Lesley Fallowfield

• BSc, DPhil
• Managing Director at University of Sussex

Background We trialled the first digital pathway (BRCA-DIRECT) aiming to improve capacity for mainstreamed BRCA testing within UK breast oncology services. Patients received standardised digital pretest information, with saliva sampling and consent to testing completed at home. For individualised support, we offered access to a clinical genetics pr...

Background The use of technology in medical education has been increasing with more students exposed to some form of online learning or tutorials, under the umbrella of virtual learning (VL). Many programmes, particularly those involving virtual reality, have centred on practical skills, such as surgical techniques or anatomical knowledge, rather t...

The window period for detection of early stage disease (pre clinical detectable phase) is only ~12months. The invivo tumour doubling time is ~2.9 months. This has important implications for diagnostic pathways and developing screening strategies.

Objective: The objective of this scoping review is to synthesise the existing literature on the knowledge and understanding of multiple myeloma patients and their informal caregivers regarding diagnosis, prognosis, and treatment options. Introduction: Knowledge plays a critical role in various aspects of disease management and overall health. Multi...

Background Genetic testing to identify germline high-risk pathogenic variants in breast cancer susceptibility genes is increasingly part of the breast cancer diagnostic pathway. Novel patient-centred pathways may offer opportunity to expand capacity and reduce turnaround time. Methods We recruited 1140 women with unselected breast cancer to underg...

Background There are calls worldwide for the mainstreaming of genetic testing in breast cancer (BC) clinics, but health care professionals (HCPs) are not always familiar with nor confident about genetic counselling. TRUSTING (Talking about Risk & uncertainties of Testing in Genetics is an educational programme shown to significantly improve HCPs’ k...

9025 Background: Family history clinics face significant capacity issues making calls for genetic testing of all breast cancer (BC) patients problematic. Mainstreaming of services by health care professionals (HCPs) is needed but many lack confidence and familiarity with genetic counseling. Following successful development and evaluation of the TRU...

527 Background: We developed two 8 min films to aid patients’ understanding about gene expression profiling (GEP) tests (Oncotype DX or Prosigna) in breast cancer. A previous study of 120 women without breast cancer demonstrated significantly better knowledge after film viewing compared to that after reading written materials (1). We present result...

Over 2.3 million people were diagnosed with breast cancer (BC) in 2022, making it the second most commonly diagnosed cancer worldwide. This number is only set to increase, with incidence predicted to grow by over 45% by 2045. Many of these patients will experience advanced or metastatic disease, which is also sometimes referred to as secondary brea...

BACKGROUND Genetic testing to identify germline high-risk pathogenic variants in breast cancer susceptibility genes is an important step in the breast cancer diagnostic pathway. To expand capacity and reduce turnaround time, testing is increasingly offered within mainstream oncology services, rather than via referral to clinical genetics. However,...

This manuscript describes the Advanced Breast Cancer (ABC) international consensus guidelines updated at the last two ABC international consensus conferences (ABC 6 in 2021, virtual, and ABC 7 in 2023, in Lisbon, Portugal), organized by the ABC Global Alliance. It provides the main recommendations on how to best manage patients with advanced breast...

Key messages • Patients with lung metastases are increasingly offered resection or ablation • Evidence that removal or ablation increases overall survival is weak • Patients need to be informed of the uncertainty and risks of harm when making decisions about treatment • With current pressures on cancer services routine resection or ablation of lung...

Background The LOw RISk DCIS (LORIS) study was set up to compare conventional surgical treatment with active monitoring in women with ductal carcinoma in situ (DCIS). Recruitment to trials with a surveillance arm is known to be challenging, so strategies to maximise patient recruitment, aimed at both patients and recruiting centres, were implemente...

Background: In UKCTOCS, there was a decrease in the diagnosis of advanced stage tubo-ovarian cancer but no reduction in deaths in the multimodal screening group compared with the no screening group. Therefore, we did exploratory analyses of patients with high-grade serous ovarian cancer to understand the reason for the discrepancy. Methods: UKCT...

