Journal Thoracic Oncology
WCLC2016-Abstract-Book_vF-WEB_revNov17-1
WCLC2016-Abstract-Book_vF-WEB_revNov17-1
Create successful ePaper yourself
Turn your PDF publications into a flip-book with our unique Google optimized e-Paper software.
Abstracts <strong>Journal</strong> of <strong>Thoracic</strong> <strong>Oncology</strong> • Volume 12 Issue S1 January 2017<br />
the epidemiological characteristics and the incidence of mutations in patients<br />
diagnosed with advanced NSCLC in our institution. Analyze toxicities and<br />
adherence to treatment. Evaluate treatments performed and the problem<br />
of the analysis of the biopsy. We analyzed patients from June 2012 to date.<br />
Results: We found 61 /326 ( 18.7%) patients with detectable EGFR mutation,<br />
47 women (77 %) and 39% smokers, 47 patients had advanced or unresectable<br />
disease. The most common sites of metastases were bone and lymph nodes.<br />
27 of the 61 patients had mutation of exon 19, 27 patients with mutation of<br />
exon 21, others in 18 and 20. Five of them with detectable T790M mutation<br />
confirmed by repeat biopsy after progressing to ITK. The most common<br />
side effects were diarrhea and rash, 12 patients had toxicities which had to<br />
reduce dose or discontinue treatment. Conclusion: The most common side<br />
effects were diarrhea and rash, 12 patients had toxicities which had to reduce<br />
dose or discontinue treatment. We had a low incidence of invalid or not<br />
evaluable biopsies. although not all patients with detectable mutation were<br />
treated with ITK, who received such treatment had good adhesion and a low<br />
percentage of patients had to discontinue treatment<br />
Keywords: EGFR, lung cancer, NSCLC<br />
POSTER SESSION 3 – P3.02B: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/<br />
IMMUNOTHERAPY<br />
EGFR CLINICAL –<br />
WEDNESDAY, DECEMBER 7, 2016<br />
P3.02B-071 FIRST-LINE GEFITINIB FOR EGFR-MUTATED LUNG<br />
ADENOCARCINOMA PATIENTS WITH BONE METASTASES - A SINGLE<br />
INSTITUTION EXPERIENCE<br />
Davorin Radosavljevic, Jelena Spasic, Nemanja Stanic, Marija Ristic, Milos<br />
Ratknic<br />
Clinic for Medical <strong>Oncology</strong>, Institute for <strong>Oncology</strong> and Radiology of Serbia,<br />
Belgrade/Serbia<br />
Background: Bone involvement has been considered as an adverse predictive<br />
factor in the systemic treatment of majority of malignant tumors. New<br />
horizon, opened with targeted agents, especially in lung cancer, faced us with<br />
encouraging results of treatment in advanced cancer patient population.<br />
Gefitinib, first generation tyrosine kinase inhibitor (TKI), has been a standard<br />
first-line treatment for EGFR mutated lung adenocarcinoma patients<br />
in Serbia since 2011. Methods: Fifty-one consecutive patients (pts) with<br />
advanced lung adenocarcinoma and EGFR mutation were treated with 1 st line<br />
gefitinib at IORS since 2011. Fourteen of them were with bone metastases<br />
(BM). We compared treatment outcome of BM group (n=14) with group of pts<br />
without BM (n=37) in terms of progression-free survival (PFS) and overall<br />
survival (OS) Results: In the group of 14 pts with BM F/M ratio was 9/6, median<br />
age 57 years (26-64), 5/14 were never smokers. Performance status (PS) 1<br />
had 7 pts, PS2 4 pts and PS3 3 pts. Eight pts had deletion of exon 19, five pts<br />
mutation in exon 21, one patient had double mutation G719X/S7681. Bone<br />
only metastases had 4/14 pts, additional metastatic sites in 10 pts were as<br />
follows: lung in 3 pts, liver in 2 pts, pleura in 3 pts and pericardium in 2 pts.<br />
The best therapy response in pts with BM was as follows: partial response<br />
in 5 pts, stable disease in 7 pts, progressive disease in 2 pts. Median PFS in<br />
