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1. Can virtual human clinicians help close the gap in colorectal cancer screening for rural adults in the United States? The influence of rural identity on perceptions of virtual human clinicians

Author

Eric J. Cooks, Kyle A. Duke, Elizabeth Flood-Grady, Melissa J. Vilaro, Rashi Ghosh, Naomi Parker, Palani Te, Thomas J. George, Benjamin C. Lok, Maribeth Williams, Peter Carek, and Janice L. Krieger

Subjects
Cancer screening disparities, Health communication, Rural health, Virtual human technology, Medicine
Abstract

Rural adults experience disparities in colorectal cancer screening, a trend even more distinct among rural Black adults. Healthcare disruptions caused by COVID-19 exacerbated inequities, heightening attention on virtual communication strategies to increase screening. Yet little is known about how rural adults perceive virtual human clinicians (VHCs). Given that identifying as rural influences perceived source credibility often through appearance judgments, the goal of this pilot was to explore how to develop VHCs that individuals highly identified with rurality find attractive. Between November 2018 and April 2019, we tested a culturally tailored, VHC-led telehealth intervention delivering evidence-based colorectal cancer prevention education with White and Black adults (N = 2079) in the United States recruited through an online panel who were non-adherent to screening guidelines and between 50 and 73 years of age. Participants were randomized on three factors (VHC race-matching, VHC gender-matching, Intervention type). Ordinal logistic regression models examined VHC appearance ratings. Participants with a high rural identity (AOR = 1.12, CI = [1.02, 1.23], p =.02) rated the VHCs more attractive. High rural belonging influenced VHC attractiveness for Black participants (AOR = 1.22, CI = [1.03, 1.44], p =.02). Also, Black participants interacting with a Black VHC and reporting high rural self-concept rated the VHC as more attractive (AOR = 2.22, CI = [1.27, 3.91], p =.01). Findings suggest adults for whom rural identity is important have more positive impressions of VHC attractiveness. For patients with strong rural identities, enhancing VHC appearance is critical to tailoring colorectal cancer prevention interventions.

Published
2022
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2. Chemotherapy is not needed when complete evacuation of gestational choriocarcinoma leads to hCG normalization.

Author

Bolze P, Schoenen S, Margaillan M, Braga A, Sauthier P, Elias K, Seckl M, Winter M, Coulter J, Lok C, Joneborg U, Undurraga Malinverno M, Hajri T, Massardier J, You B, Golfier F, and Goffin F

Subjects
Humans, Pregnancy, Female, Cohort Studies, Chorionic Gonadotropin therapeutic use, Neoplasm Recurrence, Local, Placenta pathology, Gestational Trophoblastic Disease drug therapy, Gestational Trophoblastic Disease surgery, Gestational Trophoblastic Disease pathology, Choriocarcinoma drug therapy, Uterine Neoplasms drug therapy, Uterine Neoplasms surgery
Abstract

Background: The standard treatment for gestational choriocarcinoma is chemotherapy., Objective: To describe the risk of recurrence with expectant management of gestational choriocarcinoma that has reached a normal human chorionic gonadotropin level after tumor removal without adjuvant chemotherapy., Methods: A retrospective multicenter international cohort study was conducted from 1981 to 2017 involving 11 gestational trophoblastic disease reference centers with patient's follow-up extended until 2023. Clinical and biological data of included patients were extracted from each center's database. The inclusion criteria were i) histological diagnosis of gestational choriocarcinoma in any kind of placental tissue retrieved, ii) spontaneous normalization of human chorionic gonadotropin level following choriocarcinoma retrieval, iii) patient did not receive any oncological treatment for the choriocarcinoma, iv) and at least 6 months of follow-up after the first human chorionic gonadotropin level normalization., Results: Among 80 patients with retrieved gestational choriocarcinoma and whose human chorionic gonadotropin level normalized without any other oncological therapy, none had a recurrence of choriocarcinoma after a median follow-up of 50 months. The median interval between choriocarcinoma excision and human chorionic gonadotropin level normalization was 48 days. The International Federation of Gynecology and Obstetrics/World Health Organization risk score was ≤6 in 93.7% of the cases., Conclusions: This multicenter international study reports that selected patients with gestational choriocarcinoma managed in gestational trophoblastic disease reference centers did not experience any relapse when the initial tumor evacuation is followed by human chorionic gonadotropin level normalization without any additional treatment. Expectant management may be a safe approach for highly selected patients., (© 2024 Published by Elsevier Ltd.)

Published
2024
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3. ESGO-ESMO-ESP consensus conference recommendations on ovarian cancer: pathology and molecular biology and early, advanced and recurrent disease.

Author

Ledermann JA, Matias-Guiu X, Amant F, Concin N, Davidson B, Fotopoulou C, González-Martin A, Gourley C, Leary A, Lorusso D, Banerjee S, Chiva L, Cibula D, Colombo N, Croce S, Eriksson AG, Falandry C, Fischerova D, Harter P, Joly F, Lazaro C, Lok C, Mahner S, Marmé F, Marth C, McCluggage WG, McNeish IA, Morice P, Nicum S, Oaknin A, Pérez-Fidalgo JA, Pignata S, Ramirez PT, Ray-Coquard I, Romero I, Scambia G, Sehouli J, Shapira-Frommer R, Sundar S, Tan DSP, Taskiran C, van Driel WJ, Vergote I, Planchamp F, Sessa C, and Fagotti A

Subjects
Humans, Female, Societies, Medical, Spain, Molecular Biology, Medical Oncology, Ovarian Neoplasms genetics, Ovarian Neoplasms therapy
Abstract