Randomised controlled trials are challenging to deliver. There is a constant need to review and refine recruitment and implementation strategies if they are to be completed on time and within budget. We present the strategies adopted in the United Kingdom Collaborative Trial of Ovarian Cancer Screening, one of the largest individually randomised co...

Purpose To determine the experiences, information, support needs and quality of life of women in the UK living with metastatic breast cancer (MBC) to provide content for educational materials. Methods An online survey, hosted for 3 months on a UK MBC charity website, comprised sections covering issues such as communication about MBC treatment and...

Background Ovarian and tubal cancers are lethal gynaecological cancers, with over 50% of the patients diagnosed at advanced stage. Trial design Randomised controlled trial involving 27 primary care trusts adjacent to 13 trial centres based at NHS Trusts in England, Wales and Northern Ireland. Methods Participants Postmenopausal average-risk wome...

Background Germline genetic testing affords multiple opportunities for women with breast cancer, however, current UK NHS models for delivery of germline genetic testing are clinician-intensive and only a minority of breast cancer cases access testing. Methods We designed a rapid, digital pathway, supported by a genetics specialist hotline, for del...

Background Mainstreaming of germline testing demands that all healthcare professionals have good communication skills, but few have genetic testing and counselling experience. We developed and evaluated educational workshops—Talking about Risk & UncertaintieS of Testing IN Genetics (TRUSTING). Contents included: presentations and exercises, an inte...

Background: Discussions between oncologists and patients about Gene Expression Profiling (GEP) risk of recurrence results can be challenging especially if scores are intermediate or close to the high or low risk of recurrence thresholds. Although many clinical teams provide patients with information leaflets, these often employ complex language wri...

(Abstracted from Lancet 2021;397:2182–2193) Ovarian cancer is most commonly diagnosed at an advanced stage (3 or 4) and remains the deadliest gynecologic malignancy. When diagnosed at stage 1, a survival rate of greater than 90% has been demonstrated, compared with a 5-year survival rate of 27% and 13% for stage 3 and stage 4 disease, respectively.

Objective Cutaneous squamous cell carcinoma (cSCC) is one of the most prevalent non-melanoma skin cancers worldwide. While usually treatable, patients with high-risk or advanced disease have few treatment options and limited resources available. This review assesses what online information resources are available to patients and their families abou...

Aim: To examine the burden of further treatments in patients with colorectal cancer (CRC) following a decision about lung metastasectomy. Methods: Five teams participating in the study of Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) provided details on subsequent local treatments for lung metastases including the use of chemotherapy....

Background Ovarian cancer continues to have a poor prognosis with the majority of women diagnosed with advanced disease. Therefore, we undertook the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS) to determine if population screening can reduce deaths due to the disease. We report on ovarian cancer mortality after long-term follow-up i...

Aim We wanted to examine survival in patients with resected colorectal cancer (CRC) whose lung metastases are and whose are not resected. Methods Teams participating in the study of Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC) identified potential candidates for lung metastasectomy and invited their consent to join Stage 1. Baseline dat...

Background During trials that span decades, new evidence including progress in statistical methodology, may require revision of original assumptions. An example is the continued use of a constant-effect approach to analyse the mortality reduction which is often delayed in cancer-screening trials. The latter led us to re-examine our approach for the...

Randomised controlled trials of ovarian cancer (OC) screening have not yet demonstrated an impact on disease mortality. Meanwhile, the screening data from clinical trials represents a rich resource to understand the performance of modalities used. We report here on incidence screening in the ultrasound arm of UKCTOCS. 44,799 of the 50,639 women who...

Background There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on the completeness and accuracy of national ovarian cancer and death registration in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Methods Of the 202,638 participants, 202,632 were suc...

Background During trials that span decades, new evidence including progress in statistical methodology, may require revision of original assumptions. An example is the continued use of a constant-effect approach to analyse the mortality reduction which is often delayed in cancer-screening trials. The latter led us to re-examine our approach for the...

