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Pieter E. Postmus
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MA25 - Oligometastasis: Defining, Treating, and Evaluating (ID 929)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Oligometastatic NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 13:30 - 15:00, Room 203 BD
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MA25.02 - Searching for a Definition of Synchronous Oligometastatic (sOMD)-NSCLC: A Consensus from Thoracic Oncology Experts (ID 13452)
13:40 - 13:45 | Author(s): Pieter E. Postmus
- Abstract
- Presentation
Background
Recent prospective single centre studies reported improved outcomes in patients with sOMD-NSCLC who were treated with radical intent. Since then sOMD has been perceived as a separate disease entity. However, a clear definition of sOMD-NSCLC is lacking. We aimed to develop a definition and diagnostic criteria of sOMD-NSCLC following a consensus process.
a9ded1e5ce5d75814730bb4caaf49419 Method
A European multidisciplinary consensus group was established with representatives from different scientific societies. Consensus questions were extracted from a survey, case series and a systematic review. The questions were discussed, and the statement formulated during a consensus meeting in Dublin (23.01.18).
4c3880bb027f159e801041b1021e88e8 Result
Summary of consensus statement
Defining sOMD-NSCLC
Definition of sOMD is relevant for patients in whom a radical treatment is technically feasible with acceptable toxicity, taking into account all sites, that may modify the course of the disease leading to a long-term disease control.
All sites must be technically and safely treatable.
The maximum number of metastases/organs meeting the criteria involved will depend on the possibility of offering a treatment strategy with radical intent, taking into account local control and toxicity. Based on the systematic review, a maximum of 5 metastases and 3 organs is proposed.
Diffuse serosal metastases and bone marrow involvement are excluded.
Mediastinal lymph node (MLN) involvement should be considered as locoregional disease in the definition of sOMD-NSCLC.
MLN involvement is of importance in determining if a radical local treatment of the primary tumour may be applied and the MLN will not be counted as a metastatic site.
Staging of sOMD-NSCLC
PET-CT and brain imaging are considered mandatory.
In case of a solitary liver metastasis a dedicated MRI of the liver and for a solitary pleural metastasis, thoracoscopy and biopsies of distant ipsilateral pleural sites are advised.
Staging of the mediastinum requires a minimum of a FDG-PET scan, with pathological confirmation preferred if this influences the treatment strategy.
Pathological proof is required unless the MDT decides that the risk outweighs the benefit. Pathology proof is advised for single metastatic location and if it may change the therapeutic strategy, confirmation of the MLN involvement is recommended.
8eea62084ca7e541d918e823422bd82e Conclusion
A multidisciplinary consensus statement on the definition and staging of sOMD-NSCLC was formulated taking into account results of a European survey, a systematic review and case discussion. This statement might be helpful to standardise inclusion criteria in future clinical trials. However, the definition of sOMD may change over time when more prospective data will become available.
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MA26 - New Therapies and Emerging Data in ALK, EGFR and ROS1 (ID 930)
- Event: WCLC 2018
- Type: Mini Oral Abstract Session
- Track: Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 9/26/2018, 13:30 - 15:00, Room 201 BD
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MA26.06 - Crizotinib-Treated ALK Immunopositive Metastasized NSCLC is Associated with an Unfavorable Prognosis when FISH Negative (ID 13179)
14:05 - 14:10 | Author(s): Pieter E. Postmus
- Abstract
- Presentation
Background
Metastasized NSCLC with an ALK fusion are sensitive to a range of tyrosine kinase inhibitors. ALK-positive NSCLC has been identified in the pivotal phase III trial with fluorescence in situ hybridization (ALK FISH+). These tumors are also expressing the fusion product (ALK immunohistochemistry (IHC)+). However, discrepant cases occur, including ALK IHC+ FISH-. The aim of this study was to collect ALK IHC+ cases and compare within this group response to crizotinib treatment of ALK FISH+ cases with ALK FISH- cases.
a9ded1e5ce5d75814730bb4caaf49419 Method
A prospective multicenter investigator initiated research study was started in Europe. Stage IV ALK IHC+ NSCLC cases treated with crizotinib were collected centrally. Slides were validated centrally for ALK IHC (with 5A4 ETOP and D5F3 Ventana protocol) and ALK FISH (Vysis probes).
