Outcome of patients with HER2-positive breast cancer treated with or without adjuvant trastuzumab in the Finland Capecitabine Trial (FinXX)

Abstract

Background.Little information is available about survival outcomes of patients with HER2-positive early breast cancer treated with adjuvant capecitabine-containing chemotherapy with or without trastuzumab.Patients and methods.One thousand and five hundred patients with early breast cancer were entered to the Finland Capecitabine trial (FinXX) between January 2004 and May 2007, and were randomly assigned to receive either three cycles of adjuvant TX (docetaxel, capecitabine) followed by three cycles of CEX (cyclophosphamide, epirubicin, capecitabine; TX-CEX) or three cycles of docetaxel followed by three cycles of CEF (cyclophosphamide, epirubicin, fluorouracil; T-CEF). The primary endpoint was recurrence-free survival (RFS). The study protocol was amended in May 2005 while study accrual was ongoing to allow adjuvant trastuzumab for patients with HER2-positive cancer. Of the 284 patients with HER2-positive cancer accrued to FinXX, 176 (62.0%) received trastuzumab after amending the study protocol, 131 for 12 months and 45 for nine weeks. The median follow-up time was 6.7 years.Results.Patients with HER2-positive cancer who received trastuzumab had better RFS than those who did not (five-year RFS 89.2% vs. 75.9%; HR 0.41, 95% CI 0.23–0.72; p = 0.001). Patients treated with trastuzumab for 12 months or nine weeks had similar RFS. There was no significant interaction between trastuzumab administration and the type of chemotherapy. Four (2.3%) patients treated with trastuzumab had heart failure or left ventricular dysfunction, three of these received capecitabine.Conclusion.Adjuvant trastuzumab improves RFS of patients treated with TX-CEX or T-CEF. Few patients had cardiac failure.

Adjuvant trastuzumab regimen for HER2-positive early-stage breast cancer: a systematic review and meta-analysis

“…Of these, 2,602 studies were excluded leaving 65 studies plus one additional study from reference lists, for full text assessment. Of these, 58 studies did not meet the inclusion criteria, leaving eight studies included in the review [28][29][30][31][32][33][34][35].…”

“…None of the detected non-RCTs met our criteria because their patients in the comparator group were mixed with chemotherapy and no treatment. Of these, three studies [32][33][34] were conducted in Europe, two studies [28,35] were international multicentre trials with collaborated countries from the different regions, and three studies [29][30][31] were from USA. The median follow-up period ranged from 3.9 to 11 years.…”

“…Information on intervention and comparator characteristics are summarized in Table S2 and S3 (Supporting Information). Four studies [29][30][31][32][33] administered trastuzumab in a 3-week cycle while three studies [28,34,35] implemented the weekly cycle. Courses of treatment were 12 months for seven studies [28][29][30][31][32]34,35] and 9 weeks for one study [33].…”

“…Four studies [29][30][31][32][33] administered trastuzumab in a 3-week cycle while three studies [28,34,35] implemented the weekly cycle. Courses of treatment were 12 months for seven studies [28][29][30][31][32]34,35] and 9 weeks for one study [33]. Trastuzumab was administered with chemotherapy concurrently in five studies [29][30][31][32][33] and sequentially in three studies [28,34,35].…”

Adjuvant Chemotherapy and Trastuzumab Is Safe and Effective in Older Women With Small, Node-Negative, HER2-Positive Early-Stage Breast Cancer

“…However, because some data suggested a comparable benefit for a relatively short course of trastuzumab (≤ 9 weeks) therapy, the duration of trastuzumab administration was not used to define eligibility for the current study. 4,22 Only women from the trastuzumab era who did not receive any anti-HER2 therapy were excluded. Other exclusion criteria, applicable to both cohorts, included current bilateral invasive breast cancer, a prior history of invasive breast cancer, or inadequate documentation of locoregional or systemic therapy.…”