Prognostic significance of adoptive immunotherapy with tumor-associated lymphocytes in patients with advanced gastric cancer: a randomized trial.
OBJECTIVE
We performed adoptive immunotherapy (AIT)with tumor-associated lymphocytes (TALs) in combination with chemotherapy in patients with advanced-stage gastric cancer in a randomized controlled study and investigated whether or not an improved survival effect is observed with AIT.


METHODS
Forty-four consecutive patients with stage IV gastric cancer [staged according to the International Union against Cancer classification] were prospectively assigned to the control group (chemotherapy alone) or the AIT group (AIT plus chemotherapy). Patients in the AIT group received an adoptive transfer of cultured TALs in combination with low-dose cisplatinum/5-fluorouracil chemotherapy, whereas patients in the control group received chemotherapy alone.


RESULTS
The 50% survival rates were 11.5 and 8.3 months in the AIT and control groups, respectively. The overall survival of patients in the AIT group was significantly better than that of patients in the control group, as analyzed by the log-rank test (P < 0.05). Multivariate analysis with Cox's proportional hazards model revealed that AIT provided an independent prognostic factor, indicating that AIT influenced patient survival in a positive manner.


CONCLUSIONS
AIT with TALs in combination with chemotherapy was effective in prolonging survival in patients with stage IV gastric cancer.
Kono
Koji
K
First Department of Surgery, Yamanashi Medical University, 1110 Tamaho, Yamanashi 409-3898, Japan. kojikono@res.yamanashi-med.ac.jp
Takahashi
Akihiro
A
Ichihara
Fumiko
F
Amemiya
Hideki
H
Iizuka
Hidehiko
H
Fujii
Hideki
H
Sekikawa
Takayoshi
T
Matsumoto
Yoshiro
Y
D000368:Aged; D015703:Antigens, CD / Q000276:immunology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D016219:Immunotherapy, Adoptive; D008207:Lymphatic Metastasis / Q000473:pathology; D016246:Lymphocytes, Tumor-Infiltrating / Q000276:immunology*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D015996:Survival Rate; D014409:Tumor Necrosis Factor-alpha / Q000378:metabolism
D015703:Antigens, CD; D014409:Tumor Necrosis Factor-alpha; D002945:Cisplatin; D005472:Fluorouracil