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Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations

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A special issue of Cancers (ISSN 2072-6694). This special issue belongs to the section "Clinical Research of Cancer".

Deadline for manuscript submissions: closed (31 October 2021) | Viewed by 50634

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Special Issue Editors

Prof. Dr. Peter Hau

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Guest Editor

Wilhelm Sander Neuro-Oncology Unit, University Medical Center Regensburg, 93053 Regensburg, Germany
Interests: glioma; glioblastoma; medulloblastoma; brain tumor classification; clinical trials; tumor cell invasion; tumor metabolism

Dr. Kristian W. Pajtler

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Guest Editor

German Cancer Research Center, Heidelberg, Germany
Interests: translational pediatric oncology; cancer predisposition; ependymoma; pediatric neuro-oncology; liquid biopsy

Special Issue Information

Dear Colleagues,

Medulloblastoma is a rare brain malignancy, which predominantly affects children. Postpubertal patients are affected with a significantly lower incidence. Child, adolescent and adult patients with medulloblastoma bear a low to high prognostic risk of relapse, which depends on factors such as age, tumor molecular subgroup, and diagnostic and treatment quality. Even with optimal treatment, medulloblastoma leads to death and severe disability in a large proportion of patients. Therefore, there is a great scientific and medical need to improve diagnosis and treatment.

Child, adolescent and adult medulloblastomas are biologically distinct, which mandates age-adapted treatment strategies. Significant knowledge about stratified treatment strategies has been accumulated in children and adolescents in recent decades; however, no prospective randomized trials have been performed to date in adult patients to define the most efficacious treatment in this group. In view of the toxicity of cranio-spinal radiotherapy and systemic therapy, there is also an unmet medical need to develop less toxic treatment regimens for patients with medulloblastoma, specifically in the pediatric population.

This Special Issue will summarize the current trial landscape in pediatric, adolescent and adult medulloblastoma, and will revisit the foundations of rationally designed clinical trials in the first-line and relapse settings alike. It will also provide broad scientific and clinical knowledge to the reader who wants to further explore this timely and highly relevant field of research.

Prof. Dr. Peter Hau
Dr. Kristian W. Pajtler
Guest Editors

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Keywords

medulloblastoma
cinical trials
shh
wnt
group 3
group 4
molecular classification
high-dose chemotherapy
systems therapy
immunotherapy

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Published Papers (12 papers)

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Research

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24 pages, 3325 KiB

Open AccessArticle

Local and Systemic Therapy of Recurrent Medulloblastomas in Children and Adolescents: Results of the P-HIT-REZ 2005 Study

by Christine Gaab, Jonas E. Adolph, Stephan Tippelt, Ruth Mikasch, Denise Obrecht, Martin Mynarek, Stefan Rutkowski, Stefan M. Pfister, Till Milde, Olaf Witt, Brigitte Bison, Monika Warmuth-Metz, Rolf-Dieter Kortmann, Stefan Dietzsch, Torsten Pietsch, Beate Timmermann, Ronald Sträter, Udo Bode, Andreas Faldum, Robert Kwiecien and Gudrun Fleischhack Show full author list Hide full author list

