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M. Wu
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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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P2.07-027 - Efficacy and Safety of Nivolumab Therapy for Advanced NSCLC in the Expanded Access Named Patient Program in Taiwan (ID 8711)
09:30 - 09:30 | Author(s): M. Wu
- Abstract
Background:
Nivolumab is current standard of care for patients with pretreated advanced non-small cell lung cancer (NSCLC). The patients’ and physicians’ experience of using nivolumab in real-world clinical practice in Taiwan is unknown. We aimed to evaluate the efficacy and safety of nivolumab therapy in Taiwan.
Method:
We retrospectively reviewed the medical records of the patients with age > 20 years who were diagnosed to have advanced NSCLC and received nivolumab therapy through the Expanded Access Named Patient Program in 2016. Nivolumab 3 mg/kg was administered intravenously every 2 weeks.
Result:
A total of 94 patients were included in this analysis. The median age was 60 years (range, 31-76), and 63.8% of these patients were non-smoker. Most of the patients (75.5%) had adenocarcinoma histology, and 34.0% of the patients harbored an EGFR mutation. The median cycle number of nivolumab therapy was 9 (range, 1-28). The median treatment duration was 4.6 months (95% CI, 3.0-6.6). Nivolumab monotherapy is still ongoing in 16 patients (17.0%) on the date of data cutoff. The objective response rate was 13.8%. The median overall survival was 12.0 months (95% CI, 9.2 to not reached). In univariate analysis, sex, age, smoking history, EGFR mutation, squamous histology, and previous extracranial irradiation therapy were not predictors of prolonged survival. Only ECOG performance status (PS) < 2 before starting nivolumab therapy was a predictor of prolonged survival (HR: 0.32; 95% CI, 0.17-0.59). The most common treatment related adverse events (AEs) included fatigue (34.0%), nausea (17.0%), rash (12.8%), asthenia (8.5%), and pyrexia (5.3%). Grade ≧ 3 AEs developed in 7.4% of the patients. All grades interstitial lung disease developed in 4.3% of the patients. One patient died of grade 5 diarrhea after one dose of nivolumab therapy.
Conclusion:
The efficacy and safety data in Taiwan were in line with previous clinical trial reports. Patients with PS < 2 may have better survival outcome after receiving nivolumab therapy.
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P3.01 - Advanced NSCLC (ID 621)
- Event: WCLC 2017
- Type: Poster Session with Presenters Present
- Track: Advanced NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 10/18/2017, 09:30 - 16:00, Exhibit Hall (Hall B + C)
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P3.01-016 - Factors Associated with Symptoms Improvement and HRQoL for First-Line EGFR-TKIs in NSCLC: A Multicenter Prospective SMILE Study (ID 8750)
09:30 - 09:30 | Author(s): M. Wu
- Abstract
Background:
First-line epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKI) offer an advantage compared to doublet chemotherapy in progression free survival, tolerability, and quality of life (QOL) in EGFR-mutated advanced non-small cell lung cancer (NSCLC) patients. In Taiwan, gefitinib, erlotinib and afatinib are all reimbursed as first-line therapy. It provides a rare opportunity to investigate factors associated with the extent of symptoms and QOL improvement in real-world patient population.
Method:
We conducted a multicenter, prospective, observational study to evaluate the QOL and disease-related symptoms at baseline, 2, 4, and 12 weeks in EGFR-mutated advanced NSCLC patients with first-line EGFR TKI treatment. QOL was assessed by the instrument of Functional Assessment of Cancer Therapy-Lung questionnaire (FACT-L) and Treatment Outcome Index (TOI) derived from FACT-L. Symptoms assessment was evaluated by the Lung Cancer Subscale (LCS). The mean change from baseline of QoL and LCS score was analyzed by paired t-test.
Result:
The average age was 65.1± 12.5 (range 31.4–92.9) years old, with a larger proportion of females (62.6%) than males, and more never-smokers (74.0%) than ever-smokers. Patients were treated with gefitinib 250 mg (72.4%), erlotinib 150 mg (18.9%) or afatinib 40 mg (8.7%). For FACT-L, the total score was increased by 4.0 ± 15.49 at week 2, 4.9 ± 18.31 at week 4, and 4.1 ± 20.44 at week 12 (all p<0.001). Similarly, increased TOI of 2.4 ± 11.61 (p<0.001), 3.1 ± 13.48 (p<0.001), and 2.4 ± 14.35 (p=0.009) were observed at week 2, 4, and 12, respectively. For LCS, it was slightly increased by 1.7 ± 4.59 at week 2, 2.0 ± 5.48 at week 4, and 1.9 ± 5.35 at week 12 (all p<0.001). In general, subgroup analyses indicate that patients with more than 2 metastatic sites and ex-smokers were associated with clinically meaningful improvement in terms of LCS (change in LCS ≥ 2 points). Other subgroup analyses show that patients with characteristics such as at least 3 metastatic sites, ex-smoker, PS of 1, and treatment with gefitinib group, were associated with improved QOL in terms of TOI and FACT-L.
Conclusion:
In EGFR mutated NSCLC patients, first-line EGFR-TKI treatment was associated with improvement in disease-associated symptoms and QOL. Patients with 2 or more metastatic sites and ex-smokers were associated with symptoms and QOL improvement. In addition, PS of 1 and treatment with gefitinib were associated with clinical meaningful improvement in global QOL.
