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PET imaging with 16α- 18 F-fluoro-17β-fluoroestradiol ( 18 F-FES), a radiolabeled form of estradiol, allows whole-body, noninvasive evaluation of estrogen receptor (ER). 18 F-FES is approved by the U.S. Food and Drug Administration as a diagnostic agent "for the detection of ER-positive lesions as an adjunct to biopsy in patients with recurrent or metastatic breast cancer." The Society of Nuclear Medicine and Molecular Imaging (SNMMI) convened an expert work group to comprehensively review the published literature for 18 F-FES PET in patients with ER-positive breast cancer and to establish appropriate use criteria (AUC). The findings and discussions of the SNMMI 18 F-FES work group, including example clinical scenarios, were published in full in 2022 and are available at https://www.snmmi.org/auc Of the clinical scenarios evaluated, the work group concluded that the most appropriate uses of 18 F-FES PET are to assess ER functionality when endocrine therapy is considered either at initial diagnosis of metastatic breast cancer or after progression of disease on endocrine therapy, the ER status of lesions that are difficult or dangerous to biopsy, and the ER status of lesions when other tests are inconclusive. These AUC are intended to enable appropriate clinical use of 18 F-FES PET, more efficient approval of FES use by payers, and promotion of investigation into areas requiring further research. This summary includes the rationale, methodology, and main findings of the work group and refers the reader to the complete AUC document., (© 2023 by the Society of Nuclear Medicine and Molecular Imaging.)

As the immuno-oncology field continues the rapid growth witnessed over the past decade, optimising patient outcomes requires an evolution in the current response-assessment guidelines for phase 2 and 3 immunotherapy clinical trials and clinical care. Additionally, investigational tools-including image analysis of standard-of-care scans (such as CT, magnetic resonance, and PET) with analytics, such as radiomics, functional magnetic resonance agents, and novel molecular-imaging PET agents-offer promising advancements for assessment of immunotherapy. To document current challenges and opportunities and identify next steps in immunotherapy diagnostic imaging, the National Cancer Institute Clinical Imaging Steering Committee convened a meeting with diverse representation among imaging experts and oncologists to generate a comprehensive review of the state of the field., Competing Interests: Declaration of interests EGEdV reports institutional financial support for clinical trials or contracted research from Amgen, Genentech, Roche, CytomX, G1 Therapeutics, Bayer, Synthon, Servier, Regeneron, Crescendo Biologics, GE Healthcare, and AstraZeneca; institutional financial support for advisory boards and consultancy from National Surgical Adjuvant Breast and Bowel Project, Daiichi Sankyo, and Crescendo Biologics; and non-financial interests, including non-renumerated activities and public positions as a member of the European Society for Medical Oncology (ESMO)–Magnitude of Clinical Benefit Scale working party, chair of the ESMO Cancer Medicines Working Group, co-chair of the RECIST committee, and a member of the expert panel for the selection of WHO Essential Medicine List. MDF reports institutional grant or contract payments from Merck, Bristol Myers Squibb, ImaginAb, and Carisma Therapeutics, and consulting fees and meeting and travel support from ImaginAb. DL reports stock ownership in Bristol Myers Squibb. UM reports grants, royalties and license, consulting fees, meeting and travel support, licensed patents, leadership interest, stock, receipt of materials, and other financial or non-financial interests in CytoSite Biopharma. TYP reports grants or contracts from the Pediatric Brain Tumor Consortium Neuroimaging Center; royalties from Springer; and honoraria for grand rounds, visiting professorships, and invited lectures from Cornell University, University of California San Francisco, and University of Rochester. DP reports grants to or contracts with his institution from Siemens, 511 Pharma, Nordic nanovector, Lantheus, and Fusion Pharmaceuticals; royalties or licenses to him and his institution from Trevarx; consulting fees from Siemens, Fusion Pharmaceuticals, 511 Pharma, Ipsen, Bayer, Molecular Targeting Technologies, and Curium; patents from At-211 parthanatrace; participation on an Isotope Technologies Munich (ITM) data and safety monitoring committee; and stock with Molecular Targeting