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Jin-Yuan Shih
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P1.01 - Advanced NSCLC (Not CME Accredited Session) (ID 933)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.01-11 - Named Patient Use Program for Afatinib in Advanced NSCLC with Progression on Prior Therapy: Experience from Asian Centers (ID 12968)
16:45 - 18:00 | Author(s): Jin-Yuan Shih
- Abstract
Background
A global named patient use (NPU) program for afatinib in patients with advanced/metastatic NSCLC who had progressed during prior therapy was conducted between May 2010 and January 2016 (Cappuzzo F et al, Future Oncol 2018). Here we describe treatment outcomes for patients at Asian centers.
a9ded1e5ce5d75814730bb4caaf49419 Method
Eligible patients had progressed after clinical benefit on prior erlotinib/gefitinib and/or had an activating EGFR/HER2 mutation, had exhausted all other treatments, and were ineligible for afatinib trials. Patients received afatinib (starting dose:30-50 mg/day). Dose modifications were allowed as tolerated. Time to treatment failure (TTF) was calculated from treatment initiation to discontinuation. Adverse event (AE) reporting was mandatory.
4c3880bb027f159e801041b1021e88e8 Result
Data were collected from 2242 NSCLC patients across 10 Asian countries. Patients were heavily pretreated, 62% received ≥2 prior chemotherapy lines, and for most, afatinib was 4th-line therapy; almost all had received erlotinib/gefitinib (Table 1). 97% of patients with known tumor status were EGFR mutation-positive (m+). Median TTF was 7.6 months overall, and 7.2 months in patients with EGFR m+ tumors (Table 1). TTF was >12 months in patients with EGFR exon20 insertions and Her2 mutations. ORR was numerically higher in patients with exon20 insertions and G719X/L861Q/S761I mutations than other subgroups (Table 1). Disease control rate was 78% overall. The most frequently reported AEs were rash and diarrhea; no new/unexpected safety signals were identified.
Table 1. Named patient use (NPU) program for afatinib in advanced/metastatic NSCLC: results from Asian centers Total number of patients 2242 Age; years, median 61 Female/male; % 60/40 Any prior treatment; n (%) 2223/2242 (99.2) Prior erlotinib and/or gefitinib; n (%) 2202/2223 (99.1) Prior erlotinib only; n (%) 866/2202 (39) Prior gefitinib only; n (%) 927/2202 (42) Prior lines of chemotherapy ≥3, 32%; ≥2, 62%; 1, 23%; 0, 15% Prior lines of systemic therapy ≥4, 37%; ≥3, 65%; 2, 21%; 1, 14%; 0, 0% EGFR m+; n (%) 1240/1281 (97) Specified EGFR mutation; n (%) 1101/1240 (89) TTF; months* n ORR, % n All patients with data available 7.6 1550 24.4 431 EGFR m+ 7.2 834 27.7 267 EGFR mutation specified 6.5 740 - - Common mutations (Del19 or L858R) 6.4 692 27.4 230 Uncommon mutations (all) 8.0 84 30.3 33 T790M 6.0 34 21.1 19 G719X, L861Q, or S761I 7.8 28 42.9 7 Exon 20 insertion 18.0 25 42.9 7 Her2 m+ 12.2 12 14.2 7 p.A775 G776insYVMA 12.4 7 25.0 4 *median
m+ve, mutation-positive; ORR, objective response rate;
TTF, time to treatment failure
8eea62084ca7e541d918e823422bd82e Conclusion
This analysis from Asian countries in the afatinib NPU program revealed clinically meaningful TTF/ORR in this heavily pre-treated and refractory advanced NSCLC patient population, including activity in common and uncommon EGFR mutations. TTF was numerically longer in patients with uncommon mutations (particularly EGFR exon20 insertions) and HER2 mutations than in those with common EGFR mutations. The safety profile of afatinib was consistent with non-Asian centers.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P1.15 - Treatment in the Real World - Support, Survivorship, Systems Research (Not CME Accredited Session) (ID 947)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall
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P1.15-33 - Real-World Data on Prognostic Factors for Overall Survival in NSCLC Patients Treated with Bevacizumab Combination Therapy (ID 14292)
16:45 - 18:00 | Author(s): Jin-Yuan Shih
- Abstract
Background
Bevacizumab is used as combination with chemotherapy as 1st-line treatment for non-squamous cell carcinoma. In order to understand the influence of bevacizumab on different combination medication response, this study aimed to identify independent prognostic factors for overall survival (OS) of NSCLC patients receiving bevacizumab treatment in real-world practice.
a9ded1e5ce5d75814730bb4caaf49419 Method
We performed retrospective collected non-squamous cell carcinoma patients undergoing bevacizumab treatment and analyzed their response and overall survival to bevacizumab. Demographic data, TTF-1 stain status, EGFR mutation status, and survival data were collected. Survival data analysis were plotted by the Kaplan–Meier method and compared by the log-rank test.
