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Naomi Alpert



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    IBS06 - Multimodality Treatment - Realtime Data from National Registries (Ticketed Session) (ID 37)

    • Event: WCLC 2019
    • Type: Interactive Breakfast Session
    • Track: Mesothelioma
    • Presentations: 1
    • Now Available
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      IBS06.02 - Real Time Data from US (SEERS) (Now Available) (ID 3332)

      07:00 - 08:00  |  Author(s): Naomi Alpert

      • Abstract
      • Presentation
      • Slides

      Abstract

      Real time data for Mesothelioma in US

      Maaike van Gerwen, Naomi Alpert, Andrea Wolf, Raja Flores, Emanuela Taioli

      Introduction

      The association between asbestos exposure and malignant mesothelioma has been well established. Exposure to asbestos mainly occurs through work although environmental exposure has been documented. Several countries have put in place an active epidemiologic surveillance of mesothelioma cases.

      Through a PubMed and Google Scholar search using the key words “mesothelioma” and “registry”, and by reviewing data sources of studies described in a review of environmental exposure and malignant mesothelioma, we identified existing mesothelioma registries. Countries with mesothelioma specific registries are Australia, Belgium, France, Germany, Italy, Japan, South Korea, South Africa, Turkey, and the UK. Nation-wide coverage is obtained in Italy, Australia and South Korea. Registries in Australia, France, Italy, and South Korea use interviews to obtain exposure data from the patient or a close relative, although none of these countries has a tissue bank. The UK has a mesothelioma tissue bank although it is not linked with the National Mesothelioma Audit registry. All registries have or will develop linkage with death index registries to monitor survival outcomes. (Table 1)

      The Scandinavian countries including Norway, Sweden, Finland and Denmark, have a population based cancer registry that includes mesothelioma and is linked to other databases, such as an occupational database, thus has more comprehensive information on each case.

      Mesothelioma surveillance in the US to date

      Currently, no nation-wide, mesothelioma specific registry exists in the US. Various existing databases are used to investigate mesothelioma, for instance the National Cancer Database has been used to look at prognostic factors; gender and race differences in mesothelioma survival have been studied using the Surveillance, Epidemiology, and End Results (SEER) database. All these datasets suffer of a time-lag between case occurrence, reporting, registration and eventually data availability for research purposes; these are serious limiting factors in the case of mesothelioma. Because of the rarity and lethality of the disease, a real-time capture registry is needed to thoroughly collect exposure data, complete data on treatments, quality of life before and after treatment, symptoms and pain management. All these elements are lacking in the existing databases.

      Because the US mesothelioma incidence is not decreasing as quickly as predicted and new cases still occur as well the fact that mortality rates are steady overtime, the overall health burden due to mesothelioma in the US still remains. Although the use of asbestos has been restricted or banned since 1980, several scientific questions remain open due to the long latency period between exposure and mesothelioma clinical occurrence, and to gaps in knowledge of the carcinogenesis process. Data on occupational and environmental asbestos exposure and co-exposure to other carcinogens are needed. Certain patterns, such as differences in outcomes by gender, differences in incidence rates by race, as well as geographic clusters of increased number of cases, are hard to explain with the existing data.

      Possible next steps towards a US mesothelioma registry

      “Real time” enrollment is important in order to systematically collect information on asbestos and other exposures through interviews with mesothelioma patients or a close relative. Furthermore, optimal coverage, preferably population based and nation-wide, and a simplified consent process are needed in order to capture a maximum number of cases. A centralized quality control system, standardized data collection methods, and the ability to link to relevant other existing registries are important in order to integrate the registry with clinical and prognostic information. Additionally, consistency in the design and questionnaire content with other countries would be ideal, in order to conduct comparisons and possibly pool the data. The flexibility to add or modify modules to tailor to future research questions are other preferable features for a US mesothelioma registry. (Figure 1) A discrete amount of work has been devoted to molecular markers such as mesothelin and certain germline mutations as prognostic factors. The role of these biomarkers could be validated on larger populations of patients if a comprehensive registry that includes tissue is implemented.

      Summary and conclusions

      In conclusion, with the remaining health burden due to mesothelioma, the changing landscape of asbestos exposure, and the many unanswered scientific questions, a nation-wide, real-time US mesothelioma registry is urgently needed. Methods for data sharing, linkage to existing tissue banks, and data access should be implemented and tested on a small scale before being implemented nationwide. One of the most practical outputs of these efforts would be the ability to conduct pragmatic trials that could be built out of a “real time” case capture system.

