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E.C. Gabazza
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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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P1.03-001 - The Utility of Liquid-Biopsy for Detecting EGFR Mutation in Clinical Practice: 169 Cases in a Single Institution Research Study (ID 6321)
14:30 - 14:30 | Author(s): E.C. Gabazza
- Abstract
Background:
EGFR-TKIs have promising anti-tumor activities for EGFR-mutant NSCLC, however, almost all patients invariably experience progression on EGFR-TKI therapy. The T790M mutation is known as a major mechanism of resistance to EGFR-TKIs, and re-biopsy is essential for detecting the T790M mutation in EGFR-TKI failure patients. We conducted both tissue-biopsy and liquid-biopsy for all patients who were diagnosed with NSCLC in our institution, and we retrospectively evaluated the utility of liquid-biopsy in clinical practice.
Methods:
We reviewed all patients who were diagnosed with or suspected of having NSCLC and received a liquid-biopsy between April 2015 and June 2016 in Matsusaka Municipal Hospital. The aim of this study was to evaluate the clinical benefit of liquid-biopsy by comparing of the results of the liquid-biopsies against the results of the tissue-biopsies. The proportions were compared using Chi-square statistics, or the Fisher’s exact test where appropriate.
Results:
A total of 169 patients who received liquid-biopsy for the purpose of detecting an EGFR mutation were enrolled in this assessment. The median patient age was 74 (range 37-95); 104 patients were male, 66 patients were never-smokers, 102 patients(58.3%) had been pathologically diagnosed with adenocarcinoma; 14 patients(8.3%) were both liquid-positive and tissue-positive for an EGFR mutation, 32 patients(18.9%) displayed a discrepancy, having a liquid-negative and a tissue-positive result, although no patients were liquid-positive and tissue-negative.(sensitivity, 33.3%; specificity, 100%) There were 20 patients who had an EGFR mutation detected by liquid-biopsy, and all patients with a liquid-positive result were either clinical stage 3B, 4, or in recurrence. There was a significant difference in the proportion of stage 3B, 4, and recurrent patients between liquid-positive and liquid-negative patients among EGFR mutated patients. (p<0.0001) Of all patients, 19 patients with a liquid-positive result, and 4 patients with a tissue-positive result alone, experienced EGFR-TKI therapy. There was no significant difference in the response rate to EGFR-TKIs between the liquid-positive and liquid-negative patients among EGFR mutated patients. (61.1% vs. 66.6%, p=0.684)
Conclusion:
This study demonstrated that liquid-biopsy indicates high specificity, and is available for detecting EGFR mutation in clinical practice. In addition, our institutional experience indicated that liquid-biopsy could be beneficial especially for patients who are unable to receive a tissue biopsy procedure for any reason. Although some patients had a discrepancy between the results of the liquid biopsy and the tissue-biopsy, advanced EGFR mutated NSCLC was highly detectable by liquid-biopsy. Further investigation is warranted to confirm the clinical benefit of liquid-biopsy.
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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-060 - Comparative Analysis of the Efficacy of Three 1st/2nd Generation EGFR-TKIs for EGFR Mutated NSCLC in Clinical Practice (ID 6308)
14:30 - 14:30 | Author(s): E.C. Gabazza
- Abstract
Background:
EGFR-TKIs show promising anti-tumor activities for EGFR mutated NSCLC, and three EGFR-TKIs, gefitinib (GEF), erlotinib (ERL) and afatinib (AFA), are available for treatment of NSCLC harboring an EGFR mutation in first-line settings in Japan. Which EGFR-TKI is optimal for first-line therapy in clinical practice, however, is not yet known.
Methods:
We reviewed all patients who were diagnosed with EGFR mutated NSCLC between January 2010 and April 2016 at two institutions in Mie, Japan. The aim of this retrospective study was to evaluate three EGFR-TKIs using time to treatment failure (TTF), overall survival (OS) and the response rate (RR) in clinical practice. TTF analysis was conducted on all patients, while OS analysis was conducted on patients in stages 3B or 4. Either chi-square statistics, or a Fisher’s exact test was used where appropriate to compare proportions among groups. Survival curves were calculated using the Kaplan-Meier method, and were compared using the log-rank test.
Results:
A total of 310 patients were diagnosed with EGFR mutated NSCLC in the three institutions. Of the 310 patients, 145 patients treated with EGFR-TKI were enrolled. The median age was 70 years old (range 37-95), 88 patients (62.9%) were female and 97 patients were never-smokers. Almost all patients (96.3%) were diagnosed with adenocarcinoma, with 52.4% diagnosed with Ex19 deletion, and 44.8% diagnosed with Ex21 L858R. 82 patients received gefitinib as the first EGFR-TKI, while 35 patients received erlotinib, and the remaining 28 patients received afatinib. The efficacy assessment demonstrated that there was no significant difference in TTF (9.4m;GEF, 9.3m;ERL, 14.1m;AFA), OS ( 24.8m;GEF, 22.7m;ERL, NR;AFA), and RR among the three EGFR-TKIs. Subgroup analysis indicated that adenocarcinoma, being a never-smoker, and the presence of a major mutation were predictive factors for a longer TTF of EGFR-TKI therapy. OS of patients with brain metastasis (BM) was significantly shorter than those without BM. (p=0.018)
Conclusion:
This study demonstrated a tendency of afatinib to be superior, however, there was no significant difference in TTF and OS among the three EGFR-TKIs as of submission. These results indicated that all EGFR-TKIs had equal clinical benefit at presence, with a potential superiority for afatinib. Further prospective investigations are warranted to evaluate the efficacy of these three EGFR-TKIs in clinical practice to confirm these results.
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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-099 - A Retrospective Study of the Efficacy and Safety of Nivolumab in Our Clinical Practice: A Single Institutional Experience (ID 5938)
14:30 - 14:30 | Author(s): E.C. Gabazza
- Abstract
Background:
Nivolumab is a fully humanized, IgG4 antibody that inhibits the programmed cell death protein 1 (PD-1) immune checkpoint. It has demonstrated durable responses and tolerability in patients with treatment resistant, advanced non-small-cell lung cancer (NSCLC). This retrospective study evaluates the efficacy and safety of nivolumab, which was approved for the treatment of advanced NSCLC in December 2015 in Japan.
Methods:
This study comprised 50 patients with advanced or recurrent NSCLC who were administered with nivolumab 3mg/kg IV every 2 weeks from December 2015 through April 2016 at Matsusaka Municipal Hospital.
Results:
Patient demographics were as follows: a median age of 69 years (range: 53–86); 17 females and 33 males; 12 non-smokers and 38 former or current smokers; 47 patients with ECOG performance status (PS) of 0 or 1 and three with a PS of 2; seven patients with postoperative recurrence, nine with post-definitive chemoradiotherapy, 31 with stage IV disease, and three with others; 14 patients with squamous cell carcinoma, 33 with adenocarcinoma, two with pleomorphic carcinoma, and one with NSCLC NOS; 17 patients received nivolumab as second-line and 33 patients as third-line therapy or later; and six patients with EGFR mutation and one with ALK rearrangement. Among 50 patients, nine showed partial response, 17 showed stable disease, and 22 showed progressive disease, 2 were not evaluated yet. Five patients experienced an initial increase in the size of their tumor lesions, but with a subsequent decrease in tumor burden. At the time of submission, the median PFS was 3.8 months, with OS yet to be evaluated. Grade 3–4 AEs occurred in seven patients, with Grade 5 AEs occurring in only one patient.
Conclusion:
Early data from this study suggests that nivolumab is effective and well tolerated in patients with advanced or recurrent NSCLC in a real clinical setting.