The European Society of Gynaecological Oncology, the European Society for Medical Oncology (ESMO) and the European Society of Pathology held a consensus conference (CC) on ovarian cancer on 15-16 June 2022 in Valencia, Spain. The CC panel included 44 experts in the management of ovarian cancer and pathology, an ESMO scientific advisor and a methodologist. The aim was to discuss new or contentious topics and develop recommendations to improve and harmonise the management of patients with ovarian cancer. Eighteen questions were identified for discussion under four main topics: (i) pathology and molecular biology, (ii) early-stage disease and pelvic mass in pregnancy, (iii) advanced stage (including older/frail patients) and (iv) recurrent disease. The panel was divided into four working groups (WGs) to each address questions relating to one of the four topics outlined above, based on their expertise. Relevant scientific literature was reviewed in advance. Recommendations were developed by the WGs and then presented to the entire panel for further discussion and amendment before voting. This manuscript focuses on the recommendation statements that reached a consensus, their voting results and a summary of evidence supporting each recommendation., Competing Interests: Disclosure JAL reports personal fees for advisory board membership from Artios Pharma, AstraZeneca, Bristol Myers Squibb (BMS), Clovis Oncology, Eisai, Ellipses, GSK, Immagene, ImmunoGen, Merck/MSD, Miltenyi, Novocure, Nuvation and VBL Therapeutics; personal fees as an invited speaker from AstraZeneca, Clovis Oncology, GSK and Neopharm; personal fees as an Independent Data Monitoring Committee (IDMC) member from Mersana and Sutro Bio; a remunerated leadership role as an Associate Editor of Therapeutic Advances in Medical Oncology (Sage Publishing); institutional research grants from AstraZeneca and MSD/Merck; non-remunerated roles at ESMO (Officer and Subject Editor for the Gynaecological CPGs); and a non-remunerated leadership role as Vice-President of ESGO (2019-2021). XMG reports personal fees for advisory board membership from Amgen, AstraZeneca, GSK, Janssen and Lilly; personal fees as an invited speaker from AstraZeneca, Clovis and GSK; and non-renumerated consultancy for AstraZeneca. FA reports personal fees for advisory board membership from MiMARK Diagnostics; and institutional funding from Estée Lauder. NCon reports personal fees for advisory board membership from AkesoBio, AstraZeneca, Eisai, eTheRNA Immunotherapies, GSK, ImmunoGen, Kartos, Mersana, Seagen and Seattle Genetics; personal fees as an invited speaker from Eickeler, Medconcept, Mediseminar, the Nordic Society Of Gynaecologic Oncology - Clinical Trial Unit (NSGO-CTU) and the North-Eastern German Society of Gynecological Oncology (NOGGO); travel compensation from Amgen, Genmab and Roche; compensation for educational activities from Kartos, Medscape Oncology, MSD and TouchIME; non-renumerated role as the Co-Chair of the Early Drug Development Network of European Network for Gynaecological Oncological Trial groups (ENGOT); non-renumerated role as the President of ESGO; and a non-renumerated role as a clinical trial principal investigator (PI) for Aldeyra, Clovis, Kartos, Mersana and Seagen. BD reports personal fees as an invited speaker from MSD. CFo reports personal fees as an invited speaker from Roche, AstraZeneca, MSD, Clovis, Sequana, GSK, Tesaro and Ethicon; and institutional fees as a member of the Board of Directors of the King Edward VII Hospital. AGM reports personal fees for advisory board membership from Alkermes, Amgen, AstraZeneca, Clovis Oncology, Eisai, Genmab, GSK, HederaDx, Illumina, ImmunoGen, MacroGenics, Mersana, MSD, Novartis, Oncoinvent, PharmaMar, Regeneron, Roche, SOTIO, Sutro Biopharma and Tubulis; personal fees as an invited speaker from AstraZeneca, Clovis Oncology, GSK, MSD, Novocure, Roche, Takeda and Zai Lab; institutional funding as coordinating PI from Aravive, GSK, Novartis and Roche; and non-remunerated membership of a Steering Committee for MSD. CG reports personal and institutional fees for advisory board membership from AstraZeneca, GlaxoSmithKline and MSD; personal and institutional fees as an invited speaker from AstraZeneca, Chugai, Clovis, Eisai, GSK, MSD, Roche and Takeda; personal fees for a writing engagement from Cor2Ed and PeerVoice; institutional research grants from Aprea, AstraZeneca, Medannex, Novartis and Nucana; institutional research grants as a local PI from BerGenBio, Clovis, GlaxoSmithKline, MSD, Roche and Verastem; and non-renumerated membership of the Cancer Research UK Clinical Research Committee, the German Cancer Aid Scientific Review Committee and the International Clinical Cancer Research Committee. AL reports personal fees for advisory board membership from Zentalis Pharmaceuticals; personal fees as an invited speaker from GSK and Medscape; personal fees for consultancy from GLG; personal fees for a writing engagement from Onko+; institutional fees for advisory board membership from Ability Pharma, Apmonia, AstraZeneca, Blueprint, Clovis Oncology, GSK, Merck Serono and MSD; institutional fees as an invited speaker from AstraZeneca, Clovis Oncology and Kephren Publishing; institutional fees for consultancy from Orion and Owkin; institutional fees for Steering Committee membership for MSD; institutional funding as a PI in clinical trials from Agenus, AstraZeneca, BMS, GSK, Iovance; MSD and Roche; institutional funding as a Chief Investigator in clinical trials from AstraZeneca and OSE Immunotherapeutics; institutional research grants as a PI in translational research from Association de Recherche sur les CAncers dont GYnécologiques (ARCAGY)-Groupe d'Investigateurs Nationaux pour les Etudes des Cancers de l'Ovaire (GINECO), AstraZeneca and Sanofi; a non-remunerated role as an IDMC member for Clovis Oncology, as an IDMC Chair for Pfizer (proprietary information) and as a member of the Gynecologic Cancer InterGroup (GCIG); and non-remunerated academic research projects for LXRepair and Owkin. DL reports personal fees for advisory board membership from AstraZeneca, Clovis Oncology, Corcept, Genmab, GSK, ImmunoGen, MSD, Oncoinvest, PharmaMar, Seagen and Sutro Biopharma; personal fees as an invited speaker from AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, MSD, PharmaMar and Seagen; personal fees for consultancy from AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, MSD, Novartis, PharmaMar and Seagen; travel grants from AstraZeneca, Clovis Oncology and GSK; institutional funding as coordinating PI from Clovis Oncology, Genmab and MSD; institutional funding for a clinical trial/contracted research from AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Incyte, MSD, Novartis, Roche and Seagen; institutional funding for founding an academic trial from Clovis Oncology, GSK, MSD and PharmaMar; a non-remunerated role as a PI in clinical trials for AstraZeneca, Clovis