PurposeAs demand for genetic testing grows and a wide range of health care professionals (HCPs) are potentially involved in discussions about testing and delivering results, we developed an educational package to help HCPs with these conversations.Methods To inform the content of training materials, we conducted interviews with 11 women four of who...

Aim The aim was to assess the health utility of lung metastasectomy in the treatment of patients with colorectal cancer (CRC) using the EQ‐5D‐3L questionnaire. Methods Multidisciplinary CRC teams at 14 sites recruited patients to a two‐arm randomized controlled trial—Pulmonary Metastasectomy in Colorectal Cancer (PulMiCC). Remote randomization was...

PurposeThis systematic review examined educational training interventions for healthcare professionals (HCPs) discussing genetic testing and risk for hereditary breast cancer. There was a particular focus on the presence, and content, of communication elements within these packages.Methods Searches were run via CINAHL, EMBASE, PUBMED, and PsychInfo...

Pulmonary metastasectomy is widely and increasingly practiced in the belief that this intervention can cure patients with colorectal cancer, and that without it few survive 5 years. No good evidence exists supporting such convictions, indeed recent trial results challenge them. What evidence underpins this acceptance of illusory truths or misconcep...

Objective There are widespread efforts to increase symptom awareness of ‘pelvic/abdominal pain, increased abdominal size/bloating, difficulty eating/feeling full and urinary frequency/urgency’ in an attempt to diagnose ovarian cancer earlier. Long-term survival of women with these symptoms adjusted for known prognostic factors is yet to be determin...

Background: There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on completeness and accuracy of national ovarian cancer and death registration in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Methods: Of the 202638 participants, 202584 were successf...

Background: There is a trend to increasing use of routinely collected health data to ascertain outcome measures in trials. We report on completeness and accuracy of national ovarian cancer and death registration in the United Kingdom Collaborative Trial of Ovarian Cancer Screening (UKCTOCS). Methods: Of the 202638 participants, 202632 were successf...

Background Discussing risk of recurrence and potential treatment benefit in early breast cancer can be challenging, especially when dealing with anxious patients and/or those with difficult social circumstances. UK patients usually have access to specialist breast care nurses (SBCN) who discuss in further detail the implications that the Oncotype D...

The OPTION trial examined whether or not premenopausal women with early breast cancer receiving chemotherapy benefited from ovarian function protection with goserelin. This trial showed some preservation of ovarian function and fertility in women aged 40 years or less*. Additionally the OPTION trial examined the immediate and late impact of treatme...

Background: Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised controlled trial (RCT). Methods: Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung metasta...

(348/of 350 allowed) Background: Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised trial (RCT). Methods: Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung...

(348/of 350 allowed) Background: Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised trial (RCT). Methods: Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung...

(348/of 350 allowed) Background: Lung metastasectomy in the treatment of advanced colorectal cancer has been widely adopted without good evidence of survival or palliative benefit. We aimed to test its effectiveness in a randomised trial (RCT). Methods: Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung...

Purpose Gene expression profiling (GEP) test scores calculate risks of recurrence and likely benefit of adjuvant chemotherapy in ER-positive, HER2-negative, early-stage breast cancer. As health literacy and numeracy skills in the general population are poor, healthcare professionals (HCPs) require a wide repertoire of communication skills to explai...

Background: Lung metastasectomy in the treatment of advanced colorectal cancer has been adopted and established without control data. Our aim was to test its effectiveness in a randomised trial. Methods: Multidisciplinary teams in 13 hospitals recruited participants with potentially resectable lung metastases to a multicentre 2-arm randomised trial...

Purpose The caregiver roles and responsibilities scale (CRRS) was developed to facilitate formal assessment of broad life impacts for informal (i.e. unpaid) caregivers to people with cancer. Here we report the development and initial validation. Methods The CRRS was developed from the thematic analysis of two interview studies with cancer patients...

Background: Adjuvant chemotherapy in breast cancer patients post resection has been estimated to reduce mortality rates by up to 30%. However, the heterogeneous nature of the disease and patients implies that not all patients should receive the treatment. Many existing prognostic tools, may not definitively estimate the most effective treatment str...