BM group was 10.91 months (5.87-15.94, CI 95%) and 5.78 months (3.41-8.15,<br />
CI 95%) in the group of 37 pts without BM (log rank p=0.47). Median OS in<br />
BM group was 21.95 months (17.68-26.71, CI 95%), 18.17 months (5.95-30.30,<br />
CI95%), in pts without BM (log rank p=0.26). Toxicity of gefitinib was as<br />
expected and mild: skin rash grade 1 and diarrhea grade 1 in 9 pts, elevated<br />
transaminases grade 1 in one patient and grade 2 in one patient. Conclusion:<br />
In this small set of TKI treated advanced lung adenocarcinoma patients in 1 st<br />
line, somewhat counterintuitive results were achieved: better PFS and OS<br />
results for BM group may be attributable to mutations more susceptible to<br />
TKI activity (mostly exon 19), absence of brain metastases in this group, good<br />
PS in one half of pts. But, it seems that stigma about poor results of systemic<br />
treatment in pts with BM should be set aside, at least in case of advanced<br />
adenocarcinoma of the lung and TKI.<br />
Keywords: adenocarcinoma of the lung, bone metastases, EGFR mutation,<br />
gefitinib<br />
POSTER SESSION 3 – P3.02B: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/<br />
IMMUNOTHERAPY<br />
EGFR CLINICAL –<br />
WEDNESDAY, DECEMBER 7, 2016<br />
P3.02B-072 A MULTICENTER PHASE II STUDY OF GEFITINIB<br />
IN SQUAMOUS NSCLC PATIENTS WHO FAILED FIRST-LINE<br />
CHEMOTHERAPY<br />
Hae Su Kim 1 , Tae Kyu Lim 1 , Seung-Hyun Nam 1 , Yoon Hee Choi 2 , Young-Woong<br />
Won 3 , Hoon-Gu Kim 4 , Jong-Mu Sun 5 , Jung Hye Kwon 6 , Ki-Hyang Kim 7 , Joung<br />
Soon Jang 8 , Jin Hyoung Kang 9 , Bong-Seog Kim 1<br />
1 Division of Hematology-<strong>Oncology</strong>, Department of Medicine, Veterans Health<br />
Service Medical Center, Seoul/Korea, Republic of, 2 Division of Hematology-<br />
<strong>Oncology</strong>, Department of Medicine, Dongnam Institute of Radiological and Medical<br />
Sciences, Busan/Korea, Republic of, 3 Hanyang University Guri Hospital, Guri/Korea,<br />
Republic of, 4 Gyeongsang National University, Jinju/Korea, Republic of, 5 Samsung<br />
Medical Center, Sungkyunkwan University School of Medicine, Seoul/Korea,<br />
Republic of, 6 Hallym University Medical Center, Seoul/Korea, Republic of, 7 Busan<br />
Paik Hospital, INJE University, Busan/Korea, Republic of, 8 Department of Internal<br />
Medicine, Chung-Ang University College of Medicine, Seoul/Korea, Republic of,<br />
9 Seoul St. Mary’s Hospital, the Catholic University of Korea College of Medicine,<br />
Seoul/Korea, Republic of<br />
Background: The role of EGFR tyrosine-kinase inhibitors in the second-line<br />
for patients with squamous non-small-cell lung cancer (NSCLC) remains<br />
unclear. We conducted a prospective phase II study to assess use of gefitinib<br />
in patients with squamous NSCLC as second-line chemotherapy, and<br />
investigated the predictive and prognostic value of a proteomic signature<br />
using VeriStrat test. Methods: Between December 2011 and October 2015, 56<br />
patients with histologically confirmed, second-line, Stage IIIB or IV NSCLC<br />
were enrolled in 9 centres in Republic of Korea. Patients were treated with<br />
gefitinib (250 mg per day orally). The proteomic test classification was<br />
masked for patients and investigators. The primary end point was disease<br />
control rate (DCR) at 8-weeks, and the secondary end points included<br />
toxicity, progression-free survival (PFS), overall survival (OS), and correlation<br />
between the serum proteomic test classification and treatment. This study is<br />
registered with ClinicalTrials.gov, number NCT01485809. Results: The median<br />
age was 69 years (range, 41-83) and 55 (98%) patients were male, and 49 (88%)<br />
