Safety of BLP25 liposome vaccine (L-BLP25) in Japanese patients with unresectable stage III NSCLC after primary chemoradiotherapy: preliminary results from a Phase I/II study.

Jpn J Clin Oncol 2011 May 9;41(5):718-22. Epub 2011 Mar 9.

The Cancer Institute Hospital of JFCR, 3-10-6 Ariake, Koto-ku, Tokyo 135-8550, Japan.

Preliminary safety findings are presented from the open-label Phase I part of a combined Phase I/II study of BLP25 liposome vaccine (L-BLP25) in Japanese patients with unresectable Stage III non-small-cell lung cancer after primary chemoradiotherapy. Six patients received four or more once-weekly vaccinations with L-BLP25 1000 μg subcutaneously prior to a preliminary safety evaluation. Treatment continued with once-weekly vaccinations with L-BLP25 1000 μg subcutaneously until week 8, then maintenance vaccinations every 6 weeks until progressive disease. Cyclophosphamide (300 mg/m(2) i.v. single dose) was given 3 days before first vaccination. Median age was 63.5 years and performance status was 0-1. No serious adverse events occurred; none necessitated discontinuation. L-BLP25-related adverse events (Grade 1) were myalgia, arthralgia and nausea; cyclophosphamide-related adverse events comprised dysgeusia, anorexia and nausea. The first evaluation of L-BLP25 in Japanese patients shows that it is well tolerated, and the safety profile is consistent with that seen in previous studies of Caucasian patients.

Download full-text PDF

Source
http://dx.doi.org/10.1093/jjco/hyr021DOI Listing
May 2011
2 Reads

Publication Analysis

Top Keywords

l-blp25 japanese
12
japanese patients
12
adverse events
12
stage iii
8
1000 μg
8
l-blp25 1000
8
unresectable stage
8
once-weekly vaccinations
8
preliminary safety
8
i/ii study
8
phase i/ii
8
primary chemoradiotherapy
8
patients unresectable
8
vaccinations l-blp25
8
blp25 liposome
8
liposome vaccine
8
μg subcutaneously
8
vaccine l-blp25
8
l-blp25
5
patients
5

References

(Supplied by CrossRef)

CA: A Cancer Journal for Clinicians 2008

Japanese Journal of Clinical Oncology 2008

Annals of Oncology 2009

Ettinger et al.
Journal of the National Comprehensive Cancer Network 2006

Okamoto et al.
International journal of clinical oncology / Japan Society of Clinical Oncology 2008

Furuse et al.
Journal of Clinical Oncology 1999

ONCOLOGY WILLISTON PARK 2007

Ho et al.
Cancer Research 1993

Zotter et al.
International journal of cancer. Supplement = Journal international du cancer. Supplement 1988

Agrawal et al.
International Immunology 1998

Guan et al.
Bioconjugate chemistry 1998

Similar Publications