Cancer Chemotherapy and Pharmacology

, Volume 71, Issue 2, pp 481–488 | Cite as

A randomized phase II study of biweekly irinotecan monotherapy or a combination of irinotecan plus 5-fluorouracil/leucovorin (mFOLFIRI) in patients with metastatic gastric adenocarcinoma refractory to or progressive after first-line chemotherapy

  • Sun Jin Sym
  • Junshik Hong
  • Jinny Park
  • Eun Kyung Cho
  • Jae Hoon Lee
  • Yeon Ho Park
  • Woon Ki Lee
  • Min Chung
  • Hyung-Sik Kim
  • Se Hoon Park
  • Dong Bok ShinEmail author
Original Article



The aim of this study was to evaluate the efficacy of irinotecan (CPT-11) monotherapy and CPT-11 plus 5-fluorouracil (5-FU)/leucovorin (LV) combination (mFOLFIRI) as second-line treatment in patients with advanced gastric cancer (AGC).


A total of 59 patients were randomly assigned to either CPT-11 (150 mg/m2 iv on day 1) or mFOLFIRI (CPT-11 150 mg/m2 plus LV 20 mg/m2 on day 1 followed by 5-FU 2,000 mg/m2 over 48 h), every 2 weeks. The primary end point was objective response rate (ORR).


Following random assignment, 29 patients received CPT-11 and 30 patients mFOLFIRI. The ORR was 17.2 % [95 % confidence interval (CI) 3.4–30.9] and 20.0 % (95 % CI 5.6–34.3) for the CPT-11 and mFOLFIRI arms, respectively (P = 0.525). There was no significant difference in median progression-free survival: 2.2 months (95 % CI 0.2–4.3) for CPT-11 versus 3.0 months (95 % CI 2.0–3.7) for mFOLFIRI (P = 0.481) or in median overall survival: 5.8 months (95 % CI 3.0–8.7), compared with 6.7 months (95 % CI 5.3–8.2) (P = 0.514). Grade 3/4 toxicity was observed in 21 and 28 events in the CPT-11 and mFOLFIRI arms, respectively.


Although this study had a small sample size and limited statistical power, CPT-11 monotherapy and mFOLFIRI appear to be equally active and tolerable as second-line chemotherapy for AGC. The addition of 5-FU/LV to CPT-11 did not significantly improve efficacy.


Stomach cancer Second-line Chemotherapy Irinotecan 



We thank the patients involved in this study and their families.

Conflict of interest

None declared.


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Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  • Sun Jin Sym
    • 1
  • Junshik Hong
    • 1
  • Jinny Park
    • 1
  • Eun Kyung Cho
    • 1
  • Jae Hoon Lee
    • 1
  • Yeon Ho Park
    • 2
  • Woon Ki Lee
    • 2
  • Min Chung
    • 2
  • Hyung-Sik Kim
    • 3
  • Se Hoon Park
    • 4
  • Dong Bok Shin
    • 1
    Email author
  1. 1.Division of Hematology and Oncology, Department of Internal MedicineGachon University Gil HospitalIncheonRepublic of Korea
  2. 2.Department of General SurgeryGachon University Gil HospitalIncheonRepublic of Korea
  3. 3.Department of RadiologyGachon University Gil HospitalIncheonRepublic of Korea
  4. 4.Division of Hematology and Oncology, Department of MedicineSungkyunkwan University Samsung Medical CenterSeoulRepublic of Korea

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