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S. Sugawara
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P2.03 - Chemotherapy/Targeted Therapy (ID 704)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 2
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-010 - Updated Survival Outcomes of NEJ005/TCOG0902, a Randomized PII of Gefitinib and Chemotherapy in EGFR-Mutant NSCLC (ID 7948)
09:30 - 09:30 | Author(s): S. Sugawara
- Abstract
Background:
North East Japan Study Group (NEJ) 005/ Tokyo Cooperative Oncology Group (TCOG) 0902 study has demonstrated that first-line concurrent (C) and sequential alternating (S) combination therapies of EGFR tyrosine kinase inhibitor (gefitinib) plus platinum-based doublet chemotherapy (carboplatin/pemetrexed) offer promising efficacy with predictable toxicities for patients with EGFR-mutant NSCLC (ASCO2014, Ann Oncol 2015). However, overall survival (OS) data were insufficient because of the lack of death events in the primary report.
Method:
Progression-free survival (PFS) and OS were re-evaluated at the final data cutoff point (March 2017) for the entire population (N = 80).
Result:
At the median follow-up time of 35.6 months, 88.8% of patients had progressive disease and 77.5% of patients had died. Median PFS was 17.5 months for the C regimen and 15.3 months for the S regimen (p = 0.13). Median OS time was 41.9 with the C regimen and 30.7 months with the S regimen (p = 0.036). Updated response rates were similar in both groups (90.2% and 82.1%, respectively; p = 0.34). Patients who had common mutations showed no significant differences in PFS according to type of mutation. Patients with Del19 displayed relatively better OS (median: 45.3 and 33.3 months for C and S regimens) than those with L858R (31.4 and 28.9 months). No severe adverse events including interstitial lung disease have occurred during the follow-up period since the primary report. In an exploratory analysis, there was no significant difference in post progression survival and overall survival between patients with progression of target or non-target lesions and those progressed with new lesions.
Conclusion:
This updated analysis has confirmed that PFS is improved with first-line combination therapies compared to that with gefitinib monotherapy, and the C regimen in particular offers an overall survival benefit of 42 months in the EGFR-mutated setting. Our on-going NEJ009 study will clarify whether this combinational strategy can be incorporated into routine clinical practice.
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P2.03-021 - A Phase I Study Evaluating the Combination of Afatinib, Carboplatin and Pemetrexed after Failure of 1<Sup>St</Sup> Generation EGFR-TKIs (ID 8713)
09:30 - 09:30 | Author(s): S. Sugawara
- Abstract
Background:
Despite the high response rate in patients with EGFR-mutation positive NSCLC, treatment with EGFR-TKIs is not curative and eventually there is disease progression. In patients with acquired resistance to 1[st] generation EGFR-TKIs, previous studies have demonstrated that afatinib had some clinical activity. We previously reported that the combination of gefitinib, pemetrexed and carboplatin showed promising antitumor efficacies in EGFR-mutated lung cancer patients. In this phase I trial, we assessed the safety and efficacy of afatinib combined with pemetrexed and carboplatin in NSCLC patients who acquired resistance.
Method:
Patients with EGFR-mutation positive metastatic NSCLC, who had received 1[st] line gefitinib or erlotinib and developed disease progression were eligible. Patients received pemetrexed 500 mg/m[2] and carboplatin AUC=5 on day 1 in all cohorts, and afatinib at doses of 20, 30 and 40 mg/body from day 8 to 18 of 21-day cycle. DLT was assessed after the first cycle, and doses were escalated in cohorts of 3 to 6 patients.
Result:
Eleven patients were enrolled to this trial and 9 patients were evaluable for safety and efficacy. At an afatinib dose of 30mg/body, 3 patients experienced DLT (grade 3 diarrhea, grade 3 hypokalemia, grade 4 thrombocytopenia, grade 3 amylase elevation and grade 3 gamma-glutamyl transferase). The overall response rate was 20% (95% C.I. 5.7 to 51) and median progression free survival was 16.2 months (95% C.I. 4.7 to not reached).
Conclusion:
The MTD of afatinib is 20mg/body in combination with pemetrexed 500 mg/m[2] and carboplatin AUC=5 on day 1 every 21 days. This combination demonstrated activity in EGFR mutation positive NSCLC with acquired resistance to 1[st] line EGFR-TKIs.
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P2.07 - Immunology and Immunotherapy (ID 708)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Immunology and Immunotherapy
- Presentations: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.07-004 - Immune-Related Adverse Events (irAEs) of Nivolumab Predicts Clinical Benefit in Advanced Lung Cancer Patients (ID 7956)
09:30 - 09:30 | Author(s): S. Sugawara
- Abstract
Background:
Immune checkpoint inhibition (ICI) has now become the new standard treatment for non-small-cell lung cancer (NSCLC). However, immune-related adverse events (irAEs) are frequently observed. In melanoma, those patients who had irAEs were shown to be associated with prolonged overall survival. Little is known about the correlation between the development of irAEs and clinical efficacy in NSCLC patients.
Method:
Patients with advanced NSCLC treated with nivolumab monotherapy at Sendai Kousei Hospital (n=70) between January 2016 to March 2017 were included in our study. Subjects were categorized into either the irAEs-incident group (IrAEs group) or non-irAEs-incident group (Non-irAEs group) and were evaluated with respect to objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall-survival (OS), and treatment continuation rate. They were also further divided into either responder group or non-responder group, and we analyzed predictive factors of treatment responses.
Result:
The median onset of irAEs incidence was 42 days, and categorization of irAEs identified 5 cases of interstitial pneumonia (7%), 5 cases of infusion reactions (7%), 22 cases of skin reactions (31%), 4 cases of neuromuscular disorders (6%), 7 cases of thyroid dysfunction (10%), and 1 case of hepatitis (1%). The following were observed: patient background (IrAEs / Non-irAEs group) number of cases 29/41 cases, median age both 68 years old, male 93% / 83%, treatment response CR/PR/SD/PD (0/17/10/2)/ (1/2/12/26), ORR 59% (17 cases) / 7% (3 cases) [Odds ratio: 0.06, p <.001], DCR 93% (27 cases) /37%(15 cases) [Odds ratio: 0.04, p＜.001], Median PFS (months) NR/3.0 [HR (95% CI) 0.15 (0.06–0.39), p =0.001], Median OS (months) NR/10.8 [HR (95% CI) 0.31 (0.10–0.93), p=0.0275], treatment continuation rate 69% (20 cases)/34% (14 cases) [Odds ratio: 0.24, p = 0.014]. The number of subjects in the responder group was 20 and that in the non-responder group is 50. Univariate analysis identified a significantly higher occurrence of irAEs in the responder group than in the non-responder group as well as the number of patients with higher positivity of anti-thyroid-antibody. Upon multivariate analysis, the development of irAEs [Odds ratio: 0.05, p <.001] and the positivity of anti-thyroid antibody [Odds ratio: 0.16, 0.022] were identified as independent predictors of treatment response.
Conclusion:
The development of irAEs during nivolumab monotherapy for NSCLC may be strongly correlated with improved outcomes. The development of irAEs and the positivity of anti-thyroid antibody were independent predictors of treatment efficacy.