Cancers 2022, 14(3), 471; https://doi.org/10.3390/cancers14030471 - 18 Jan 2022

Cited by 12 | Viewed by 3600

Abstract

Recurrent medulloblastomas are associated with survival rates <10%. Adequate multimodal therapy is being discussed as having a major impact on survival. In this study, 93 patients with recurrent medulloblastoma treated in the German P-HIT-REZ 2005 Study were analyzed for survival (PFS, OS) dependent on patient, disease, and treatment characteristics. The median age at the first recurrence was 10.1 years (IQR: 6.9–16.1). Median PFS and OS, at first recurrence, were 7.9 months (CI: 5.7–10.0) and 18.5 months (CI: 13.6–23.5), respectively. Early relapses/progressions (<18 months, n = 30/93) found mainly in molecular subgroup 3 were associated with markedly worse median PFS (HR: 2.34) and OS (HR: 3.26) in regression analyses. A significant survival advantage was found for the use of volume-reducing surgery as well as radiotherapy. Intravenous chemotherapy with carboplatin and etoposide (ivCHT, n = 28/93) showed improved PFS and OS data and the best objective response rate (ORR) was 66.7% compared to oral temozolomide (oCHT, n = 47/93) which was 34.8%. Intraventricular (n = 43) as well as high-dose chemotherapy (n = 17) at first relapse was not related to a significant survival benefit. Although the results are limited due to a non-randomized study design, they may serve as a basis for future treatment decisions in order to improve the patients’ survival. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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Review

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14 pages, 292 KiB

Open AccessReview

High-Dose Chemotherapy in Children with Newly Diagnosed Medulloblastoma

by Lucie Lafay-Cousin and Christelle Dufour

Cancers 2022, 14(3), 837; https://doi.org/10.3390/cancers14030837 - 7 Feb 2022

Cited by 15 | Viewed by 5183

Abstract

High-dose chemotherapy with stem cell rescue has been used as an adjuvant therapy or as salvage therapy to treat pediatric patients with brain tumors, and to avoid deleterious side effects of radiotherapy in infants and very young children. Here, we present the most recent trials using high-dose chemotherapy regimens for medulloblastoma in children, and we discuss their contribution to improved survival and describe their toxicity profile and limitations. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

22 pages, 1687 KiB

Open AccessReview

The Current Landscape of Targeted Clinical Trials in Non-WNT/Non-SHH Medulloblastoma

by David R. Ghasemi, Gudrun Fleischhack, Till Milde and Kristian W. Pajtler

Cancers 2022, 14(3), 679; https://doi.org/10.3390/cancers14030679 - 28 Jan 2022

Cited by 7 | Viewed by 5046

Abstract

Medulloblastoma is an embryonal pediatric brain tumor and can be divided into at least four molecularly defined groups. The category non-WNT/non-SHH medulloblastoma summarizes medulloblastoma groups 3 and 4 and is characterized by considerable genetic and clinical heterogeneity. New therapeutic strategies are needed to increase survival rates and to reduce treatment-related toxicity. We performed a noncomprehensive targeted review of the current clinical trial landscape and literature to summarize innovative treatment options for non-WNT/non-SHH medulloblastoma. A multitude of new drugs is currently evaluated in trials for which non-WNT/non-SHH patients are eligible, for instance immunotherapy, kinase inhibitors, and drugs targeting the epigenome. However, the majority of these trials is not restricted to medulloblastoma and lacks molecular classification. Whereas many new molecular targets have been identified in the last decade, which are currently tested in clinical trials, several challenges remain on the way to reach a new therapeutic strategy for non-WNT/non-SHH medulloblastoma. These include the severe lack of faithful preclinical models and predictive biomarkers, the question on how to stratify patients for clinical trials, and the relative lack of studies that recruit large, homogeneous patient collectives. Innovative trial designs and international collaboration will be a key to eventually overcome these obstacles. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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12 pages, 399 KiB

Open AccessReview

The Alliance AMBUSH Trial: Rationale and Design

by Anita Mahajan, Helen Shih, Marta Penas-Prado, Keith Ligon, Kenneth Aldape, Leland S. Hu, Ashlee R. Loughan, Michael R. Basso, Heather E. Leeper, Brian V. Nahed, Shannon L. Stott, Susan Geyer, Caterina Giannini and Evanthia Galanis

