Annual Meeting Proceedings Part 1 - American Society of Clinical ...

7561 General Poster Session (Board #47C), Sat, 1:15 PM-5:15 PM
A phase II study of erlotinib monotherpay in patients with previously treated
advanced non-small cell lung cancer (NSCLC) without EGFR gene mutation
who have never/light smoking history: NEJ006/TCOG0903. Presenting
Author: Yoshiki Ishii, Dokkyo Medical University School of Medicine,
Shimotoga, Japan
Background: Epidermal growth factor receptor (EGFR) tyrosine kinase
inhibitors (TKIs) have demonstrated good response in NSCLC harboring
EGFR gene mutation. However, survival benefit from erlotinib was observed
also in NSCLC patients with wild type (wt) EGFR gene in subsets of several
phase III trials. Additionally, smoking status could be a predictive factor of
erlotinib efficacy, This study aimed to evaluate the efficacy of erlotinib in
Japanese NSCLC patients with wt-EGFR and find a biomarker that predicts
the efficacy of erlotinib other than EGFR gene mutation. Methods: The
primary endpoint was an objective response rate. Secondary endpoints
included disease control rate, overall survival, and safety. Advanced NSCLC
patients without EGFR gene mutation who had received one to three prior
chemotherapy regimens and who had never smoked or light smoked
(Brinkman Index: less than200) were eligible in this study. EGFR gene
status was evaluated by the PNA-LNA PCR clamp method. Erlotinib was
administered daily (150mg/day) until disease progression or unacceptable
toxicities. Results: Forty seven patients were enrolled between March 2010
and November 2011. One patient was excluded for evaluation because
having mutation of EGFR. Efficacy and safety were evaluated among 46
patients. Best responses were PR 7 (15.2%), SD 12 (26.1%), PD 26
(46.4%), NE 1 (2.2%). Response rate and disease control rate were 15.2%
(95%CI: 4.9-25.5%) and 41.3 % (95%CI 27.1-55.5%) respectively.
Grade 3 or 4 adverse events were anorexia (4), skin rash (2), neutropenia
(1), leukopenia (1), anemia (2), elevation of AST/ALT (1), rectal ulcer (1),
and cerebral infarction (1).Two patients suffered grade 3 interstitial lung
disease. Conclusions: This is the first report to evaluate Erlotinib efficacy in
selected NSCLC who do not possess EGFR gene mutation. Erlotinib showed
significant anti-tumor activity in pretreated never or light smoked Japanese
NSCLC patients without EGFR gene mutation. The results of biomakr
analysis will be presented at the meeting.
7564 General Poster Session (Board #47F), Sat, 1:15 PM-5:15 PM
Elderly and younger patients with non-small cell lung cancer (NSCLC)
derive similar benefit from second-line chemotherapy: A retrospective
subset analysis of second-line chemotherapy trials conducted from the
Hellenic Cooperative Research Group (HORG). Presenting Author: Sofia
Agelaki, Department of Medical Oncology, University General Hospital of
Heraklion, Heraklion, Greece
Background: Elderly patients (pts) achieve a similar survival benefit, with
acceptable toxicity, from first-line chemotherapy for the treatment of
advanced NSCLC compared with their younger counterparts. There have
been no second-line trials specifically designed for elderly pts and few data
exist on the efficacy and tolerability of second-line therapy in this
population. Moreover, little if any information exists on the frequency of
administration of second-line chemotherapy in these pts. Methods: The files
of 2004 pts with advanced NSCLC enrolled into first-line chemotherapy
trials performed by HORG from 1995 to 2007 were reviewed. A total of 600
pts who received second-line chemotherapy within the context of clinical
trials were identified. Patients’ data were analysed for efficacy and toxicity
according to age. Results: Second-line chemotherapy was administered in
24% and 34% of pts �65 and �65 years old after failure of prior therapy
(p�0.0001). A total of 219 (24.8%) of 600 pts who received second-line
treatment were �65 years old (median age 70 yrs, range 65-82). Response
rates to second-line therapy were 11.9% for older pts compared to 12.3%
for younger pts (p�ns). TTP was 2.8 and 3.1 months for older and younger
pts, respectively (p�ns). Elderly pts receiving second-line chemotherapy
had a median survival of 7.7 months compared with 8.2 months for younger
pts (p�ns). Similar rates of haematological and non-haematological
toxicities were encountered between the two groups. Conclusions: The
participation of elderly pts to second-line chemotherapy trials was lower
compared to younger patients. There was no significant difference in
outcome or toxicity between elderly and younger pts. For elderly pts with
advanced NSCLC and good performance status, second-line chemotherapy
is appropriate. However, specific second-line trials in older pts are required
since those included in the current analysis were probably highly selected
to fit the inclusion criteria.
