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N. Ueno
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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. Ueno
- 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.
