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Marco Alloisio
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P3.08 - Oligometastatic NSCLC (Not CME Accredited Session) (ID 974)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.08-04 - OMEGA, A Randomized Trial of Local Ablative Therapy Vs. Conventional Treatment in Oligometastatic NSCLC – Trial in Progress (ID 13971)
12:00 - 13:30 | Author(s): Marco Alloisio
- Abstract
Background
A recent randomized phase 2 study has shown that local ablative therapy in addition to systemic treatment was superior to maintenance therapy in prolonging disease-free survival in NSCLC patients harboring up to three metastatic sites.
Oligometastatic lung cancer (OM-NSCLC) seems thus to be associated with a better prognosis than usual Stage IV non-small cell lung cancer when radical local therapy of all metastatic sites is administered but the impact of such an approach on overall survival and quality of life remains unclear
a9ded1e5ce5d75814730bb4caaf49419 Method
A consortium of tertiary referral centres involved in Lung Cancer management at the national level was established with the aim of setting up a randomized trial addressing this issue
4c3880bb027f159e801041b1021e88e8 Result
A randomized trial of local ablative therapy in OM-NSCLC patients with potentially resectable or locally controlled primary tumors has been designed and 7 tertiary referral centers agreed to participate
Patients with synchronous or metachronous oligometastatic lung cancer (1-3 metastatic lesions) will be randomized to local ablative therapy + standard treatment Vs. standard treatment.
Balancing between study arms will be performed according to synchronous vs. metachronous presentation, Number of oligometastases, Nodal status and Oncogene-addiction or PDL-1 expression.
Primary outcome will be Overall Survival (OS) from randomization. The sample size is set to 195 patients.
Inclusion criteria include adequate performance status, primary tumor controlled or controllable staging with whole-body FDG PET scan and brain MRI, fit to receive at least 3 cycles of platinum-based doublet chemotherapy, or immunotherapy or targeted agents according to molecular profile.
Exclusion criteria include cerebral oligometastasis alone (will receive local therapy in any case),
metastasis in sites where normal radiotherapy constraints cannot be met, multiple subsolid nodules in the absence of extrapulmonary metastasis, prior malignant tumor with some exceptions, relevant co-morbidities that would significantly reduce life expectancy on their own,
Disease state and life status assessed on a 2-monthly basis by physical examination, whole-body CT scan plus repeat PET-scan if needed and Brain MRI if brain metastasis at enrolment. Toxicity and adverse events will be assessed according to NCI-Common Terminology Criteria. Quality of life will be assessed at randomization and after six months by the SF36/LCSS.
8eea62084ca7e541d918e823422bd82e Conclusion
There is a clear need for randomized controlled trials with overall survival as their main endpoint to confirm whether local ablative therapy indeed has a role in the management of oligometastatic lung cancer. The Omega trial will try to respond to such a need.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P3.11 - Screening and Early Detection (Not CME Accredited Session) (ID 977)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 12:00 - 13:30, Exhibit Hall
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P3.11-25 - Analysis Indicates Low Incremental Cost-Effectiveness Ratio for Implementation of Lung Cancer Screening in Italy (ID 12905)
12:00 - 13:30 | Author(s): Marco Alloisio
- Abstract
Background
Given the potential of early lung cancer detection to improve survival, accurate assessment of the cost-effectiveness of low-dose computed tomography (LDCT) screening is crucial. We report the results of a cost-effectiveness analysis of screening for Italian persons at high risk of lung cancer from the public payer’s perspective
a9ded1e5ce5d75814730bb4caaf49419 Method
The study built on a mathematical decision model to estimate the cost-effectiveness of annual LDCT screening for 5 years in a high-risk population of smokers (at least 30 pack-years) aged 55-79 years. The stage distribution of patients diagnosed as part of the COSMOS screening study was used for the “screening arm;” the stage distribution of patients in the SEER database was used for the “usual care arm.” Treatment costs were determined using detailed individual-level administrative information from our Institutional database of lung cancer patients. Lung cancer survival in screened patients was adjusted for 2 year-lead time bias. The model estimated expected future life years using survival probabilities according to age, sex, and lung cancer stage (or no lung cancer). Quality-Adjusted Life Years (QALYs) gained and Life Years (LY) gained were estimated.
4c3880bb027f159e801041b1021e88e8 Result
The base-case incremental cost for each QALY gained was 4747,57 Euro. The incremental cost-effectiveness ratio (ICER) for each LY gained was 4069 Euro. An extensive sensitivity analysis showed that model outcomes were particularly sensitive to lung cancer prevalence, the sensitivity and specificity of screening, and the lead-time bias assumed.
8eea62084ca7e541d918e823422bd82e Conclusion
Our analysis indicates that LDCT screening is associated with a low ICER of 4069 Euro, meaning that this is the yearly incremental cost of saving the life of a patient, and is lower than the ICER accepted by the Italian government. The implication is that implementation of screening throughout Italy can be achieved at a relatively low cost, a finding which should be taken into account by health policy decision-maker.
6f8b794f3246b0c1e1780bb4d4d5dc53