Oncology, Genmab, GSK, ImmunoGen, Incyte, MSD, Novartis, PharmaMar, Roche and Seagen; and a non-remunerated role as a member of the Board of Directors of GCIG. SB reports personal fees for advisory board membership from Amgen, AstraZeneca, Eisai, Epsilogen, GSK, ImmunoGen, Mersana, MSD, Novartis, Oncxerna, Regeneron, Roche, Seagen, Shattuck Labs and Verastem; personal fees as an invited speaker from Amgen, AstraZeneca, Clovis, GSK, Medscape, Novacure, Peerview, Pfizer, Research to Practice and Takeda; ownership of stocks/shares of PerciHealth; institutional research grants from AstraZeneca and GSK; a non-remunerated role as a PI for AstraZeneca (academic-sponsored ENGOT-GYN1/ATARI phase II international trial), GSK (academic-sponsored MONITOR-UK trial) and Verastem (ENGOTov60/GOG3052/RAMP201 phase II clinical trial - global lead); a non-renumerated leadership role as Board member of the International Cancer Foundation; and a non-renumerated advisory role as a medical advisor of Ovacome Charity. LC reports personal fees as an invited speaker from AstraZeneca and Corza Medical; and institutional fees as an invited speaker from GSK and Roche. DC reports personal fees for advisory board membership from Akesobio, GSK, MSD, Novocure, Roche, Seagen and SOTIO; and personal fees as an invited speaker from AstraZeneca. NCol reports personal fees for advisory board membership from AstraZeneca, Clovis Oncology, Eisai, GSK, ImmunoGen, Mersana, MSD/Merck, Nuvation Bio, Onxerna, Pfizer, PharmaMar, Pieris and Roche; personal fees as an invited speaker from AstraZeneca and Novartis; institutional research grants from AstraZeneca, PharmaMar and Roche; a non-renumerated membership of the ESMO Guidelines Steering Committee; and a non-renumerated leadership role as Chair of the Alleanza Contro il Tumore Ovarico (ACTO) Scientific Committee. SC declares no conflicts of interest. AGE reports personal fees for advisory board membership from AstraZeneca; personal fees as an invited speaker from GSK and Intuitive Surgical; personal fees as the social media editor of the International Journal of Gynecologic Cancer; and a non-remunerated role as PI of the SENTICOL III trial in Norway for GINECO/NSGO. CFa reports personal fees for advisory board membership from Baxter, Chugai Pharma, Clovis Oncology, Eisai, GSK and Teva; personal fees as an invited speaker from Astellas Pharma, AstraZeneca, Biogaran, BMS, GSK, Janssen Oncology, Leo Pharma, Lilly, MSD Oncology, Novartis, Pfizer Seagen and Viatris; institutional funding as coordinating PI from Astellas Pharma, Chugai Pharma, Pfizer and Pierre Fabre; institutional funding as local PI from Pfizer; non-renumerated congress participation for AstraZeneca, Janssen Oncology, Leo Pharma and Pierre Fabre; and non-renumerated membership of the European Union of Geriatric Medicine Society, the French Society of Geriatrics and Gerontology, the International Society of Geriatric Oncology and the French Society of Geriatric Oncology. DF declares no conflicts of interest. PH reports personal fees for advisory board membership from AstraZeneca, Clovis Oncology, GSK, ImmunoGen, Mersana, Miltenyi, MSD, Novartis and Roche; personal fees as an invited speaker from Amgen, Eisai, Stryker and Zai Lab; personal fees for lectures from AstraZeneca, GSK, MSD and Roche; personal fees as an IDMC member from SOTIO; institutional funding as Trial Chair from AstraZeneca, GSK, ImmunoGen and Roche; institutional funding as local PI from Genmab; institutional funding from Clovis Oncology and Seagen; and a non-remunerated role as PI for AstraZeneca. FJ reports personal fees for advisory board membership from AstraZeneca, Bayer, BMS, Eisai, GSK, Ipsen, Janssen, MSD, Novocure and Seagen; personal fees as an invited speaker from Amgen, Astellas, AstraZeneca, Eisai, GSK, Ipsen, Janssen, MSD and Novartis/3A; institutional funding as coordinating PI from AstraZeneca and GSK; an institutional research grant from BMS; non-renumerated membership of GCIG; and travel compensation from Eisai, GSK, Ipsen and MSD. CLa personal fees for advisory board membership from AstraZeneca and Illumina; and institutional funding from AstraZeneca. CLo declares no conflicts of interest. SM reports personal fees and reimbursement for advisory board membership from AbbVie, AstraZeneca, Clovis, Eisai and Novartis; personal fees and reimbursement as an invited speaker from GSK, Hubro, MSD, Nykode, Pfizer, Roche and Tesaro; and institutional research grants from AstraZeneca, Eisai, Roche and Tesaro. FM reports personal fees for advisory board membership from AstraZeneca, Eisai, GenomicHealth, Gilead/Immunomedics, MSD, Myriad, Novartis, PharmaMar, Roche and Seagen; personal fees as an invited speaker from AstraZeneca, Clovis, GSK/Tesaro, Lilly and Pfizer; institutional fees for advisory board membership from Immunicom and Roche; institutional fees as an invited speaker from AstraZeneca, Daiichi Sankyo, GSK and Seagen; institutional funding as coordinating PI from AGO Research GmbH, AstraZeneca, the German Breast Group, Gilead/Immunomedics and Roche; institutional funding as local PI from Eisai, GSK, MSD, Novartis, Roche and Vaccibody; and institutional funding from AstraZeneca, Lilly and Seagen. CM reports personal fees for advisory board membership from Amgen, AstraZeneca, GlaxoSmithKline, MSD, Novartis, PharmaMar, Roche Austria and Seagen; and personal fees as an invited speaker from Amgen, AstraZeneca, GlaxoSmithKline, MSD, Novartis, PharmaMar, Roche and Seagen. WGM reports personal fees as an invited speaker from GSK. IAM reports personal fees for advisory board membership from Alkermes, AstraZeneca, Clovis Oncology, Duke Street Bio, GSK, OncoC4, Roche and Theolytics; personal fees for consultancy from Duke Street Bio; personal fees for travel from AstraZeneca and GSK; institutional funding from AstraZeneca; and a non-remunerated role as a member of the Board of Directors (Trustee) of Worldwide Cancer Research. PM reports personal fees for advisory board membership from AstraZeneca, GSK and ImmunoGen. SN reports personal fees for advisory board membership from AstraZeneca and GSK; personal fees as an invited speaker from AstraZeneca, Clovis and GSK; personal fees for Scientific Committee membership from GSK; ownership of stocks/shares of GSK; and institutional funding from AstraZeneca. AO reports personal fees for advisory board membership from Agenus, AstraZeneca, Clovis Oncology, Corcept Therapeutics, Deciphera Pharmaceuticals, Eisai, Exelisis, EMD Serono, F. Hoffmann-La Roche, Genmab, GSK, ImmunoGen, Itheos, Merck Sharps & Dohme de España, SA, Mersana Therapeutics, Novocure, OneXerna Therapeutics, Inc., PharmaMar, Regeneron, Sattucklabs, Seagen and Sutro Biopharma; personal fees for travel/accommodation from AstraZeneca, PharmaMar and Roche; institutional funding from Abbvie Deutschland, Advaxis Inc., Aeterna Zentaris, Amgen, Aprea Therapeutics AB, BMS, Clovis Oncology Inc., Eisai Ltd., F. Hoffmann-La Roche Ltd., ImmunoGen Inc., Merck, Sharp & Dohme de España SA, Millennium