Surgery versus radiochemotherapy for resectable locally invasive pancreatic cancer: final results of a randomized multi-institutional trial.
OBJECTIVE
Although the outcome of surgery for locally advanced pancreatic cancer remains poor, it is improving, with 5-year survival up to about 10% in Japan. The preliminary results of our multi-institutional randomized controlled trial revealed better survival after surgery than after radiochemotherapy. We report the final results of this study after 5 years of follow-up.


METHODS
Patients with preoperative findings of pancreatic cancer invading the pancreatic capsule without involvement of the superior mesenteric or common hepatic arteries, or distant metastasis, were included in this randomized controlled trial, with their consent. If the laparotomy findings were consistent with these criteria, the patient was randomized to a surgery group or a radiochemotherapy group (5-fluorouracil 200 mg/m2/day and 5040 Gy radiotherapy). We compared the mean survival time, 3-and 5-year survival rates, and hazard ratio.


RESULTS
The surgery and radiochemotherapy groups comprised 20 and 22 patients, respectively. Patients were followed up for 5 years or longer, or until an event occurred to preclude this. The surgery group had significantly better survival than the radiochemotherapy group (P<0.03). Surgery increased the survival time and 3-year survival rate by an average of 11.8 months and 20%, respectively, and it halved the instantaneous mortality (hazard) rate.


CONCLUSIONS
Locally invasive pancreatic cancer without distant metastases or major arterial invasion is treated most effectively by surgical resection.
Doi
Ryuichiro
R
Department of Surgery, Kyoto University, 54 Shogoinkawaracho, Sakyo-ku, Kyoto, 606-8507, Japan.
Imamura
Masayuki
M
Hosotani
Ryo
R
Imaizumi
Toshihide
T
Hatori
Takashi
T
Takasaki
Ken
K
Funakoshi
Akihiro
A
Wakasugi
Hideyuki
H
Asano
Takehide
T
Hishinuma
Shoichi
S
Ogata
Yoshiro
Y
Sunamura
Makoto
M
Yamaguchi
Koji
K
Tanaka
Masao
M
Takao
Sonshin
S
Aikou
Takashi
T
Hirata
Koichi
K
Maguchi
Hiroyuki
H
Aiura
Koichi
K
Aoki
Tatsuya
T
Kakita
Akira
A
Sasaki
Makoto
M
Ozaki
Masahiko
M
Matsusue
Satoru
S
Higashide
Shunichi
S
Noda
Hideki
H
Ikeda
Seiyo
S
Maetani
Shunzo
S
Yoshida
Shigeaki
S
D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005472:Fluorouracil / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010180:Pancreatectomy; D010190:Pancreatic Neoplasms / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery*; D016019:Survival Analysis
D000970:Antineoplastic Agents; D005472:Fluorouracil