Cancers 2022, 14(2), 414; https://doi.org/10.3390/cancers14020414 - 14 Jan 2022

Cited by 8 | Viewed by 2767

Abstract

Unlike medulloblastoma (MB) in children, robust prospective trials have not taken place for older patients due to the low incidence of MB in adults and adolescent and young adults (AYA). Current MB treatment paradigms for older patients have been extrapolated from the pediatric experience even though questions exist about the applicability of these approaches. Clinical and molecular classification of MB now provides better prognostication and is being incorporated in pediatric therapeutic trials. It has been established that genomic alterations leading to activation of the sonic hedgehog (SHH) pathway occur in approximately 60% of MB in patients over the age of 16 years. Within this cohort, protein patched homolog (PTCH) and smoothened (SMO) mutations are commonly found. Among patients whose tumors harbor the SHH molecular signature, it is estimated that over 80% of patients could respond to SHH pathway inhibitors. Given the advances in the understanding of molecular subgroups and the lack of robust clinical data for adult/AYA MB, the Alliance for Clinical Trial in Oncology group developed the AMBUSH trial: Comprehensive Management of AYA and Adult Patients with Medulloblastoma or Pineal Embryonal Tumors with a Randomized Placebo Controlled Phase II Focusing on Sonic Hedgehog Pathway Inhibition in SHH Subgroup Patients (Adult & Adolescent MedulloBlastoma Using Sonic Hedgehog Trial). This trial will enroll patients 18 years of age or older with MB (any molecular subgroup and risk stratification) or pineal embryonal tumor. Patients will be assigned to one of three cohorts: (1) average risk non-SHH-MB, (2) average risk SHH-MB, and (3) high risk MB or pineal embryonal tumors. All patients will receive protocol-directed comprehensive treatment with radiation therapy and chemotherapy. Patients with SHH-MB in cohort 1 will be randomized to a smoothened inhibitor or placebo as maintenance therapy for one year. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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21 pages, 772 KiB

Open AccessReview

Clinical Trials in High-Risk Medulloblastoma: Evolution of the SIOP-Europe HR-MB Trial

by Simon Bailey, Nicolas André, Lorenza Gandola, Maura Massimino, Keith Wheatley, Simon Gates, Victoria Homer, Stefan Rutkowski and Steven C. Clifford

Cancers 2022, 14(2), 374; https://doi.org/10.3390/cancers14020374 - 13 Jan 2022

Cited by 28 | Viewed by 5462 | Correction

Abstract

Medulloblastoma patients receive adapted therapies stratified according to their risk-profile. Favourable, standard, and high disease-risk groups are each defined by the status of clinical and pathological risk factors, alongside an evolving repertoire of diagnostic and prognostic biomarkers. Medulloblastoma clinical trials in Europe are coordinated by the International Society for Paediatric Oncology (SIOP-Europe) brain tumour group. Favourable and standard-risk patients are eligible for the SIOP-PNET5-MB clinical trial protocol. In contrast, therapies for high-risk disease worldwide have, to date, encompassed a range of different treatment philosophies, with no clear consensus on approach. Higher radiotherapy doses are typically deployed, delivered either conventionally or in hyper-fractionated/accelerated regimens. Similarly, both standard and high-dose chemotherapies were assessed. However, trials to date in high-risk medulloblastoma have commonly been institutional or national, based on modest cohort sizes, and have not evaluated the relative performance of different strategies in a randomised fashion. We describe the concepts and design of the SIOP-E high-risk medulloblastoma clinical trial (SIOP-HR-MB), the first international biomarker-driven, randomised, clinical trial for high-risk medulloblastoma. SIOP-HR-MB is programmed to recruit >800 patients in 16 countries across Europe; its primary objectives are to assess the relative efficacies of the alternative established regimens. The HR-MB patient population is molecularly and clinically defined, and upfront assessments incorporate a standardised central review of molecular pathology, radiology, and radiotherapy quality assurance. Secondary objectives include the assessment of (i) novel therapies within an upfront ‘window’ and (ii) therapy-associated neuropsychology, toxicity, and late effects, alongside (iii) the collection of materials for comprehensive integrated studies of biological determinants within the SIOP-HR-MB cohort. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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15 pages, 588 KiB