Pharmaceuticals Inc., PharmaMar SA, Regeneron Pharmaceuticals and Tesaro Inc.; non-remunerated roles at ESMO (member, Officer, Co-Chair of the ESMO Gynaecological Cancers Congress 2023-2025, Chair of the Gynaecological Track ESMO 2019, Scientific Track Member Gynaecological Cancers ESMO 2018, ESMO 2020, ESMO 2022, member of the Gynaecological Cancers Faculty and Subject Editor for the Gynaecological CPGs); non-remunerated roles at GCIG [member and Cervix Cancer Chair on behalf of the Spanish Ovarian Cancer Research Group (GEICO)]; and memberships of the American Society of Clinical Oncology, the Gynecologic Oncology Group and the Spanish Association of Medical Oncology (SEOM). JAPF reports personal fees for advisory board membership from Abilify Pharma, AstraZeneca, Clovis, GSK, PharmaMar and Roche; personal fees as an invited speaker from AstraZeneca, Clovis, GSK and PharmaMar; employment as Associate Professor at the University of Valencia; institutional funding as coordinating PI from AstraZeneca; institutional funding from Novartis and GSK; institutional research grants from GSK and PharmaMar; personal fees as a member of a Steering Committee for Artios Pharma and AstraZeneca; a non-renumerated role as coordinating PI of a phase III trial for Novartis; non-renumerated membership of BIG, the Early Drug Development working group at ENGOT and the Adolescent and Young Adults working group at SEOM; a non-renumerated role as Co-chair of the Phase 2 group at GCIG; non-renumerated roles as member of the Executive Committee and Head of the Scientific Committee at GEICO; and non-renumerated roles as member of the Executive Committee and co-coordinator of Uterine Sarcoma Group at the Spanish Sarcoma Research Group. SP reports personal fees for advisory board membership from AstraZeneca, Clovis, GSK, MSD, PharmaMar and Roche; and institutional funding from AstraZeneca, MSD, Pfizer and Roche. PTR declares no conflicts of interest. IRC reports personal fees for advisory board membership from Adaptimmune, Agenus, Amgen, AstraZeneca, BMS, Clovis Oncology, Daiichi Sankyo, Deciphera, EQRX, Eisai, GSK, MacroGenics, Merck Sereno, Mersana, Novartis, Oxnea, Roche and Sutro Biopharma; institutional fees for advisory board membership from MSD; institutional fees for translational research from BMS; a non-remunerated role as President of GINECO; and a non-remunerated role as PI for PAOLA-1. IR reports personal fees for advisory board membership and as an invited speaker from AstraZeneca, Clovis, GSK, PharmaMar and Roche; institutional funding from AstraZeneca; an institutional research grant from GSK; a non-renumerated advisory role at GEICO; and non-renumerated membership of SEOM. GS reports personal fees as an invited speaker from AstraZeneca/MSD, Baxter Healthcare, GlaxoSmithKline, Intuitive Surgical Inc., Johnson & Johnson and Olympus Europa; personal fees for expert testimony from Covidien AG (a Medtronic company); institutional funding as coordinating PI from AstraZeneca, Bayer AG, Clovis Oncology, Kiromic, Merck, Novocure Ltd. and Oncoquest Pharmaceuticals Inc. JS reports personal fees for advisory board membership from AstraZeneca, GSK, Immunogene, Incyte, MSD, Novocure, Roche, Tesaro and Tubulis; personal fees as an invited speaker from Eisai; institutional funding from AstraZeneca, GSK and Roche; non-renumerated ENGOT/NOGGO proprietary information; non-renumerated leadership roles at AGO (Arbeitsgemeinschaft für Gynäkologische Onkologie), NOGGO and PARSGO (Pan-Arabian Research Society of Gynecological Oncology); and non-renumerated membership of the ESGO Council. RSF reports personal fees for advisory board membership from MSD and Neopharm; personal fees as an invited speaker from AstraZeneca, BMS, Medison, MSD, Novartis and Roche; personal fees for consultancy from Medison; personal fees as a member of a Steering Committee for MSD and VBL; non-renumerated membership of a Steering Committee for AstraZeneca; and an institutional research grant from MSD. SS reports personal fees as an invited speaker from AstraZeneca, GSK and MSD; an institutional research grant from AOA Dx; and a leadership role for the National Ovarian Cancer Audit (UK). DSPT reports personal fees for advisory board membership from AstraZeneca, Bayer, Boehringer Ingelheim, Eisai, Genmab, GSK, MSD and Roche; personal fees as an invited speaker from AstraZeneca, Eisai, GSK, Merck Serono, MSD, Roche and Takeda; ownership of stocks/shares of Asian Microbiome Library (AMiLi); institutional research grants from AstraZeneca, Bayer, Karyopharm Therapeutics and Roche; institutional funding as coordinating PI from AstraZeneca and Bergen Bio; institutional funding as local PI from Bayer, Byondis B.V. and Zeria Pharmaceutical Co Ltd.; a previous non-renumerated role as Chair of the Asia-Pacific Gynecologic Oncology Trials Group (APGOT); a previous non-renumerated role as the Society President of the Gynecologic Cancer Group Singapore; non-renumerated membership of the Board of Directors of the GCIG; and product samples from AstraZeneca, Cyclacel Pharmaceuticals, Eisai and MSD (non-financial interest). CT declares no conflicts of interest. WJvD declares no conflicts of interest. IV reports past personal fees for advisory board consultancy from Agenus, Aksebio China, AstraZeneca, BMS, Deciphera Pharmaceuticals, Eisai, F. Hoffmann-La Roche Ltd., Genmab, GSK, ImmunoGen Inc., Jazzpharma, Karyopharm, Molecular Partners, MSD, Novartis, Novocure, Oncoinvent AS, Regeneron, Seagen and SOTIO a.s.; past institutional fees for advisory board consultancy from Amgen (Europe), AstraZeneca, Carrick Therapeutics, Clovis Oncology Inc., Deciphera Pharmaceuticals, Elevar Therapeutics, F. Hoffmann-La Roche Ltd., Genmab, GSK, Mersana, Millennium Pharmaceuticals, MSD, Oncoinvent AS, SOTIO a.s., Verastem Oncology and Zentalis; and institutional research grants from Amgen, Genmab, Oncoinvent AS and Roche. FP declares no conflicts of interest. CS reports personal fees as a Gynaeco-oncology Certificate of Advanced Studies Coordinator for the European School of Oncology; personal fees as a DMC member from Merck; non-renumerated advisory roles for ESMO as a member of the Compliance Committee and an ESMO extended member of the Women for Oncology Committee; and a non-renumerated role as an advisor for the ESMO Living Guidelines. AF reports personal fees for advisory board membership from AstraZeneca and MSD; personal fees as an invited speaker from Fondazione Internazionale Menarini, GSK, Johnson & Johnson and PharmaMar; and institutional funding as coordinating PI from AstraZeneca, Johnson & Johnson and Roche., (Copyright © 2024 European Society for Medical Oncology, European Society of Gynecological Oncology, European Society of Pathology. Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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4. The progression-free survival ratio as outcome measure in recurrent ovarian carcinoma patients: Current and future perspectives.

