European Society For Medical Oncology Research Articles

Oncological Surveillance After Radical Cystectomy: a Narrative Review of the Enhanced Recovery After Surgery Cystectomy Committee

Purpose: Follow-up after cystectomy aims to detect relapse, but there are discrepancies in recommendations among guidelines. Routine follow-up for asymptomatic recurrences in urothelial cancer is primarily based on nonvalidated risk factors from retrospective cohort studies in single institutions. This review provides an overview of follow-up investigations, schedules, and potential risk factors of recurrence. Materials and methods: We conducted a narrative literature search on PubMed and reviewed guidelines (European Society for Medical Oncology, European Association of Urology, National Comprehensive Cancer Network, American Urology Association, and National Institute for Health and Care Excellence) and institutional protocols for cystectomy patients. Results: Our analysis included 29 studies with 23,218 patients. Most relapses occurred within 2 years, either locally or as distant recurrences in the chest, liver, bones, or brain. Factors increasing relapse risk included higher tumor stage, nodal involvement, histological subtypes, and lymphovascular invasion. Surveillance protocols varied in frequency and type of investigation. Limited recommendations were available for patients with ypT0, pT0, or non–muscle-invasive bladder cancer. Conclusions: Further research is needed to evaluate the impact of postcystectomy follow-up protocols on oncological outcomes and establish optimal surveillance procedures.

Biomarker Testing for Actionable Alterations in NSCLC-Perspectives from US-Based Academic and Community Oncologists: A Podcast.

The identification of actionable oncogenic driver mutations in patients with non-small cell lung cancer impacts therapy selection, and appropriate therapy administration results in improvements in clinical outcomes. Although biomarker testing for actionable oncogenic driver mutations is recommended in national and international guidelines, there are still unmet needs in the real world. Through this podcast we provide, from a US perspective, an overview and discuss challenges in biomarker testing from both an academic and a community oncologist viewpoint. We describe the importance of comprehensive testing, actionable biomarkers as recommended by guidelines such as National Comprehensive Cancer Network® (NCCN®) and European Society for Medical Oncology, types of tests and assessment techniques for detection of actionable biomarkers, and challenges in testing. These challenges include the lack of awareness of the biomarker testing guidelines among physicians, inconsistent reimbursement, longer turnaround time resulting in delays in therapy initiation, and nihilism associated with particular patient characteristics. To tackle these challenges, we offer recommendations from the perspective of our own clinical settings.

Cryoablation of the adenohypophysis in the treatment of chronic pain syndrome in patients with stage IV malignant neoplasms

Background. The data of the European Society For Medical Oncology (ESMO) indicate that 64.0% of cancer patients with the fourth stage of cancer have chronic pain syndrome, which is the main factor that significantly affects the quality of life. In 46.0% of patients, it is not possible to obtain a stable analgesic effect with modern methods of analgesia, including interventional methods and pharmacotherapy. Refractory oncological pain stimulates the search for new methods of pain relief.
 Purpose – retrospective assessment of the effectiveness of the selective stereo- tactic transnasal transsphenoidal cryoablation of the adenohypophysis in the treatment of chronic pain syndrome in patients with stage IV malignant neoplasms.
 Materials and methods. 45 microsurgeries were performed – stereotactic selective transnasal transsphenoidal cryoablation of the adenohypophysis with endoscopy. Over the period from 2014 to 2018, 45 patients with stage IV malignant hormone- dependent neoplasms of various somatic organs and chronic pain syndrome underwent microsurgery.
 Results. The analgesic effect appeared 4–6 hours after the microsurgery. In 95.6% of patients, an analgesic effect was achieved to a greater extent (according to the numeric rating scale (NRS) for pain, its intensity decreased from 7–9 points to 1–3 points); in other patients, the analgesic effect was achieved to a lesser extent (according to the NRS, pain intensity decreased from 7–9 points to 3–5 points), regardless of the condition and age of the patient. Accordingly, the dosage was reduced or opioid analgesics were discontinued. Severe complications after the cryoablation of adenohypophysis, such as meningitis, diabetes insipidus, and hypopituitary syndrome were not observed. In the postoperative period, three patients were treated for mild hypopituitary syndrome, and two patients were treated for liquorrhea with conservative therapy for 3–5 days.
 Conclusions. Stereotactic selective transnasal transsphenoidal cryoablation of the adenohypophysis is an effective microsurgery in the treatment of chronic pain syndrome in stage IV cancer patients. It improves the patient’s condition and quality of life. The analgesic effect appears in the first hours after surgery. Due to the use of cryoprobes with a diameter of 1.2 mm and 1.8 mm, the surgery is minimally traumatic and can be performed on patients in critical condition.

