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N. Masuda
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P1.03 - Chemotherapy/Targeted Therapy (ID 689)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Chemotherapy/Targeted Therapy
- Presentations: 1
- Moderators:
- Coordinates: 10/16/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P1.03-008 - Analysis of Data on Interstitial Lung Disease Onset and Its Risk Following Treatment of ALK-positive NSCLC with Xalkori (ID 9146)
09:30 - 09:30 | Author(s): N. Masuda
- Abstract
Background:
Incidence and potential risk factors of interstitial lung disease (ILD) were evaluated in patients with ALK-positive non-small cell lung cancer (NSCLC) enrolled for all-case surveillance of Xalkori.
Method:
The survey was conducted on all patients treated with XALKORI[®] 200mg/250mg capsules. The observation period was 52 weeks from the initiation of treatment with Xalkori, or time from treatment commencement until treatment discontinuation in patients who discontinued treatment prematurely. Investigator-reported cases of ILD were assessed by the ILD independent review committee consisting of external experts to evaluate background risk factors potentially associated with the onset of ILD.
Result:
Among 2059 patients enrolled for this survey from May 2012 to October 2014, 1972 were included in a safety analysis. Among 139 reported cases of patients developing ILD following Xalkori treatment, 116 patients were confirmed to have ILD (incidence rate of 5.9%). The breakdown of these cases was mainly as follows: 63 (54%) patients were male, 52 (45%) were female, 57 (49%) were aged at least 65 years, 3 (2.6%) had a previous history of ILD, and 63 (54%) had smoking history, including former smokers. Giving the breakdown by Grade, 46 patients had Grade 2 or lower ILD, and 70 patients had Grade 3 or higher, including 22 with Grade 5 (mortality rate of 1.1%). Ninety-one patients (78.4%) developed ILD within 12 weeks after treatment commencement. The background factors with statistically significant differences among patients included age, body surface area, Eastern Cooperative Oncology Group Performance Status (ECOG PS) and smoking history. Also the multivariate analysis revealed that aging, poor ECOG PS, former smokers and previous history or complications of ILD were correlated with the occurrence of ILD.
Conclusion:
The onset time, the incidence of ILD and risk factors obtained from this surveillance didn’t seem to be significant difference with those of EGFR TKIs reported previously.
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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: 1
- Moderators:
- Coordinates: 10/17/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P2.03-002 - Impact of EGFR-Tyrosine Kinase Inhibitors for Postoperative Recurrent Non-Small Cell Lung Cancer Harboring EGFR Mutations (ID 7359)
09:30 - 09:30 | Author(s): N. Masuda
- Abstract
Background:
It is unclear whether there is a difference in the efficacy of treatment by EGFR-TKI between patients with postoperative recurrent non-small cell lung cancer (NSCLC) and those with stage IV NSCLC harboring EGFR mutations.
Method:
The records of NSCLC patients harboring EGFR mutations who were treated with gefitinib or erlotinib were retrospectively reviewed, and the treatment outcomes were evaluated. Moreover, we performed an immunohistochemical analysis of PD-L1 expression in tumor lesions of the postoperative recurrence group.
Result:
In 205 patients, both the progression-free survival time (9.4 versus 16.9 months) and the median survival time (24.7 versus 37.4 months) were significantly longer in the postoperative group than stage IV group. Additionally, multivariate analysis identified that postoperative recurrence was as an independent predictor of the PFS and OS, as well as performance status and smoking status. The PFS durations were 15.7 and 16.6 months for the high PD-L1 expression and low PD-L1 expression groups, respectively, and a significant difference was not observed (P = 0.73).
Conclusion:
The findings of this study provide a valuable rationale for considering postoperative recurrence as a predictive factor for favorable PFS and overall survival in patients with NSCLC harboring activating EGFR mutations receiving EGFR-TKI.
