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Y. Horio
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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
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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 - 12:15 | Author(s): Y. Horio
- 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.
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ORAL 22 - Moving Beyond a Smoking Related-Cancer to the Young, Never-smokers and Inherited Disease (ID 117)
- Event: WCLC 2015
- Type: Oral Session
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:K. Suda, H.A. Wakelee
- Coordinates: 9/08/2015, 10:45 - 12:15, Mile High Ballroom 1a-1f
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ORAL22.07 - Oncogenic Profiling in Lung Adenocarcinoma Emerged in the Youth (ID 686)
10:45 - 12:15 | Author(s): Y. Horio
- Abstract
- Presentation
Background:
EGFR, Kras mutations and EML4-ALK translocations were frequently positive in adenocarcinoma among lung cancer, and in fewer cases HER2, BRAF mutations or RET, ROS1 translocations were identified. Although adenocarcinomas emerged in the youth are estimatedly associated with some driver oncogenes including these mutations/translocations, the detail remains unknown.
Methods:
We retrospectively screened 55 consecutive patients who were diagnosed as stage I-IV adenocarcinoma at the age of 40 years or less in 2009-2014. We analyzed clinical and genetic characteristics among them.
Results:
Out of 55 patients, 21 (38%) were male, 24 (44%) were never-smoker, and 38 (69%) were stage IV, with the median age of 36 years (range; 26-40). Forty-five patients (82%) were identified some driver oncogene. 26 (47%) had EML4-ALK translocation, 13 (24%) had EGFR mutation, and 2 (4%) had Kras mutation. We examined rare oncogenes in 10 out of 14 triple-negative patients, which revealed three patients had HER2 mutation and two had RET translocation.
Conclusion:
82% of adenocarcinomas emerged in the youth were identified some targetable driver oncogenes. Not only EGFR mutation or EML4-ALK translocation, rare oncogene examination is necessary especially among these populations.
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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)
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P2.01-059 - Does Pemetrexed/Platinum Fit All Patients with Non-Squamous Non-Small Cell Lung Cancer? A Retrospective Study of Clinical Factors and Outcomes (ID 2308)
09:30 - 17:00 | Author(s): Y. Horio
- Abstract
Background:
Pemetrexed/platinum is one of the standard treatment regimens for patients with advanced non-squamous non-small cell lung cancer(NSCLC). The aim of this study was to examine the association between survival of lung cancer patients treated with pemetrexed/platinum and clinical factors.
Methods:
The medical records of advanced or relapsed non-squamous NSCLC patients treated with pemetrexed/platinum at our hospital between January 2010 and December 2013 were reviewed. Basic characteristics, histological subtypes of NSCLC, driver mutation status, TTF1 staining status and status of treatment with taxane were evaluated for association with the survival from pemetrexed/platinum started day to deaths.
Results:
Two hundreds nine records were reviewed. The median age was 62 (28-79), 60% were male, 40% were never smoker, 89% had an ECOG PS0-1 and 11% had a PS 2-3. The median value of CEA and CYFRA were 10.5 ng/ml and 3.0 ng/ml, respectively. 93% were diagnosed as adenocarcinoma and 7% were diagnosed as other subtypes (large, adenosquamous, sarcomatoid and not otherwise specified). 79% (81/102) had a positive TTF1 staining. 26% had EGFR mutation, 7% had ALK fusion and 11% had KRAS mutation. 36% of patients were received bevacizumab with pemetrexed/platinum. 35% of patients were treated with cisplatin. The response rate of pemetrexed/platinum was 34.8%. Median overall survival was 537days. 65% of patients were treated with taxane and the response rate was 15.0%. In multivariate analysis, poor PS(HR 1.33; p=0.027), others in histological subtypes (HR2.00; p=0.047) and K-RAS mutation(HR 2.74; p=0.021) correlated significantly with a shorter overall survival and low CYFRA(≤3.0ng/ml, HR 0.55; p=0.002) correlated significantly with a longer overall survival.
Conclusion:
High CYFRA, KRAS mutation and others in histological subtypes may be associated with shorter overall survival treated with pemetrexed/platinum in non-squamous NSCLC. The development of effective treatment regimens for such patients is needed to improve their outcomes.