4c3880bb027f159e801041b1021e88e8 Result
The study started April 1, 2014 and closed in November 2017. Fifteen centers participated. Registration of 3523 ALK IHC tests revealed prevalence of 2.6% ALK IHC+ cases. Local ALK FISH analysis resulted in 46 concordant (ALK IHC+/FISH+) and 18 discordant (ALK IHC+/FISH-) cases. Central validation revealed 37 concordant and 6 discordant cases, 5 of which had follow-up. Validation was hampered by limited amount of tissue in biopsy samples. The time to treatment failure did not differ for concordant nor discordant cases, and neither for local nor validated ALK testing (HR=0.78; 95% CI= 0.27-2.3; p=0.64) and (HR=2.2; 95% CI= 0.72-6.5; p=0.16), respectively). However, overall survival was significantly better for concordant cases than discordant cases after central validation (HR=4.5; 95% CI= 1.2-15.9; p=0.010), but not according to local testing (HR=1.7; 95% CI= 0.45-6.2; p=0.44).
8eea62084ca7e541d918e823422bd82e Conclusion
ALK IHC+ FISH- NSCLC cases are an infrequent finding. We recommend such cases to be validated carefully because our data indicate that ALK IHC+ FISH- cases have a worse survival when treated by crizotinib compared to ALK IHC+ FISH+ cases.
This study was funded by an independent research grant by Pfizer
6f8b794f3246b0c1e1780bb4d4d5dc53Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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MTE15 - Who is Too High Risk for a VATS Resection? (Ticketed Session) (ID 825)
- Event: WCLC 2018
- Type: Meet the Expert Session
- Track: Treatment of Early Stage/Localized Disease
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 07:00 - 08:00, Room 205 BD
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MTE15.02 - Who is Too High Risk for a VATS Resection? (ID 11573)
07:30 - 08:00 | Presenting Author(s): Pieter E. Postmus
- Abstract
- Presentation
Abstract not provided
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 2
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-70 - Efficacy and Safety of Second- or Third-Line Nab-Paclitaxel + Durvalumab in Patients with Advanced NSCLC (ABOUND.2L+) (ID 13042)
16:45 - 18:00 | Author(s): Pieter E. Postmus
- Abstract
Background
Cytotoxic chemotherapy may enhance the effect of immune checkpoint blockers (ICBs) through interaction with the immune system (immunostimulation) and cancer cells (increased antigenicity). The phase II ABOUND.2L+ trial investigated second-/third-line nab-paclitaxel monotherapy, nab-paclitaxel + CC-486, or nab-paclitaxel + durvalumab in patients with previously treated advanced-stage NSCLC. This report presents an updated analysis of the efficacy and safety from the nab-paclitaxel + durvalumab treatment arm.
a9ded1e5ce5d75814730bb4caaf49419 Method
Patients ≥ 18 years with advanced NSCLC and no more than 1 prior line of platinum-containing chemotherapy (ICBs in prior line, first/second, allowed) were included. Patients were treated with nab-paclitaxel on days 1 and 8 + durvalumab 1125 mg on day 15 of a 21-day cycle until unacceptable toxicity or progressive disease as per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or immune-related RECIST v1.1. The primary endpoint was progression-free survival (PFS). Key secondary endpoints included overall response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
4c3880bb027f159e801041b1021e88e8 Result
A total of 79 patients were assigned to nab-paclitaxel + durvalumab. The median age of patients in that arm was 63.0 years; 68.4% were male, 97.5% were white, 77.2% had ECOG performance status 1, and 69.6% had nonsquamous histology; 8 patients received prior ICBs. Median and 1-year PFS were 4.5 months (95% CI: 3.45-5.88) and 25.7% (95% CI 16.3-36.2); median PFS in those with and without prior ICB treatment was NE (95% CI 1.38-NE) and 4.4 months (95% CI 2.96-5.68) and in those with squamous and nonsquamous histology was 6.0 months (95% CI 2.99-7.75) and 4.2 months (95% CI 2.86-5.75). The ORR was 27.8%, and DCR was 70.9%. Median OS was 10.1 months (95% CI: 7.75-NE). Median percentage of per protocol dose was 87.5% for nab-paclitaxel and 82.9% for durvalumab. All patients had at least 1 treatment-emergent adverse event (TEAE), and 67.9% had at least 1 grade 3 or 4 TEAE. Common TEAEs of special interest (all grades) included peripheral neuropathy (grouped term; 37.2%), diarrhea (34.6%), anemia (30.8%), dyspnea (25.6%), nausea (24.4%), cough (24.4%), pyrexia (19.2%), and neutropenia (17.9%). TEAEs leading to dose interruption/reduction (nab-paclitaxel and/or durvalumab) were reported in 73.1% of patients, and those leading to discontinuation in 11.5%.
