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Annals of Oncology
histology, stage of disease, presence of BM, survial were collected and analyzed. A
multivariate logistic regression model was used to identiy the predictors of BM.
Results: Among 596 NSCLC patients with a mean follow-up time of 12.5± 12.5
months and a mortality rate of 62% at the last follow up, 187 (31%) experienced BM
during their disease course. The accumulative incidence of BM was higher in patients
with adenocarcinoma (ADC) than those with squamous cell carcinoma (SCC) (36% vs
13%, p < 0.001). On multivatiate analysis, female, age < 60 years, ADC and stage 3b/4
were significantly associated with BM (OR = 1.67, 95% CI = 1.06-2.63, p = 0.025, and
OR = 1.89, 95% CI = 1.28-2.78, p = 0.001, and OR = 2.67, 95% CI = 1.35-5.26, p =
0.017, and OR = 3.94, 95% CI = 2.15-7.13, p < 0.001, respectively). The incidence of
BM in stage 3b/4 NSCLC patients was 36% and varied from 14% to 59% in patients
with or without identified risk facotrs. Specifically, ADC patients with age less than 60
years were more likely to experience BM than the elder with SCC (OR = 5.46, 95% CI
= 2.79-10.71, p < 0.001). Additionally, prolonged survial after diagnosis of lung cancer
heightened the risk of BM; its incidence was 42%, 54% and 64% in patients who
survived longer than 3, 12 and 24 moths, respectively.
Conclusion: We find that gender, age and histological subtype are independent
factors predicting BM in NSCLC patients and suggest identification of patients at
high risks for BM might help detect BM earlier and facilitate the design of clinical
trials aming at the prevention of BM.
Disclosure: All authors have declared no conflicts of interest.
1306P INITIAL REPORT OF COHORT STUDY IN PATIENTS WITH
NON-SMALL-CELL LUNG CANCER (NSCLC) WHO WERE
TREATED WITH 1ST-LINE PLATINUM-BASED
CHEMOTHERAPY (SAPPHIRE STUDY)
Y. Naito 1 , K. Kishi 2 ,K.Yoh 3 , Y. Goto 4 , Y. Ohashi 5 , H. Kunitoh 6
1 Dept. of Hematology and Medical Oncology, National Cancer Center Hospital
East, Kashiwa, JAPAN, 2 Dept. of Respiratory Medicine, Toranomon Hospital,
Tokyo, JAPAN, 3 Division of Thoracic Oncology, National Cancer Center Hospital
East, Kashiwa, JAPAN, 4 Department of Respiratory Medicine, Graduate School
of Medicine, University of Tokyo, Tokyo, JAPAN, 5 Department of Biostatistics,
School of Public Health, University of Tokyo, Tokyo, JAPAN, 6 Department of
Respiratory Medicine, Mitsui Memorial Hospital, Tokyo, JAPAN
Background: Although 2nd-line chemotherapy comprises the standard of care for
NSCLC, not every patient could receive one. How many and why did they miss the
opportunity are not fully investigated.
Methods: We prospectively registered consecutive patients with NSCLC treated with
platinum-based 1st-line therapy from April 2010 to September 2011 from 30
institutions in Japan. Baseline characteristics, regimens and responses for the 1st-line
therapy, whether the patients received 2nd-line chemotherapy or not, and if not
treated, the reason was recorded. This study was supported by the Public Health
Research Center Foundation CSPOR.
Results: A total of 866 patients were registered. Patient characteristics were: median
age, 65 (24 - 80); female patients, 27.5%; ECOG PS 0 or 1, 91.6%; adenocarcinoma,
69.6%; squamous cell carcinoma, 20.1%; never smoker, 20.1%; EGFR activating
mutation positive, 10.2%. Maintenance chemotherapy was administered to 28.9%
(131 / 454) of patients whose disease did not progress during the course of 1st-line
chemotherapy. Among 592 patients with at least 6 months of follow-up, 193 were
excluded (129 PD during the course of 1st-line chemotherapy, 20 ongoing 1st-line
chemotherapy, and 44 others). The remaining 399 patients were analyzed with regard
to administration of 2nd-line chemotherapy. A total of 135 patients (33.8%) did not
receive 2nd-line chemotherapy, and the reasons were: without disease progression, 42
(31.1%); declined PS, 55 (40.7%); patient refusal, 20 (14.8%); death of any cause, 5
(3.7%). Therefore, approximately 20% of patients missed their opportunity to receive
appropriate 2nd-line chemotherapy during follow-up period after completion of
effective 1st-line therapy.
Conclusion: This is the largest prospective observational study exploring the
proportion and the reasons for NSCLC patients not receiving 2nd-line
chemotherapies. Further investigations to identify predictive factors for ‘missing the
opportunity for 2nd-line chemotherapy’ are underway.
