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Journal of Immunology Research
Volume 2016 (2016), Article ID 1745108, 7 pages
http://dx.doi.org/10.1155/2016/1745108
Clinical Study

Randomized Phase II Study of Docetaxel plus Personalized Peptide Vaccination versus Docetaxel plus Placebo for Patients with Previously Treated Advanced Wild Type EGFR Non-Small-Cell Lung Cancer

1Department of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan
2Sendai Kousei Hospital, Sendai, Japan
3Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan
4Department of Respiratory Medicine, Miyagi Cancer Center, Miyagi, Japan
5Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan
6Department of Surgery, Kurume University School of Medicine, Kurume, Japan
7Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan
8Kanagawa Cancer Center Research Institute, Yokohama, Japan
9Biostatistics Center, School of Medicine, Kurume University, Kurume, Japan
10Center for Clinical and Translational Research, Kyushu University, Fukuoka, Japan
11Cancer Vaccine Development Division, Kurume University Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan
12Division of Clinical Research, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan
13Cancer Vaccine Center, Kurume University School of Medicine, Kurume, Japan

Received 25 January 2016; Accepted 7 April 2016

Academic Editor: Senthamil Selvan

Copyright © 2016 Koichi Takayama et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Objectives. To evaluate the efficacy and safety of personalized peptide vaccination (PPV) combined with chemotherapy for patients with previously treated advanced non-small-cell lung cancer (NSCLC). Patients and Methods. Previously treated PS0-1 patients with IIIB/IV EGFR (epidermal growth factor receptor) wild genotype NSCLC were randomly assigned to docetaxel (60 mg/m2 on Day 1) plus PPV based on preexisting host immunity or docetaxel plus placebo. Docetaxel administration was repeated every 3 weeks until disease progression. Personalized peptides or placebo was injected subcutaneously weekly in the first 8 weeks and biweekly in subsequent 16 weeks. The primary efficacy endpoint was progression-free survival (PFS). Results. PPV related toxicity was grade 2 or less skin reaction. The median PFS for placebo arm and PPV arm was 52 days and 59 days, respectively. There was no significant difference between two arms by log-rank test (). Interestingly, PFS and overall survival (OS) in humoral immunological responder were significantly longer than those in nonresponder. Conclusion. PPV did not improve the survival in combination with docetaxel for previously treated advanced NSCLC. However, PPV may be efficacious for the humoral immunological responders and a further clinical investigation is needed.