Open AccessReview

Molecular Targeted Therapies: Time for a Paradigm Shift in Medulloblastoma Treatment?

by Lidia Gatto, Enrico Franceschi, Alicia Tosoni, Vincenzo Di Nunno, Stefania Bartolini and Alba Ariela Brandes

Cancers 2022, 14(2), 333; https://doi.org/10.3390/cancers14020333 - 11 Jan 2022

Cited by 8 | Viewed by 3341

Abstract

Medulloblastoma is a rare malignancy of the posterior cranial fossa. Although until now considered a single disease, according to the current WHO classification, it is a heterogeneous tumor that comprises multiple molecularly defined subgroups, with distinct gene expression profiles, pathogenetic driver alterations, clinical behaviors and age at onset. Adult medulloblastoma, in particular, is considered a rarer “orphan” entity in neuro-oncology practice because while treatments have progressively evolved for the pediatric population, no practice-changing prospective, randomized clinical trials have been performed in adults. In this scenario, the toughest challenge is to transfer the advances in cancer genomics into new molecularly targeted therapeutics, to improve the prognosis of this neoplasm and the treatment-related toxicities. Herein, we focus on the recent advances in targeted therapy of medulloblastoma based on the new and deeper knowledge of disease biology. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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34 pages, 2241 KiB

Open AccessReview

Relapsed Medulloblastoma in Pre-Irradiated Patients: Current Practice for Diagnostics and Treatment

by Rebecca M. Hill, Sabine L. A. Plasschaert, Beate Timmermann, Christelle Dufour, Kristian Aquilina, Shivaram Avula, Laura Donovan, Maarten Lequin, Torsten Pietsch, Ulrich Thomale, Stephan Tippelt, Pieter Wesseling, Stefan Rutkowski, Steven C. Clifford, Stefan M. Pfister, Simon Bailey and Gudrun Fleischhack

Cancers 2022, 14(1), 126; https://doi.org/10.3390/cancers14010126 - 28 Dec 2021

Cited by 15 | Viewed by 5994

Abstract

Relapsed medulloblastoma (rMB) accounts for a considerable, and disproportionate amount of childhood cancer deaths. Recent advances have gone someway to characterising disease biology at relapse including second malignancies that often cannot be distinguished from relapse on imaging alone. Furthermore, there are now multiple international early-phase trials exploring drug–target matches across a range of high-risk/relapsed paediatric tumours. Despite these advances, treatment at relapse in pre-irradiated patients is typically non-curative and focuses on providing life-prolonging and symptom-modifying care that is tailored to the needs and wishes of the individual and their family. Here, we describe the current understanding of prognostic factors at disease relapse such as principal molecular group, adverse molecular biology, and timing of relapse. We provide an overview of the clinical diagnostic process including signs and symptoms, staging investigations, and molecular pathology, followed by a summary of treatment modalities and considerations. Finally, we summarise future directions to progress understanding of treatment resistance and the biological mechanisms underpinning early therapy-refractory and relapsed disease. These initiatives include development of comprehensive and collaborative molecular profiling approaches at relapse, liquid biopsies such as cerebrospinal fluid (CSF) as a biomarker of minimal residual disease (MRD), modelling strategies, and the use of primary tumour material for real-time drug screening approaches. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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14 pages, 1000 KiB

Open AccessReview

Pediatric versus Adult Medulloblastoma: Towards a Definition That Goes beyond Age

by Joseph R. Wooley and Marta Penas-Prado

Cancers 2021, 13(24), 6313; https://doi.org/10.3390/cancers13246313 - 16 Dec 2021