4c3880bb027f159e801041b1021e88e8 Result
From November 2009 to October 2015, 114 non-squamous cell carcinoma patients treated with bevacizumab were enrolled for analysis. The median overall survival was 21.9 months. There were 11 patients who received continuous bevacizumab beyond disease progress of 1st-line treatment and in all treatment courses. They had longer overall survival than those (N = 103) who did not received bevacizumab in all treatment courses (p = 0.003). The patients harboring positive TTF-1 tumor also had a longer overall survival than those harboring negative TTF-1 tumors (p = 0.025). Multivariate analysis revealed that patients harboring tumor with positive staining of TTF-1 (p < 0.001) and those received bevaciz
8eea62084ca7e541d918e823422bd82e Conclusion
umab in all treatment course (p = 0.013) had a longer median OS.
Non-squamous cell carcinoma patients receiving bevacizumab beyond 1st-line treatment failure, as all treatment course, had a longer median OS than those received bevacizumab in partial course.
6f8b794f3246b0c1e1780bb4d4d5dc53
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P2.01 - Advanced NSCLC (Not CME Accredited Session) (ID 950)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.01-74 - Docetaxel-Related Febrile Neutropenia (FN) And Patient Reported Symptoms/ QOL (PROs) in East Asian (EA) and Non-EA Patients (ID 11871)
16:45 - 18:00 | Author(s): Jin-Yuan Shih
- Abstract
Background
A post hoc analysis of JVCG, a Japanese phase 2 trial suggested that the QOL (quality of life) deteriorated more rapidly in patients with docetaxel-related FN than in patients without FN. A post hoc analysis of REVEL, a global phase 3 trial, was performed to explore the association between FN and PROs in East Asian (EA) (Korea, Taiwan) and Non-EA patients.
a9ded1e5ce5d75814730bb4caaf49419 Method
Lung Cancer Symptom Scale (LCSS) and EQ-5D-3L were assessed at baseline, every cycle, at discontinuation and 30-day follow up. The summary statistics of LCSS total score and EQ-5D Visual Analog Scale (VAS) score were calculated. Time to deterioration (TtD) was defined as the time from randomization to the first 15-mm increase from baseline for the LCSS and first 15% decrease for the EQ-5D VAS and analysed with the Kaplan-Meier method and Cox proportional hazard model by treatment-emergent FN status regardless of assigned treatment. Also the changes in LCSS total score and EQ-5D VAS score from baseline to the treatment completion were summarized.
4c3880bb027f159e801041b1021e88e8 Result
1253 patients randomized to receive RAM+DOC (EA: n=43 and Non-EA: 585) or PLA+DOC (n=46 and 579). FN occurred in 21.3% of EA and 12.3% of Non-EA patients. Patient compliance with the LCSS and EQ-5D were 84.2% and 84.4%, respectively in EA and 82.7% and 83.2% in Non-EA patients. For EA patients, HRs (95% CI) for TtD were 0.572 (0.250, 1.313) in LCSS total and 0.792 (0.350, 1.790) in EQ-5D VAS, indicating longer TtD in PROs for patients without FN. For Non-EA patients, HRs (95% CI) for TtD were 0.994 (0.728, 1.357) in LCSS total and 1.023 (0.787, 1.330) in EQ-5D VAS and there seemed to be no difference in TtD between patients with and without FN. At treatment completion, the unadjusted mean change from baseline of LCSS total was numerically lower in EA patients without FN: 12.97 (with FN) vs 5.94 (without FN) (p=0.1748) and significantly lower in Non-EA patients without FN: 10.50 (with FN) vs 5.55 (without FN) (p=0.0147), demonstrating a greater PROs deterioration in patients with FN.
8eea62084ca7e541d918e823422bd82e Conclusion
PROs of EA patients with FN deteriorated more rapidly than in those without FN in contrast with non-EA patients. This finding was consistent with a result in the Japanese phase 2 JVCG trial. Also Non-EA patients without FN maintained their PROs significantly better than patients with FN upon treatment completion. This trend was also shown in EA patients. Prevention of docetaxel-related FN may contribute to maintaining QOL.
6f8b794f3246b0c1e1780bb4d4d5dc53
