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Project Radiology UFIM

SUMMARY OF THE RESEARCH PROJECT
FUNDED BY THE BUZZI UNICEM FOUNDATION

Support activities for the medical and healthcare providers involved in clinical trials and clinical practice of the Unità Funzionale Interaziendale Mesotelioma (Interhospital Mesothelioma Functional Unit – UFIM).

INTRODUCTION

  • Assessing the response to chemotherapy is a crucial aspect in oncology and closely tied to the clinical decision whether or not to continue current treatment. Oncologists need to be able to rely on the radiologist’s correct assessment of the response to treatment in both routine clinical practice and in controlled and uncontrolled clinical trials. Assessing treatment response is not as simple or quick for some tumors as it is for others. Mesothelioma is among the rare solid tumors in adults that probably poses more problems in this regard. Unlike other tumors which grow in discrete and easily measurable masses whose increased diameter serves as a reference for assessment, mesothelioma grows by greater or lesser pleural thickening inside the thoracic cavity. The difficulty of measuring the tumor has even led to the definition of different criteria for the ad hoc assessment of treatment response which were presented to the scientific community over 10 years ago (Byrne and Nowak, Ann of Oncol 2004), but which were only fully implemented in clinical research a few years ago. These criteria use a specific protocol (mRECIST for mesothelioma) that differs from the standard protocol (RECIST 1.1). They are more reproducible but are mainly associated with improved respiratory function. The greater the mRECIST response, the better the recovery of the patient's respiratory function.
  • Another fundamental aspect of mesothelioma is staging, which is based on assessing the extent of disease in the thorax and whether it has infiltrated the structures adjacent to the pleura, as well as the presence and sites of lymph node involvement and the presence of distant metastasis.
  • Staging is mainly based on radiological imaging. A few months ago, a new staging system was presented for the 8th Edition of the UICC classification (which will replace IMIG1995). The work to define this new system began in 2010 and is supported by the analysis of a large dataset of 3,519 patients, 2,460 of whom are evaluable (diagnosed between 1995-2013), and which modifies the descriptors of tumor extension and the final classification in the subdivision of stages. The goal is to arrive at a correct prognostic stratification to help identify those patient groups that can benefit from multimodal treatments.
  • Last but not least, the radiologist plays a very important role in the diagnosis of patients who present without pleural effusion at the time of biopsy, which requires special expertise, and also during the course of therapies for the invasive procedures required to palliate the symptoms that occur (pleural, pericardial, peritoneal effusion).

As described above, the radiologist clearly plays an essential role in the evaluation process of patients with pleural mesothelioma not only with respect to initiating the correct therapeutic strategy and making the most appropriate decisions during the course of treatment, but also in implementing invasive procedures to help control symptoms. The radiologist is an integral component of the Gruppo Interdisciplinare Cure GIC Mesotelioma Interaziendale (Interhospital Mesothelioma GIC Interdisciplinary Treatment Group).

LOCAL SITUATION
Within the UFIM framework, over 1,000 CT (computerized tomography) scans are performed each year of patients with pleural mesothelioma for staging or re-evaluation, and over 80 invasive procedures are performed on these patients (thoracentesis, paracentesis, diagnostic biopsies, fitting permanent drains). There are currently 11 clinical studies in malignant mesothelioma being conducted within UFIM, including one sponsored Phase II / III study and three sponsored Phase II studies whose protocols strictly require CT scans to assess the activity of the study treatment based on modified RECIST criteria. UFIM currently manages approximately 150 patients as part of clinical studies or who are treated with standard therapies or who are simply monitored.
There are currently about 35 patients enrolled in interventional studies, whose numbers continue to increase and thus requiring professionals who are specifically dedicated to reading the CT scans of patients enrolled in the studies to ensure the quality of the data. Patients who receive standard therapies are also evaluated using mRECIST criteria and are included in the new staging system so that the level of service provided in clinical practice is as high as that required by the study protocols.
A dedicated radiologist is a necessary component of the medical and healthcare staff involved in conducting clinical studies. The radiologist is responsible for interpreting and managing the data resulting from the instrumental examinations of the patients enrolled within increasingly shorter timeframes, as required by the study protocols. The role of the radiologist is even more important as a support for the CT scans that will be reviewed centrally by laboratories designated by the sponsors of some studies, an aspect that is becoming increasingly required by current and future sponsored international studies.
Additionally, as a result of the experience acquired by UFIM mainly due to the provision of ad hoc funding for the training of this role in the past, mesothelioma patients and their families often request second opinions specifically to evaluate CT scans performed at other treatment centers that do not routinely use mRECIST criteria.