Integrating palliative care into the evolving landscape of oncology

Patients with cancer have many palliative care needs. Robust evidence supports the early integration of palliative care into the care of patients with advanced cancer. International organizations, such as the American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO), have recommended early, longitudinal integration of palliative care into oncology care throughout the cancer trajectory. In this review, we pose a series of clinical questions related to the current state of early palliative care integration into oncology. We review the evidence to address each of these questions and highlight areas for further investigation. As cancer care continues to evolve, incorporating new treatment modalities and improving patient outcomes, we reflect on how to apply the existing evidence supporting early palliative care-oncology integration into this ever-changing therapeutic landscape and how specialty palliative care might adapt to meet the evolving needs of patients, caregivers, and the multidisciplinary oncology team.

Essential cancer medicines: adding feasibility to the magnitude of clinical benefit value chain

Cancer is a global public health problem, requiring efficient health system investments to deliver sustainable impact on population health. Access to medicines is a critical component of health systems, having a crucial role in delivering therapeutic benefits. Since 1977, the World Health Organization (WHO) has published a Model List of Essential Medicines (EML) that includes key health interventions for the prevention and control of conditions of public health relevance. Essential medicines are selected for inclusion in the EML based on the evidence of efficacy, safety, therapeutic value, and the potential to impact population health. With the rapid changes in the therapeutic landscape of cancer treatment with new medicine approvals, there is a critical need to select and prioritise specific cancer interventions based on their intrinsic value. The European Society for Medical Oncology (ESMO) has developed a decisional methodology based on a threshold with a minimum set of technical specifications and a consensus-based procedure for decisions to select candidate cancer medicines to be submitted to the WHO for consideration for the WHO EML. ESMO recognises the WHO EML as an important reference guide for medicines that all countries should include in their national EMLs. Cancer medicines on the WHO EML are used in the treatment of the majority of cancers, and are recommended in the evidence-based ESMO Clinical Practice Guidelines that medical oncologists use to treat patients. ESMO's submissions to the WHO EML in 2019 and 2021 and their respective outcomes are presented in the manuscript. Due to the rising costs associated with newly available therapies, structured, reproducible, and field-tested tools to evaluate the added clinical benefit from these therapies need to be implemented in pre-selecting potential candidate medicines to be included in the WHO EML. ESMO is proud to collaborate closely with WHO on this important global public health initiative.

Deep learning-based detection and quantification of brain metastases on black-blood imaging can provide treatment suggestions: a clinical cohort study

ObjectivesWe aimed to evaluate whether deep learning–based detection and quantification of brain metastasis (BM) may suggest treatment options for patients with BMs.MethodsThe deep learning system (DLS) for detection and quantification of BM was developed in 193 patients and applied to 112 patients that were newly detected on black-blood contrast-enhanced T1-weighted imaging. Patients were assigned to one of 3 treatment suggestion groups according to the European Association of Neuro-Oncology (EANO)-European Society for Medical Oncology (ESMO) recommendations using number and volume of the BMs detected by the DLS: short-term imaging follow-up without treatment (group A), surgery or stereotactic radiosurgery (limited BM, group B), or whole-brain radiotherapy or systemic chemotherapy (extensive BM, group C). The concordance between the DLS-based groups and clinical decisions was analyzed with or without consideration of targeted agents. The performance of distinguishing high-risk (B + C) was calculated.ResultsAmong 112 patients (mean age 64.3 years, 63 men), group C had the largest number and volume of BM, followed by group B (4.4 and 851.6 mm3) and A (1.5 and 15.5 mm3). The DLS-based groups were concordant with the actual clinical decisions, with an accuracy of 76.8% (86 of 112). Modified accuracy considering targeted agents was 81.3% (91 of 112). The DLS showed 95% (82/86) sensitivity and 81% (21/26) specificity for distinguishing the high risk.ConclusionDLS-based detection and quantification of BM have the potential to be helpful in the determination of treatment options for both low- and high-risk groups of limited and extensive BMs.Clinical relevance statementFor patients with newly diagnosed brain metastasis, deep learning–based detection and quantification may be used in clinical settings where prompt and accurate treatment decisions are required, which can lead to better patient outcomes.Key Points• Deep learning–based brain metastasis detection and quantification showed excellent agreement with ground-truth classifications.• By setting an algorithm to suggest treatment based on the number and volume of brain metastases detected by the deep learning system, the concordance was 81.3%.• When dividing patients into low- and high-risk groups, the sensitivity for detecting the latter was 95%.