Author

van de Kruis N, van der Ploeg P, Wilting JHC, Caroline Vos M, Thijs AMJ, de Hullu J, Ottevanger PB, Lok C, and Piek JMJ

Abstract

Objective: Clinical efficacy of cytostatic anticancer agents can be determined with the progression-free survival (PFS) ratio. This outcome measure compares PFS achieved by a new treatment (PFS2) to the PFS of the most recent treatment on which the patient has experienced progression (PFS1). Clinical benefit has been defined as a PFS-ratio (PFS2/PFS1) > 1.3. However, in order to demonstrate significant benefit, trial designs require an assumption on the proportion of patients who reach this ratio during palliative options. For ovarian carcinoma, data is lacking to support this assumption. Therefore in this study, we assess the PFS-ratio in recurrent ovarian carcinoma patients treated with current palliative options., Methods: We included 67 patients with recurrent high-grade serous (HGSC, 73.1%) or low-grade (LGOC, 26.9%) ovarian carcinoma. We determined the median PFS-ratio and investigated the association with clinicopathological characteristics., Results: Overall, we observed a median PFS-ratio of 0.69. The proportion of patients with a PFS-ratio > 1.3 was 22.4%. For HGSC patients, the median PFS-ratio was significantly lower than for LGOC patients (respectively, 0.58 and 1.26, p  = 0.007). Multivariate logistic regression analysis revealed that the LGOC subtype and CA125 tumor marker concentration were independent factors related to a PFS-ratio > 1.3., Conclusions: Although the PFS-ratio represents a meaningful outcome measure in studies investigating cytostatic anticancer agents, we conclude that it is influenced by tumor histology and biological behavior. In future research, these factors should be taken into account when determining thresholds for clinical benefit in trial designs., Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2022 Published by Elsevier Inc.)

Published
2022
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5. Breast cancer during pregnancy: epidemiology, phenotypes, presentation during pregnancy and therapeutic modalities.

Author

Boere I, Lok C, Poortmans P, Koppert L, Painter R, Vd Heuvel-Eibrink MM, and Amant F

Subjects
Breast, Female, Humans, Mammography, Neoplasm Staging, Phenotype, Positron Emission Tomography Computed Tomography, Pregnancy, Breast Neoplasms diagnosis, Breast Neoplasms epidemiology, Breast Neoplasms therapy
Abstract

Although it is uncommon in general, breast cancer is the most commonly diagnosed cancer during pregnancy. While treatment for pregnant patients should adhere to treatment guidelines for non-pregnant patients, there exist specific considerations concerning diagnosis, staging, oncological treatment, and obstetrical care. Imaging and staging are preferably performed using breast ultrasound and mammography. Other ionizing radiation imaging modalities, including computed tomography (CT) and Positron Emission Tomography/ Computed Tomography (PET/CT), can be selectively performed when the estimated benefit for the mother outweighs the risks to the foetus, e.g., when the results will change clinical management. MRI is appropriate to stage for distant disease on the indication. Breast cancer during pregnancy is less often hormone receptor-positive and more frequently triple-negative breast cancer compared to age-matched controls. The basic principle is that women should receive state-of-the-art oncological treatment without delay if possible and that the pregnancy should be maintained as long as possible. Treatment strategy should be multidisciplinary defined, carefully weighing the selection, sequence, and timing of treatment modalities depending on patient-, tumour-, and pregnancy-related characteristics, as well as patient preferences. Initiating cancer treatment during pregnancy often decreases the risks of early delivery and prematurity. Breast cancer surgery is possible during all trimesters. Radiotherapy is possible during pregnancy in the first half of pregnancy. Chemotherapy can be safely administered starting from 12 weeks of gestational age, but endocrine and HER2 targeted therapy are contraindicated throughout the whole pregnancy. Importantly, foetal growth should be monitored and long-term follow-up of the children is encouraged in dedicated centres., Competing Interests: Declaration of competing interest The authors have no conflicts of interest., (Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2022
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6. Autochthonous leprosy in Europe: a case report and literature review.

