Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE randomized clinical trial

被引:2
作者
Schmidt, Marcus [1 ]
Nitz, Ulrike [2 ]
Reimer, Toralf [3 ]
Schmatloch, Sabine [4 ]
Graf, Heiko [5 ]
Just, Marianne [6 ]
Stickeler, Elmar [7 ]
Untch, Michael [8 ]
Runnebaum, Ingo [9 ]
Belau, Antje [10 ]
Huober, Jens [11 ,12 ]
Jackisch, Christian [13 ]
Hofmann, Manfred [14 ]
Krocker, Jutta [15 ]
Nekljudova, Valentina [16 ]
Loibl, Sibylle [16 ]
机构
[1] Univ Klinikum Mainz, Mainz, Germany
[2] West German Study Grp, Monchengladbach, Germany
[3] Univ Frauenklin, Klinikum Sudstadt, Rostock, Germany
[4] Elisabeth Hosp, Kassel, Germany
[5] HELIOS Klinikum Meiningen GmbH, Meiningen, Germany
[6] Onkol Schwerpunktpraxis, Bielefeld, Germany
[7] Klin Gynakol & Geburtsmedizin, Klin Gynakol & Geburtsmed, Aachen, Germany
[8] HELIOS Klin, Berlin, Germany
[9] Klinik, Klinik & Poliklin Frauenheilkunde & Fortpflanzungs, Jena, Germany
[10] Frauenarztpraxis Belau, Greifswald, Germany
[11] Univ Klinikum Ulm, Ulm, Germany
[12] Dept Interdisziplinare Med Dienste, Kantonsspital St Gallen, Brustzentrum, St Gallen, Switzerland
[13] Sana Klinikum Offenbach, Offenbach, Germany
[14] Vinzenz von Paul Kliniken, Vinzenz von Paul Klin, Stuttgart, Germany
[15] Sana Klinikum Lichtenberg, Berlin, Germany
[16] German Breast Grp, Dornhofstr 10, D-63263 Neu Isenburg, Germany
关键词
Breast cancer; Clinical trial; Adjuvant therapy; Capecitabine; Ibandronate; PHASE-II TRIAL; WOMEN; CHEMOTHERAPY; AGE; THERAPY; OSTEOPOROSIS; COMORBIDITY;
D O I
10.1016/j.ejca.2023.113324
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Aim of the study: Evaluation of the impact of a de-escaleted chemotherapy regimen consisting of capecitabine (Cap) on invasive disease-free survival (iDFS) in patients >= 65 years with node-positive/high-risk node-negative early breast cancer (BC) receiving ibandronate (Ib). Methods: ICE (Ib with or without Cap in Elderly patients with early breast cancer) was a multicentre phase 3 clinical trial with a 2020 update of long-term follow-up for overall survival enroling node-positive/high-risk node-negative patients >= 65 years with early BC. Patients were randomised to Cap 2000 mg/m2 day 1-14 q3w for 6 cycles plus Ib (50 mg p.o. daily or alternatively 6 mg intravenous q4w) or Ib alone for 2 years. Endocrine therapy was recommended for hormone receptor (HR)-positive patients. The primary endpoint was iDFS analysed using Cox proportional hazards regression and log-rank analysis. Results: 1358 (96.4%) of 1409 randomised patients started treatment. 564 (83.4%) completed 6 cycles of Cap. 513 (77.7%) and 516 (78.8%) completed Ib in the Cap+Ib and Ib alone arm, respectively. Median age was 71 (range 64-88) years, 1099 (81%) were HR-positive, 705 (51.9%) node-negative. At a median follow-up of 61.3 months, 5-year iDFS was 78.8% for Cap+Ib versus 75.0% for Ib alone (p = 0.80). Effects were independent of age, nodal, and HR status. The addition of Cap caused significantly higher skin and gastrointestinal toxicity. Conclusions: The adjuvant combination of Cap+Ib did not show significantly better iDFS than Ib alone in node-positive/high-risk node-negative older BC patients, of whom HR-positive patients were also treated with endocrine therapy.
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页数:13
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