ESMO/ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2023.

The European Society for Medical Oncology (ESMO) and ASCO are publishing a new edition of the ESMO/ASCO Global Curriculum (GC) with contributions from more than 150 authors. The purpose of the GC is to provide recommendations for the training of physicians in medical oncology and to establish a set of educational standards for trainees to qualify as medical oncologists. This edition builds on prior ones in 2004, 2010, and 2016 and incorporates scientific advances and input from an ESMO ASCO survey on GC adoption conducted in 2019, which revealed that GC has been adopted or adapted in as many as two thirds of the countries surveyed. To make GC even more useful and applicable, certain subchapters were rearranged into stand-alone chapters, that is, cancer epidemiology, diagnostics, and research. In line with recent progress in the field of multidisciplinary cancer care new (sub)chapters, such as image-guided therapy, cell-based therapy, and nutritional support, were added. Moreover, this edition includes an entirely new chapter dedicated to cancer control principles, aiming to ensure that medical oncologists are able to identify and implement sustainable and equitable cancer care, tailored to local needs and resources. Besides content renewal, modern didactic principles were introduced. GC content is presented using two chapter templates (cancer-specific and non-cancer-specific), with three didactic points (objectives, key concepts, and skills). The next step is promoting GC as a contemporary and comprehensive document applicable all over the world, particularly due to its capacity to harmonize education in medical oncology and, in so doing, help to reduce global disparities in cancer care.

Gastric squamous cell carcinoma: A rare malignancy, literature review and management recommendations (Review).

Gastric cancer serves a major role in the global cancer burden, being the fourth most frequent cause of mortality among all types of cancer. Gastric squamous cell carcinoma (GSCC) is a rare histological variant accounting for 0.04-0.5% of all gastric cancer cases. Diagnostic work-up of GSCC is essential and involves multiple criteria: i) Tumour not located in the cardia, ii) no oesophageal extension of the tumour, and iii) no evidence of SCC in any other part of the body. Little is known about this rare variant in terms of pathogenesis, risk factors or evolution. Consequently, neither the European Society of Medical Oncology nor the National Comprehensive Cancer Network societies have published recommendations for GSCC. The aim of the present review is to provide an in-depth analysis of the current literature on this pathology, from pathophysiological hypothesis and clinical presentation to diagnostic work-up and treatment trends, in order to establish a possible management algorithm.

Pharmacotherapy for Cancer Treatment-Related Cardiac Dysfunction and Heart Failure in Childhood Cancer Survivors.

