PMID- 20664989 OWN - NLM STAT- MEDLINE DCOM- 20101123 LR - 20221207 IS - 1791-2431 (Electronic) IS - 1021-335X (Linking) VI - 24 IP - 3 DP - 2010 Sep TI - A phase II study of personalized peptide vaccination combined with gemcitabine for non-resectable pancreatic cancer patients. PG - 795-801 AB - We evaluated the safety of, and clinical and immune responses to personalized peptide vaccination with gemcitabine (GEM) as the first line therapy in patients with non-resectable pancreatic cancer. Pre-vaccination peripheral blood mononuclear cells (PBMCs) and plasma were prepared to examine cellular and humoral responses to 14 and 16 peptides in human leukocyte antigen (HLA)-A24+ or -A2+ patients, respectively. Only the reactive peptides (maximum of 4) were administered weekly at 3 mg/peptide. GEM was administered at 1000 mg/m(2) per week for 3 weeks, followed by 1 week of rest. Twenty-one patients with untreated and non-resectable pancreatic cancer were enrolled. The combination therapy was generally well tolerated. Boosting of cellular and humoral responses to the vaccinated peptides was observed in the post-vaccination (eighth) PBMCs and plasma from 14 of 18 and 13 of 18 patients tested, respectively. The best clinical responses were 7 cases of partial response, 9 cases of stable disease, and 5 cases of progressive disease. Median survival time of all 21 patients was 9.0 months (95% CI, 6-15.5 months) with a one year survival rate of 38%. Immune boosting in both cellular and humoral responses was well correlated with overall survival with a hazard ratio of 0.2 (95% CI, 0.06-0.73; log-rank p=0.0239). These results suggest a potential clinical benefit of this combination therapy for non-resectable pancreatic cancer patients as the first line therapy. Further exploration of this approach is warranted. FAU - Yanagimoto, Hiroaki AU - Yanagimoto H AD - Department of Surgery, Kansai Medical University, Hirakata, Japan. FAU - Shiomi, Hisanori AU - Shiomi H FAU - Satoi, Sohei AU - Satoi S FAU - Mine, Takashi AU - Mine T FAU - Toyokawa, Hideyoshi AU - Toyokawa H FAU - Yamamoto, Tomohisa AU - Yamamoto T FAU - Tani, Tohru AU - Tani T FAU - Yamada, Akira AU - Yamada A FAU - Kwon, A-Hon AU - Kwon AH FAU - Komatsu, Nobukazu AU - Komatsu N FAU - Itoh, Kyogo AU - Itoh K FAU - Noguchi, Masanori AU - Noguchi M LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study PT - Research Support, Non-U.S. Gov't PL - Greece TA - Oncol Rep JT - Oncology reports JID - 9422756 RN - 0 (Antimetabolites, Antineoplastic) RN - 0 (Cancer Vaccines) RN - 0 (HLA Antigens) RN - 0 (Vaccines, Subunit) RN - 0W860991D6 (Deoxycytidine) RN - 0 (Gemcitabine) SB - IM MH - Aged MH - Aged, 80 and over MH - Antimetabolites, Antineoplastic/adverse effects/*therapeutic use MH - Cancer Vaccines/adverse effects/*therapeutic use MH - Deoxycytidine/adverse effects/*analogs & derivatives/therapeutic use MH - Female MH - HLA Antigens/immunology MH - Humans MH - Immunity, Cellular MH - Immunity, Humoral MH - Japan MH - Kaplan-Meier Estimate MH - Male MH - Middle Aged MH - Neoplasm Staging MH - Pancreatic Neoplasms/drug therapy/immunology/mortality/pathology/*therapy MH - Time Factors MH - Treatment Outcome MH - Vaccines, Subunit/therapeutic use MH - Gemcitabine EDAT- 2010/07/29 06:00 MHDA- 2010/12/14 06:00 CRDT- 2010/07/29 06:00 PHST- 2010/07/29 06:00 [entrez] PHST- 2010/07/29 06:00 [pubmed] PHST- 2010/12/14 06:00 [medline] AID - 10.3892/or_00000923 [doi] PST - ppublish SO - Oncol Rep. 2010 Sep;24(3):795-801. doi: 10.3892/or_00000923.