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Prognostic factors related to add-on dendritic cell vaccines on patients with inoperable pancreatic cancer receiving chemotherapy: a multicenter analysis
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
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
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.
Keywords:
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