The number of childhood cancer survivors is increasing rapidly. According to American Association for Cancer Research, there aremore than 750,000 childhood cancer survivors in the United States and Europe. As the number of childhood cancer survivors increases, so does cancer treatment-related cardiac dysfunction (CTRCD), leading to heart failure (HF). It has been reported that childhood cancer survivors who received anthracyclines are 15 times more likely to have late cancer treatment-related HF and have a 5-fold higher risk of death from cardiovascular (CV) disease than the general population. CV disease is the leading cause of death in childhood cancer survivors. The increasing need to manage cancer survivor patients has led to the rapid creation and adaptation of cardio-oncology. Cardio-oncology is a multidisciplinary science that monitors, treats, and prevents CTRCD. Many guidelines and position statements have been published to help diagnose and manage CTRCD, including those from the American Society of Clinical Oncology, the European Society of Cardiology, the Canadian Cardiovascular Society, the European Society of Medical Oncology, the International Late Effects of Childhood Cancer Guideline Harmonization Group, and many others. However, there remains a gap in identifying high-risk patients likely to develop cardiomyopathy and HF in later life, thus reducing primary and secondary measures being instituted, and when to start treatment when there is echocardiographic evidence of left ventricular (LV) dysfunctionswithout symptoms of HF. There are no randomized controlled clinical trials for treatment for CTRCD leading to HF in childhood cancer survivors. The treatment of HF due to cancer treatment is similar to the guidelines for general HF. This review describes the latest pharmacologic therapy for preventing and treating LV dysfunction and HF in childhood cancer survivors based on expert consensus guidelines and extrapolating data from adult HF trials.

A Review of the Recommendations and Strength of Evidence for Clinical Practice Guidelines on the Management of Small Renal Masses.

Introduction With the rise in the detection of incidental small renal masses (SRM), the management paradigm for these patients has become an issue of increasing concern. We aim to identify areas of consensus, controversy, and opportunities for improvement among recently published guidelines and assess the strength of evidence for the management of SRMs. Methods We reviewed practice guidelines for SRMs promulgated by the American Urological Association, European Association of Urology, National Comprehensive Cancer Network, American Society of Clinical Oncology, European Society for Medical Oncology, and the Chinese Society of Clinical Oncology. Levels of evidence and strength of recommendations for evaluation, management and follow-up were analyzed with regard to consensus, conflict, and neglect. Results There is consensus among guidelines for the initial evaluation and treatment of SRMs, however, discrepancies exist with regard to indications for active surveillance, thermal ablation and timing/method of follow-up after treatment. Routine renal mass biopsy is not recommended by any guideline. Overwhelmingly, guideline statements are based on low to moderate levels of evidence; only 23% of the reviewed guidelines were based on high-level evidence; 38% based on moderate and 39% on low-level evidence or expert opinion. Conclusions Despite all six guidelines sharing a consensus on most management topics regarding SRMs, the ongoing lack of high-level evidence precludes gold standard recommendations in the areas of diagnosis, treatment, and follow-up. More high-quality studies are needed in order to develop stronger, data-supported universal guideline for the management of SRMs.

Management of cutaneous melanoma: update on current treatment from surgical perspective

Incidence and mortality rate of cutaneous melanoma substantially varies across the globe depending upon early detection and management. Therapeutic developments have revolutionized the treatment. The aim of this paper is to discuss the treatment options for localized and advanced disease in the context of surgery, adjuvant, and neoadjuvant treatment. PubMed, Medline, Guidelines of European Society of Medical Oncology, National Institute of Clinical Excellence, American Joint Committee on Cancer on Melanoma, publications from 2012-2022 were searched. Low risk node negative disease (stage I and IIA) melanoma patients should have curative surgical wide local excision along with SLNB with no adjuvant therapy. High risk node negative disease (stage IIB and IIC) should be treated with curative surgery and SLNB followed by adjuvant immunotherapy. Low risk node positive disease (stage IIIA) surgical resection with SLNB followed by adjuvant systemic therapy, depending upon BRAF mutation status of tumour. High risk node positive microscopic disease (stage IIIB, IIIC, IIID) BRAF V600 mutation, primary resection with SLNB followed by nivolumab or combination of BRAF + MEK inhibitors. For BRAF wild-type tumours, adjuvant immunotherapy with programmed cell death-1 (PD-1) inhibitor. Patient with macroscopic disease that is resectable neoadjuvant combination immunotherapy followed by surgery with lymph node dissection. Metastatic disease (stage IV) regardless, adjuvant combination immunotherapy followed by maintenance nivolumab. Surgical excision is the treatment of choice for most patients with loco regional cutaneous melanoma and is curative in most cases. Checkpoint inhibitors and targeted therapies are important advances in adjuvant, neo adjuvant settings. Despite all the progress, melanoma remains challenging to treat.

Editorial introductions.

Editorial introductions.

