Phase III trial of radiosensitizer PR-350 combined with intraoperative radiotherapy for the treatment of locally advanced pancreatic cancer.
A randomized, controlled trial was conducted to clarify the effect of novel radiosensitizer, PR-350, accompanied by intraoperative radiology (IOR) on locally advanced pancreatic cancer. Between July 1999 and March 2002, 48 patients were enrolled in this clinical trial and received either PR-350 or placebo. Any differences between the PR-350 group (n = 22) and control group (n = 25) were not statically significant. All patients were evaluated, and none of them showed toxicity, with the exception of 1 patient from the control group, and the PR-350 compound was considered to be safe. The efficacy of IOR with PR-350 was evaluated using CT examination. The committee responsible for evaluating efficacy reported that 47.4% of the PR-350 group showed the effective response, compared with 21.7% of the control group (P = 0.1067, Fisher analysis). At 6 months following treatment, the tumor mass reduction rate in the PR-350 group was significantly improved (P = 0.0274). By the time of the last follow-up in July 2003, 17 PR-350 patients and 24 control patients group had died of the disease. The median survival period of the PR-350 group was thus 318.5 days and that of the control group is 303.0 days. One-year survival rates of the PR-350 group and control group were 36.4% and 32.0%, respectively. Although the PR-350 group did not demonstrate significantly better survival than the control group, 4 of 22 PR-350 patients were still living more than 2 years after the end of the trial, compared with only 1 of 25 patients from the control group. The mechanism of this increased therapeutic response to radiotherapy using PR-350 must be clarified to establish more effective strategy for pancreatic cancer treatment.
Sunamura
Makoto
M
Division of Gastroenterological Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan. msun-thk@umin.ac.jp
Karasawa
Katsuyuki
K
Okamoto
Atutake
A
Ogata
Yoshiro
Y
Nemoto
Kenji
K
Hosotani
Ryo
R
Nishimura
Yasumasa
Y
Matsui
Kenichi
K
Matsuno
Seiki
S
D000230:Adenocarcinoma / Q000175:diagnosis / Q000532:radiotherapy* / Q000601:surgery; D000368:Aged; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects / Q000737:chemistry / Q000627:therapeutic use*; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000175:diagnosis / Q000532:radiotherapy* / Q000601:surgery; D011838:Radiation-Sensitizing Agents / Q000009:adverse effects / Q000737:chemistry; D016019:Survival Analysis
D007093:Imidazoles; D011838:Radiation-Sensitizing Agents; C106738:doranidazole