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 re...
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| Format: | Article |
| Language: | English |
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Wiley
2016-01-01
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| Series: | Journal of Immunology Research |
| Online Access: | http://dx.doi.org/10.1155/2016/1745108 |
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| author | Koichi Takayama Shunichi Sugawara Yasuo Saijo Makoto Maemondo Atsushi Sato Shinzo Takamori Taishi Harada Tetsuro Sasada Tatsuyuki Kakuma Junji Kishimoto Akira Yamada Masanori Noguchi Kyogo Itoh Yoichi Nakanishi |
| author_facet | Koichi Takayama Shunichi Sugawara Yasuo Saijo Makoto Maemondo Atsushi Sato Shinzo Takamori Taishi Harada Tetsuro Sasada Tatsuyuki Kakuma Junji Kishimoto Akira Yamada Masanori Noguchi Kyogo Itoh Yoichi Nakanishi |
| author_sort | Koichi Takayama |
| collection | DOAJ |
| description | 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 (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. |
| format | Article |
| id | doaj-art-63b25f2fda2442d389ea8c13949a9802 |
| institution | Kabale University |
| issn | 2314-8861 2314-7156 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Immunology Research |
| spelling | doaj-art-63b25f2fda2442d389ea8c13949a98022025-02-03T05:47:17ZengWileyJournal of Immunology Research2314-88612314-71562016-01-01201610.1155/2016/17451081745108Randomized 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 CancerKoichi Takayama0Shunichi Sugawara1Yasuo Saijo2Makoto Maemondo3Atsushi Sato4Shinzo Takamori5Taishi Harada6Tetsuro Sasada7Tatsuyuki Kakuma8Junji Kishimoto9Akira Yamada10Masanori Noguchi11Kyogo Itoh12Yoichi Nakanishi13Department of Respirology, Kyoto Prefectural University of Medicine, Kyoto, JapanSendai Kousei Hospital, Sendai, JapanDepartment of Medical Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, JapanDepartment of Respiratory Medicine, Miyagi Cancer Center, Miyagi, JapanDepartment of Medical Oncology, Hirosaki University Graduate School of Medicine, Hirosaki, JapanDepartment of Surgery, Kurume University School of Medicine, Kurume, JapanResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanKanagawa Cancer Center Research Institute, Yokohama, JapanBiostatistics Center, School of Medicine, Kurume University, Kurume, JapanCenter for Clinical and Translational Research, Kyushu University, Fukuoka, JapanCancer Vaccine Development Division, Kurume University Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, JapanDivision of Clinical Research, Research Center for Innovative Cancer Therapy, Kurume University School of Medicine, Kurume, JapanCancer Vaccine Center, Kurume University School of Medicine, Kurume, JapanResearch Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, JapanObjectives. 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 (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.http://dx.doi.org/10.1155/2016/1745108 |
| spellingShingle | Koichi Takayama Shunichi Sugawara Yasuo Saijo Makoto Maemondo Atsushi Sato Shinzo Takamori Taishi Harada Tetsuro Sasada Tatsuyuki Kakuma Junji Kishimoto Akira Yamada Masanori Noguchi Kyogo Itoh Yoichi Nakanishi 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 Journal of Immunology Research |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://dx.doi.org/10.1155/2016/1745108 |
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