Protecting the health care workforce from cytotoxic drugs contamination in the hospital wards: the results of the pan-European MASHA-2 project

Abstract Background: A fundamental requirement to ensure the safety of health care workers is to reduce environmental contamination with cytotoxic medicines. Objectives: The primary objective of this collaborative project between the European Society of Oncology Pharmacy (ESOP) and the European Society for Medical Oncology (ESMO) was to evaluate cytotoxic medicine contamination on surfaces in European hospital wards. The secondary objectives were (a) to detect possible internal bodily exposure in staff members and (b) to evaluate the impact of teaching safe handling practices. Materials and methods: Surface contamination in the chemotherapy administration areas was measured in 28 hospitals from 16 European countries before (part I) and after (part II) staff training through a standardized tutorial. Contamination with four antineoplastic medicines and total platinum was assessed using wipe samples taken from four comparable surfaces in each part of the project. In addition, hospitals that showed a high level of surface contamination, collected 24-hour urine of five staff members (part III). The samples were analyzed by liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) and inductively coupled plasma-mass spectrometry (ICP-MS). Results: In total, 112 and 104 wipe samples (part I and part II) and 32 urine samples (part III) were collected. Surface contamination occurred in all participating hospitals. The most contaminated spot was the floor in the nurses' station. The most frequently found compound was platinum, and the medicine that showed the highest amount of contamination was cyclophosphamide (8.18 ng/cm2 in part I and 0.53 ng/cm2 in part II). Urine samples were positive for gemcitabine and cyclophosphamide in 1 and 2 nurses, respectively. The intervention by tutorial lowered the levels of contamination, both in number (from 48% to 41%) and in amount of contamination. Conclusion: The MASHA-2 study shows that contamination of surfaces with cytotoxic medicines in European hospitals is a widespread phenomenon. Bodily exposure of nurses was clearly detected. Surface contamination decreased after training on safe handling practices. Nevertheless, further optimization of occupational safety is warranted.

The value of serum HE4 and CA125 levels for monitoring the recurrence and risk stratification of endometrial endometrioid carcinoma

To evaluate the role of serum human epididymis secretory protein 4 (HE4) and carbohydrate antigen 125 (CA125) levels for predicting and monitoring the recurrence of endometrial endometrioid carcinoma (EEC) and assessing preoperative risk stratification in EEC patients. A total of 434 EEC patients were selected for this retrospective study between May 2011 and August 2018. Serum HE4 and CA125 levels were analyzed before the initial treatment, at the first postoperative follow-up, and at recurrence or the last follow-up. Patients were risk stratified according to the European Society for Medical Oncology (ESMO), European Society for Radiotherapy & Oncology (ESTRO) and European Society of Gynaecological Oncology (ESGO) guideline. We compared the ability of these biomarkers for prediction and monitoring by performing receiver operating characteristic curve analysis and identified optimal cut-off values by determining the Youden index. Kaplan-Meier analyses were also performed to determine prognostic value. Preoperative serum HE4 was identified as a significant predictor for the recurrence of EEC (p = 0.014). Preoperative serum HE4 and CA125 levels were related to depth of myometrial invasion, lymph node status and FIGO stage. Serum HE4 and CA125 levels were both statistically significant markers for monitoring the recurrence of EEC (P = 0.000 for each biomarker). When combined, the two markers showed higher levels of sensitivity and specificity. The two biomarkers were also significant biomarkers for evaluating the risk stratification of patients undergoing lymphadenectomy (P = 0.000 for each biomarker). For premenopausal stage I patients, preoperative serum HE4 and CA125 levels were significant predictors of the need for ovarian preservation (P = 0.000 and P = 0.002, respectively). For premenopausal patients with stage I intramucosal differentiation, preoperative serum levels of HE4 were significant predictors for fertility preservation (P = 0.024). Preoperative serum HE4 level can be used to predict the recurrence of EEC. Postoperative serum HE4 and CA125 levels can be used to monitor the recurrence of EEC and are more sensitive when combined. Preoperative serum levels of CA125 and HE4 levels are of significant value for risk stratification in EEC patients.

Increasing differential diagnosis between lipoma and liposarcoma through radiomics: a narrative review.

