Capecitabine in Combination with Standard (Neo)Adjuvant Regimens in Early Breast Cancer: Survival Outcome from a Meta-Analysis of Randomized Controlled Trials

Abstract

Capecitabine has been investigated in early breast cancer in several studies, but it was undefined that whether it could improve survival. To investigate whether the addition of capecitabine affected survival in patients with early breast cancer, a meta-analysis was conducted and overall survival (OS), disease-free survival (DFS), and toxicity were assessed. The PubMed, Embase databases and the Cochrane Central Register of Controlled Trials were searched for studies between January 2006 and April 2016. Hazard ratios (HRs) with their 95% confidence intervals (CIs), or data for calculating HRs with 95% CI were derived. Seven trials with 9097 patients, consisted of 4 adjuvant and 3 neoadjuvant studies, were included in this meta-analysis. Adding capecitabine showed no improvement in DFS (HR = 0.93; 95% CI, 0.85-1.02; P = 0.12), whereas a significant improvement in OS was observed (HR = 0.85; 95% CI, 0.75-0.96; P = 0.008). A sub-analysis of DFS showed that benefit of capecitabine derived from patients with triple negative subtype and with extensive axillary involvement. Safety profiles were consistent with the known side-effects of capecitabine, but more patients discontinued scheduled treatment in the capecitabine group. Combining capecitabine with standard (neo)adjuvant regimens in early breast cancer demonstrated a significantly superior OS, and indicated DFS improvement in some subtypes with high risk of recurrence. Selection of subtypes was a key to identify patients who might gain survival benefit from capecitabine.

The role of capecitabine-based neoadjuvant and adjuvant chemotherapy in early-stage triple-negative breast cancer: a systematic review and meta-analysis

“…Recently, several randomized clinical trials (RCTs) have evaluated the clinical value of combined treatment with capecitabine for TNBC, but the outcomes of these studies were still controversial [14][15][16][17][18][19][20][21][22]. Seven meta-analyses summarizing the role of capecitabine in breast cancer adjuvant and neoadjuvant chemotherapy have been performed, six of which included all subtypes of patients, not just TNBC patients [13,[23][24][25][26][27][28]. Some meta-analyses estimated disease-free survival (DFS) of TNBC in a subgroup, and only three reported overall survival (OS) [13,26,28], but the DFS and OS of TNBC results were controversial.…”

The Clinical Value of Chemotherapy Combined With Capecitabine in Triple-Negative Breast Cancer—A Meta-Analysis

“…For some patients with special baseline characteristics, the benefits of capecitabine may be more obvious according to more clinical data and more rigorous analysis. The positive efficacy of adding capecitabine might depend on patient’s race, age and different clinical characteristics of patients ( Zhang et al, 2016 ; Li Y. et al, 2020 ; Huo et al, 2021 ).…”

“…Compared to other meta-analysis, we included more data and performed other subgroup analysis including the effect of capecitabine and cyclophosphamide in combination and the influence of capecitabine dose on adjuvant chemotherapy ( Zhang et al, 2016 ; Natori et al, 2017 ; Li Y. et al, 2020 ; Huo et al, 2021 ). The meta-analysis by Yan Li et al focused on the role of adjuvant capecitabine in standard chemotherapy, the influence of region and treatment period on the effect of capecitabine were analyzed in the subgroup.…”

Estudo de biodisponibilidade comparativa da Capecitabina em participantes sadios do sexo masculino após alimentação

“…The adverse events demonstrated the safety of capecitabine studies in healthy subjects. [14,15,16,17,18,19]. Our method has good sensitivity (LOQ of 1 ng/ mL), retention time of 1.90 minutes, run time of 2.8 minutes, liquid-liquid extraction and deuterated IS, permitting a high throughput.…”

“…É considerada tratamento de primeira linha para o câncer esofagogástrico avançado em combinação com um regime à base de platina [16,17]. Já no câncer de mama, sua indicação é nos casos metastático ou localmente avançado, em combinação com docetaxel após falha no uso antraciclina ou em monoterapia após falha de taxane e como adjuvante com antraciclina ou taxane [17][18][19]. Sabe-se ainda que a capecitabina tem sido utilizada também em pacientes com carcinomas prostáticos, pancreáticos, cabeça e pescoço, renais e ovarianos, como agente único ou em combinação com outras drogas [17,20,21].…”