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NSCLC diagnosis and time of BM diagnosis were estimated using Kaplan-Meier
method. Association between delayed WBRT, after at least 2 cycles of chemotherapy
(CT) or not, and death was evaluated using multivariable Cox proportional hazards
model adjusted for gender, histology, smoking status and RPA score.
Results: We included 175 consecutive pts: 61% were male, median age was 57 years
[range = 27-79]. 68% had adenocarcinoma, 15% were never smoked. At first diagnosis of
NSCLC, the TNM 2009 stage was mainly IV (68%) and III (21%). 42 % of BM were
synchronous and 36% pts had no extracranial metastasis. The number of BM was: one
in 34%, and more than three lesions in 41%. Karnofsky index was >= 70% in 79% of
pts. The RPA class was good-I in 13 pts and poor-III in 37 pts. Radical surgery was
performed in 23 pts (16%) while 8 pts (4.6%) received SRS. 70% had CT with a median
nbr of 1 line [0-6], 31% were treated with anti EGFR therapy. Median OS from NSCLC
diagnosis was 18 (95%CI = [15;20]) months. Median OS from BM diagnosis was 9m
(95%CI = [7.6;10.6]) for the whole population, 43 m for RPA class I, 10 m for class II
and 2 m for class III. In 26% of the pts, WBRT was delayed and delayed WBRT was not
associated with survival in multivariable analysis (HR = 1.24 95%CI.0.85-1.80).
Conclusions: Our results suggest that in NSCLC with BM, RPA class II could be
easily treated with systemic therapy, with then long survival, selected RPA class III
may benefit WBRT and systemic treatment. ALK and EGFR status will be presented.
Disclosure: All authors have declared no conflicts of interest.
1285P BIWEEKLY CARBOPLATIN AND PACLITAXEL AS FIRST-LINE
THERAPY FOR ELDERLY ADVANCED NON-SMALL CELL
LUNG CANCER PATIENTS (PHASE II STUDY)
I. Kota, K. Soejima, K. Naoki, H. Yasuda, H. Terai, A. Daisuke, K. Ohgino,
S. Yoda, S. Ikemura, T. Betsuyaku
Respiratory Medicine, Keio University School of Medicine, Tokyo, JAPAN
Background: Incidence of elderly patients with advanced non-small cell lung cancer
(NSCLC) is increasing, however the treatment for elderly patients is still waiting for the
best answer. Although several studies had suggested the advantage of chemotherapy with
platinum doublet for elderly patients with advanced NSCLC (e.g. Quoix E, et al., The
Lancet 378, 2011), the application of platinum doublet to the elderly is still controversial.
To evaluate the efficacy and tolerability of combination chemotherapy with biweekly
carboplatin (CBDCA) and paclitaxel (PTX) for elderly patients with advanced NSCLC,
we conducted a multicenter non-randomized open label phase II trial.
Methods: Eligibility criteria were as follows; histologically proven NSCLC, aged 70
years and older, ECOG Performance Status (PS) of 0 to 2, clinical stage IIIB and IV,
chemotherapy naïve, and adequate organ function. Patients received CBDCA (AUC
= 2.5) and PTX (90 mg/m2) on day 1 and 15 every 4-week for up to 6 cycles, until
disease progression or intolerable toxicity. The primary endpoint was ORR, and the
secondary endpoints were PFS, OS and tolerability.
Results: 60 patients (median age 78 years old, range 70-85) were enrolled. 45 patients
were male and 45 were stage IV. PS 0/1/2 were 26/30/4, respectively. The median
number of treatment cycle was 3 (1-6). CR/PR/SD/PD were 0/28.9/37.8/33.3% as the
best response, giving an ORR of 28.9 % and DCR of 66.7%. Median PFS and OS
were 5.3 month (95% CI: 3.1-7.5) and 26.7 month (95% CI: 18.2-35.1), respectively.
Grade 3/4 hematological toxicities were neutropenia (27%), leucopenia (15%) and
anemia (8%). Grade 3 non-hematological toxicities were infusion reaction (2%),
anorexia (2%), infection (10%), thrombosis (2%), fatigue (3%), diarrhea (2%) and
gastrointestinal bleeding (3%). Although no grade 4 non-hematological toxicity was
observed, one patient died probably due to treatment-related interstitial pneumonitis.