Author

Beauvillain Q, Lok C, Joachim C, Hamdad F, Lafabregue E, Attencourt C, Sevestre H, and Chaby G

Subjects
Aged, Europe, Female, Humans, Erythema Nodosum, Hypersensitivity, Leprosy diagnosis, Leprosy drug therapy, Leprosy epidemiology, Leprosy, Lepromatous diagnosis, Leprosy, Lepromatous drug therapy, Leprosy, Multibacillary
Abstract

Leprosy is currently uncommon in Europe: the diagnosed cases are almost all imported from endemic areas. We report on an autochthonous case of borderline lepromatous leprosy in a 71-year-old Portuguese woman. The case was complicated by a reversal reaction and then by erythema nodosum leprosum. A literature review identified 18 reported cases of European autochthonous leprosy since 2000; all but one were observed in Mediterranean countries. Therefore, active clusters of leprosy persist in Europe, particularly in Spain, Greece, Portugal, and Italy., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2021
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7. Clinical presentation and diagnosis of Gestational Trophoblastic Disease.

Author

Lok C, Frijstein M, and van Trommel N

Subjects
Female, Humans, Placenta, Pregnancy, Choriocarcinoma, Gestational Trophoblastic Disease diagnosis, Gestational Trophoblastic Disease therapy, Hydatidiform Mole diagnostic imaging, Uterine Neoplasms diagnostic imaging, Uterine Neoplasms therapy
Abstract

Gestational trophoblastic disease (GTD) is a heterogeneous group of pregnancy-related disorders characterized by abnormal proliferation of trophoblastic tissue. It encompasses the premalignant partial and complete hydatidiform mole but also the malignant invasive mole, choriocarcinoma, placental-site trophoblastic tumor, and epithelioid trophoblastic tumor. The clinical presentation changed to earlier detection after the introduction of first trimester ultrasounds. Patients are often asymptomatic, but vaginal bleeding continues to be the most common presenting symptom. Other symptoms can develop in the case of metastatic disease. Ultrasound, serum human chorionic gonadotrophin, and sometimes additional imaging such as CT, MRI, or PET can confirm the diagnosis and stage of disease. Familiarity with the pathogenesis, classification, imaging features, and treatment of GTD facilitates diagnosis and appropriate management., Competing Interests: Conflict of interest I hereby declare that C Lok, M Frijstein, and N van Trommel have no conflicts of interest for the publication of our manuscript entitled “Clinical presentation and diagnosis of Gestational Trophoblastic Disease” for Best Practice & Research Clinical Obstetrics & Gynaecology: an invited Review for Issue 35.5/Volume 74., (Copyright © 2020. Published by Elsevier Ltd.)

Published
2021
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9. [Genital lymphedema associated with Crohn's disease].

Author

Garny de La Rivière C, Caudron A, Heyman B, and Lok C

Subjects
Genital Diseases, Male etiology, Humans, Male, Middle Aged, Crohn Disease complications, Lymphedema etiology, Penile Diseases etiology, Scrotum
Abstract

Introduction: Crohn's disease is a chronic inflammatory intestinal pathology which can be associated to different extra-digestive manifestations. We reported a case of recurrent genital lymphedema leading to Crohn's disease diagnosis., Case Report: A 49-year-old man was referred for increased penis and scrotal volume, associated with recurrent febrile flare during the 10 previous years. Clinically, we noted an inflammatory penis and scrotum lymphedema. Clinical urological examination, and biological, bacteriological, computer-tomography examinations were negative. Metastatic Crohn's disease was diagnosed in association with concomitant severe terminal ileitis. Treatment with corticosteroids and azathioprine resulted in significant decrease of inflammatory genital lymphedema., Conclusion: Genital inflammatory lymphedema occurs during inflammatory, infectious, and tumor diseases. Some cases of metastatic genital lymphedema related to Crohn's disease are described, most often in children. Inflammatory genital lymphedema associated with gastrointestinal symptoms may suggest Crohn's disease., (Copyright © 2014 Société nationale française de médecine interne (SNFMI). Published by Elsevier SAS. All rights reserved.)

Published
2015
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10. Adjuvant prophylactic regional radiotherapy versus observation in stage I Merkel cell carcinoma: a multicentric prospective randomized study.

Author

Jouary T, Leyral C, Dreno B, Doussau A, Sassolas B, Beylot-Barry M, Renaud-Vilmer C, Guillot B, Bernard P, Lok C, Bedane C, Cambazard F, Misery L, Estève E, Dalac S, Machet L, Grange F, Young P, Granel-Brocard F, Truchetet F, Vergier B, Delaunay MM, and Grob JJ

Subjects
Adult, Aged, Aged, 80 and over, Carcinoma, Merkel Cell mortality, Carcinoma, Merkel Cell pathology, Carcinoma, Merkel Cell surgery, Disease-Free Survival, Early Termination of Clinical Trials, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Prospective Studies, Radiotherapy, Adjuvant, Skin Neoplasms mortality, Skin Neoplasms pathology, Skin Neoplasms surgery, Carcinoma, Merkel Cell radiotherapy, Skin Neoplasms radiotherapy
Abstract

Background: The treatment of stage I Merkel cell carcinoma (MCC) usually includes wide local excision (WLE) combined with irradiation of the tumor bed (ITB). No randomized study has ever been conducted in MCC. The purpose of this study was to assess the efficacy and safety of prophylactic adjuvant radiotherapy on the regional nodes., Patients and Methods: In this randomized open controlled study, patients for a stage I MCC treated by WLE and ITB were randomly assigned to regional adjuvant radiotherapy versus observation. Overall survival (OS) and probability of regional recurrence (PRR) were primary end points. Progression-free survival (PFS) and tolerance of irradiation were secondary end points., Results: Eighty-three patients were included before premature interruption of the trial, due to a drop in the recruitment mainly due to the introduction of the sentinel node dissection in the management of MCC. No significant improvement in OS (P = 0.989) or PFS (P = 0.4) could be demonstrated after regional irradiation, which, however, significantly reduced the PRR (P = 0.007) with 16.7% regional recurrence rate in the observation arm versus 0% in the treatment arm. The treatment was well tolerated., Conclusion: The adjuvant regional irradiation significantly decreased the PRR in MCC, but benefit in survival could not be demonstrated.