Lung Cancer—Non-small Cell Metastatic
495s
7563 General Poster Session (Board #47E), Sat, 1:15 PM-5:15 PM
First-line gefitinib for elderly patients with advanced non-small cell lung
cancer (NSCLC) harboring EGFR mutations: A combined analysis of NEJ
studies. Presenting Author: Sodai Narumi, Department of Respiratory
Medicine, Tohoku University Graduate school of Medicine, Sendai, Japan
Background: The first-line treatment with gefitinib has been established as a
standard of care for advanced NSCLC patients with EGFR mutation by
previous studies including NEJ002. Since the percentage of elderly
population in those studies was lower than that of real situation, further
validation of its usefulness for elderly patients with EGFR-mutated NSCLC
is warranted. Methods: The efficacy and safety data of fit elderly patients
(70 years or older with PS 0-2) with EGFR-mutated NSCLC who received
the first-line gefitinib in NEJ001 (phase 2), NEJ002 (phase 3), and
NEJ003 (phase 2) were combined. Same population treated with the
first-line carboplatin plus paclitaxel in NEJ002 (n�34) were also examined
their efficacy and safety for reference. Regarding the toxicity and quality of
life (QOL), the comparison between elderly patients and younger patients
(� 70 years old) both treated with first-line gefitinib in NEJ002 was also
performed. Results: Data from 71 patients (7 from NEJ001, 33 from
NEJ002, 31 from NEJ003) treated with first-line gefitinib were combined.
Patients’ characteristics were as follows; mean age: 76.8 years (range
70-89), female: 73%, never smoker: 75%, PS 0-1: 92%. Overall response
rate (73.2%) and median progression-free survival (14.3 months) in this
group were significantly better than those in the reference group (26.5%
and 5.7 months, respectively). Despite fewer patients received second-line
chemotherapy in the first-line gefitinib group, its median overall survival
(30.8 months) was not inferior to that of reference group (26.4 months).
Regarding toxicities such as liver dysfunction, rash, diarrhea, and pneumonitis,
and QOL examined by self questionnaires, there were no difference
between the elderly patients and younger patients in NEJ002. Conclusions:
First-line gefitinib still achieved high efficacy with acceptable toxicity in fit
elderly patients with advanced NSCLC harboring EGFR mutation. Considering
that elderly patients tend to receive fewer treatment lines compared
with younger patients, first-line gefitinib would be strongly recommended
for this population to avoid the risk of missing its administration.
7565 General Poster Session (Board #47G), Sat, 1:15 PM-5:15 PM
Randomized phase II trial of carboplatin combined with weekly paclitaxel
(CP) and docetaxel alone (D) in elderly patients (pts) with advanced
non-small cell lung cancer (NSCLC): NJLCG 0801. Presenting Author:
Shunichi Sugawara, Sendai Kousei Hospital, Sendai, Japan
Background: Standard first-line chemotherapy for elderly NSCLC pts has
been considered as a monotherapy with vinorelbine or gemcitabine globally.
However, we have demonstrated the high efficacy of CP for elderly pts
in our previous trial (Ann Oncol 2010). Meanwhile, D has been considered
as an alternative option for this population in Japan according to the result
of WJTOG9904 (JCO 2006). Thus we compared the two regimens to select
the proper candidate for future phase III trial. Methods: Eligible pts were
aged 70 years or older with newly diagnosed stage IIIB/IV NSCLC; ECOG
performance status 0-1; adequate organ function; written informed consent.
Pts were randomized to receive carboplatin (AUC 6) on day 1 and
paclitaxel (70mg/m2 on day 1, 8, and 15) every 4 weeks or D (60mg/m2 on
day 1) every 3 weeks. The primary endpoint was overall response rate
(ORR), and secondary endpoints were progression-free survival (PFS),
overall survival, and toxicity profile. Assuming that ORR of 40% would be
potential usefulness while ORR of 20% would be the lower limit of interest,
40 pts in each arm were required if expect 10% loss to follow up. Results:
Between July 2006 and September 2010, 84 pts were enrolled and 41 pts
in CP arm and 42 pts in D arm were eligible (median age, 76 years; 75%
male; 72% stage IV). Median treatment cycle was 4 in each arm (CP, range
1-6; D, range 1-8). ORRs were 51% (95%CI: 36-66%) and 26% (95%CI:
12-39%) in the CP and D arm, respectively. With a median follow-up of
18.4 months, median PFS were 6.5 and 3.9 months in the CP and D arm,
respectively (Logrank, P�0.0027). Grade 3 or severer toxicities were as
follows: neutropenia (CP, 56% and D, 79%), anemia (CP, 15% and D,
7%), thrombocytopenia (CP, 10% and D, 0%), infection (CP, 20% and D,
25%). One treatment-related death due to neutropenia, pneumonia, and
lethal arrhythmia occurred in D arm but none in CP arm. Conclusions: The
platinum doublet CP achieved higher activity with an acceptable toxicity
profile for elderly pts with advanced NSCLC compared to monotherapy with
D. The superiority of CP to the monotherapy in this trial is consistent with
results of recent IFCT-0501 trial (Lancet 2011).
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