What is Alliance Against Cancer
Alleanza Contro il Cancro (ACC), or Alliance Against Cancer is a scientific society, founded in 2002, under the supervision of the Ministry of Health, with the aim of promoting active collaboration between Italian Research Institutes for Cancer Care, promoting the exchange of knowledge and scientific information and create a common development strategy in oncology research.
Today, the ACC includes 20 partners, supervised by the Ministry of Health, which includes 11 cancer institutes, 3 research-oriented general hospitals, 2 pediatric hospitals, 3 specialized hospitals in the field of dermatology, neurology and orthopedics and the Higher Health Institute.
The goal of ACC is also to create clinical networks to promote the development of research projects between different institutions and improve the quality of care, as well as organize educational activities and collaborations with other scientific societies in order to draw up recommendations for the diagnosis and treatment of cancer.
Research project in patients with lung cancer
ACC is pursuing an ambitious research project aimed at improving the care of patients with non-small cell lung cancer.
The technological advances of the last ten years have made it possible to expand our knowledge of the biology of lung tumors and to identify molecular driver changes, responsible for the growth of the tumor itself. At present, non-small cell lung cancer is no longer considered as a single disease, but as a complex of rare diseases, classified on the basis of the molecular alterations present, some of which are targets of highly effective biological drugs.
Several national programs have assessed the feasibility of large-scale molecular screening. The first of these is a study conducted in 14 American centers, it evaluated the presence of molecular alterations in 14 genes in 1102 patients with advanced NSCLC. In 64% of the cases a molecular alteration was identified in a driver gene and 44% of these patients received targeted drug therapy. This was associated with a significant improvement in overall survival: patients with molecular alterations who had received a target treatment had a significantly higher survival than patients with the same molecular characteristics but who had not received targeted therapy, or those in whom no molecular target was identified.
It is evident that a nationally based screening program, led by a consortium comprising different institutions, is the key to success that allows more patients to receive targeted drugs and this leads to an increase in overall survival.
In recent years, the use of next generation sequencing (NGS) has become part of the routine. NGS allows to analyze many genes simultaneously with relatively small amounts of tissue. Several protocols on a national scale, designed in collaboration with pharmaceutical companies, are currently underway (SAFIRO2 in France, the Lung Matrix in Great Britain and the Lung Map study in the United States).
Alliance Against Cancer (ACC) has recently developed a panel of genes, which allows the simultaneous analysis of sequences of 182 genes, 139 gene translocations and 141 germline variations in 86 genes.
The objective of the study that ACC and the Ministry of Health are promoting is to validate oncocytes in new cases of locally advanced or metastatic non-small cell lung cancer patients in the 18 ACC institutions. This is the first Italian prospective study that evaluates the use of NGS to classify patients with non-small cell lung cancer. The objective of the study, designed by Dr. Vanesa Gregorc, is to improve the performance of molecular diagnostics in Italian institutes in order to offer better and new therapeutic opportunities to patients with lung cancer.
Study design
The study is divided into two phases: the demonstration project, with the aim of prospectively validating the panel of genes in 1000 patients diagnosed with lung cancer, and the umbrella project, with the aim of choosing the treatment based on molecular characterization. The success of this second part will also involve the collaboration of AIFA, pharmaceutical companies and academic institutions. The two projects will be started in parallel. The demonstration project will last 12 months and about 1000 patients will be enrolled, while the umbrella project will be started in parallel.
Patients with molecular alterations, for which target therapy has already been approved by the Regulatory Authorities, will receive the reference treatment as first line according to the National Guidelines.
For patients with molecular alterations for which a target therapy has already been tested in a phase two study, if feasible, an extended access program will be required or in agreement with AIFA, the possibility of getting these drugs prescribed so that patients can benefit from them. Moreover, in collaboration with pharmaceutical companies, studies with new generation targeted drugs will be started throughout the course of the study.
The goal and therapeutic implications are ambitious. To improve the quality of care, we must invest in research, and to do good research, we must collaborate and design common projects .
ACC study update – January 2020
Enrollment in the study is ongoing. The protocol has been activated in new centers. The objective behind this is to allow more patients to take advantage of the extensive genetic profiling. Knowing the underlying biology of the disease you are suffering from opens the doors to more therapeutic options.
The protocol is currently active in the following centers:
- Ospedale San Raffaele, Milano
- Casa Sollievo della Sofferenza, San Giovanni Rotondo
- Istituto Tumori G. Paolo II, Bari
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola
- Istituto Regina Elena, Roma
- La Maddalena S.p.A., Palermo
- Azienda Ospedaliera “Villa Sofia – Cervello”, Palermo
- Istituto Nazionale Tumori, Milano
- IRCCS CROB, Rionero in Vulture (Pz)
- Istituto Nazionale Tumori Fondazione G. Pascale, Napoli
- IRCCS AOU San Martino – IST, Genova
- Istituto di Candiolo, FPO-IRCCS, Candiolo
- Istituto Europeo di Oncologia, Milano
- Istituto Clinico Humanitas, Rozzano
- Centro di Riferimento Oncologico di Aviano (PN)
- Istituto Oncologico Veneto, Padova
- Ospedale Cannizzaro, Catania
- Istituto Dermatologico Italiano, Roma
- Arcispedale Santa Maria Nuova, Reggio Emilia
- Policlinico Universitario Fondazione Agostino Gemelli, Roma
- Azienda Ospedaliera Universitaria di Parma, Parma
This great amount of effort, funded by the Ministry of Health, aims to improve the use of molecular diagnostics in Italy and make the country autonomous with regards to molecular profiling of patients with solid tumors.
While other studies are being conducted in other countries, the Italian one gathers one oft he largest patient cohorts.
This will allow us to both obtain large amounts of data regarding lung cancer biology as well as to integrate both molecular and clinical information, thus improving our knowledge.
At the moment, 224 patients are enrolled in the study. The preliminary results demonstrate that the NGS panel provides good sensitivity and specificity. The panel was developed in an academic setting, and we are currently testing it in the clinic.
