Mount Vernon Hospital is located in Northwood, an area of north-west Greater London. It is one of two hospitals run by The Hillingdon Hospitals NHS Foundation Trust.
Multi-centre, multi-vendor validation of artificial intelligence (AI) software to detect clinically significant prostate cancer (PCa) using multiparametric magnetic resonance imaging (MRI) is lacking. We compared a new AI solution, validated on a separate dataset from different UK hospitals, to the original multidisciplinary team (MDT)-supported radiologist’s interpretations. A Conformité Européenne (CE)-marked deep-learning (DL) computer-aided detection (CAD) medical device (Pi) was trained to detect Gleason Grade Group (GG) ≥ 2 cancer using retrospective data from the PROSTATEx dataset and five UK hospitals (793 patients). Our separate validation dataset was on six machines from two manufacturers across six sites (252 patients). Data included in the study were from MRI scans performed between August 2018 to October 2022. Patients with a negative MRI who did not undergo biopsy were assumed to be negative (90.4
BACKGROUND:Localised squamous cell carcinoma of the anus is treated with radical chemoradiotherapy. Cure rates are high, but treatment can result in substantial acute and long-term morbidity. We aimed to assess whether lower dose chemoradiotherapy maintains high local control rates in patients with early-stage disease, with the secondary aim of reducing toxicity. METHODS:ACT4 is a phase 2, prospective, multicentre, open-label, two-arm non-comparative, randomised, controlled trial, investigating reduced-dose intensity-modulated radiotherapy (rd-IMRT: 41·4 Gy in 23 fractions) in patients with early-stage anal cancer; T1-2 (≤4 cm) N0-NxM0. Eligible patients were at least 16 years of age, with an Eastern Cooperative Oncology Group performance status of 0-1. The primary outcome is 3-year loco-regional failure rates. Patients were randomly assigned 1:2 (with stratification by T stage, N stage, gender, HIV status, and randomising site) to standard-dose IMRT (sd-IMRT: 50·4 Gy in 28 fractions) or rd-IMRT with concurrent mitomycin and capecitabine chemotherapy. Here, we report the pre-planned, modified intention-to-treat analysis of secondary endpoints 6 months after treatment end-complete clinical response, compliance, patient-reported outcomes (EORTC QLQ-C30 and ANL27), and safety data. The trial is registered at the ISRCTN registry (ISRCTN88455282) and is ongoing but no longer recruiting. FINDINGS:163 patients were recruited from 28 UK tertiary centres between April 24, 2017, and Dec 1, 2020. 160 patients were included in the primary analysis (sd-IMRT n=55; dr-IMRT n=105). Data on ethnicity were not collected. The median patient age was 66 years (IQR 58-72 years); 117 (73%) were female and 43 (27%) male; and 129 (94%) of 138 evaluable samples were p16 positive. Complete clinical responses at 6 months were 87% (46 of 53) for sd-IMRT and 92% (89 of 97) for rd-IMRT. Radiotherapy interruptions of 3 days or more occurred in 14 (26%) of 55 patients in sd-IMRT and 16 (15%) of 105 patients in rd-IMRT. Chemotherapy modifications occurred in 27 (49%) of 55 patients in sd-IMRT and 39 (37%) of 105 patients in rd-IMRT. Grade 3 or worse acute toxicity was reported in 25 (46%) of 55 patients in sd-IMRT and 37 (35%) of 105 patients in rd-IMRT. The most common grade 3 or worse adverse events were radiation dermatitis (seven [13%] of 55 in sd-IMRT and ten [10%] of 105 in rd-IMRT), and diarrhoea (four [7%] of 55 in sd-IMRT and nine [9%] of 105 in rd-IMRT). Serious adverse events occurred in eight (15%) of 55 patients in sd-IMRT and ten (10%) of 105 patients in rd-IMRT. Patient-reported outcomes for most issues deteriorated at the end of treatment and resolved to baseline by 6 weeks in both groups. Poorer sexual function for men and women was observed at 6 months following sd-IMRT. INTERPRETATION:Good 6-month complete clinical responses rates were seen in both groups. Early results suggest rd-IMRT is well tolerated with oncological outcomes maintained. 3-year locoregional failure rates are awaited. FUNDING:Cancer Research UK and Stand Up to Cancer.
There are multiple contemporary systemic therapy options for patients with HER2-positive advanced breast cancer. However, there are few longitudinal data regarding what proportion of patients go on to receive later lines of therapy, real-world outcomes and the impact of brain metastases. We therefore conducted a prospective, multicentre non-interventional study to describe the anti-cancer treatment regimens used and clinical outcomes in patients with HER2-positive advanced breast cancer across multiple lines of therapy undergoing treatment in routine clinical care. Adult patients diagnosed with HER2-positive advanced breast cancer were recruited to a prospective, multicentre non-interventional study to observe treatment patterns and outcomes. Three hundred and eleven patients were recruited with median age 57 years. Of those patients initiating first, second-, and third-line treatment, 72 (23.2
Background and objectives: We assessed the agreement between prostate-specific antigen (PSA) and imaging responses using whole-body magnetic resonance imaging (wbMRI). Our aim was to explore the potential prognostic value of PSA and wbMRI responses in metastatic hormone-na & iuml;ve prostate cancer (mHNPC) and castration-resistant PC (mCRPC). Methods: wbMRI was prospectively performed in 37 patients with mHNPC and 51 with mCRPC before and after 6-12 mo of androgen deprivation therapy and an androgen receptor pathway inhibitor (ARPI). Imaging responses were defined according to the Metastasis Reporting and Data System for PC (MET-RADS-P) criteria. A PSA response was defined as PSA <= 0.2 ng/ml in mHNPC and a >= 50% decrease from the pretreatment level in mCRPC. Agreement between PSA and wbMRI responses was assessed using Cohen's j. The association between time to subsequent treatment and overall survival (OS) was analyzed using Cox regression analysis. Key findings and limitations: Agreement between PSA and wbMRI responses was fair in mHNPC (j = 0.30) but none to slight in mCRPC (j = 0.15). In mHNPC, patients with a PSA or wbMRI response were less likely to receive subsequent treatments; wbMRI progression was associated with a significantly higher risk of death (hazard ratio 8.59; p = 0.002). In mCRPC, two-thirds of patients with a PSA response showed progression on wbMRI; neither PSA nor wbMRI progression changed the likelihood of starting a subsequent treatment or the risk of death. Conclusions and clinical implications: In mHNPC, wbMRI progression was associated with a higher risk of needing subsequent treatment and shorter OS. Patient summary: We evaluated the agreement between routine PSA (prostate-specific antigen) test results and whole-body MRI (magnetic resonance imaging) scans for assessing the response of metastatic prostate cancer to treatment. There was disagree-ment between the PSA and MRI results, mainly for patients with cancer that was resis-tant to hormone-based treatment. Combining PSA with whole-body MRI might provide a more accurate picture of the response of advanced prostate cancer to treatment. (c) 2024 The Author(s). Published by Elsevier B.V. on behalf of European Association of Urology. This is an open access article under the CC BY-NC-ND license (http://creative-commons.org/licenses/by-nc-nd/4.0/).