Technologies and Trevarx. LS reports institutional grants or contracts from Johnson & Johnson, patents from Varian Medial Systems, and data and safety monitoring board or advisory board participation with Merck, BMS, and Regeneron. YT provided medical writing assistance funded by NCI. AJT reports an institutional research grant from the Cystic Fibrosis Foundation, royalties from Elsevier, consulting fees from Applied Radiology, travel support from KLAS Research, and unpaid leadership roles in the Society for Imaging Informatics in Medicine and the Society for Pediatric Radiology. RLW reports grants or contracts from Bristol Myers Squibb, Bayer, Actinium Pharmaceuticals, ITM, Siemens, and NIH; consulting fees from Seno medical, Actinium Pharmaceuticals, and Clarity Pharmaceuticals; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from ITM, Voximetry, American College of Nuclear Medicine, and NIH (not for this workshop or manuscript); support for meetings and travel from the Society of Nuclear Medicine and the World Theranostics Conference; data and safety monitoring board and advisory board participation from Bayer; a recent past-presidency at Society of Nuclear Medicine and Molecular Imaging; and stock in Clarity Pharmaceuticals and Voximetry. JW reports grants from Bristol Myers Squibb and Sephora; institutional royalties for xenogeneic DNA vaccines, Newcastle disease viruses for cancer therapy, myeloid-derived suppressor cell assay, and prediction of responsiveness to treatment with immunomodulatory therapeutics and method of monitoring abscopal effects during such treatment; licenses for anti-PD1 antibodies, anti-CTLA4 antibodies, and anti-GITR antibodies, and methods of use thereof; consulting fees from Amgen, Apricity, Ascentage Pharma, Astellas, AstraZeneca, Bicara Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, CellCarta, Chugai, Daiichi Sankyo, Dragonfly, Georgiamune, Idera, Imvaq, Larkspur, Maverick Therapeutics, Merck, Psioxus, Recepta, Trishula, Sellas, Surface Oncology, and Werewolf therapeutics; support for meetings and travel from Society for Immunotherapy of Cancer (SITC) and Parker Institute for Cancer Immunotherapy; a leadership or fiduciary role in SITC; and stock in Apricity, CellCarta, Ascentage, Beigene, Imvaq, Linneaus, Georgiamune, Maverick, Tizona Pharma, and Trieza. JW also reports patents for recombinant poxviruses for cancer immunotherapy, phosphatidylserine targeting agents, immunosuppressive follicular helper-like T cells modulated by immune checkpoint blockade, identifying and treating subjects at risk for checkpoint blockade therapy-associated colitis, CAR(+) T cells targeting differentiation antigens as means to treat cancer, anti-CD40 agonist monoclonal antibody fused to monophosphoryl lipid A for cancer therapy, and engineered vaccinia viruses for cancer immunotherapy. AMW reports consulting fees, a leadership or fiduciary role (board member), and stock options in ImaginAb; and speaker honoraria payments from Roche and AstraZeneca. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Our study aimed to assess inequities in the clinical trial participation for the selected patient groups. We searched the Food and Drug Administration (FDA) database and extracted phase-III clinical trial data from MEDLINE for each approved drug by the FDA between January 1, 2006, and June 30, 2020. We analyzed the inclusion/exclusion criteria, participation according to gender, ethnic group, performance score, the positivity of HBV and HCV, and HIV, having comorbidities and brain metastasis. We compared the findings with that of the general population by retrieving data from the Surveillance, Epidemiology and End Results (SEER) database. We identified 142 phase III pivotal oncology trials that enrolled 105 397 patients. The proportion of female patients in trials was lower than their relative prevalence in the general population from SEER region (36% vs 49.6%, P < .001). The rates of black patients included were lower than their relative prevalence from SEER region (2.1% vs 9.8%, P < .001). 1.3% and 0.8% of patients had HBV and HCV infections, respectively. The patients' numbers with organ dysfunction were not established due to insufficient data from clinical trials. 1.6% of all patients had controlled brain metastasis. Black patients, women and patients with brain metastasis or with HBV and HCV were underrepresented. Our study underscores the importance of expanding the inclusion/exclusion criteria of pivotal oncology trials to be more representative of patients seen in clinical practice., (© 2021 UICC.)

