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K. Nackaerts
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OA05 - Treatment Advances in SCLC (ID 373)
- Event: WCLC 2016
- Type: Oral Session
- Track: SCLC/Neuroendocrine Tumors
- Presentations: 1
- Moderators:A. Ardizzoni, J. Pujol
- Coordinates: 12/05/2016, 14:20 - 15:50, Strauss 2
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OA05.05 - Randomized Phase 2 Study: Alisertib (MLN8237) or Placebo + Paclitaxel as Second-Line Therapy for Small-Cell Lung Cancer (SCLC) (ID 4855)
14:20 - 15:50 | Author(s): K. Nackaerts
- Abstract
- Presentation
Background:
Alisertib, an investigational selective Aurora A kinase inhibitor, showed single-agent antitumor activity in preclinical in vivo SCLC models and was synergistic with paclitaxel in this setting. We report the efficacy, quality of life (QoL), and safety from this study.
Methods:
Patients ≥18 years with SCLC relapsed <180 days after standard first-line platinum-based chemotherapy were randomized 1:1 to alisertib 40 mg orally twice-daily on days 1–3, 8–10, 15–17 + paclitaxel 60 mg/m[2] IV on days 1, 8, 15 (Arm A) or matched placebo + paclitaxel 80 mg/m[2] (Arm B) in 28-day cycles. Patients were stratified using an interactive voice response system (IVRS) by type of relapse post-frontline platinum (sensitive vs resistant/refractory) and presence/absence of brain metastases at baseline. Protocol Amendment 2 corrected the definition for relapse per standard guidance; stratification factors were corrected accordingly. Primary endpoint was progression-free survival (PFS) per stratified log-rank test. QoL outcomes were assessed per EORTC QLQ-C30 and -LC13.
Results:
178 patients were randomized, 89/89 to Arm A/B (median age 62/62 years). Survival, response, QoL, and safety results are presented in the Table. The analysis of PFS using IVRS stratification favored Arm A, as did the analysis per corrected stratification factors. Mean EORTC QLQ-C30 QoL scores were similar between arms, as were mean change-from-baseline values at end of treatment (-5.7 in Arm A vs -4 in Arm B). Figure 1
Conclusion:
Alisertib + paclitaxel shows favorable PFS over placebo + paclitaxel with both initial and updated IVRS stratification. A similar favorable trend was also observed for OS and ORR although not statistically significant. Comparable changes in QoL scores were observed from baseline in both arms. The alisertib + paclitaxel arm showed higher rates of AEs and discontinuation due to AEs. Updated survival analyses are pending.
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OA22 - Novel Trials and Biomarkers in Malignant Pleural Mesothelioma (ID 403)
- Event: WCLC 2016
- Type: Oral Session
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:H. Pass, N. Van Zandwijk
- Coordinates: 12/07/2016, 14:20 - 15:50, Strauss 3
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OA22.05 - Breath Analysis by Gas Chromatography-Mass Spectrometry Can Be Used to Screen for Pleural Mesothelioma (ID 4845)
14:20 - 15:50 | Author(s): K. Nackaerts
- Abstract
- Presentation
Background:
Malignant pleural mesothelioma (MPM) is an asbestos-related tumour with poor prognosis. Since MPM is diagnosed at advanced stage due to non-specific symptoms and investigations, it is thought that only an early diagnosis will improve patient’s outcome. Breathomics allows to detect volatile organic compounds (VOCs) in breath which can be used as non-invasive biomarkers. Although we were able to discriminate MPM patients from controls using ion mobility spectrometry breathomics, we were not able to identify specific VOCs. Therefore, we aimed to identify VOCs in the breath of MPM persons and persons at risk with gas chromatography-mass spectrometry (GC-MS).
Methods:
Fourteen MPM patients, eighteen asymptomatic asbestos-exposed individuals, 16 individuals with benign asbestos-related diseases and fourteen healthy non-exposed persons were included. After 2 hours of fasting, participants breathed tidally for 5 minutes through a mouthpiece connected to a VOC filter. Subsequently, a full vital capacity was captured in a Tedlar bag of which 500 ml was immediately transferred on a Tenax[GR]-column. Samples were thermally desorbed followed by GC-MS analysis (Agilent 6890A–Thermo Focus DSQII). VOCs were manually selected in the chromatogram and standardised to an internal standard (toluene-d8). Only VOCs with a S/N-ratio>10 were used. Using SPSSv23, significant differences were searched and ROC-curves for discriminating MPM from all control groups were constructed. VOCs which had an AUC~ROC~>0.80 are reported.