Soft tissue sarcomas (STSs) are rare, heterogeneous, and very often asymptomatic diseases. Their diagnosis is fundamental, as is the identification of the degree of malignancy, which may be high, medium, or low. The Italian Medical Oncology Association and European Society of Medical Oncology (ESMO) guidelines recommend magnetic resonance imaging (MRI) because the clinical examination is typically ineffective. The diagnosis of these rare diseases with artificial intelligence (AI) techniques presents reduced datasets and therefore less robust methods. However, the combination of AI techniques with radiomics may be a new angle in diagnosing rare diseases such as STSs. Results obtained are promising within the literature, not only for the performance but also for the explicability of the data. In fact, one can make tumor classification, site localization, and prediction of the risk of developing metastasis. Thanks to the synergy between computer scientists and radiologists, linking numerical features to radiological evidence with excellent performance could be a new step forward for the diagnosis of rare diseases.

MET Inhibitors for Papillary Renal Cell Carcinoma

BACKGROUND: Papillary renal cell carcinoma (PRCC) has a relatively poor prognosis in the metastatic setting. In contrast to clear cell kidney cancer, there are limited treatment options specifically tested in PRCC. Alterations in the MET pathway are common in PRCC and may play a pivotal role in promoting tumor growth and the development of resistance to systemic therapy. OBJECTIVE: Current data on the efficacy of MET inhibitors over standard of care in PRCC is immature and evolving. The purpose of this systematic review is to assess and summarize the results and limitations of landmark trials of MET inhibitors for PRCC as well as to discuss barriers faced by trials of these drugs. METHODS: Manuscripts and abstracts were collected from PubMed, the American Society of Clinical Oncology (ASCO) historical abstracts and European Society for Medical Oncology (ESMO) historical abstracts. Included studies must have been either a clinical trial, systematic review or narrative review and included PRCC patients. Patients must have been treated with a selective or non-selective MET inhibitor. After the final application of criteria, 30 studies were included. RESULTS/CONCLUSIONS: Cabozantinib has the best evidence for use showing improved outcomes in PRCC. Other MET inhibitors, including savolitinib, crizotinib, and foretinib have shown possible benefit in patients with MET-positive disease, but the inconsistent definition of MET status and a low patient accrual rate prevented further extrapolation of the individual trial results. Future trials of single agent savolitinib, as well as combination MET inhibitor/ immuno-oncology (IO) therapies, have the potential to change the therapeutic landscape of using MET inhibitors for PRCC.

HTA and Reimbursement Status of Metastatic Hormone‑Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer, and Metastatic Castration-Resistant Prostate Cancer Treatments in Europe: A Patient Access Landscape Review

Background: Prostate cancer is the second most common cancer in men, with up to one-third of men being diagnosed in their lifetime. Recently, novel therapies have received regulatory approval with significant improvement in overall survival for metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and nonmetastatic castration-resistant prostate cancer. To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). Objective: This review aimed to map HTA status, reimbursement restrictions, and patient access for 3 advanced prostate cancer indications across 23 European countries during 2011-2021. Methods: HTA, country reimbursement lists, and ESMO-MCBS scorecards were reviewed for evidence and data across 26 European countries. Results: The analysis demonstrated that only in Greece, Germany, and Sweden was there full access across all included prostate cancer treatments. Treatments available for metastatic castration-resistant prostate cancer were widely reimbursed, with both abiraterone and enzalutamide accessible in all countries. In 3 countries (Hungary, the Netherlands, and Switzerland), there was a statistically significant difference (P<.05) between status of reimbursement and ESMO-MCBS “substantial benefit” (score of 4 or 5) vs “no substantial benefit” (score <4). Conclusion: Overall, the impact of the ESMO-MCBS on reimbursement decisions in Europe is unclear, with significant variation across the countries included in this review.

HTA and Reimbursement Status of Metastatic Hormone‑Sensitive Prostate Cancer, Non-Metastatic Castration-Resistant Prostate Cancer, and Metastatic Castration-Resistant Prostate Cancer Treatments in Europe: A Patient Access Landscape Review.

