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.
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/m(2) 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 (p = 0.42). 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.
Department of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Koichi
K
Takayama
Sendai Kousei Hospital, Sendai, Japan.
Shunichi
S
Sugawara
Department of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
Yasuo
Y
Saijo
Department of Respiratory Medicine, Miyagi Cancer Center, Miyagi, Japan.
Makoto
M
Maemondo
Department of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, Japan.
Atsushi
A
Sato
Department of Surgery, Kurume University School of Medicine, Kurume, Japan.
Shinzo
S
Takamori
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Taishi
T
Harada
Kanagawa Cancer Center Research Institute, Yokohama, Japan.
Tetsuro
T
Sasada
Biostatistics Center, School of Medicine, Kurume University, Kurume, Japan.
Tatsuyuki
T
Kakuma
Center for Clinical and Translational Research, Kyushu University, Fukuoka, Japan.
Junji
J
Kishimoto
Cancer Vaccine Development Division, Kurume University Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Akira
A
Yamada
Division of Clinical Research, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, Japan.
Masanori
M
Noguchi
Cancer Vaccine Center, Kurume University School of Medicine, Kurume, Japan.
Kyogo
K
Itoh
Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.
Yoichi
Y
Nakanishi
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers; D019496:Cancer Vaccines / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000175:diagnosis / Q000235:genetics / Q000276:immunology / Q000628:therapy*; D000077143:Docetaxel; D066246:ErbB Receptors / Q000235:genetics; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007111:Immunity, Cellular; D056724:Immunity, Humoral; D008175:Lung Neoplasms / Q000175:diagnosis / Q000235:genetics / Q000276:immunology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D022223:Vaccines, Subunit / Q000008:administration & dosage* / Q000009:adverse effects
D000970:Antineoplastic Agents; D015415:Biomarkers; D019496:Cancer Vaccines; D043823:Taxoids; D022223:Vaccines, Subunit; D000077143:Docetaxel; D066246:ErbB Receptors