Results:
114 VOCs were selected of which 17 were significantly different between MPM patients and controls. Of these, 7 had AUC~ROC~>0.80 and are possible markers for MPM diagnosis.Figure 1
Conclusion:
The large discriminative power and good sensitivity and specificity imply the possibility to use breath analysis for MPM screening. Therefore, persons exposed to asbestos with a positive test should be considered for follow-up in a cost-effective way, decreasing the need for CT-scans and radiation exposure in low-risk persons. Further work includes combining models for discrimination and validating these findings.
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P3.03 - Poster Session with Presenters Present (ID 473)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Mesothelioma/Thymic Malignancies/Esophageal Cancer/Other Thoracic Malignancies
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.03-049 - Optimisation of Malignant Mesothelioma Registration at the Belgian Cancer Registry (ID 3907)
14:30 - 15:45 | Author(s): K. Nackaerts
- Abstract
Background:
Malignant mesothelioma (MM) is a rare but aggressive cancer mostly caused by asbestos exposure, and for which diagnosis is difficult to make. Completeness and correctness of MM registration at the Belgian Cancer Registry (BCR) is assessed using information from three independent national databases, i.e. the standard cancer registration, the population-based mortality statistics (death certificates, COD) and the Belgian Mesothelioma Registry (BMR).
Methods:
The study cohort includes all MM diagnoses reported to BCR (incidence years 2004-2012; n=2,344), all patients reviewed by the pathology commission of BMR (2004-2012; n=2,019), and COD data for all Belgian citizens (2004-2013). All available data are compared for diagnosis and immunohistochemical (IHC) tests as derived from the available pathology reports (APD) at BCR or registered by BMR.
Results:
Preliminary analyses (n=1,927; 81% of the study cohort) showed that 94% of diagnoses were concordant between BCR and BMR. The proportion of MM without specified histological diagnosis (28% before project start) could be reduced to less than 1%. IHC results derived from APD and/or BMR were available for 86% of the cases. The most commonly performed markers were calretinin, CEA, CK5/6 and TTF1, as expected. Different IHC patterns could be distinguished in concordance with MM histology. MM was mentioned in 165 COD between 2004-2011 that remained uncoupled to BCR. For 139 patients registered at BCR with a different diagnosis, COD indicated MM as cause of death.
Conclusion:
This projects aims to achieve a complete and correct registration of MM diagnoses in Belgium by comparing information from three independent national databases. Discordant cases will be explored in detail and if necessary, a pathology revision will be performed. Once a definitive database is obtained, further analyses will be conducted including in-depth profiling of long-term survivors and description of treatment patterns for MM.
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P3.05 - Poster Session with Presenters Present (ID 475)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Palliative Care/Ethics
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.05-005 - Geriatric Assessment and Functional Decline in Older Patients with Lung Cancer (ID 4095)
14:30 - 15:45 | Author(s): K. Nackaerts
- Abstract
Background:
Physicians treating lung cancer are confronted with an expanding group of older patients. Treatment of these patients is complex and focusses on improving quality of life, maintenance of functional status (FS) and prolonging overall survival (OS). The present study aims to evaluate the role of geriatric assessment (GA) and the evolution of FS in older patients with lung cancer, and to identify predictors for functional decline and OS.
Methods:
Patients ≥70 years with a new diagnosis of lung cancer were included. At baseline, GA was performed, including FS measured by Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL). ADL and IADL were reevaluated 2-3 months after diagnosis. OS was collected. Determination of predictors of functional decline on ADL and IADL and of OS was performed by univariate and multivariable logistic and Cox regression.
Results:
245 patients with a median age of 76 years were included from October 2009 till January 2015. The majority of patients (58%) had stage IV disease. Treatment consisted of surgery in 20 patients (8%), radiotherapy in 105 patients (43%) and chemotherapy or targeted therapy in 125 patients (51%). At baseline, GA deficiencies were observed in all domains, most prominent for comorbidities (78%), fatigue (76%) and nutrition (76%). 240 patients (98%) had at least 2/10 abnormal domains with a median of 5. ADL and IADL impairments were detected in 51% and 63% of patients respectively. Follow-up ADL and IADL data were available for 145 patients. Functional decline for ADL was observed in 23% (95%CI 16,2; 29,9) and for IADL in 45% (95%CI 36,9;53,1) of patients. In multivariable analysis, radiotherapy was predictive for ADL decline. No other predictive factors for ADL or IADL decline were identified. In multivariable Cox regression, stage, gender and age were predictive for survival .
Conclusion:
Older patients with lung cancer are a high risk population with deficiencies in multiple geriatric domains. During treatment functional decline is observed in half of the patients, more prominently for IADL. Functional decline on ADL at 2-3 months is predicted by radiotherapy, possibly related to the acute toxicities of this treatment. None of the specific domains of the GA nor cumulative deficits on GA were predictive for functional decline or survival. Further research should focus on the role of interventions on evolution of quality of life.