Background: Prostate cancer is the second most common cancer in men, with up to one-third of men being diagnosed in their lifetime. Recently, novel therapies have received regulatory approval with significant improvement in overall survival for metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, and nonmetastatic castration-resistant prostate cancer. To improve decision-making regarding the value of anticancer therapies and support standardized assessment for use by health technology assessment (HTA) agencies, the European Society for Medical Oncology (ESMO) has developed a Magnitude of Clinical Benefit Scale (MCBS). Objective: This review aimed to map HTA status, reimbursement restrictions, and patient access for 3 advanced prostate cancer indications across 23 European countries during 2011-2021. Methods: HTA, country reimbursement lists, and ESMO-MCBS scorecards were reviewed for evidence and data across 26 European countries. Results: The analysis demonstrated that only in Greece, Germany, and Sweden was there full access across all included prostate cancer treatments. Treatments available for metastatic castration-resistant prostate cancer were widely reimbursed, with both abiraterone and enzalutamide accessible in all countries. In 3 countries (Hungary, the Netherlands, and Switzerland), there was a statistically significant difference (P<.05) between status of reimbursement and ESMO-MCBS "substantial benefit" (score of 4 or 5) vs "no substantial benefit" (score <4). Conclusion: Overall, the impact of the ESMO-MCBS on reimbursement decisions in Europe is unclear, with significant variation across the countries included in this review.

ESMO-Magnitude of Clinical Benefit Scale for haematological malignancies (ESMO-MCBS:H) version 1.0

The European Society for Medical Oncology (ESMO)-Magnitude of Clinical Benefit Scale (MCBS) has been accepted as a robust tool to evaluate the magnitude of clinical benefit reported in trials for oncological therapies. However, the ESMO-MCBS hitherto has only been validated for solid tumours. With the rapid development of novel therapies for haematological malignancies, we aimed to develop an ESMO-MCBS version that is specifically designed and validated for haematological malignancies. ESMO and the European Hematology Association (EHA) initiated a collaboration to develop a version for haematological malignancies (ESMO-MCBS:H). The process incorporated five landmarks: field testing of the ESMO-MCBS version 1.1 (v1.1) to identify shortcomings specific to haematological diseases, drafting of the ESMO-MCBS:H forms, peer review and revision of the draft based on re-scoring (resulting in a second draft), assessment of reasonableness of the scores generated, final review and approval by ESMO and EHA including executive boards. Based on the field testing results of 80 haematological trials and extensive review for feasibility and reasonableness, five amendments to ESMO-MCBS were incorporated in the ESMO-MCBS:H addressing the identified shortcomings. These concerned mainly clinical trial endpoints that differ in haematology versus solid oncology and the very indolent nature of nevertheless incurable diseases such as follicular lymphoma, which hampers presentation of mature data. In addition, general changes incorporated in the draft version of the ESMO-MCBS v2 were included, and specific forms for haematological malignancies generated. Here we present the final approved forms of the ESMO-MCBS:H, including instructions. The haematology-specific version ESMO-MCBS:H allows now full applicability of the scale for evaluating the magnitude of clinical benefit derived from clinical studies in haematological malignancies.

Local Recurrences in Rectal Cancer: MRI vs. CT

Rectal cancers are often considered a distinct disease from colon cancers as their survival and management are different. Particularly, the risk for local recurrence (LR) is greater than in colon cancer. There are many factors predisposing to LR such as postoperative histopathological features or the mesorectal plane of surgical resection. In addition, the pattern of LR in rectal cancer has a prognostic significance and an important role in the choice of operative approach and. Therefore, an optimal follow up based on imaging is critical in rectal cancer. The aim of this review is to analyse the risk and the pattern of local recurrences in rectal cancer and to provide an overview of the role of imaging in early detection of LRs. We performed a literature review of studies published on Web of Science and MEDLINE up to January 2023. We also reviewed the current guidelines of National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO). Although the timing and the modality of follow-up is not yet established, the guidelines usually recommend a time frame of 5 years post surgical resection of the rectum. Computed Tomography (CT) scans and/or Magnetic Resonance Imaging (MRI) are the main imaging techniques recommended in the follow-up of these patients. PET-CT is not recommended by guidelines during post-operative surveillance and it is generally used for problem solving.