GOALS OF THE PROJECT
1) Provide continuity to the role of a dedicated radiologist who has become an invaluable figure in the clinical practice of UFIM

2) Promote increased use of specific imaging for mesothelioma through the radiologist coming into contact with other colleagues

3) Allow other radiologists identified by the chief of radiology to acquire the necessary instruments to be able to read routine CT scans using the new disease staging and mRECIST critera

The number of studies requiring mRECIST assessment is as follows:

- 8 interventional studies

- 3 observational studies

All the studies have been approved by the Interhospital Ethical Committee, based at the Azienda Ospedaliera di Alessandria (Alessandria Hospital).
Additional studies will be implemented for which the center has already received confirmation of eligibility to conduct them.

INTERVENTIONAL STUDIES
- “Double blind, randomised, multicentre, phase II/III study of nintedanib in combination with pemetrexed/cisplatin followed by continuing nintedanib monotherapy versus placebo in combination with pemetrexed/cisplatin followed by continuing placebo monotherapy for the treatment of patients with unresectable malignant pleural mesothelioma” (LUME-Meso)

- “A phase II study on the activity of trabectedin in chemonaive biphasic/sarcomaotid or pretreated malignant pleural mesothelioma (MPM)” (ATREUS)

- "A Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of Amatuximab in Combination with Pemetrexed and Cisplatin in Subjects” (MORAb-009-201)

- "Phase II Study of NGR-hTNF Versus Placebo as Maintenance Treatment in Patients With Advanced Malignant Pleural Mesothelioma” (NGR019)

- “Studio prospettico randomizzato di fase III sull’efficacia della pleurectomia/decorticazione nel trattamento del mesotelioma pleurico maligno” (PASS) (Randomized, prospective Phase III study of the efficacy of pleurectomy/decortication in the treatment of malignant pleural mesothelioma (PASS)

- “A Phase II Trial of Pemetrexed and cisplatin or carboplatin in combination with NovoTTF Therapy as First-line Treatment in Malignant Pleural Mesothelioma” (EF-23)

- “A Phase II Randomized Study of Pembrolizumab in patients with advanced malignant pleural mesothelioma” (IND.227)

- "A double-blind, placebo controlled, Randomized multicenter Phase II Study evaluating Gemcitabine with or without Ramucirumab as II line treatment for advanced malignant pleural mesothelioma” (RAMES)

OBSERVATIONAL STUDIES
- "Studio osservazionale registro delle patologie pleuriche e del mesotelioma” (REGCLIN-MM) (Observational registry study of pleural diseases and mesothelioma)

- "Progetto di ricerca epidemiologica con dati genetici “Modificatori su base genetica del rischio di mesotelioma " (MESOGENRISK) (Epidemiological research project using genetic data “Modifiers based on the genetic risk of mesothelioma”

- "Progetto di ricerca sugli effetti psicologici dell’esposizione ad amianto in pazienti affetti da mesotelioma pleurico o altra patologia oncologica asbesto correlata“ (AVPM-pazienti) (Research project on the psychological effects of asbestos exposure in patients with pleural mesothelioma or other asbestos-related cancer)

STUDIES TO BE IMPLEMENTED:

- "A randomized, double-blind, placebo-controlled Phase III study of anetumab ravtansine (BAY 94-9343) in combination with pemetrexed and cisplatin as 1st treatment in patients with malignant pleural mesothelioma overexpressing mesothelin” (BAY 94-9343)

- "A phase II study to investigate the activity and safety of anti-PD-L1 antibody (Durvalumab) In ADvancEd pretreated malignant pleural Mesothelioma” (DIADEM)

- "Lurbinectedin (PM01183) as systemic chemotherapy in progressive malignant mesothelioma: An early Phase II study” (SAKK 17/16)

- "A randomised Phase II open-label study with a Phase Ib safety lead-in cohort of ONCOS-102, an immune-priming GM-CSF coding oncolytic adenovirus, and pemetrexed/cisplatin in patients with unresectable malignant pleural mesothelioma” (MESOS)

- Polaris Study: Randomized, Double-Blind Phase 2/3 Study in Subjects with Malignant Pleural Mesothelioma with Low Argininosuccinate Synthetase 1 Expression to Assess ADI-PEG 20 with Pemetrexed and Cisplatin (ATOMIC-Meso Phase 2/3 Study)

- "Pembrolizumab and trabectedin in advanced pretreated malignant pleural mesothelioma (MPM)” (PETRA)

- "A single arm multicenter phase II study of Atezolizumab in metastatic pleural mesothelioma progressed during or after one or two systemic treatments” (ML39453)

SUMMARY OF THE FINANCIAL PLAN
An estimated € 30 000,00 will be required.

ITEM
Support staff for the medical
personnel for 12 months   

AMOUNT
€ 30 000,00

(includes the overall contract management costs)