Cited by 10 | Viewed by 4056

Abstract

Medulloblastoma is a rare malignant brain tumor that predominantly affects children but also occurs in adults. The incidence declines significantly after age 15, and distinct tumor molecular features are seen across the age spectrum. Standard of care treatment consists of maximal safe surgical resection followed by adjuvant radiation and/or chemotherapy. Adjuvant treatment decisions are based on individual patient risk factors and have been informed by decades of prospective clinical trials. These trials have historically relied on arbitrary age cutoffs for inclusion (age 16, 18, or 21, for example), while trials that include adult patients or stratify patients by molecular features of disease have been rare. The aim of this literature review is to review the history of clinical trials in medulloblastoma, with an emphasis on selection criteria, and argue in favor of rational and inclusive trials based on molecular features of disease as opposed to chronological age. We performed a scoping literature review for medulloblastoma and clinical trials and include a summary of those results. We also discuss some of the significant advances made in understanding the molecular biology of medulloblastoma within the past decade, most notably the identification of four distinct subgroups based on gene expression profiling. We will also cite the recent experiences of childhood leukemia and the emergence of tissue-agnostic therapies as examples of successes of rationally designed, inclusive trials translating to improved clinical outcomes for patients across the age spectrum. Despite the prior trial history and recent molecular advances outcomes remain poor for ~30% of medulloblastoma patients. We believe that defining patients by the specific molecular alterations their tumors harbor is the best way to ensure they can access potentially efficacious therapies on clinical trials. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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16 pages, 1876 KiB

Open AccessFeature PaperReview

SIOP PNET5 MB Trial: History and Concept of a Molecularly Stratified Clinical Trial of Risk-Adapted Therapies for Standard-Risk Medulloblastoma

by Martin Mynarek, Till Milde, Laetitia Padovani, Geert O. Janssens, Robert Kwiecien, Veronique Mosseri, Steven C. Clifford, François Doz and Stefan Rutkowski

Cancers 2021, 13(23), 6077; https://doi.org/10.3390/cancers13236077 - 2 Dec 2021

Cited by 26 | Viewed by 3575

Abstract

Background. SIOP PNET5 MB was initiated in 2014 as the first European trial using clinical, histological, and molecular parameters to stratify treatments for children and adolescents with standard-risk medulloblastoma. Methods. Stratification by upfront assessment of molecular parameters requires the timely submission of adequate tumour tissue. In the standard-risk phase-III cohort, defined by the absence of high-risk criteria (M0, R0), pathological (non-LCA), and molecular biomarkers (MYCN amplification in SHH–MB or MYC amplification), a randomized intensification by carboplatin concomitant with radiotherapy is investigated. In the LR stratum for localized WNT-activated medulloblastoma and age <16 years, a reduction of craniospinal radiotherapy dose to 18 Gy and a reduced maintenance chemotherapy are investigated. Two additional strata (WNT-HR, SHH-TP53) were implemented during the trial. Results. SIOP PNET5 MB is actively recruiting. The availability of adequate tumour tissue for upfront real-time biological assessments to assess inclusion criteria has proven feasible. Conclusion. SIOP PNET5 MB has demonstrated that implementation of biological parameters for stratification is feasible in a prospective multicentre setting, and may improve risk-adapted treatment. Comprehensive research studies may allow assessment of additional parameters, e.g., novel medulloblastoma subtypes, and identification and validation of biomarkers for the further refinement of risk-adapted treatment in the future. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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16 pages, 312 KiB

Open AccessReview

Radiotherapy in Medulloblastoma—Evolution of Treatment, Current Concepts and Future Perspectives

by Clemens Seidel, Sina Heider, Peter Hau, Annegret Glasow, Stefan Dietzsch and Rolf-Dieter Kortmann

Cancers 2021, 13(23), 5945; https://doi.org/10.3390/cancers13235945 - 26 Nov 2021