Published
2012
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11. A comparison of two regimens of topical corticosteroids in the treatment of patients with bullous pemphigoid: a multicenter randomized study.

Author

Joly P, Roujeau JC, Benichou J, Delaporte E, D'Incan M, Dreno B, Bedane C, Sparsa A, Gorin I, Picard C, Tancrede-Bohin E, Sassolas B, Lok C, Guillaume JC, Doutre MS, Richard MA, Caux F, Prost C, Plantin P, Chosidow O, Pauwels C, Maillard H, Saiag P, Descamps V, Chevrant-Breton J, Dereure O, Hellot MF, Esteve E, and Bernard P

Subjects
Administration, Topical, Adrenal Glands drug effects, Aged, Aged, 80 and over, Clobetasol adverse effects, Disease-Free Survival, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Glucocorticoids adverse effects, Humans, Hypothalamo-Hypophyseal System drug effects, Male, Proportional Hazards Models, Recurrence, Treatment Outcome, Clobetasol administration & dosage, Glucocorticoids administration & dosage, Pemphigoid, Bullous drug therapy
Abstract

Superpotent topical corticosteroids (CS) have been demonstrated to improve bullous pemphigoid (BP) patients' survival. We assessed whether a mild regimen using lower doses of topical CS and a shorter duration could improve the outcome of BP patients even more. Three-hundred and twelve BP patients were included in a multicenter randomized controlled trial and stratified depending on the extent of BP as moderate (n=134) or extensive (n=178). Patients were randomly assigned to the standard regimen (clobetasol propionate cream, 40 g per day initially, with CS tapering over 12 months) or the mild regimen (10-30 g per day), with CS tapering over 4 months. A noninferior rate of BP control was obtained with the mild regimen 156/159 (98%) as compared with the standard regimen 150/150 (100%; P=0.005). Event-free survival, that is, the combined outcome of deaths and life-threatening adverse events did not differ between the two treatment groups (P=0.77). However, upon adjusting through the Cox model for age and Karnofsky score, a strong beneficial effect of the mild regimen was observed in patients with moderate BP, with an almost twofold decrease in the risk of death or life-threatening adverse events relative to the standard regimen (hazard ratio=0.54; 95% confidence interval, 0.30-0.97; P=0.039). This mild regimen allows a 70% reduction of the cumulative doses of CS and improves BP patients' outcome.

Published
2009
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12. Impact of protein deficiency on venous ulcer healing.

Author

Legendre C, Debure C, Meaume S, Lok C, Golmard JL, and Senet P

Subjects
Aged, Aged, 80 and over, Biomarkers blood, C-Reactive Protein metabolism, Case-Control Studies, Female, France epidemiology, Humans, Male, Middle Aged, Nutrition Assessment, Pilot Projects, Prealbumin metabolism, Prevalence, Prognosis, Prospective Studies, Protein Deficiency complications, Protein Deficiency physiopathology, Serum Albumin metabolism, Time Factors, Varicose Ulcer complications, Varicose Ulcer epidemiology, Protein Deficiency epidemiology, Varicose Ulcer physiopathology, Wound Healing
Abstract

Objective: The prevalence of protein deficiency and its impact on wound healing is not known for leg ulcers. The aim of this study was to determine the prevalence of protein deficiency in outpatients presenting with leg ulcers and the parameter's prognostic value for wound outcome., Design of Study: Prospective controlled observational study., Setting: Ambulatory patients referred for chronic wounds to four university hospitals., Methods: Consecutive out-patients with a leg ulcer present for at least 2 months, related to venous insufficiency, associated or not with moderate peripheral arterial disease (ankle-brachial pressure index > 0.7), were included in a prospective study. Wound evaluation (area and occurrence of complications) was performed at baseline and at 12 weeks of follow-up. Biologic nutrition assessment (serum albumin, transthyretin, c-reactive protein) was performed at baseline. The control group consisted of consecutive patients free of leg ulceration and attending the dermatology outpatient clinic for remissive skin cancer or miscellaneous skin disorders., Results: Forty one patients and 43 controls were included. Serum albumin level was under 35 g/L (normal values: 36-44 g/L) in 27% of the patients and 2% of the controls (P < .001). At 12 weeks, 34% of the patients had an increase in wound area. Wound infections occurred in 12% (n = 5) of the patients. Protein deficiency was independently associated with an increase in wound area at 12 weeks (P = .034) and the presence of an inflammatory syndrome was associated with the occurrence of wound complications (wound infection or hospitalization) during follow-up (P < .001)., Conclusion: The prevalence of protein deficiency in out-patients with leg ulcers is high and significantly associated with a poor healing prognosis.

Published
2008
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13. Venous leg ulcer: a meta-analysis of adjunctive therapy with micronized purified flavonoid fraction.

