Journal Thoracic Oncology
WCLC2016-Abstract-Book_vF-WEB_revNov17-1
WCLC2016-Abstract-Book_vF-WEB_revNov17-1
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Abstracts <strong>Journal</strong> of <strong>Thoracic</strong> <strong>Oncology</strong> • Volume 12 Issue S1 January 2017<br />
CBDCA/PTX in PS0-1 patients with advanced NSCLC, especially squamous<br />
histology (J Clin Oncol 30:2055-2062.2012). Furthermore, in elderly patients<br />
over 70 years old, CBDCA/nab-PTX tended to show superior PFS and OS on<br />
the basis of better tolerability compared with CBDCA/PTX. Thus, CBDCA/<br />
nab-PTX could be a valid treatment option for PS2 patients whose PS is<br />
exacerbated due to mass effect of NSCLC despite appropriate organ function.<br />
Methods: This phase 2 trial is enrolling untreated PS2 patients with NSCLC<br />
and appropriate organ function under 75 years old. Patients are included if<br />
they had histologically/cytologically confirmed stage IIIB/IV NSCLC unfit for<br />
surgery or radiotherapy, whereas they are excluded if they had uncontrolled<br />
symptomatic brain metastasis or uncontrolled pleural effusion. The primary<br />
endpoint is PFS rate at 6months. Achievement of more than 50% is considered<br />
worthy of further development of this combination therapy, whereas that<br />
of less than 30% is considered insufficient for further investigation. The<br />
estimated power of this design is 80% with a type I error of 0.05, resulting in<br />
35 patients needed. Considering that about 20% of patients are likely to be<br />
excluded from the trial, we planned to enroll 45 patients. Patients are treated<br />
with nab-PTX (70 mg/m 2 on day1, 8, and15, q4w) and CBDCA (AUC 5 on day1,<br />
q4w), up to 6 cycles. Concurrently, Quality of life and Charlson Comorbidity<br />
Index are planned to be checked about the patients treated with this regimen.<br />
This study is open for enrollment and recruitment is ongoing. Clinical trial<br />
information: UMIN000019458. Results: Section not applicable Conclusion:<br />
Section not applicable<br />
Keywords: phase II, PS2, NSCLC<br />
There are two parts to this study: the first/primary part will evaluate the<br />
ability of neoadjuvant atezolizumab to produce objective pathologic<br />
responses in patients with early stage NSCLC. Atezolizumab 1200 mg IV<br />
will be given every 3 weeks for two doses. Surgical resection of tumors<br />
following treatment will allow determination of pathologic response<br />
rates and potential predictive biomarkers. Part 2 is exploratory and will<br />
evaluate atezolizumab adjuvant therapy for up to 12 months in patients who<br />
demonstrate clinical benefit (evidence of pathologic response or absence<br />
of radiographic progression) in Part 1. After surgical resection, patients<br />
may receive SOC adjuvant chemotherapy (with or without radiation) before<br />
starting atezolizumab adjuvant therapy in Part 2. The primary objectives<br />
are safety and major pathologic response based on surgical resection.<br />
Secondary objectives include overall response rate based on PD-L1 status,<br />
mutational load, antigen burden, and RNA-sequencing. This trial presents a<br />
unique opportunity to evaluate exploratory biomarkers, including pre- and<br />
post-treatment biopsy assessment of evolution of immune related markers<br />
associated with response. Results: Section not applicable Conclusion: Section<br />
not applicable<br />
Keywords: neoadjuvant, Immunotherapy, PD-L1, non-small cell lung cancer<br />
POSTER SESSION 2 – P2.06: SCIENTIFIC CO-OPERATION/RESEARCH GROUPS<br />
PHASE II + NK –<br />
TUESDAY, DECEMBER 6, 2016<br />
POSTER SESSION 2 – P2.06: SCIENTIFIC CO-OPERATION/RESEARCH GROUPS<br />
PHASE II + NK –<br />
TUESDAY, DECEMBER 6, 2016<br />
P2.06-019 A PHASE II STUDY OF ATEZOLIZUMAB AS NEOADJUVANT<br />
