Virtual Library
Start Your Search
T. Inoue
Author of
-
+
ORAL 01 - Chemotherapy Developments for Lung Cancer (ID 88)
- Event: WCLC 2015
- Type: Oral Session
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:G. Blumenschein, S. Lee
- Coordinates: 9/07/2015, 10:45 - 12:15, 401-404
-
+
ORAL01.01 - Randomized Phase III Study of Nedaplatin plus Docetaxel versus Cisplatin plus Docetaxel for Advanced Squamous Cell Lung Cancer (WJOG5208L) (ID 621)
10:45 - 10:56 | Author(s): T. Inoue
- Abstract
- Presentation
Background:
Nedaplatin (N) is a second-generation platinum compound with lower nausea/vomiting and nephrotoxicity than cisplatin (C). Nedaplatin plus docetaxel (ND) showed a promising efficacy with acceptable toxicity for advanced squamous cell lung cancer (SqLC) in the previous phase II study.
Methods:
Eligible patients (pts) were those with pathologically proven SqLC with stage IIIB/IV or postoperative recurrence, aged 20-74 years and ECOG PS 0-1. Pts were randomized 1:1 to ND (N 100 mg/m[2] and docetaxel (D) 60mg/m[2] iv, q3w, up to 6 cycles) or C plus D (CD) (C 80 mg/m[2] and D 60mg/m[2] iv, q3w, up to 6 cycles) according to stage, gender and institution. The primary endpoint was overall survival (OS), and secondary endpoints included progression-free survival (PFS), response rate (RR) and adverse events (AEs). Target sample size of 350 provided 90% statistical power to detect a hazard ratio of 0.71 with one-sided type I error of 0.05.
Results:
Between July 2009 and July 2012, 355 pts were randomized. Of 349 for efficacy analysis (ND 177; CD 172), baseline characteristics were well-balanced between two arms. ND had a significantly longer OS (p=0.037, one-sided stratified log-rank test). The OS HR was 0.81 (90%CI, 0.67-0.98) with a median OS of 13.6 months [m] for ND and 11.4 for CD. ND had a longer PFS (p=0.050) with a HR of 0.83 (0.69-1.00) and a median PFS of 4.9 m in ND and 4.5 in CD. RR was 54.5% in ND vs 52.9% in CD (p=0.829). Grade 3 or higher AEs of nausea (4.0% vs 14.3%), fatigue (3.4% vs 10.9%), hyponatremia (13.6% vs 30.3%) and hypokalemia (2.3% vs 8.6%) are more frequent in CD. Grade 3 or higher AEs of neutrophils (82.5% vs 70.3%) and platelets (9.0% vs 0.0%) are more frequent in ND, but there was no difference in grade 3 or higher febrile neutropenia (13.6% vs 15.4%). Treatment related deaths occurred in 4 and 3 pts in ND and CD, respectively.
Conclusion:
ND showed a significantly longer OS as compared to CD with different toxicity profile. ND will be considered as a new standard treatment for advanced or relapsed SqLC. Clinical trial information: UMIN000002015.
Only Members that have purchased this event or have registered via an access code will be able to view this content. To view this presentation, please login, select "Add to Cart" and proceed to checkout. If you would like to become a member of IASLC, please click here.
-
+
P2.01 - Poster Session/ Treatment of Advanced Diseases – NSCLC (ID 207)
- Event: WCLC 2015
- Type: Poster
- Track: Treatment of Advanced Diseases - NSCLC
- Presentations: 1
- Moderators:
- Coordinates: 9/08/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
-
+
P2.01-014 - EGFR Tyrosine Kinase Inhibitor and Chemotherapy in EGFR Mutation-Positive Non-Small Cell Lung Cancer (ID 2378)
09:30 - 09:30 | Author(s): T. Inoue
- Abstract
Background:
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are recommended in the first-line setting for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC). However, it remains unclear whether frontline EGFR TKIs are better strategy than first-line chemotherapy in EGFR-mutant patients. Generally, EGFR-TKIs had no significant benefits in overall survival (OS) compared with chemotherapy in both first-line and second-line setting. This retrospective study compared survival benefits in patients treated with post-TKI chemotherapy and first-line chemotherapy controls.
Methods:
This retrospective study included 442 EGFR-mutant patients in our institute. We examined EGFR gene status from 2007 to 2015. The patients treated from 1999 to 2015. The study group contained 173 patients treated with first-line EGFR-TKI and the control group contained 109 patients who received EGFR-TKI after first-line chemotherapy. The overall survival (OS) was assessed.
Results:
There was no significant difference between first-line chemotherapy and EGFR-TKI in OS for patients with mutation-positive NSCLC (median OS; 43 vs. 38 months, P = 1.645). There was substantial difference in OS between patients with postoperative recurrence and those with III/IV stage disease. Among patients with III/IV stage NSCLC, median OS was 40.8 months in first-line chemotherapy group, 30.5 months in chemotherapy after frontline EGFR-TKI group and 21.1 months in only EGFR-TKI group.
Conclusion:
In EGFR-mutant patients, both EGFR-TKI and chemotherapy improve the survival. Among patients with advanced NSCLC, EGFR-TKI after first-line chemotherapy may improve survival than frontline EGFR-TKI. These findings need to be validated in further randomized trials.
