Conti Matteo, Bolzacchini Elena, Luchena Giovanna, Bertu' Lorenza, Tagliabue Paola, Aglione Stefania, Ardizzoia Antonio, Arnoffi Jessica, Guida Francesco Maria, Bertolini Alessandro, Pastorini Alessandro, Duro Maria, Bettega Donato, Roda' Giovambattista, Artale Salvatore, Squizzato Alessandro, Giordano Monica
Oncology Unit, Sant'Anna Hospital, ASST Lariana, 22042 San Fermo della Battaglia, Italy.
Department of Medicine and Surgery, University of Insubria, 21100 Varese, Italy.
Cancers (Basel). 2023 Jul 2;15(13):3465. doi: 10.3390/cancers15133465.
Trifluridine/tipiracil (TAS-102) is an oral chemotherapy approved for the treatment of metastatic colorectal cancer. The efficacy and tolerability of TAS-102 were shown in phase II-III clinical trials and in several real-life studies. The elderly and other special subgroups are underrepresented in published literature. We conducted a retrospective multicenter study to assess the effectiveness and safety of TAS-102 in consecutive patients with pretreated mCRC. In particular, we estimated the effectiveness and safety of TAS-102 in elderly patients (aged ≥70, ≥75 and ≥80 years) and in special subgroups, e.g., patients with concomitant heart disease. One hundred and sixty patients were enrolled. In particular, 71 patients (44%) were 70 years of age or older, 50 (31%) were 75 years of age or older, and 23 (14%) were 80 years of age or older. 19 patients (12%) had a concomitant chronic heart disease, three (2%) patients were HIV positive, and one (<1%) patient had a gene polymorphism. In 115 (72%) cases TAS-102 was administered as a third-line treatment. The median overall survival (OS) in the overall population was 8 months (95% confidence interval [CI], 6-9), while the median progression-free survival (PFS) was 3 months (95% CI, 3-4). No significant age-related reduction in effectiveness was observed in the subpopulations of elderly patients included. The toxicity profile was acceptable in both the whole and subgroups' population. Our study confirms the effectiveness and safety of TAS-102 in patients with pretreated mCRC, suggesting a similar risk-benefit profile in the elderly.
曲氟尿苷/替匹嘧啶（TAS-102）是一种被批准用于治疗转移性结直肠癌的口服化疗药物。TAS-102的疗效和耐受性已在II-III期临床试验及多项真实世界研究中得到证实。老年患者及其他特殊亚组在已发表的文献中代表性不足。我们开展了一项回顾性多中心研究，以评估TAS-102在连续的经治转移性结直肠癌患者中的有效性和安全性。具体而言，我们评估了TAS-102在老年患者（年龄≥70岁、≥75岁和≥80岁）及特殊亚组（如合并心脏病的患者）中的有效性和安全性。共纳入160例患者。其中，71例（44%）患者年龄在70岁及以上，50例（31%）患者年龄在75岁及以上，23例（14%）患者年龄在80岁及以上。19例（12%）患者合并慢性心脏病，3例（2%）患者HIV阳性，1例（<1%）患者存在基因多态性。115例（72%）患者将TAS-102作为三线治疗药物。总体人群的中位总生存期（OS）为8个月（95%置信区间[CI]，6-9），而中位无进展生存期（PFS）为3个月（95%CI，3-4）。在所纳入的老年患者亚组中，未观察到有效性随年龄增长而显著降低。整体人群及各亚组人群的毒性特征均可接受。我们的研究证实了TAS-102在经治转移性结直肠癌患者中的有效性和安全性，提示在老年患者中具有相似的风险效益比。
