title: Phase I/II study of adjuvant immunotherapy with sentinel lymph node T lymphocytes in patients with colorectal cancer.
abstract: Although the development of multi-disciplinary management has improved the survival of colorectal cancer (CRC), the prognosis of metastatic CRC patients remains poor. Accumulating evidence has demonstrated that immunotherapy with cancer vaccines and adoptive T cell transfusions may improve outcomes as an adjuvant to current standard CRC treatment. In this phase I/II study, 71 CRC patients who underwent radical surgery (stage I-III, n = 46) or palliative surgery (stage IV with non-resectable synchronous metastases, n = 25) were included. In the first part of this study, sentinel lymph nodes (SLNs) were intraoperatively identified in 55 patients (46 with stage I-III CRC and 9 with stage IV CRC). SLN-T lymphocytes were expanded ex vivo for a median of 28.5 days (range 23-33 days). Thereafter, a median of 153 × 10(6) cells (range 20.7-639.0 × 10(6)) were transfused. No treatment-related toxicity was observed. In the second part of this study, the stage IV patients were routinely followed. The 24-month survival rate of the SLN-T lymphocyte group was significantly higher than that of the control group: 55.6 versus 17.5% (p = 0.02). The median overall survival of the SLN-T lymphocyte and control groups was 28 and 14 months, respectively. Our study showed that adjuvant SLN-T lymphocyte immunotherapy is feasible and safe for postoperative CRC patients. Additionally, this therapy may improve the long-term survival of metastatic CRC. Further investigation of the clinical efficacy and anti-tumor immunity is warranted.
authors.affiliation: Department of Colorectal Surgery, The Affiliated Hospital of Guiyang Medical College, Guiyang, People's Republic of China.
authors.forename: Yun-Huan
authors.initials: YH
authors.lastname: Zhen
authors.forename: Xiao-Hui
authors.initials: XH
authors.lastname: Liu
authors.forename: Yuan
authors.initials: Y
authors.lastname: Yang
authors.forename: Bo
authors.initials: B
authors.lastname: Li
authors.forename: Jing-Ling
authors.initials: JL
authors.lastname: Tang
authors.forename: Qiang-Xing
authors.initials: QX
authors.lastname: Zeng
authors.forename: Jie
authors.initials: J
authors.lastname: Hu
authors.forename: Xing-Nan
authors.initials: XN
authors.lastname: Zeng
authors.forename: Lu
authors.initials: L
authors.lastname: Zhang
authors.forename: Ze-Jun
authors.initials: ZJ
authors.lastname: Wang
authors.forename: Xiao-Yun
authors.initials: XY
authors.lastname: Li
authors.forename: Hui-Xin
authors.initials: HX
authors.lastname: Ge
authors.forename: Ola
authors.initials: O
authors.lastname: Winqvist
authors.forename: Ping-Sheng
authors.initials: PS
authors.lastname: Hu
authors.forename: Jin
authors.initials: J
authors.lastname: Xiu
mesh_terms: D000276:Adjuvants, Immunologic; D000368:Aged; D015179:Colorectal Neoplasms / Q000276:immunology* / Q000473:pathology / Q000628:therapy*; D005260:Female; D006801:Humans; D007167:Immunotherapy / Q000379:methods*; D016219:Immunotherapy, Adoptive / Q000379:methods*; D008198:Lymph Nodes / Q000473:pathology*; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D013601:T-Lymphocytes / Q000276:immunology* / Q000473:pathology / Q000637:transplantation*
chemical_list: D000276:Adjuvants, Immunologic