title: Phase II study of irinotecan plus capecitabine in anthracycline- and taxane- pretreated patients with metastatic breast cancer.
abstract: 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/m(2) I on days 1 and 8 and 1,000 mg/m(2) 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.
authors.affiliation: Center for Breast Cancer, Research Institute and Hospital, National Cancer Center, 809 Madu-1-dong, Ilsandong-gu, Goyang-si, Gyeonggi-do 410-769, Republic of Korea.
authors.forename: Keun Seok
authors.initials: KS
authors.lastname: Lee
authors.forename: In Hae
authors.initials: IH
authors.lastname: Park
authors.forename: Byung-Ho
authors.initials: BH
authors.lastname: Nam
authors.forename: Jungsil
authors.initials: J
authors.lastname: Ro
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D000077146:Irinotecan; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D043823:Taxoids; D003841:Deoxycytidine; C080625:taxane; D000069287:Capecitabine; D000077146:Irinotecan; D005472:Fluorouracil; D002166:Camptothecin