8eea62084ca7e541d918e823422bd82e Conclusion
nab-Paclitaxel + durvalumab demonstrated promising antitumor activity and manageable toxicity in second- or third-line treatment of patients with advanced NSCLC. NCT02250326.
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P1.01-93 - Quality of Life in Patients with Advanced NSCLC Treated in Second- or Third-Line with Nab-Paclitaxel + Durvalumab: ABOUND.2L+ (ID 12993)
16:45 - 18:00 | Author(s): Pieter E. Postmus
- Abstract
Background
Quality of life (QoL) can be adversely affected in patients with advanced NSCLC, particularly those receiving second- or third-line treatment. In these patients, checkpoint inhibitors are a recommended treatment option. Through multiple mechanisms, including the release of tumor antigens via tumor cell lysis, chemotherapy can augment immunotherapeutic effects, which is the rationale for combining chemotherapy with immunotherapy agents. The phase II ABOUND.2L+ trial investigated second- or third-line nab-paclitaxel either alone or in combination with CC-486 or durvalumab in patients with advanced NSCLC. The objective of this analysis is to report QoL outcomes in patients treated with nab-paclitaxel + durvalumab from the ABOUND.2L+ trial.
a9ded1e5ce5d75814730bb4caaf49419 Method
Enrolled patients were ≥ 18 years with advanced NSCLC and no more than 1 prior line of platinum-containing chemotherapy. Immunotherapy in a prior line, first or second, was allowed. Patients were treated with nab-paclitaxel on days 1 and 8 + durvalumab 1125 mg on day 15 of a 21-day cycle. Treatment continued until unacceptable toxicity or disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 or immune-related RECIST v1.1. The primary endpoint was progression-free survival. QoL was a prespecified exploratory endpoint assessed using the Lung Cancer Symptom Scale (LCSS), EuroQol 5D-5L, and EORTC QLQ-C30 on day 1 of each cycle, and was examined through 6 cycles of treatment for this analysis.
4c3880bb027f159e801041b1021e88e8 Result
A total of 79 patients were assigned to the nab-paclitaxel + durvalumab arm. The median age was 63.0 years. Most patients were white (97.5%), male (68.4%), and had ECOG PS of 1 (77.2%). For the entire study, baseline and ≥ 1 postbaseline QoL assessments were completed by 58 (73.4%) patients. 41 patients completed 6 cycles of treatment with nab-paclitaxel + durvalumab. After cycle 6, the mean change from baseline in LCSS total score and pulmonary symptom score was 0.1 and −0.2, respectively. LCSS hemoptysis score improved relative to baseline at every treatment cycle; mean change from baseline after 6 cycles was 0.8. Mean change from baseline in the EuroQol 5D-5L visual analog scale score and EORTC QLQ-C30 global health status/QoL scale score after 6 cycles of treatment was 2.5 and −1.19, respectively.
8eea62084ca7e541d918e823422bd82e Conclusion
In general, patients with advanced NSCLC treated with second- or third-line nab-paclitaxel + durvalumab maintained their QoL through 6 cycles of treatment. NCT02250326.
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