Araya, Tomoyuki

Fujimura, Masaki

Kasahara, Kazuo

Kimura, Hideharu

Nakao, Shinji

Shibata, Kazuhiko

Shirasaki, Hiroki

Sone, Takashi

Elsevier - Publisher Connector 

: P2-228: Bi-weekly administration of gemcitabine plus vinorelbine in elderly patients with advanced non-small-cell lung cancer: Multi-center phase II trial 

Copyright © 2007 by the International Association for the Study of Lung Cancer S663
Journal of Thoracic Oncology • Volume 2, Number 8, Supplement 4, August 2007  12th World Conference on Lung Cancer
at P. Incidence of grade III and IV neutropenia was 9% on D and none 
on P. Incidence of grade III and IV respiratory infection was 12% on D 
and 5% on P. Median OS was 17.94 months (95%CI: 14.82-21.06) for 
D and 18.92 months (95%CI: 13.24-24.61) for P (p=0.849). Median 
TTP from 1st line was 7.36 months (95%CI: 6.46-8.26) for D and 5.55 
months (95%CI: 4.43-6.67) for P (p=0.080). Median TTP from 2nd line 
was 3.75 months (95%CI: 1.98-5.52) for D and 3.18 months (95%CI: 
0.44-5.94) for P (p= 0.520).
Conclusions: As published, these results shows on our unselected 
daily practice population with NSCLC, a similar TTP and OS using 
docetaxel or pemetrexed as 2nd line treatment, but this later drug op-
tion shows a clear more favourable safety proﬁle.
P2-228 NSCLC: Cytotoxic Chemotherapy Posters, Tue, Sept 4 
Bi-weekly administration of gemcitabine plus vinorelbine in elderly 
patients with advanced non-small-cell lung cancer: Multi-center 
phase II trial
Araya, Tomoyuki1 Kasahara, Kazuo1 Kimura, Hideharu1 Shibata, 
Kazuhiko2 Shirasaki, Hiroki3 Sone, Takashi4 Fujimura, Masaki1 Nakao, 
Shinji1 
1 Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Ja-
pan 2 Internal Medicine, Kouseiren Takaoka Hospital, Takaoka, Japan 3 
Internal Medicine, Fukui Saiseikai Hospital, Fukui, Japan 4 Kanazawa 
Medical Center, Kanazawa, Japan 
Purpose: Gemcitabine (GEM) and Vinorelbine (VNR) have dem-
onstrated activity as a ﬁrst-line treatment in elderly patients with 
advanced non-small-cell lung cancer (NSCLC). We conducted a mul-
ticenter phase II trial to evaluate the efﬁcacy and toxicity of bi-weekly 
administration of gemcitabine plus vinorelbine in elderly patients with 
advanced NSCLC. 
Patients and methods: Forty-six chemotherapy-naive elderly (age: 70 
years or older) NSCLC patients were enrolled. Patients were eligible if 
they had histologically or cytologically conﬁrmed unresectable NSCLC 
with measurable and/or assessable disease. Patients received GEM 
(1000 mg/m2) and VNR (25 mg/m2) every 2 weeks. 
Results: The objective response rate of this treatment was 22.7% (95% 
Conﬁdence Interval (CI), 10.3-35.1%), median survival time was 310 
days, and median time to progression was 133 days. The one-year sur-
vival rate was 40.9% (95% CI, 26.3-55.4%), and most adverse events 
were mild. Only 3 (6.8%) patients needed to omit GEM because of 
grade 4 neutropenia or due to physician judgment. No patients suffered 
treatment-related death. 
Conclusions: Bi-weekly administration of gemcitabine plus vinorel-
bine in elderly patients was an effective, feasible and well-tolerated 
treatment schedule.
P2-229 NSCLC: Cytotoxic Chemotherapy Posters, Tue, Sept 4 
Phase II study of docetaxel and S-1 combination therapy in 
patients with previously treated non-small-cell lung cancer
Atagi, S.1 Kawahara, M1 Kubo, A1 Kawaguchi, T1 Yumine, K1 Okishio, 
K1 Tomizawa, Y2 Komatsu, H3 Fukai, S4 
1 Kinki-Chuo Chest Medical Center, Sakai, Japan 2 Nishigunma Nation-
al Hospital, Gunma, Japan 3 National Chushin-Matsumoto Hospital, 
Nagano, Japan 4 Ibaragihigashi National Hospital, Ibaragi, Japan 
Background: Docetaxel is active against chemotherapy-pretreated 
non-small-cell lung cancer (NSCLC). S-1 is a novel oral ﬂuoropyrimi-