Disclosure: All authors have declared no conflicts of interest.
1307P EFFECTIVENESS OF ERLOTINIB TREATMENT IN K-RAS
WILD TYPE LUNG ADENOCARCINOMAS –RESULTS OF A
HUNGARIAN OBSERVATIONAL COHORT STUDY (MOTIVATE)
G. Ostoros 1 , V. Sárosi 2 , G. Losonczy 3 , J. Strausz 4 , E. Tolnay 5 , L. Molnár 6
1 Department VIII, National Korányi Institute of Pulmonology, Budapest,
HUNGARY, 2 1st Department of Internal Medicine Pulmonology Department,
University of Pécs, Pécs, HUNGARY, 3 Department of Pulmonology, Semmelweis
University, Budapest, HUNGARY, 4 Department Vi., National Korányi Institute of
Pulmonology, Budapest, HUNGARY, 5 2nd Department, Pest County Institution
of Pulmonology, Törökbálint, HUNGARY, 6 Pulmonology Department, Borsod
County Szent Ferenc Hospital, Miskolc, HUNGARY
Background: Erlotinib as a targeted therapy is a highly potent inhibitor of epidermal
growth factor receptor tyrosine-kinase activity. K-RAS mutations are found in
25-35% of lung adenocarcinomas, and these mutations may be predictive of
resistance to treatment with erlotinib. The aim of our analysis was to investigate
prospectively the efficacy and safety of second and third line erlotinib treatment in
advanced lung adenocarcinoma excluding the K-RAS mutation positive cases.
Materials and methods: This observational study was conducted in 27 Hungarian
sites. Enrolled patients were treated with erlotinib. Analyzed patients have
histologically or cytologically verified, advanced (IIIB/IV), K-RAS (codon-12,
codon-13) mutation negative lung adenocarcinoma, refractory to at least one prior
chemotherapy. Primary endpoint was progression-free survival. Secondary endpoints
were best tumor response rate according to RECIST, overall survival and safety.
Results: 327 patients’ data were analyzed, who were enrolled between February 2008
and December 2010. The study closure date was 31. December 2011. Baseline
patients’ characteristics: median age: 60,3 years; male: 50,2%; stage: III/B: 31,1%, IV:
68,9%; smoking status: former/current/never smoker: 39,1/28,8/31,9%. ECOG PS: 0/
1/2/3: 35,9/51,8/11/1,2%. Best tumor response: CR/PR/SD/PD were achieved: 0,9/
16,2/41,9/24,5 % of all patients. The disease control rate was 70,48% in patients for
whom the best response data were available . The median progression-free survival
(PFS) was 3.27 months. The median overall survival was 14,1 months. For ECOG PS
0-1 patients, the median OS was 16,1 months and the median PFS was 3,47 months,
while median OS of 2.5 and median PFS of 1,9 months were detected for ECOG PS
2-3 patients.
Conclusions: Our results confirm the favorable efficacy of erlotinib in K-RAS
mutation negative lung adenocarcinoma with an OS of 14,1 months in this real-life
setting. A remarkable, 16.1 months median OS was identified in patients with ECOG
PS 0-1 receiving erlotinib.
Disclosure: G. Ostoros: corporate-sponsored research: investigator in
company-sponsored (Roche) trials. All other authors have declared no conflicts of
interest.
1308P PKM2 EXPRESSION MAY PREDICT CHEMOSENSITIVITY TO
CISPLATIN-BASED CHEMOTHERAPY IN METASTATIC
NON-SMALL CELL LUNG CANCER (NSCLC)
C. Papadaki 1 , M. Sfakianaki 1 , E. Lagoudaki 2 , G. Giagkas 1 , E. Tsakalaki 1 ,
M. Trypaki 1 , S. Pontikakis 1 , A. Koulouridi 1 , V. Georgoulias 3 , I. Souglakos 4
1 Laboratory of Tumor Cell Biology, School of Medicine, University of Crete,
Heraklion, GREECE, 2 Laboratory of Pathology, School of Medicine, University of
Crete, Heraklion, GREECE, 3 Medical Oncology, University Hospital of Heraklion,
Heraklion, GREECE, 4 Medical Oncology, University General Hospital of Heraklion,
Heraklion, GREECE
Background: Tumor cells have been shown to express exclusively the embryonic M2
isoform of pyruvate kinase (PKM2). Overexpression of PKM2 has been correlated
with cisplatin resistance in cell lines and xenograft models. We evaluated the
predictive significance of PKM2 in patients with stage IV NSCLC.
Methods: PKM2 mRNA expression was analysed by RT-qPCR in microdissected
FFPE primary tumors from 305 NSCLC patients (148 as training set and 157 as
experimental set) treated with front-line cisplatin-based chemotherapy and 85
patients treated with a non-platinum doublet (as validation set).
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds409 | ix429