Introduction: In patients with metastatic melanoma, progression of a single tumour lesion (solitary progression) after response to immune checkpoint inhibition (ICI) is increasingly treated with local therapy. We evaluated the role of local therapy for solitary progression in melanoma., Patients and Methods: Patients with metastatic melanoma treated with ICI between 2010 and 2019 with solitary progression as first progressive event were included from 17 centres in 9 countries. Follow-up and survival are reported from ICI initiation., Results: We identified 294 patients with solitary progression after stable disease in 15%, partial response in 55% and complete response in 30%. The median follow-up was 43 months; the median time to solitary progression was 13 months, and the median time to subsequent progression after treatment of solitary progression (TTSP) was 33 months. The estimated 3-year overall survival (OS) was 79%; median OS was not reached. Treatment consisted of systemic therapy (18%), local therapy (36%), both combined (42%) or active surveillance (4%). In 44% of patients treated for solitary progression, no subsequent progression occurred. For solitary progression during ICI (n = 143), the median TTSP was 29 months. Both TTSP and OS were similar for local therapy, ICI continuation and both combined. For solitary progression post ICI (n = 151), the median TTSP was 35 months. TTSP was higher for ICI recommencement plus local therapy than local therapy or ICI recommencement alone (p = 0.006), without OS differences., Conclusion: Almost half of patients with melanoma treated for solitary progression after initial response to ICI had no subsequent progression. This study suggests that local therapy can benefit patients and is associated with favourable long-term outcomes., Competing Interests: Conflict of interest statement All authors declare no direct conflict with this work. For unrelated conflicts, K.P.M.S. has an advisory role for Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, AbbVie and Pierre Fabre and has received honoraria from Merck Sharp & Dohme, Novartis and Roche. L.Z. has an advisory role for Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre, Sanofi and Sun Pharma; has received research funding from Novartis; has received honoraria from Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Pierre Fabre and Roche and has received travel support from Amgen, Bristol Myers Squibb, Novartis, Pierre Fabre, Sanofi and Sun Pharma. E.W.K. has an advisory role for Bristol Myers Squibb, Merck, Novartis and Pierre Fabre; has received research funding from Bristol Myers Squibb and has received travel support from Roche. C.A. has received travel support from Amgen, Bristol Myers Squibb and Roche. D.B.J. has an advisory role for Array BioPharma, Bristol Myers Squibb, Incyte, Merck and Novartis; has received research funding from Bristol Myers Squibb and Incyte and has received travel support from Genentech. Adriana H. is an employee of AstraZeneca with stock options in the company, has received honoraria from Novartis; has an advisory role for L.E.K. Consulting and has received travel support from Roche. J.M. has received honoraria from Amgen, Bristol Myers Squibb, Merck-Pfizer, MSD, Novartis and Pierre Fabre; has an advisory role for Amgen, Merck-Pfizer, Merck Sharp & Dohme, Novartis and Pierre Fabre and has received travel support from Bristol Myers Squibb, L'Oreal, MSD, Pierre Fabre and Ultrasun. P.B. has received travel support from MSD. Y.J.L.J. has received travel support from Bristol Myers Squibb, MSD and Pfizer. V.A. has received honoraria from Bristol Myers Squibb, Genentech, Merck Serono, Merck Sharp & Dohme, Novartis and Pierre Fabre; has an advisory role for Bristol Myers Squibb, Merck Serono, Merck Sharp & Dohme, Novartis, Pierre Fabre and Roche and has received travel support from Bristol Myers Squibb, Merck Sharp & Dohme, OncoSec and Pierre Fabre. P.A.A. has an advisory role for 4SC, Alkermes, Amgen, Array BioPharma, Bristol Myers Squibb, Genentech, Genmab, Idera, Immunoscore, Incyte, Italfarmaco, MedImmune, Merck Serono, Merck Sharp & Dohme, Nektar, NewLink Genetics, Novartis, Pierre Fabre, Sandoz, Sanofi, Sun Pharma, Syndax and Ultimovacs; has received research funding from Array BioPharma, Bristol Myers Squibb and Genentech; has received travel support from Merck Sharp & Dohme and is a stockowner of PrimeVax. Andrew H. has received honoraria from Merck and Novartis and has an advisory role for Novartis and Pierre Fabre. A.M.M. has an advisory role for Bristol Myers Squibb, MSD Oncology, Novartis, Pierre Fabre and Roche. G.V.L. is a consultant advisor for Aduro Biotech, Inc., Amgen Inc., Array BioPharma Inc., Boehringer Ingelheim International