Irinotcan is not FDA approved. It is also not particularly effective in taxane pre-treated patients.A retrospective analysis showed that salvage chemotherapy with irinotecan may be inactive against advanced and metastatic breast cancer pretreated with both doxorubicin and docetaxel. The objective response rate was only 5.0% (95% CI: 0–15.5%) and the median time to progression was 35 days. These results indicated very low activity compared with the result of phase II trials in Japan, in which docetaxel had not been used in previous treatment. The most recent study, showed that it is an active drug but concluded: “Irinotecan is active with good tolerability in refractory MBC. Irinotecan (especially weekly) warrants additional study as monotherapy and in combination regimens in this setting.”
E. A. Perez, D. W. Hillman, J. A. Mailliard, J. N. Ingle, J. M. Ryan, T. R. Fitch, K. M. Rowland, C. G. Kardinal, J. E. Krook, J. W. Kugler, et al.
Randomized Phase II Study of Two Irinotecan Schedules for Patients With Metastatic Breast Cancer Refractory to an Anthracycline, a Taxane, or Both
J. Clin. Oncol., July 15, 2004; 22(14): 2849 – 2855.
Yasushi Shigeoka , Kuniaki Itoh , Tadahiko Igarashi , Kenichi Ishizawa , Toshiaki Saeki , Hirofumi Fujii , Hironobu Minami , Shigeru Imoto , and Yasutsuna Sasaki
Clinical Effect of Irinotecan in Advanced and Metastatic Breast Cancer Patients Previously Treated with Doxorubicin- and Docetaxel-containing Regimens
Jpn. J. Clin. Oncol. 31: 370-374.