had an ECOG PS of 1. Fifty five (98%) of patients had received platinum-based<br />
chemotherapy. The DCR at 8 weeks was 50.0% (95% confidence interval<br />
[CI] 34.8-63.4). With a median follow-up of 5.5 months, the median PFS<br />
and OS were 2.8 (95% CI 1.3-4.3) and 6.4 (5.4-7.4) months, respectively. The<br />
most common adverse event were rash (16 [29%]) and diarrhea (14 [25%]).<br />
Pretreatment plasma was available for 50 samples, and VeriStrat testing was<br />
successful in 45 samples (90%) with 71% classified as Good. The median PFS<br />
were 3.2 (95% CI 1.9-4.7) and 2.4 (1.5-3.3) months for VeriStrat Good vs. Poor<br />
patients, respectively (p=0.639). The median OS of VeriStrat Good was longer<br />
than those of VeriStrat Poor (11.4 [5.7-17.0] vs 4.8 [2.5-7.0] months), which was<br />
not statistically significant (p=0.052). Conclusion: These data suggest that<br />
gefitinib is modest activity as second-line chemotherapy in patients with<br />
squamous NSCLC. Serum proteomic test using VeriStrat is not prognostic for<br />
both OS and PFS among squamous NSCLC patients treated with gefitinib.<br />
Keywords: Prospective study, NSCLC, gefitinib<br />
POSTER SESSION 3 – P3.02B: ADVANCED NSCLC & CHEMOTHERAPY/TARGETED THERAPY/<br />
IMMUNOTHERAPY<br />
EGFR CLINICAL –<br />
WEDNESDAY, DECEMBER 7, 2016<br />
P3.02B-073 A PHASE II, LIQUID BIOPSY STUDY USING DIGITAL<br />
PCR IN EGFR MUTATED, LUNG CANCER PATIENTS TREATED WITH<br />
AFATINIB (WJOG 8114LTR)<br />
Hiroaki Akamatsu 1 , Yasuhiro Koh 1 , Satoshi Morita 2 , Daichi Fujimoto 3 , Isamu<br />
Okamoto 4 , Akihiro Bessho 5 , Koichi Azuma 6 , Kazuhiko Nakagawa 7 , Nobuyuki<br />
Yamamoto 1<br />
1 Respiratory Medicine and Clinical <strong>Oncology</strong>, Wakayama Medical University,<br />
Wakayama/Japan, 2 Kyoto University, Kyoto/Japan, 3 Department of Respiratory<br />
Medicine, Kobe City Medical Center General Hospital, Kobe-City/Japan, 4 Research<br />
Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu<br />
University, Fukuoka/Japan, 5 Japanese Red Cross Okayama Hospital, Okayama/<br />
Japan, 6 Division of Respirology, Neurology, and Rheumatology, Department of<br />
Internal Medicine, Kurume University School of Medicine, Kurume/Japan, 7 Medical<br />
<strong>Oncology</strong>, Kindai University Faculty of Medicine, Osaka-Sayama/Japan<br />
Background: Liquid biopsy is an ideal strategy to monitor mutation status<br />
of cancer repeatedly and less invasively. In chronic myeloid leukemia, early<br />
remission of mutated cells was reported as a surrogate of longer efficacy.<br />
In epidermal growth factor (EGFR) mutated non-small cell lung cancer<br />
(NSCLC), to detect resistant mutation (exon20 T790M) during treatment<br />
is clinically important because newer tyrosine kinase inhibitors (TKIs)<br />
have been developed. Although some reports have mentioned the utility<br />
of liquid biopsy in EGFR mutated NSCLC, most were single-institutional,<br />
retrospective studies. Methods: West Japan <strong>Oncology</strong> Group (WJOG) 8114LTR<br />
is a multi-institutional, prospective liquid biopsy study in advanced NSCLC.<br />
Chemotherapy naïve, advanced NSCLC patients with EGFR-sensitizing<br />
mutation will receive afatinib monotherapy (40 mg/body) until progressive<br />
disease (PD) or unacceptable toxicity. Plasma DNA will be obtained from<br />
patients at baseline, 2, 4, 8, 12, 24, 48 weeks, and at PD. Three types of<br />
common EGFR mutations (exon 19 deletion, exon 20 T790M and exon 21<br />
L858R) will be analyzed using plasma DNA with multiplexed, pico-droplet<br />
digital PCR assay (RainDrop® system, RainDance Technologies, Billerica, MA).<br />
Copyright © 2016 by the International Association for the Study of Lung Cancer<br />
S647