Phase II trial of S-1 and concurrent radiotherapy in patients with locally advanced pancreatic cancer.
OBJECTIVE
S-1 has a favorable effect in unresectable pancreatic cancer and a potential radiosensitizer. In addition, daily oral administration of S-1 is more convenient than continuous infusion of 5-fluorouracil. This study was designed to evaluate the efficacy and safety of S-1 and concurrent radiotherapy in patients with locally advanced pancreatic cancer.


METHODS
Eligibility criteria were histologically proven pancreatic adenocarcinoma, locally advanced disease, and no previous treatment. S-1 was administered orally at a dose of 40 mg/m(2) twice daily from day 1 to 14 and from day 22 to 35, and concurrent radiotherapy (a total dose of 50.4 Gy) was delivered in 28 fractions. One month after treatment completion, tumor response was evaluated by computed tomography (CT).


RESULTS
A total of 25 patients were evaluable for efficacy and toxicity on the basis of the intention-to-treat analysis. The response rate and disease control rate were 24.0 and 68.0%, respectively. There was no treatment-related death or grade 4 toxicity. The most common grade 3 hematologic and non-hematologic toxicities were thrombocytopenia (4.0%) and anorexia (20%), respectively. All toxicities were tolerable and transient. The median time-to-progression and median overall survival were 6.5 months (95% confidence interval, 4.1-9.0 months) and 12.9 months (95% confidence interval, 6.7-19.0 months), respectively, and the 1-year survival rate was estimated to be 43%.


CONCLUSIONS
S-1 and concurrent radiotherapy shows favorable efficacy for disease control against locally advanced pancreatic cancer and was well tolerated with no severe toxicities.
Kim
Hee Man
HM
Division of Gastroenterology, Department of Internal Medicine and Yonsei Institute of Gastroenterology, Yonsei University College of Medicine, Seongsanno, Seodaemun-gu, Seoul, Republic of Korea.
Bang
Seungmin
S
Park
Jeong Youp
JY
Seong
Jinsil
J
Song
Si Young
SY
Chung
Jae Bock
JB
Park
Seung Woo
SW
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003131:Combined Modality Therapy; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D015996:Survival Rate; D005641:Tegafur / Q000627:therapeutic use*; D016896:Treatment Outcome
D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid