Prognostic factors related to add-on dendritic cell vaccines on patients with inoperable pancreatic cancer receiving chemotherapy: a multicenter analysis |
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Authors: | Masanori Kobayashi Shigetaka Shimodaira Kazuhiro Nagai Masahiro Ogasawara Hidenori Takahashi Hirofumi Abe Mitsugu Tanii Masato Okamoto Sun-ichi Tsujitani Seiichi Yusa Takefumi Ishidao Junji Kishimoto Yuta Shibamoto Masaki Nagaya Yoshikazu Yonemitsu |
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Institution: | 1. Seren Clinic Nagoya, Nagoya, Aichi, 460-0008, Japan 2. Cell Processing Center, Shinshu University Hospital, Matsumoto, Nagano, 390-8621, Japan 3. Transfusion and Cell Therapy Unit, Nagasaki University Hospital, Nagasaki, 852-8501, Japan 4. Department of Hematology, Sapporo Hokuyu Hospital, Sapporo, Hokkaido, 003-0006, Japan 5. Seren Clinic Fukuoka, Fukuoka, 810-0001, Japan 6. Seren Clinic Kobe, Kobe, Hyogo, 650-0001, Japan 7. Institute for Advanced Medical Research, Keio University School of Medicine, Tokyo, 160-8582, Japan 8. National Center for Global Health and Medicine, Tokyo, 162-8655, Japan 9. Research and Development Division, Tella Inc., Tokyo, Japan 10. Data Management Center, Center for Clinical and Translational Research, Kyushu University Hospital, Fukuoka, Japan 11. Department of Radiology, Nagoya City University Graduate School of Medical Sciences, Nagoya, 467-8601, Japan 12. Seren Clinic Tokyo, 2-10-2, Shirokanedai, Minato-ku, Tokyo, 108-0071, Japan 13. Department of Immunology, St. Marianna University, Kawasaki, 261-8511, Japan 14. R&D Laboratory for Innovative Biotherapeutics, Graduate School of Pharmaceutical Sciences, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
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Abstract: | Objective Dendritic cell (DC)-based cancer vaccines may have a significant benefit to patients with advanced pancreatic cancer. However, variations among clinical studies make it difficult to compare clinical outcomes. Here, we identified factors that determined the clinical benefits by analyzing data obtained at seven Japanese institutions that employed the same DC preparation and treatment regimens. Methods Of 354 patients who met the inclusion criteria, 255 patients who received standard chemotherapy combined with peptide-pulsed DC vaccines were analyzed. Results The mean survival time from diagnosis was 16.5 months (95 % CI 14.4–18.5) and that from the first vaccination was 9.9 months (95 % CI 8.0–12.9). Known prognostic baseline factors related to advanced pancreatic cancer, namely ECOG-PS, peritoneal metastasis, liver metastasis, and the prognostic nutrition index, were also representative. Importantly, we found that erythema reaction after vaccination was an independent and treatment-related prognostic factor for better survival and that OK-432 might be a good adjuvant enhancing the antitumor immunity during DC vaccination. Conclusions This is the first report of a multicenter clinical study suggesting the feasibility and possible clinical benefit of an add-on DC vaccine in patients with advanced pancreatic cancer who are undergoing chemotherapy. These findings need to be addressed in well-controlled prospective randomized trials. |
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