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J. Sun
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P3.02b - Poster Session with Presenters Present (ID 494)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02b-072 - A Multicenter Phase II Study of Gefitinib in Squamous NSCLC Patients Who Failed First-Line Chemotherapy (ID 4320)
14:30 - 14:30 | Author(s): J. Sun
- Abstract
Background:
The role of EGFR tyrosine-kinase inhibitors in the second-line for patients with squamous non-small-cell lung cancer (NSCLC) remains unclear. We conducted a prospective phase II study to assess use of gefitinib in patients with squamous NSCLC as second-line chemotherapy, and investigated the predictive and prognostic value of a proteomic signature using VeriStrat test.
Methods:
Between December 2011 and October 2015, 56 patients with histologically confirmed, second-line, Stage IIIB or IV NSCLC were enrolled in 9 centres in Republic of Korea. Patients were treated with gefitinib (250 mg per day orally). The proteomic test classification was masked for patients and investigators. The primary end point was disease control rate (DCR) at 8-weeks, and the secondary end points included toxicity, progression-free survival (PFS), overall survival (OS), and correlation between the serum proteomic test classification and treatment. This study is registered with ClinicalTrials.gov, number NCT01485809.
Results:
The median age was 69 years (range, 41-83) and 55 (98%) patients were male, and 49 (88%) had an ECOG PS of 1. Fifty five (98%) of patients had received platinum-based chemotherapy. The DCR at 8 weeks was 50.0% (95% confidence interval [CI] 34.8-63.4). With a median follow-up of 5.5 months, the median PFS and OS were 2.8 (95% CI 1.3-4.3) and 6.4 (5.4-7.4) months, respectively. The most common adverse event were rash (16 [29%]) and diarrhea (14 [25%]). Pretreatment plasma was available for 50 samples, and VeriStrat testing was successful in 45 samples (90%) with 71% classified as Good. The median PFS were 3.2 (95% CI 1.9-4.7) and 2.4 (1.5-3.3) months for VeriStrat Good vs. Poor patients, respectively (p=0.639). The median OS of VeriStrat Good was longer than those of VeriStrat Poor (11.4 [5.7-17.0] vs 4.8 [2.5-7.0] months), which was not statistically significant (p=0.052).
Conclusion:
These data suggest that gefitinib is modest activity as second-line chemotherapy in patients with squamous NSCLC. Serum proteomic test using VeriStrat is not prognostic for both OS and PFS among squamous NSCLC patients treated with gefitinib.
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P3.02c - Poster Session with Presenters Present (ID 472)
- Event: WCLC 2016
- Type: Poster Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 12/07/2016, 14:30 - 15:45, Hall B (Poster Area)
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P3.02c-035 - Comparison of RECIST to Immune-Related Response Criteria (irRC) in Patients with NSCLC Treated with Immune-Check Point Inhibitor (ID 4962)
14:30 - 14:30 | Author(s): J. Sun
- Abstract
Background:
Immune check point inhibitor has become essential therapeutic option for advanced non-small cell lung cancer (NSCLC). Immune-related response in NSCLC has not been well evaluated, thus we assessed the tumor response using Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) and immune-related response criteria (irRC) to identify atypical response in patients with advanced NSCLC treated with immunotherapeutic agents.
Methods:
Patients received immune check point inhibitors (pembrolizumab, atezolizumab, nivolumab, pembrolizumab plus tremelimumab) at Samsung Medical Center between July 2014 and October 2015. The tumor response was assessed according to both RECIST v1.1 and irRC. Pseudoprogression was defined as progressive disease at any time of assessment and not at next assessment per RECIST v1.1 or irRC.
Results:
Figure 1 Total 41 patients were analyzed, most of patients (80.5%) received anti-PD-1 agents (pembrolizumab or nivolumab) and 6 patients were treated with anti-PD-L1, atezolizumab, 2 patients received combination treatment with pembrolizumab and tremelimumab. Two patients showed pseudoprogression followed by regression per RECIST v1.1 not per irRC. 4 patients with progressive disease per RECIST v1.1 were partial response per irRC, objective response was 29.2% per RECIST v1.1 and 34.1% per irRC, respectively. There was no significant difference in response rate between two methods (p=0.923). The median duration of follow-up was 19.8 months, and the median progression-free survival of all patients was 4.5 months (95% CI 2.7-6.3)
Conclusion:
These results suggest that pseuoprogression is not frequently observed in NSCLC, and conventional RECIST v1.1 might underestimate the benefit of immune check point inhibitors. Given the small number of patients studied and short-term follow-up, further study will be warranted whether treatment with immune checkpoint inhibitor beyond RECIST progression can be benefit to patient with advanced NSCLC.