Purpose: Trials of novel drugs used in advanced disease often show only progression-free survival or modest overall survival benefits. Hypothetical studies suggest that stabilisation of metastatic disease and/or symptom burden are worth treatment-related side effects. We examined this premise contemporaneously using qualitative and quantitative me...

Purpose: The Patient Roles and Responsibilities Scale (PRRS) was developed to enable a broader evaluation of the impact of cancer and cancer treatment, measuring 'real world' roles and responsibilities such as caring for others and financial and employment responsibilities. Here, we report the development and initial validation. Methods: The 29-...

Aims: Delaying progression, ameliorating symptoms and maintaining quality of life (QoL) are primary aims of treatment for metastatic castrate-resistant prostate cancer (mCRPC). Real-world rather than clinical trial data about symptoms and side-effects are sparse. In EXTREQOL, patients' QoL, pain and information needs were recorded during treatment...

Methods: 14 oncologists in 7 UK hospitals saw 149 pts judged to have equivocal indications for chemotherapy. Provisional treatment decisions were recorded then reconsidered when EPClin results were available. Pre and post test results, patients completed State/Trait Anxiety Inventories (STAI) and the decisional conflict scale (DCS). Oncologists al...

Background: Ovarian suppression in premenopausal women is known to reduce breast cancer risk. This study aimed to assess uptake and compliance with ovarian suppression using the LHRH analogue, goserelin, with add-back raloxifene, as a potential regimen for breast cancer prevention. Methods: Women at ≥30% lifetime risk breast cancer were approach...

Purpose: The aim of this study was to explore the impact of extended cancer survival on broader aspects of life and wellbeing such as occupational, financial and family life for patients with advanced cancer and their nominated informal caregivers. Methods: In-depth qualitative interviews were transcribed verbatim. A thematic framework was devel...

Aim: To assess efficacy (event-free survival, EFS) and safety in patients followed up for 3 years in the PrefHer study (NCT01401166). Patients and methods: Post surgery and post chemotherapy in the (neo)adjuvant setting, patients with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer were randomised to receive four cyc...

Background Adjuvant chemotherapy in breast cancer patients post resection has been estimated to reduce mortality rates by up to 30%. However, the heterogeneous nature of the disease and patients implies that not all patients should receive the treatment. Many existing prognostic tools, may not definitively estimate the most effective treatment stra...

Aim: To assess the safety and tolerability of switching between subcutaneous (SC) and intravenous (IV) trastuzumab in the PrefHer study (NCT01401166). Patients and methods: Patients with HER2-positive early breast cancer completed (neo)adjuvant chemotherapy and were randomised to receive four cycles of SC trastuzumab, via single-use injection de...

e12002 Background: Endopredict is a multigene test including tumor size and nodal status; it predicts low or high risk of distant recurrence in patients (pts) with ER+ve, HER2–ve breast cancer treated with adjuvant endocrine therapy alone. We compared adj chemotherapy decisions pre and post Endopredict test results, pts’ anxiety, decisional conflic...

Purpose The Intergroup Exemestane Study, an investigator-led study of 4,724 postmenopausal patients with early breast cancer (clinical trial information: ISRCTN11883920), has previously demonstrated that a switch from adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane was associated with clinically relevant improvements in eff...

PurposePatients with advanced disease are living longer and commonly used patient-reported outcome measures (PROMs) may miss relevant elements of the quality of extended survival. This systematic review examines the measures used to capture aspects of the quality of survival including impact on patients’ everyday lives such as finances, work and fa...

In the original article, author F. Penault-Llorca's name was incorrectly written as F. Pernault-Llorca. This has been corrected online. © The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

The success of a clinical trial is often dependant on whether recruitment targets can be met in the required time frame. Surgeons want to gather robust evidence but may experience considerable discomfort in relation to their clinical instincts and concerns about patient eligibility and safety. The ongoing POSNOC study design is pragmatic to maximis...

Background: The independent review of the UK National Health Service Breast Screening Programme reported (The Lancet, Volume 380, Issue 9855, Page 1778, 17 Nov 2012) on the benefits and harms of breast screening. It concluded that breast screening saves lives and acknowledged the existence of overtreatment. It encouraged randomized trials to elucid...