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    MA07 - Clinical Questions and Potential Blood Markers for Immunotherapy (ID 125)

    • Event: WCLC 2019
    • Type: Mini Oral Session
    • Track: Immuno-oncology
    • Presentations: 1
    • Now Available
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      MA07.10 - The Influence of Sex on Immunotherapy Efficacy in Non-Small Cell Lung Cancer (Now Available) (ID 712)

      13:30 - 15:00  |  Author(s): Naomi Alpert

      • Abstract
      • Presentation
      • Slides

      Background

      Patient’s sex impacts clinical outcomes for multiple cancers, including non-small cell lung cancer (NSCLC). A recent meta-analysis demonstrated sex may also impact response to novel immunotherapeutic agents, where men appear to derive greater benefit than women. However, the role of important clinical confounders of immunotherapy response that differ according to sex was not accounted for. The aim of this project was to investigate the effect of sex on immunotherapy benefit for NSCLC patients using a large, nationally representative database while adjusting for important clinical confounders.

      Method

      Advanced metastatic NSCLC patients diagnosed between 2013-2015 were identified in the National Cancer Database (NCDB). A Cox Proportional Hazards model was used to assess the interaction between sex and immunotherapy treatment for overall survival. This model was also adjusted for histology, stage, age, race, tumor size, comorbidities and other treatment (i.e. chemotherapy, radiation).

      Result

      Of 103,525 advanced NSCLC patients, 69,120 (67%) had adequate follow-up information for survival analysis. Of these, 37,423 (54.1%) were males and 31,697 (45.9%) females; 4,012 patients received immunotherapy as first-course treatment. In the adjusted model, both males (Hazard Ratio [HR]adj: 0.77, 95% Confidence Interval [CI] 0.73-0.81) and females (HRadj: 0.80, 95% CI 0.76-0.85) receiving immunotherapy had improved survival compared to those not receiving immunotherapy. The interaction between sex and immunotherapy was not significant (p=0.2539) after adjusting for clinical variables. Among the covariates, younger age, adenocarcinoma histology, Black race, smaller tumor size, lower comorbidity score and additional cancer treatment (either chemotherapy or radiation) were independently associated with better survival (p<0.0001 for all comparisons).

      Conclusion

      Patient sex does not appear to affect the benefit of immunotherapy in advanced NSCLC patients after adjusting for potential clinical confounders. Other clinical factors may play a role in immunotherapy response and should be explored in future research.

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    P2.06 - Mesothelioma (ID 170)

    • Event: WCLC 2019
    • Type: Poster Viewing in the Exhibit Hall
    • Track: Mesothelioma
    • Presentations: 1
    • Moderators:
    • Coordinates: 9/09/2019, 10:15 - 18:15, Exhibit Hall
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      P2.06-16 - Racial Disparities in Treatment Patterns and Survival Among Surgically Treated Malignant Pleural Mesothelioma Patients (ID 1869)

      10:15 - 18:15  |  Author(s): Naomi Alpert

      • Abstract
      • Slides

      Background

      Although surgical intervention improves survival for patients with malignant pleural mesothelioma (MPM), black patients are less likely to receive surgery. It is not known what the treatment patterns in MPM surgical patients are according to race. This study sought to examine treatment patterns and survival between black and white surgical patients using a large nationwide cancer database.

      Method

      This study used the National Cancer Database (NCDB) to examine the subset of black and white MPM patients who received surgery, defined as pleurectomy/decortication (P/D) or extrapleural pneumonectomy (EPP). Multivariable logistic regressions were used to evaluate the racial differences in the extent of surgery, receipt of additional treatment (chemotherapy and/or radiotherapy), and 30-/90- day mortality, while accounting for clinical and demographic factors. A multivariable Cox proportional hazards model was used to assess the independent associations of race with overall survival. Association between race and survival was also analyzed using a 1:1 propensity score matching with the greedy algorithm.

      Result

      There were 2550 MPM patients in the NCDB who received surgery; 2462 white (96.5%) and 88 black (3.5%). Most patients received P/D (77.8%); 63.8% received additional treatment. Black patients were significantly less likely to receive EPP (ORadj: 0.36, 95% CI: 0.17-0.78). There was no significant difference with race in the receipt of additional treatment (ORadj: 0.79, 95% CI: 0.46-1.34); EPP patients were significantly more likely to receive additional treatment (ORadj: 1.34, 95% CI: 1.02-1.74). Black patients tended to have worse 30- and 90- day mortality than white patients (ORadj: 1.52, 95% CI: 0.58-4.01; ORadj: 1.50, 95% CI: 0.75-3.01, respectively). There was no significant difference in overall survival between black and white patients (HRadj: 0.96, 95% CI: 0.72-1.27); patients who had treatment in addition to surgery had significantly better survival (HRadj: 0.71, 95% CI: 0.64-0.80). Results remained similar after propensity matching.

      Conclusion

      Among MPM patients receiving surgery, black patients received less extensive surgery, and are less likely to receive additional treatment, indicating less aggressive treatment overall. Although overall survival was similar, black patients tended to have worse short term outcomes after surgery. Racial disparities in treatment and short term outcomes need to be better addressed.

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