Investigational New Drugs

, Volume 31, Issue 1, pp 152–159 | Cite as

Phase II study of irinotecan plus capecitabine in anthracycline- and taxane- pretreated patients with metastatic breast cancer

  • Keun Seok Lee
  • In Hae Park
  • Byung-Ho Nam
  • Jungsil RoEmail author


To evaluate the efficacy and tolerability of combined treatment with irinotecan (I) and capecitabine (X), we conducted a phase II study of the IX combination in anthracycline- and taxane-pretreated patients with metastatic breast cancer (MBC). Patients received 80 mg/m2 I on days 1 and 8 and 1,000 mg/m2 X twice daily on days 1–14 of 21-day cycles until disease progression. The primary endpoint was the objective response rate (ORR), and the secondary endpoints were progression-free survival (PFS), overall survival (OS), and safety. Thirty-six patients were enrolled between September 2006 and April 2008. The median follow-up was 47.6 months. The ORR was 58.3 % (95 % CI, 42.2–72.9), with 3 complete responses and 18 partial responses. The median PFS was 7.6 months (95 % CI, 5.0–10.2), and the median OS was 20.0 months (95 % CI, 11.6–28.4). Neutropenia was the most common adverse event (grade 3, 30.6 %; grade 4, 27.8 %) with febrile neutropenia in 2 patients (5.6 %). Three patients (8.3 %) had grade 3 diarrhea, 3 patients (8.3 %) had grade 3 asthenia, and 1 patient (2.8 %) had grade 3 hand-foot syndrome. The IX combination was effective and tolerable for anthracycline- and taxane-pretreated patients with MBC. A phase III trial of this combination is ongoing.


Capecitabine Chemotherapy Irinotecan Metastatic breast cancer 



Supported in part by NCC grant 0610240–3. Irinotecan was supplied by Shin Poong Pharmaceutical Co. Ltd.


The authors have declared no conflicts of interest.


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Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Keun Seok Lee
    • 1
  • In Hae Park
    • 1
  • Byung-Ho Nam
    • 1
  • Jungsil Ro
    • 1
    Email author
  1. 1.Center for Breast CancerResearch Institute and Hospital, National Cancer CenterGoyang-siRepublic of Korea

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