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Annals of Oncology
pemetrexed (PEM) maintenance therapy produced a high magnitude of PFS
improvement. The OLCSG 0903 phase 2 trial investigated efficacy and safety of cisplatin
(CDDP)-docetaxel (DOC)-BEV induction therapy followed by BEV-PEM maintenance
therapy in patients with advanced nonsquamous non-small cell lung carcinoma.
Methods: In this trial, 40 patients with good PS (0 or 1) participated in the induction
phase, specified as four cycles of induction CDDP (80 mg/m 2 ), DOC (60 mg/m 2 ) and
BEV (15 mg/kg) on day 1 of a 21-day cycle. Patients who had not progressed during
CDDP-DOC-BEV induction received maintenance BEV (15 mg/kg) and PEM (500
mg/m 2 ) on day 1 of a 21-day cycle until disease progression. The primary endpoint
was PFS, and the secondary endpoints included toxicity, OS and response rate.
Results: Patient characteristics were as follows: median age: 62 years; 78% male;
100% Japanese; 30% PS 0; 73% stage IV; and 70% adenocarcinoma. At the time of
this analysis, 23pts (58%) discontinued the treatment, and the proportion of
discontinuations to AEs was 35% (8/23). The principal toxicity was
myelosuppression (grade 4 hematological: 20 patients [50%]), and grade 3/4 febrile
neutropenia was observed in 10 (25%) despite no treatment-related deaths. The
objective response rate and disease control rate (% patients with CR/PR/SD) was
82.5% and 97.5%, respectively. The median PFS time was 10.2 months, and the
6-month PFS rate was 63.2% (95% confidence interval: 44.9-76.9 %).
Conclusions: CDDP-DOC-BEV followed by BEV-PEM maintenance seems an
effective and moderately tolerated treatment for patients with advanced
nonsquamous non-small cell lung carcinoma.
Disclosure: K. Hotta: Eli Lilly Japan sanofi-aventis Chugai Pharmaceutical Co. Ltd
Nippon Kayaku. N. Takigawa: Eli Lilly Japan sanofi-aventis Chugai Pharmaceutical
Co. Ltd. K. Kiura: Eli Lilly Japan sanofi-aventis Chugai Pharmaceutical Co. Ltd
Nippon Kayaku. All other authors have declared no conflicts of interest.
1328 META-ANALYSIS OF RELATIONSHIP BETWEEN SKIN RASH
AND OUTCOME IN NON-SMALL-CELL LUNG CANCER
(NSCLC) PATIENTS TREATED WITH ERLOTINIB (E) AND
GEFITINIB (G)
K.F. Borgonovo, F. Petrelli, M. Cabiddu, M. Ghilardi, M. Cremonesi, F. Maspero,
S. Barni
Medical Oncology Division, Azienda Ospedaliera Treviglio-Caravaggio, Treviglio,
ITALY
Introduction: Dermatological toxicity in the form of acneiform rash is a common
event in NSCLC patients being treated with anti-EGFR TKIs. An association between
clinical benefit by EGFR-targeted therapy and development of this form of skin
toxicity has been noted. The objective of this meta-analysis was to assess the predictive
value of skin rash for outcome in patients with NSCLC treated with E or G.
Materials and methods: Prospective clinical trials or retrospective case series with
reported survival (OS), progression (PFS/TTP) and response rate (RR) as a function
of skin rash were serched in PubMed until January 2012. The selected studies have to
include adult patients with histologically confirmed NSCLC treated with G or E,
alone or in combination with other approved agents. Hazard ratios with 95%
confidence intervals (HRs) for PFS/TTP and OS and risk ratios (RRs) for response
rate in patients with rash were pooled in a meta-analysis.
Results: Twenty-four publications were included in this meta-analysis (17
prospective trials and 7 retrospective case series) for a total of 3032 patients. For the
primary endpoint (OS) the occurrence of skin rash was significantly associated with
reduced risk of death in patients treated with E or G (HR 0.30, p 3 14/7;
non-smoker/smoker: 13/8, with EGFR mutations/without EGFR mutations – 12/9.
Results: Median PFS was 7 months overall, ORR was 75% (9/12, 8 partial responses,
1 complete response) and the MoS was not reached in patients with EGFR
mutations. Median PFS was 2 months overall, no objective responses and the MoS
was 4 months in patients without EGFR mutations. Differences are statistically
significent in ORR and PFS (p < 0.05).
Conclusions: EGFR TKIs showed high effectiveness and good disease control in
patients with brain metastases from NSCLC with EGFR mutations.
Disclosure: All authors have declared no conflicts of interest.
1331 COMPARISON OF SURVIVAL IN PATIENTS WITH ADVANCED
LUNG ADENOCARCINOMA TREATED BEFORE AND AFTER
GEFITINIB APPROVAL IN CHINA
Y. Shi 1 ,Y.Liu 1 , X. Hao 1 ,J.Li 1 ,X.Hu 1 , Y. Wang 1 , Z. Wang 2 , H. Wang 1 , X. Han 1 ,
X. Zhang 1
1 Oncology, Cancer Hospital-China Academy of Medical Sciences, Beijing,
CHINA, 2 Medical Oncology, Cancer Hospital-Chao Yang District BeijingCAMS
and PUMC, Beijing, CHINA
Objective: This study compared the overall survival (OS) between advanced lung
adenocarcinoma patients of before and after gefitinib approval in China.
Methods: The clinical data of 558 advanced lung adenocarcinoma patients who ever
received palliative chemotherapy were reviewed retrospectively. According to a
matched-pair case-control study design, 255 patients of before gefitinib approval who
only received palliative chemotherapy and 255 patients of after gefitinib approval
who received gefitinib treatment were matched by age, sex and smoking history.
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds409 | ix435