title: Efficacy and safety of irinotecan plus S-1 (IRIS) therapy to treat advanced/recurrent colorectal cancer.
abstract: BACKGROUND
  5-Fluorouracil (5-FU), leucovorin, and oxaliplatin (FOLFOX) therapy and 5-FU, leucovorin, and irinotecan (FOLFIRI) therapy are standard chemotherapies to treat advanced/recurrent colorectal cancer. However, these chemotherapies require continuous infusion of 5-FU for a prolonged time of 40 h or more, every two weeks. Accordingly, these chemotherapies require hospitalization and placement of a central venous catheter. Because of frequent catheterization, long-term use of these therapies potentially risks complications such as infection and thrombosis. In contrast, S-1 (tegaful, gimeracil, oteracil) combined with irinotecan (IRIS) therapy involves giving one drug orally and infusing the other for about two hours every two weeks, so placement of a central venous catheter is not necessary. The current study examined the efficacy and safety of IRIS therapy in 90 patients at this Hospital who underwent such therapy to treat advanced/recurrent colorectal cancer.
  
  
  METHODS
  The study comprised 90 patients who underwent IRIS therapy to treat advanced/recurrent colorectal cancer from December 2004 to December 2011.
  
  
  RESULTS
  The ratio of male-to-female patients was 64:26. The mean age at the start of IRIS therapy was 64.5 years, and patients underwent an average of 11 courses of therapy. The response rate to IRIS therapy was 14.8%, the disease control rate was 60.5%, and the overall survival time was 26.7 months. The incidence of adverse events was 70.0%, and the incidence of grade 3 or more severe adverse reactions was 17.8%.
  
  
  CONCLUSIONS
  In comparison to the standard therapies of FOLFOX and FOLFIRI, IRIS therapy had a lower response rate but led to an equivalent overall survival time. IRIS therapy had a low incidence of serious adverse events and allowed patients to continue therapy on an out-patient basis. These findings indicate that IRIS therapy may be a useful form of chemotherapy to treat advanced/recurrent colorectal cancer.
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan daijiro@fukuoka-u.ac.jp.
authors: Daijiro
authors: D
authors: Higashi
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Yuji
authors: Y
authors: Egawa
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Yukiko
authors: Y
authors: Hirano
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Kimikazu
authors: K
authors: Hirano
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Toru
authors: T
authors: Miyake
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Hiroyuki
authors: H
authors: Takahashi
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Shugo
authors: S
authors: Uwatoko
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Sosei
authors: S
authors: Abe
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Satoshi
authors: S
authors: Yamamoto
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Koji
authors: K
authors: Mikami
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Kitaro
authors: K
authors: Futami
authors: Department of Surgery, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Takafumi
authors: T
authors: Maekawa
authors: Department of Pharmacy, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Ryuichi
authors: R
authors: Inoue
authors: Department of Pharmacy, Fukuoka University Chikushi Hospital, Chikushino-shi, Fukuoka, Japan.
authors: Motoyasu
authors: M
authors: Miyazaki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000401:mortality; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin
keywords: Colorectal cancer; S-1; chemotherapy; irinotecan