The authors regret to misspell Dr F. Penault-Llorca's family name. The authors would like to apologise for any inconvenience caused.

PurposeThe use of novel and often expensive drugs offering limited survival benefit in advanced disease is controversial. Treatment recommendations are influenced by patient characteristics and trial data showing overall response rates (ORR), progression-free survival (PFS) and overall survival (OS). PFS is frequently the primary outcome in licenci...

Introduction: The increasing survivor population of breast cancer has shifted research and practice interests into the impacts of the disease and treatment in quality of life aspects. The lack of tools available in Portuguese to objectively evaluate sexual function led to the development of this study, which aimed to cross-culturally adapt and vali...

Cancer clinicians frequently deal with emotionally challenging situations such as discussing the diagnosis or prognosis and transitions to palliative care with patients and their families. The doctor/patient relationship may be short and intensive or one lasting for many years. Until fairly recently, a formal paternalistic relationship was the norm...

Introduction: The increasing survivor population of breast cancer has shifted research and practice interests into the impacts of the disease and treatment in quality of life aspects. The lack of tools available in Portuguese to objectively evaluate sexual function led to the development of this study, which aimed to cross-culturally adapt and val...

Ovarian cancer is not a single disease and can be subdivided into at least five different histological subtypes that have different identifiable risk factors, cells of origin, molecular compositions, clinical features and treatments. Ovarian cancer is a global problem, is typically diagnosed at a late stage and has no effective screening strategy....

Background The randomised phase III TANIA trial demonstrated that continuing bevacizumab with second-line chemotherapy for locally recurrent/metastatic breast cancer (LR/mBC) after progression on first-line bevacizumab-containing therapy significantly improved progression-free survival (PFS) compared with chemotherapy alone (hazard ratio [HR]=0.75,...

Purpose Informal caregivers provide invaluable help and support to people with cancer. As treatments extend survival and the potential burdens on carers increase, there is a need to assess the impact of the role. This systematic review identified instruments that measure the impact of caregiving, evaluated their psychometric performance specificall...

The majority of men treated for prostate cancer will eventually develop castrate-resistant disease (CRPC) with metastases (mCRPC). There are several options for further treatment: chemotherapy, third-line hormone therapy, radium, immunotherapy, and palliation. Current ASCO guidelines for survivors of prostate cancer recommend that an individual’s i...

Many novel therapies are available for use in patients with metastatic castration-resistant prostate cancer (mCRPC), some of which convey substantial progression-free survival and overall survival benefits. Delaying disease progression and providing palliation of symptoms are primary therapeutic aims of treating patients with mCRPC; therefore, ensu...

Introduction The poor prognosis for ovarian cancer 1 motivated us to start a programme of screening research 30 years ago. 2 We have since reported CA125 as a predictor of ovarian cancer risk, 3,4 high specifi city 2 and preliminary evidence of a survival benefi t 5 of multimodal screening using CA125 interpreted with a cutoff with transvaginal ult...

Purpose: To develop recommendations about endocrine therapy for women with hormone receptor (HR) -positive metastatic breast cancer (MBC). Methods: The American Society of Clinical Oncology convened an Expert Panel to conduct a systematic review of evidence from 2008 through 2015 to create recommendations informed by that evidence. Outcomes of i...

To the Editor Discussions around the diagnosis, treatment, and outcomes after a diagnosis of ductal carcinoma in situ (DCIS) continue to generate great interest. Narod and colleagues1 confirm findings from other studies that have repeatedly shown a low breast cancer–specific mortality following a diagnosis of DCIS (3.3% at 20 years) and support the...

Background: The independent review of the UK National Health Service Breast Screening Programme reported (The Lancet, Volume 380, Issue 9855, Pages 1778 - 1786, 17 November 2012) on the benefits & harms of breast screening. It concluded that breast screening saves lives & acknowledged overtreatment. It encouraged randomized trials to elucidate the...