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G. Fasola
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MA14 - Immunotherapy in Advanced NSCLC: Biomarkers and Costs (ID 394)
- Event: WCLC 2016
- Type: Mini Oral Session
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:M. Reck, D.R. Spigel
- Coordinates: 12/06/2016, 16:00 - 17:30, Strauss 2
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MA14.06 - Nivolumab in Never Smoker Patients with Advanced Squamous NSCLC: Results from the Italian Expanded Access Programme (EAP) (ID 4765)
16:36 - 16:42 | Author(s): G. Fasola
- Abstract
- Presentation
Background:
Nivolumab is the first checkpoint inhibitor approved for the treatment of Sq-NSCLC to show a survival benefit vs the standard of care docetaxel in the randomised, phase III, CheckMate 017 study. In the nivolumab development program, a greater clinical benefit was shown in current and former smokers than in never smokers. Nevertheless, no data are available in this respect from a real world setting. For this reason, we decided to use the data collected in the EAP in order to assess the effectiveness and tolerability of nivolumab treatment in the never smoker patient population.
Methods:
Nivolumab was provided upon physician request for patients aged ≥18 years who had relapsed after a minimum of one prior systemic treatment for stage IIIB/stage IV Sq-NSCLC. Nivolumab 3 mg/kg was administered intravenously every 2 weeks for <24 months. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events using Common Terminology Criteria for Adverse Events.
Results:
Of 372 patients with Sq-NSCLC participating in the EAP in Italy, 38 (10.2%) were never smokers, a proportion very similar to the one observed in Checkmate 017 (10%). With a median number of doses of 8 (range, 1–22) and a median follow-up of 5.6 months, the disease control rate in this group was 50%, including 9 patients with a partial response and 10 with stable disease. Eight patients were treated beyond RECIST-defined progression, with 4 of them achieving disease control. As of April 2016, median progression-free survival and overall survival were 3.5 months and not reached, respectively. 17 patients (44.7%) discontinued treatment for any reason except toxicity and 5 (13.1%) discontinued due to AE.
Conclusion:
These preliminary results, although obtained from a small sample size, suggest that nivolumab is effective and well tolerated in a never smoker group of patients with advanced Sq-NCLCS in the real life and warrant further investigation in this area.
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P1.03 - Poster Session with Presenters Present (ID 455)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Radiology/Staging/Screening
- Presentations: 1
- Moderators:
- Coordinates: 12/05/2016, 14:30 - 15:45, Hall B (Poster Area)
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P1.03-035 - Does Screening with Low-Dose Computed Tomography (LDCT) of Asbestos Exposed Subjects Reduce Mortality for Lung Cancer (LC)? (ID 5586)
14:30 - 14:30 | Author(s): G. Fasola
- Abstract
Background:
Our previous prospective non-randomized ATOM002 study showed that LDCT screening of asbestos exposed subjects can identify LC at an earlier, and potentially more curable, stage than chest radiographs (CXR) (Fasola et al, The Oncologist 2007). The ATOM002 participants were selected from subjects enrolled in a surveillance program for asbestos exposed workers at the Monfalcone Occupational Health Unit in the Friuli Venezia Giulia (FVG) region, Italy. Here, we report a cohort mortality study of asbestos exposed subjects from that surveillance program, comparing outcomes in the ATOM002 participants and contemporary nonparticipants.
Methods:
Within a cohort of 2,433 asbestos exposed subjects, we compared mortality between the ATOM study participants (who had additional baseline and 1 year LDCT) and nonparticipants (n=926 and 1,507, respectively). The follow-up period spanned the years 2002-2011. Cox models were performed to assess survival for all causes, all cancers, LC and malignant pleural mesothelioma. Final models estimating mortality hazard ratios (HR) were adjusted for smoking habits, age, level of asbestos exposure and Charlson-Quan comorbidity index. For external comparison, we estimated the standardized mortality rate ratio (SMR) using FVG regional standard rates.
Results:
There was a significant 59.3% (95%CI: 3.9-82.8) reduction in adjusted mortality for LC among ATOM002 participants vs. nonparticipants. LC crude mortality was 99.4 per 100,000 person-year in participants (8 LC deaths) compared to 430.4 per 100,000 person-year in nonparticipants (50 LC deaths). Mortality was also reduced for all causes (HR=0.61; 95%CI 0.44-0.84), but not for all cancers (HR=0.97; 95%CI 0.62-1.50) or malignant pleural mesothelioma (HR=0.86; 95%CI 0.31-2.41). Compared with regional mortality rates, a trend towards reduced mortality for LC was found among ATOM002 participants (SMR =0.55; 95%CI 0.24-1.09), in contrast to a statistically significant increase in the nonparticipants (SMR = 2.07; 95%CI 1.53-2.73).
Conclusion:
In our cohort, participation in the LDCT based screening study was associated with reduced mortality for LC compared to empiric CXR based public health surveillance. To our knowledge, this is the first report suggesting reduction in mortality for LC with LDCT screening in an asbestos exposed population. LDCT screening might therefore be a reasonable approach for surveillance in these populations.