Author

Coleridge-Smith P, Lok C, and Ramelet AA

Subjects
Administration, Oral, Aged, Chemotherapy, Adjuvant, Diosmin administration & dosage, Female, Humans, Male, Middle Aged, Randomized Controlled Trials as Topic, Time Factors, Wound Healing drug effects, Diosmin therapeutic use, Varicose Ulcer therapy
Abstract

Objective: To assess the effect of oral treatment with micronized purified flavonoid fraction (MPFF) on leg ulcer healing., Design: Meta-analysis of randomised prospective studies using MPFF in addition to conventional treatment., Materials and Methods: Five prospective, randomised, controlled studies in which 723 patients with venous ulcers were treated between 1996 and 2001 were identified. Conventional treatment (compression and local care) in addition to MPFF was compared to conventional treatment plus placebo in two studies (N = 309), or with conventional treatment alone in three studies (N = 414). The primary end point was complete ulcer healing at 6 months., Results: At 6 months, the chance of healing ulcer was 32% better in patients treated with adjunctive MPFF than in those managed by conventional therapy alone (RRR: 32%; CI, 3-70%). This difference was present from month 2 (RRR: 44%; CI, 7-94%), and was associated with a shorter time to healing (16 versus 21 weeks; P = 0.0034). The main benefit of MPFF was present in the subgroup of ulcers between 5 and 10 cm2 in area (RRR: 40%; CI, 6-87%), and those present for 6-12 months duration (RRR: 44%; CI, 6-97%)., Conclusion: These results confirm that venous ulcer healing is accelerated by MPFF treatment. MPFF might be a useful adjunct to conventional therapy in large and long standing ulcers.

Published
2005
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14. [Angioedema and angiotensin converting enzyme inhibitors: a report of 19 cases].

Author

Ducroix JP, Outurquin S, Benabes-Jezraoui B, Gras V, Chaby G, Strunski V, Salle V, Smail A, Lok C, and Andrejak M

Subjects
Adult, Aged, Bradykinin pharmacology, Female, Humans, Hypertension drug therapy, Male, Middle Aged, Population Surveillance, Angioedema chemically induced, Angiotensin-Converting Enzyme Inhibitors adverse effects, Angiotensin-Converting Enzyme Inhibitors therapeutic use
Abstract

Purpose: Inhibitors of angiotensin-converting enzyme are worldwide used and are a real progress for the treatment of systemic hypertension or cardiac failure and are a real progress. The most common adverse side effect is cough. Angioedema is a sudden and localized edema involving the deeper cutaneous and mucosa tissue lappers. 0.1-0.5% of patients treated by ACE inhibitors could develop angioedema., Materials and Methods: We report a series of 19 cases, recruited in the Parmacovigilance Center of the University Hospital of Amiens from 1997 to 2003., Results: All the patients had a facial swelling edema at initial presentation. Intestinal mucosa or preputial are misleading localisations. In 1/3 of cases, angioedema appeared after the first administration, in 1/3 of cases it appeared with a delay of 1-2 years. The oropharynx localisation with glottic involvement may need an airway intervention. One patient died from pulmonary distress at home., Conclusion: The pathophysiology is current unknown although there is increasing evidence for bradykinin accumulation involvement. The treatment by ACE inhibitors must be broken off; angiotensin II antagonists may be an alternative treatment, but has to be introduced carefully.

Published
2004
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15. Randomised trial of interferon alpha-2a as adjuvant therapy in resected primary melanoma thicker than 1.5 mm without clinically detectable node metastases. French Cooperative Group on Melanoma.

Author

Grob JJ, Dreno B, de la Salmonière P, Delaunay M, Cupissol D, Guillot B, Souteyrand P, Sassolas B, Cesarini JP, Lionnet S, Lok C, Chastang C, and Bonerandi JJ

Subjects
Antineoplastic Agents adverse effects, Combined Modality Therapy, Disease-Free Survival, Female, Follow-Up Studies, Humans, Interferon alpha-2, Interferon-alpha adverse effects, Lymphatic Metastasis, Male, Melanoma mortality, Melanoma secondary, Melanoma surgery, Middle Aged, Neoplasm Recurrence, Local epidemiology, Proportional Hazards Models, Prospective Studies, Recombinant Proteins, Risk Assessment, Skin Neoplasms mortality, Skin Neoplasms pathology, Skin Neoplasms surgery, Time Factors, Antineoplastic Agents therapeutic use, Interferon-alpha therapeutic use, Melanoma therapy, Skin Neoplasms therapy
Abstract

Background: Owing to the limited efficacy of therapy on melanoma at the stage of distant metastases, a well-tolerated adjuvant therapy is needed for patients with high-risk primary melanoma. Our hypothesis was that an adjuvant treatment with low doses of interferon alpha could be effective in patients with localised melanoma., Methods: After resection of a primary cutaneous melanoma thicker than 1.5 mm, patients without clinically detectable node metastases were randomly assigned to receive either 3x10(6) IU interferon alpha-2a, three-times weekly for 18 months, or no treatment. The primary endpoint was the relapse-free interval., Findings: 499 patients were enrolled, of whom 489 were eligible. When used as part of a sequential procedure, interferon alpha-2a was of significant benefit for relapse-free interval (p=0.038). A long-term analysis, after a median follow-up of 5 years, showed a significant extension of relapse-free interval (p=0.035) and a clear trend towards an increase in overall survival (p=0.059) in interferon alpha-2a-treated patients compared with controls. There were 100 relapses and 59 deaths among the 244 interferon alpha-2a-treated patients compared with 119 relapses and 76 deaths among the 245 controls. The estimated 3-year-relapse rates were 32% in the interferon alpha-2a group and 44% in controls; the 3-year death rates were 15% and 21%, respectively. Only 10% of patients experienced WHO grade 3 or 4 adverse events. Treatment was compatible with normal daily life., Interpretation: Adjuvant therapy of high-risk melanoma with low doses of interferon alpha-2a for 18 months is safe and is beneficial when started before clinically detectable node metastases develop.

Published
1998
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16. [Acute generalized exanthematous pustulosis].

Author

Epelbaum S, Benhamou PH, Lok C, Rossi D, Labeille B, Denoeux J, and Piussan C

Subjects
Adolescent, Amoxicillin therapeutic use, Diagnosis, Differential, Humans, Male, Psoriasis diagnosis, Tonsillitis diagnosis, Tonsillitis drug therapy, Amoxicillin adverse effects, Drug Eruptions etiology, Exanthema chemically induced
Abstract

The authors report the case of a young patient who developed an eruption resembling an acute generalized pustular dermatitis after amoxicillin therapy for a tonsillitis. The nosological distinctions between this clinical entity and pustular psoriasis are discussed.

Published
1989

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