Cited by 18 | Viewed by 4300

Abstract

Medulloblastoma is the most frequent malignant brain tumor in children. During the last decades, the therapeutic landscape has changed significantly with craniospinal irradiation as the backbone of treatment. Survival times have increased and treatments were stratified according to clinical and later molecular risk factors. In this review, current evidence regarding the efficacy and toxicity of radiotherapy in medulloblastoma is summarized and discussed mainly based on data of controlled trials. Current concepts and future perspectives based on current risk classification are outlined. With the introduction of CSI, medulloblastoma has become a curable disease. Due to combination with chemotherapy, survival rates have increased significantly, allowing for a reduction in radiation dose and a decrease of toxicity in low- and standard-risk patients. Furthermore, modern radiotherapy techniques are able to avoid side effects in a fragile patient population. However, high-risk patients remain with relevant mortality and many patients still suffer from treatment related toxicity. Treatment needs to be continually refined with regard to more efficacious combinatorial treatment in the future. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

20 pages, 1225 KiB

Open AccessReview

Development of Randomized Trials in Adults with Medulloblastoma—The Example of EORTC 1634-BTG/NOA-23

by Peter Hau, Didier Frappaz, Elizabeth Hovey, Martin G. McCabe, Kristian W. Pajtler, Benedikt Wiestler, Clemens Seidel, Stephanie E. Combs, Linda Dirven, Martin Klein, Antoinette Anazodo, Elke Hattingen, Silvia Hofer, Stefan M. Pfister, Claus Zimmer, Rolf-Dieter Kortmann, Marie-Pierre Sunyach, Ronan Tanguy, Rachel Effeney, Andreas von Deimling, Felix Sahm, Stefan Rutkowski, Anna S. Berghoff, Enrico Franceschi, Estela Pineda, Dagmar Beier, Ellen Peeters, Thierry Gorlia, Maureen Vanlancker, Jacoline E. C. Bromberg, Julien Gautier, David S. Ziegler, Matthias Preusser, Wolfgang Wick and Michael Weller Show full author list Hide full author list

Cancers 2021, 13(14), 3451; https://doi.org/10.3390/cancers13143451 - 9 Jul 2021

Cited by 12 | Viewed by 4765

Abstract

Medulloblastoma is a rare brain malignancy. Patients after puberty are rare and bear an intermediate prognosis. Standard treatment consists of maximal resection plus radio-chemotherapy. Treatment toxicity is high and produces disabling long-term side effects. The sonic hedgehog (SHH) subgroup is highly overrepresented in the post-pubertal and adult population and can be targeted by smoothened (SMO) inhibitors. No practice-changing prospective randomized data have been generated in adults. The EORTC 1634-BTG/NOA-23 trial will randomize patients between standard-dose vs. reduced-dosed craniospinal radiotherapy and SHH-subgroup patients between the SMO inhibitor sonidegib (Odomzo^TM, Sun Pharmaceuticals Industries, Inc., New York, USA) in addition to standard radio-chemotherapy vs. standard radio-chemotherapy alone to improve outcomes in view of decreased radiotherapy-related toxicity and increased efficacy. We will further investigate tumor tissue, blood, and cerebrospinal fluid as well as magnetic resonance imaging and radiotherapy plans to generate information that helps to further improve treatment outcomes. Given that treatment side effects typically occur late, long-term follow-up will monitor classic side effects of therapy, but also health-related quality of life, cognition, social and professional outcome, and reproduction and fertility. In summary, we will generate unprecedented data that will be translated into treatment changes in post-pubertal patients with medulloblastoma and will help to design future clinical trials. Full article

(This article belongs to the Special Issue Medulloblastoma Systemic Therapy Clinical Trials and Their Foundations)

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2 pages, 178 KiB

Open AccessCorrection

Correction: Bailey et al. Clinical Trials in High-Risk Medulloblastoma: Evolution of the SIOP-Europe HR-MB Trial. Cancers 2022, 14, 374

by Simon Bailey, Nicolas André, Lorenza Gandola, Maura Massimino, Keith Wheatley, Simon Gates, Victoria Homer, Stefan Rutkowski and Steven C. Clifford

Cancers 2024, 16(6), 1084; https://doi.org/10.3390/cancers16061084 - 7 Mar 2024

Cited by 2 | Viewed by 999

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