The adverse events were relatively mild and manageable.
Conclusions: The combination of biweekly CBDCA (AUC = 2.5) and PTX
(90 mg/m2) was effective and well tolerated for elderly patients with advanced
NSCLC. (This study was registered at UMIN 000001328)
Disclosure: All authors have declared no conflicts of interest.
1286P A PHASE II STUDY OF PEMETREXED IN
CHEMOTHERAPY-NAïVE ELDERLY PATIENTS WITH
ADVANCED NON-SQUAMOUS NON-SMALL-CELL LUNG
CANCER: HANSHIN ONCOLOGY GROUP 003
M. Iwasaku 1 , Y. Hattori 2 , S. Morita 3 , H. Yoshioka 1 , K. Otsuka 4 , N. Katakami 5 ,
S. Fujita 5 , S. Yokota 6 , F. Imamura 7 , S. Negoro 8
1 Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, JAPAN,
2 Department of Thoracic Oncology, Hyogo Cancer Center, Akashi, JAPAN,
3 Biostatistics and Epidemiology, Yokohama City University Medical Center,
Yokohama, JAPAN, 4 Division of Respiratory Medicine, Kobe City Medical Center
General Hospital, Kobe, JAPAN, 5 Integrated Oncology, Institute of Biomedical
Research and Innovation Hospital, Kobe, JAPAN, 6 Department of Thoracic
Oncology, National Hospital Organization Toneyama National Hospital, Toyonaka,
JAPAN, 7 Department of Thoracic Oncology, Osaka Medical Center for Cancer
and Cardiovascular Diseases, Osaka, JAPAN, 8 Thoracic Oncology, Hyogo
Cancer Center, Akashi, JAPAN
Background: Single-agent chemotherapy (ie, doxetaxel, gemcitabine or vinorelbine)
is one of the standard treatments for elderly patients with advanced NSCLC.
Annals of Oncology
Pemetrexed has clinically equivalent efficacy, but with less toxicity compared to
doxetaxel in the second line setting of patients with advanced NSCLC. We conducted
a phase II trial to evaluate the efficacy and safety of frontline pemetrexed in elderly
patients with advanced non-squamous (non-Sq) NSCLC.
Methods: In this multicenter phase II trial, we recruited elderly patients with non-Sq
NSCLC. Eligibility criteria were as follows: chemonaïve; locally advanced or
metastatic non-Sq NSCLC; age 75 or older; ECOG performance status 0-1; adequate
organ function. Patients received pemetrexed (500 mg/m2) intravenously on day 1
every 3 weeks until disease progression had been confirmed. The primary endpoint
was response rate (RR). The secondary endpoints included progression free survival
(PFS), overall survival (OS), disease control rate (DCR) and safety. The planned
sample size was 45 patients.
Results: Between August 2009 and July 2011, 47 patients were enrolled. Median age
was 79 years (range: 75-91), 57% (20/47) were male, 36% (17/47) had never smoked,
85% (40/47) had adenocarcinoma, 72% (34/47) had stage IV and 41% (16/39) had
EGFR tyrosine kinase activating mutation. Median number of cycles was 4 (1 to 15).
RR was 13.3% (95%CI: 5.1, 26.8), DCR was 66.7% (95%CI: 51.0, 80.0), PFS was 4.9
months (95%CI: 3.0, 6.2 months), median OS was not reached. The most frequent
treatment-related AEs were anemia, fatigue, hypocalcemia, mostly grade1/2.
Treatment-related Grade 3/4 AEs were reported in 17.8% of patients (mostly
neutropenia and fatigue). No treatment-related death occurred.
Conclusions: The efficacy and limited side effects of pemetrexed are promising in
elderly patients with non-Sq NSCLC.
Disclosure: S. Negoro: HONORARIA: Lily. All other authors have declared no
conflicts of interest.