GmbH, Bristol Myers Squibb, Highlight Therapeutics S.L., Merck Sharp & Dohme, Novartis Pharma AG, QBiotics Group Limited, Regeneron Pharmaceuticals, Inc. and SkylineDX B.V. C.L. had received honoraria from Amgen, Bristol Myers Squibb, Incyte, Merck Sharp & Dohme, Novartis, Pfizer, Pierre Fabre and Roche; has an advisory role for Amgen, Bristol Myers Squibb, Merck Serono, Merck Sharp & Dohme, Novartis, Roche and Sanofi; has received research funding from Bristol Myers Squibb and Roche and has received travel support from Bristol Myers Squibb and Merck Sharp & Dohme. A.A.M.v.d.V. has an advisory role for Bristol Myers Squibb, Eisai, Ipsen, MSD Oncology, Merck, Novartis, Pfizer, Pierre Fabre, Roche and Sanofi and has received research funding from Bayer and travel support from Bayer, MSD Oncology, Novartis and Roche. M.S.C. has an advisory role for Amgen, Bristol Myers Squibb, Eisai, IDEAYA Biosciences, Merck and Co, Merck Sharp & Dohme, Nektar, Novartis, Pierre Fabre, Roche, Sanofi and QBiotics and has received honoraria from Bristol Myers Squibb, Merck Sharp & Dohme and Novartis. S.S. has received honoraria from AstraZeneca, Bristol Myers Squibb, Merck and Merck Serono; has an advisory role for Amgen, Bristol Myers Squibb, MSD, Novartis and Roche outside the submitted work and has received research funding from Amgen, AstraZeneca, Endocyte, Genentech and Merck Sharp & Dohme. E.G.E.d.V. has an advisory role for Daiichi Sankyo, NSABP and Sanofi; has received research funding from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Servier and Synthon and is the chair of ESMO Cancer Medicines Working Group, chair of RECITS committee and member of the ESMO-MCBS working group. C.U.B. has received research funding from Bristol Myers Squibb, Novartis and NanoString; has an advisory role for Bristol Myers Squibb, Merck Sharp & Dohme, Roche, Novartis, GlaxoSmithKline, AstraZeneca, Pfizer, Lilly, Genmab and Pierre Fabre and is a stockowner of Uniti Cars. M.J. has an advisory role for Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, AstraZeneca, Tesaro and Pierre Fabre., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Click here to listen to the Podcast BACKGROUND: Form 1 of the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) serves to grade therapies with curative intent. Hitherto only few trials with curative intent have been field tested using form 1. We aimed to evaluate the applicability of the scale and to assess the reasonableness of the generated scores in early colon cancer, in order to identify shortcomings that may be rectified in future amendments., Methods: Adjuvant studies were identified in PubMed, Food and Drug Administration and European Medicines Agency registration sites, as well as ESMO and National Comprehensive Cancer Network guidelines. Studies meeting inclusion criteria were graded using form 1 of the ESMO-MCBS V.1.1 and field tested by ESMO Colorectal Cancer Faculty. Shortcomings of the scale were identified and evaluated., Results: Eighteen of 57 trials and 7 out of 14 meta-analyses identified met criteria for ESMO-MCBS V.1.1 grading. In stage III colon cancer, randomised clinical trials and meta-analyses of modulated 5-fluorouracil (5-FU) based chemotherapy versus surgery scored ESMO-MCBS grade A and randomised controlled trials (RCTs) and meta-analyses comprising oxaliplatin added to this 5-FU backbone showed a more modest additional overall survival benefit (grade A and B). For stage II colon cancer, the findings are less consistent. The fluoropyrimidine trials in stage II were graded 'no evaluable benefit' but the most recent meta-analysis demonstrated a 5.4% survival advantage after 8 years follow-up (grade A). RCTs and a meta-analysis adding oxaliplatin demonstrated no added benefit. Exploratory toxicity evaluation and annotation was problematic given inconsistent toxicity reporting and limited results of late toxicity. Field testers (n=37) reviewed the scores, 25 confirmed their reasonableness, 12 found them mostly reasonable. Moreover, they identified the inability of crediting improved convenience in non-inferiority trials as a shortcoming., Conclusion: Form 1 of the ESMO-MCBS V.1.1 provided very reasonable grading for adjuvant colon cancer studies., Competing Interests: Competing interests: EGEdV reports Institutional Financial Support for her advisory role from Daiichi Sankyo, Merck, NSABP, Pfizer, Sanofi, Synthon and Institutional Financial Support for clinical trials or contracted research from Amgen, AstraZeneca, Bayer, Chugai Pharma, CytomX Therapeutics, G1 Therapeutics, Genentech, Nordic Nanovector, Radius Health, Regeneron, Roche, Synthon, all outside the submitted work., (© Author (s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.)