AND ADJUVANT THERAPY IN PATIENTS (PTS) WITH RESECTABLE<br />
NON-SMALL CELL LUNG CANCER (NSCLC)<br />
Dwight Owen 1 , Paul Bunn, Jr. 2 , Bruce Johnson 3 , David Kwiatkowski 3 , Mark<br />
Kris 4 , Ignacio Wistuba 5 , Mayank Gandhi 6 , See Phan 6 , David Shames 6 , Katja<br />
Schulze 6 , Coen Bernaards 7 , Dara Aisner 8 , Jamie Chaft 4 , Justin Gainor 9 , Jay<br />
Lee 10 , John Minna 11 , Mari Mino-Kenudson 12 , Celia Garcia-Prieto 13 , Valerie<br />
Rusch 14 , Anita Sabichi 15 , Liza Villaruz 16 , Antoinette Wozniak 17 , David Carbone 18<br />
1 Ohio State University Comprehensive Cancer Center, Columbus/OH/United<br />
States of America, 2 Department of Medical <strong>Oncology</strong>, University of Colorado<br />
Denver, Aurora/CO/United States of America, 3 Medical <strong>Oncology</strong>, Dana-Farber<br />
Cancer Institute, Boston/MA/United States of America, 4 <strong>Thoracic</strong> <strong>Oncology</strong>,<br />
Memorial Sloan Kettering Cancer Center, New York/NY/United States of America,<br />
5 Department of Molecular and Cellular <strong>Oncology</strong>, MD Anderson Cancer Center,<br />
Houston/TX/United States of America, 6 Genentech, Inc., San Francisco/CA/United<br />
States of America, 7 Biostatistics, Genentech, Inc., San Francisco/CA/United States<br />
of America, 8 Pathology, University of Colorado Denver, Aurora/CO/United States<br />
of America, 9 Cancer Center, Massachusetts General Hospital, Boston/MA/United<br />
States of America, 10 <strong>Thoracic</strong> Surgery, UCLA Medical Center, Santa Monica/CA/<br />
United States of America, 11 Hamon Center for Therapeutic <strong>Oncology</strong> Research,<br />
University of Texas Southwestern Medical Center, Dallas/TX/United States of<br />
America, 12 Pathology, Massachusetts General Hospital, Boston/MA/United States<br />
of America, 13 MD Anderson Cancer Center, Houston/TX/United States of America,<br />
14 <strong>Thoracic</strong> Service, Department of Surgery, Memorial Sloan Kettering Cancer<br />
Center, New York/NY/United States of America, 15 Department of Medical <strong>Oncology</strong>,<br />
Baylor College of Medicine, Houston/TX/United States of America, 16 <strong>Oncology</strong>,<br />
University of Pittsburgh School of Medicine, Pittsburgh/PA/United States of<br />
America, 17 <strong>Oncology</strong>, Karmanos Cancer Institute, Detroit/MI/United States of<br />
America, 18 Medical <strong>Oncology</strong>, Ohio State University Comprehensive Cancer Center,<br />
Columbus/OH/United States of America<br />
Background: There is no curative treatment for patients with NSCLC who<br />
develop metastatic disease after resection. Trials of neoadjuvant and<br />
adjuvant chemotherapy have demonstrated an absolute survival benefit<br />
of 5% for patients with stages IB, II, and IIIA disease. Clearly, developing<br />
new treatment strategies to improve survival following resection is critical<br />
to improving outcomes for this patient population. Immunotherapy with<br />
checkpoint inhibitors such as antibodies to PD-1 and PD-L1 has demonstrated<br />
superior survival compared to chemotherapy in randomized clinical trials.<br />
PD-L1 expression is being investigated as a predictive biomarker for these<br />
therapies, but its ability to predict response has varied in published<br />
trials. Atezolizumab is a humanized IgG1 monoclonal PD-L1 antibody that<br />
was recently evaluated in the POPLAR trial (NCT01903993), a phase II<br />
randomized trial of patients with NSCLC who progressed on platinum based<br />
chemotherapy. Atezolizumab therapy improved overall survival compared<br />
with docetaxel (12.6 months vs. 9.7 months, HR 0.73 [95% CI 0.53 – 0.99])<br />
with a manageable safety profile. Improvement in survival correlated with<br />
PD-L1 immunohistochemistry expression of tumor and tumor-infiltrating<br />