1287P FINAL RESULTS OF A PHASE 2, OPEN-LABEL STUDY OF
RAMUCIRUMAB (IMC-1121B; RAM), AN IGG1 MAB
TARGETING VEGFR-2, WITH PACLITAXEL AND
CARBOPLATIN AS FIRST-LINE THERAPY IN PATIENTS (PTS)
WITH STAGE IIIB/IV NON-SMALL CELL LUNG CANCER
(NSCLC) (NCT00735696)
D.R. Camidge 1 , R.C. Doebele 1 , M. Ballas 2 , T. Jahan 3 , M. Haigentz 4 ,
D. Hoffman 5 , J. Spicer 6 , H. West 7 , S. Yurasov 8 , A.C. Mita 9
1 Oncology, University of Colorado Cancer Center, Aurora, CO, UNITED STATES
OF AMERICA, 2 Oncology, New York University Langone School of Medicine,
New York, NY, UNITED STATES OF AMERICA, 3 Division of Hematology/
Oncology, University of California - San Francisco, San Francisco, CA, UNITED
STATES OF AMERICA, 4 Department of Medicine (oncology), Albert Einstein
College of Medicine/Montefiore Medical Center, Bronx, NY, UNITED STATES OF
AMERICA, 5 Oncology/hematology, Tower Hematology Oncology Medical Group,
Beverly Hills, CA, UNITED STATES OF AMERICA, 6 Department, King’s College
School of Medicine and Guy’s Hospital, London, UNITED KINGDOM, 7 Oncology
- Medical, Swedish Cancer Institute, Seattle, WA, UNITED STATES OF
AMERICA, 8 Medical, ImClone Systems, Bridgewater, NJ, UNITED STATES OF
AMERICA, 9 Oncology, University of Texas Health Sciences Center, San Antonio,
TX, UNITED STATES OF AMERICA
Background: VEGF-mediated angiogenesis contributes to NSCLC pathogenesis.
RAM is a recombinant human mAb that binds the extracellular domain of the
vascular endothelial growth factor receptor-2 (VEGFR-2) and inhibits cancer growth
in diverse preclinical models.
Methods: Pts with advanced NSCLC (Stage IIIb not suitable for locoregional therapy
or Stage IV) were eligible. Squamous histology and treated brain metastases were
allowed. Exclusion criteria included prior bevacizumab, blood vessel invasion,
intratumor cavitation, and recent gross hemoptysis. Pts received RAM 10 mg/kg,
paclitaxel 200 mg/m 2 , and carboplatin AUC = 6 on Day 1 of a 3-week cycle for up to
6 cycles, followed by maintenance RAM. The primary endpoint was PFS at 6 months
(m); secondary/exploratory endpoints were safety, ORR, OS rate at 1 year, PK/PD
profiles, and immunogenicity.
Results: 40 pts were treated (15M:25F; median age 60; 39 nonsquamous / 1
squamous); all have discontinued. 39 pts were evaluable for response. 22 of 40
treated pts had an objective response (1 CR, 21 PR; ORR = 55%). 14 pts had a best
response of SD. Median PFS was 7.85 m (95% CI: 5.49 m-9.86 m), and the PFS rate
at 6 m was 62.5% (90% CI: 48.3%-75.3%); the 1-year survival rate was 74.6% (95%
CI: 57.9%-85.4%). 34 of 40 pts (85%) reported an AE at least possibly related to
RAM; the most common related AEs were fatigue (53%), peripheral neuropathy
(33%), nausea (28%), myalgia (23%), and epistaxis (23%). Related AEs of Gr ≥ 3
were reported for 15 pts; the most common were neutropenia (5 pts),
thrombocytopenia (4 pts), fatigue, febrile neutropenia (3 pts each), peripheral
neuropathy and pulmonary embolism (2 pts each). There were 5 pts with a total of 6
Gr 4 related events: febrile neutropenia, pulmonary embolism (2 pts each),
neutropenia and thrombocytopenia (1 pt each).
Conclusions: RAM in combination with paclitaxel and carboplatin shows promising
efficacy based on the overall disease control rate (CR + PR + SD) reaching 90% and
PFS rate at 6 m of 62.5%, and is well tolerated by patients with NSCLC.
Disclosure: D.R. Camidge: I have received research funding from Eli Lilly and
Company and honoraria from ImClone Systems. R.C. Doebele: Research Funding:
ImClone Systems, Eli Lilly & Co., Pfizer Inc. Honoraria: Boehringer Ingelheim,
ix422 | Abstracts Volume 23 | Supplement 9 | September 2012