dine, composed of tegafur, 5-chloro-2,4-dihydroxypyridine (dihydro-
pyrimidine dehydrogenase inhibitor), and potassium oxonate (orotate 
phosphoribosyl transferase inhibitor). It has been commercially avail-
able and used for NSCLC in Japan. We conducted this study to evaluate 
the efﬁcacy and safety of docetaxel combined with S-1 in NSCLC 
patients (pts) who were previously treated with one or more regimens.
Methods: Eligible pts were required to have histologically or cytologi-
cally conﬁrmed measurable or evaluable stage IIIB or IV NSCLC, age≥ 
20 years, one or more previous chemotherapy, a performance status 
(PS) 0-1, and adequate organ function and bone marrow reserve. In this 
study, pts received S-1 (80mg/m2 orally on days 1-14) and docetaxel 
(40mg/m2 IV on days 1). Treatment was repeated every 3 weeks.
Results: Between January 2005 and May 2006, 30 pts were enrolled on 
this study. 29 pts were eligible and evaluable. Median age was 67 (48-
79), male/female (23/6), PS 0/1 (9/20), stage IIIB/IV (7/22), and prior 
chemotherapy regimen 1/2/3 (23/4/2). 28 pts received a platinum-based 
chemotherapy. Response: PR=7(24%), SD=13, PD=7, NE=2. Median 
survival time was 10.2 months. Grade 3/4 toxicities (% of pts) were as 
follows: leukocytes 6/0 (20.6%), neutrophils 7/3 (34.4%), platelets 0/0, 
infection 0/1 (3.4%), fever 2/0 (6.9%), diarrhea 1/0 (3.4%), neurology 
0/1 (3.4%), and mucositis 1/0 (3.4%). There were no treatment-related 
deaths.
Conclusions: The combination of docetaxel and S-1 was effective with
acceptable toxicity in pts with previously treated NSCLC. These results 
warrant further investigations of this regimen a randomized controlled 
trial as a second-line treatment for NSCLC.
P2-230 NSCLC: Cytotoxic Chemotherapy Posters, Tue, Sept 4 
A Phase I Study of Nontoxic Suramin As A Chemosensitizer In 
Pretreated/Refractory Non-Small Cell Lung Cancer (NSCLC) 
Patients
Au, J. L. S. Olencki, T. Wientjes, M. G. Otterson, G. Saab, T. Grainger, 
A Yeh, T. Jensen, R. Young, D. Calero, M.villalona 
The Ohio State University, Columbus, OH, USA
Background: Primary and acquired resistance to chemotherapy have 
been primary determinants of poor outcome in pts with metastatic 
NSCLC. Our group has shown that non-cytotoxic dose of suramin 
(10-50 ?M) produces chemosensitization in multiple preclinical tumor 
models, including chemo-pretreated tumors. 
Methods: Platinum-pretreated pts with stage IIIB/IV NSCLC (no 
prior docetaxel or gemcitabine allowed, allowed prior suramin) were 
randomized to receive 3 cycles of docetaxel (75 mg/m2 IV over 1 h q 3 
wks) + suramin (Arm A) or gemcitabine (1250 mg/m2 IV over 30 min 
d 1 and 8 q 3 wks) + suramin (Arm B). Suramin was infused over 30 
min, 2.5 hr prior to the chemotherapy. Suramin dose was calculated us-
ing a previously established dosing nomogram: Dose in mg = FACTOR 
x (actual body surface area) 2. Factor was 125 for the ﬁrst dose, and, 
for subsequent doses, was adjusted based on the time elapsed since the 
previous dose. Pts received either Arm A or Arm B and, after radiologic 
evaluation at 9 weeks (3 cycles), pts showing objective response (CR/
PR) were continued on the same Arm until progressive disease (PD) at 
which time pts crossed over to the other Arm, whereas pts with stable 
or PD immediately crossed over to the other Arm. Radiologic evalua-
tion was repeated after 3 cycles of treatments.


file:///data/core-remote/dit/data/elsevier/pdf/742/aHR0cDovL2FwaS5lbHNldmllci5jb20vY29udGVudC9hcnRpY2xlL3BpaS9zMTU1NjA4NjQxNTM0NjAyNQ==.pdf

: P2-228: Bi-weekly administration of gemcitabine plus vinorelbine in elderly patients with advanced non-small-cell lung cancer: Multi-center phase II trial

Abstract

Similar works

Full text

Available Versions

Elsevier - Publisher Connector

Elsevier - Publisher Connector