immune cells. Methods: Trial design: This phase II, open-label, single-arm<br />
study is designed to evaluate the efficacy and safety of atezolizumab as<br />
a neoadjuvant therapy in patients with Stage IB, II, or IIIA NSCLC prior to<br />
curative-intent resection. Approximately 180 patients with NSCLC will be<br />
enrolled in this study at 15 academic medical centers in the United States.<br />
P2.06-020 A OPEN-LABEL RANDOMISED CONTROLLED TRIAL<br />
OF FIRST-LINE GENEXOL-PM/ CREL-BASED PACLITAXEL PLUS<br />
CISPLATIN IN ADVANCED NSCLC PATIENTS<br />
Baohui Han 1 , Yi Long Wu 2 , Meiqi Shi 3 , Aiqin Gu 1 , Xueyan Zhang 1 , Bo Jin 1 , Yanjie<br />
Niu 1 , Yu Dong 1 , Ping Gu 1<br />
1 Shanghai Chest Hospital, Shanghai/China, 2 Guangdong General Hospital,<br />
Guangzhou/China, 3 Jiangsu Cancer Hospital, Nanjing/China<br />
Background: Genexol-PM is a novel Cremophor EL(CrEL)-free polymeric<br />
micelle formation of paclitaxel.This multicentre study was designed to<br />
compare Genexol-PM and CrEL-based paclitaxel in combination with cisplatin<br />
in terms of efficacy and safety as first-line therapy in advanced non-small<br />
cell lung cancer. Methods: Chemonaive patients aged from 18 to 70 years<br />
with histologically or cytologically confirmed, locally advanced, metastatic<br />
or recurrent advanced NSCLC and an ECOG performance status of 0–1 were<br />
randomised 2:1 to the treatment group (Genexol-PM+ cisplatin ) and the<br />
controll group (paclitaxel+cisplatin) .Patients were treated with Genexol-<br />
PM 230mg/m2 intravenously without premedication or paclitaxel 175mg/<br />
m2 intravenously with premedication plus cisplatin 70mg/m2 on day 1 of a<br />
3-week cycle for up to six cycles. Intrapatient dose escalation of Genexol-PM<br />
to 300mg/m2 was carried out in treatment group from the second cycle if the<br />
prespecified toxic effects were not observed after the first cycle. Results: 170<br />
patients were randomised into the study. PFS and OS data are not yet mature.<br />
Conclusion: This multicentre study is in progress.<br />
Keywords: non-small cell lung cancer, Genexol-PM, paclitaxel<br />
POSTER SESSION 2 – P2.06: SCIENTIFIC CO-OPERATION/RESEARCH GROUPS<br />
PHASE III –<br />
TUESDAY, DECEMBER 6, 2016<br />
P2.06-021 EFFICACY AND SAFETY OF ASP8273 VERSUS ERLOTINIB<br />
OR GEFITINIB AS FIRST-LINE TREATMENT IN SUBJECTS WITH<br />
EGFR MUT+ NSCLC<br />
Ronan Kelly 1 , LEORA HORN 2 , JAMES CHIH-HSIN YANG 3 , DAE HO<br />
LEE 4 , BHARDWAJ DESAI 5 , TANYA FLEEGE 5 , FEI JIE 5 , SRINIVASU<br />
POONDRU 5 , ANNE KEATING 5 , DEBBIE WHITCOMB 5 , TOSEI<br />
MURASE 6 , KOICHI UEGAKI 6 , KOUJI AOYAMA 6 , KAZUHIKO<br />
NAKAGAWA 7<br />
1 Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore/MD/United<br />
States of America, 2 Vanderbilt–Ingram Comprehensive Cancer Center, Nashvillle/<br />
TN/United States of America, 3 National Taiwan University Hospital, Taipei City/<br />
Taiwan, 4 Asan Medical Center, Seoul/Korea, Republic of, 5 Astellas Pharma Us, Inc,<br />
Northbrook/IL/United States of America, 6 Astellas Pharma Inc., Chuo-Ku/Japan,<br />
7 Kindai University Faculty of Medicine, Osaka-Sayama/Japan<br />
Background: Epidermal growth factor receptor (EGFR) tyrosine kinase<br />
inhibitors (TKIs) have shown antitumor efficacy and prolonged progressionfree<br />
survival (PFS) in patients with non-small cell lung cancer (NSCLC)<br />
harboring EGFR activation mutations; however, acquired resistance often<br />
develops limiting clinical efficacy. ASP8273 is an irreversible, once-daily<br />
(QD), orally available TKI with activity against both activating and resistance<br />
EGFR mutations (ex19del, L858R, T790M). Preliminary findings from Phase<br />
Copyright © 2016 by the International Association for the Study of Lung Cancer<br />
S567
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