ArticlePDF Available

P-087A phase II study of a combination treatment of alternate-day S-1 and lentinan as first-line chemotherapy for unresectable or recurrent gastric cancer

Authors:
posters
P087 A phase II study of a combination treatment of alternate-day
S-1 and lentinan as first-line chemotherapy for
unresectable or recurrent gastric cancer
S. Yoshino1, T. Nishimura2, K. Sakata2, S. Yoshida3, T. Furuya4, T. Yamamoto5,
T. Kawaoka6, R. Shimizu7,T.Sato
8, K. Matoba9, H. Morioka10, M. Iida1,
N. Suzuki1, S. Takeda1, T. Ueno1, S. Hazama11, H. Nagano1
1
Yamaguchi University Graduate School of Medicine, Department of
Gastroenterological, Breast and Endocrine Surgery, Ube, Japan
2
Shimonoseki Medical Center, Department of Digestive Surgery, Sh imonoseki,
Japan
3
Saint Hill Hospital, Ube, Japan
4
Kanmon Medical Center, Department of Surgery, Shimonoseki, Japan
5
Tsushimi Hospital, Department of Surgery, Hagi, Japan
6
Ube Industries Central Hospital, Department of Surgery, Ube, Japan
7
Ogori Daiichi General Hospital, Department of Surgery, Yamaguchi, Japan
8
Onoda Red Cross Hospital, Department of Surgery, Sanyo Onoda, Japan
9
Yawatahama City General Hospital, Department of Surgery, Yawatahama, Japan
10
Mine City Mitou Hospital, Department of Surgery, Mine, Japan
11
Yamaguchi University Department of Gastroenterological, Breast and Endocrine
Surgery, Ube, Japan
Introduction: Treatment with S-1 plus cisplatin is a standard regimen for unresectable
or recurrent gastric cancer. However, adverse events are commonly observed in this
regimen, so S-1 monotherapy is one of the treatment option especially in elderly
patients. Even in the S-1 treatment, the standard schedule of a 4-week daily
administration followed by a 2-week rest frequently causes adverse events. We
attempted an alternate-day therapy with S-1 plus antitumor polysaccharide lentinan to
reduce the adverse events and to achieve long-term administration.
Methods: This is a phase II, multi-institutional, prospective study. S-1 was
administered according to the schedule for the alternate-day regimen (on Monday,
Wednesday, Friday and Sunday) in the recommended dosage of 40 mg/m
2
twice with
weekly intravenous administration of lentinan (2mg/body) in patients with
unresectable or recurrent gastric cancer. Treatment was continued until disease
progression or appearance of intolerable adverse events. Eligibility criteria of the
patients included no prior chemotherapy, no requirement of measurable lesions fitting
RECIST, 20 years of age or olderand no upper age limit. The primary endpoint was
time to treatment failure (TTF). The secondary endpoints were overall survival (OS),
progression-free survival (PFS), response rate (RR) and occurrence rate of adverse
events. The sample size was calculated according to the two stage design of Simon. We
hypothesized that alternate-day S-1 regimen would be effective if the TTF reached 3
months. Therefore, the present study was designed to detect a TTF of 4.5 months as
compared to a minimal TTF of 3 months, with an alpha error of 0.05 and a beta error
of 0.2. The required number was estimated as 37 patients.
Results: In 37 eligible patients, the median age was 74 years (46-83 years), with 27
males and 10 females. The median TTF was 5.3 months (95% CI, 3.5-7.1) and the
median OS was 12.1 months (95% CI, 9.6-14.6). The reason for treatment
discontinuation was progressive disease in all eligible patients, so the median PFS was
same as the median TTF. Of the 37 patients, 29 had measurable lesions according to
RECIST. Four patients showed partial response (PR), and RR was 13.8%. Eighteen
patients showed stable disease (SD). The disease control rate (PR + SD) was 75.9%.
Although half of the patients ware over 74 years, adverse events were relatively mild. All
grades neutropenia developed in 29.7%, and grade 3 neutropenia developed only in one
patients. Non-hematologic adverse events were rarely observed. Grade 1 anorexia,
nausea, fatigue, diarrhea and stomatitis developed in 13.5, 10.8, 13.5, 10.8 and 8.1%,
respectively. Only one patient experienced grade 2 anorexia.
Conclusion: A combination of alternate-day S-1 and lentinan treatment for
unresectable or recurrent gastric cancer is well-tolerated and effective, with a favorable
toxicity profile. The present combination regimen at this schedule is one of the
treatment options for elderly patients.
© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
All rights reserved. For permissions, please email: journals.permissions@oup.com.
posters
Annals of Oncology 27 (Supplement 2): ii1ii85, 2016
doi:10.1093/annonc/mdw199.84
Article
Background It is reported that natural glucan has many physiological and biological activities based on its special chemical structure. Scope and approach However, the structure-activity relationship of natural glucan is still unclear. This review discussed the extraction, activities and chemical properties of natural glucans. Key findings and conclusions Natural glucan has many powerful biological activities. Natural glucan is considered as a new type of natural medicine, which has significant pharmacological effects compared with common drugs. The market demand and the lack of research and development at home and abroad provide a good opportunity for the deep development and utilization of glucan. With the improvement of preparation technology and the innovation of separation and purification technology, glucan will be more and more widely used in the field of food industry.
ResearchGate has not been able to resolve any references for this publication.