degree than anastrozole in the serum and breast tumor. Concerns have been raised that greater potency may adversely affect patients' quality of life (QOL).

A Rasch and confirmatory factor analysis of the general health questionnaire (GHQ)--12.

Background: The General Health Questionnaire (GHQ) - 12 was designed as a short questionnaire to assess psychiatric morbidity. Despite the fact that studies have suggested a number of competing multidimensional factor structures, it continues to be largely used as a unidimensional instrument. This may have an impact on the identification of psychiatric morbidity in target populations.

Communication and informed consent in phase 1 trials: a review of the literature from January 2005 to July 2009.

Objective And Methods: A review conducted in 2005 identified many of the communication difficulties experienced by patients and doctors when discussing phase 1 (P1) oncology trials. The current paper is an update of the area and focuses on studies that measure patient comprehension of information given during the P1 trial discussion and ways to enhance understanding. A literature search was performed for relevant articles published between January 2005 and July 1st 2009.

International guidelines for management of metastatic breast cancer: combination vs sequential single-agent chemotherapy.

Compared with treatment options for early-stage breast cancer, few data exist regarding the optimal use of chemotherapy for metastatic breast cancer (MBC). The choice of using a combination of cytotoxic chemotherapies vs sequential single agents is controversial. At the 6th European Breast Cancer Conference, the European School of Oncology Metastatic Breast Cancer Task Force convened an open debate on the relative benefits of combination vs sequential therapy.

Effects of anastrozole on cognitive performance in postmenopausal women: a randomised, double-blind chemoprevention trial (IBIS II).

Background: Mild cognitive impairments have been recorded in cross-sectional studies of women with breast cancer receiving endocrine treatment. More comprehensive studies were warranted because aromatase inhibitors are being used increasingly in both chemoprevention and adjuvant settings. We report findings from the cognitive subprotocol of the International Breast Intervention Study (IBIS II), a double-blind placebo-controlled trial of anastrozole in postmenopausal women at high risk of developing breast cancer.

Rasch fit statistics and sample size considerations for polytomous data.

Background: Previous research on educational data has demonstrated that Rasch fit statistics (mean squares and t-statistics) are highly susceptible to sample size variation for dichotomously scored rating data, although little is known about this relationship for polytomous data. These statistics help inform researchers about how well items fit to a unidimensional latent trait, and are an important adjunct to modern psychometrics. Given the increasing use of Rasch models in health research the purpose of this study was therefore to explore the relationship between fit statistics and sample size for polytomous data.

Recognition and management of treatment-related side effects for breast cancer patients receiving adjuvant endocrine therapy.

In postmenopausal women with hormone receptor-positive early-stage breast cancer, the use of aromatase inhibitors (AIs) to suppress estrogen is associated with improved clinical outcomes compared with tamoxifen therapy. Women receiving such endocrine therapy may experience treatment-related side effects that negatively affect health-related quality of life (QoL) and adherence to therapy. In published clinical trials and in clinical practice, adverse events (AEs) constitute the main reason for nonadherence to endocrine treatment.

Fallowfield's Sexual Activity Questionnaire in women with without and at risk of cancer.

Objectives: To determine the effect of cancer, cancer risk, menopausal status and psychological factors on sexual activity as measured by Fallowfield's Sexual Activity Questionnaire (FSAQ).

Study Design And Main Outcome Measures: Five groups of women completed the FSAQ: 1451 healthy women who were participating in an ovarian cancer screening trial; 488 healthy women at increased risk of breast cancer who were participating in a chemoprevention trial; 154 healthy women at increased risk of breast cancer who had been offered risk-reducing surgery; 117 women with advanced ovarian cancer; and a healthy non-study sample of 162 women.

Results: There were significant between-group differences regarding age (F=1373.

After going through chemotherapy I can't see another needle.

Needle anxiety not only impacts on a patient's quality of life but can delay or prevent future medical care. Our survey of women with breast cancer indicated that 78/208 women (37.5%) reported feeling anxious about injections.

Quality of life in the intergroup exemestane study: a randomized trial of exemestane versus continued tamoxifen after 2 to 3 years of tamoxifen in postmenopausal women with primary breast cancer.

Purpose: To compare and describe the quality of life (QOL) of women allocated to tamoxifen or exemestane within the Intergroup Exemestane Study (IES).

Patients And Methods: Postmenopausal women with primary breast cancer who were disease free after 2 to 3 years were randomly assigned to switch from tamoxifen to exemestane or continue with tamoxifen until 5 years of treatment were completed. A subset of IES centers participated in a QOL substudy.