Background: Patients with refractory metastatic colorectal cancer (mCRC) rarely receive third-line or further treatment. In this context, regorafenib (R) and trifluridine/tipiracil (T) are two important novel therapeutic choices with statistically significant increases in overall survival (OS), progression-free survival (PFS), and disease control, with different toxicity profiles. This study is a subgroup analysis of our larger retrospective study, already published, whose objective was to assess the outcomes of patients when R and T were given sequentially.Patients and Methods: The study involved thirteen Italian cancer centers on a 10-year retrospective observation (2012–2022). In this subgroup analysis, we focused our attention on the correlation between the first drug treatment duration (<3 months, 3 to <6 months and ≥6 months) and survival outcomes in patients who had received the sequence regorafenib-to-trifluridine/tipiracil, or vice versa.Results: The initial study included 866 patients with mCRC who received sequential T/R, or R/T, or T or R alone. This analysis is focused on evaluating the impact of the duration of the first treatment in the sequence on clinical outcomes (OS, PFS) and includes 146 and 116 patients of the T/R and R/T sequences, respectively. Based on the duration of the first drug treatment, subgroups for the T/R sequence included 27 patients (18.4%) who received T for <3 months, 86 (58.9%) treated for 3 to <6 months, and 33 (22.6%) treated for ≥6 months; in the reverse sequence (R as the first drug), subgroups included 18 patients (15.5%) who received their first treatment for <3 months, 62 (53.4%) treated for 3 to <6 months, and 35 (31.0%) treated for ≥6 months. In patients who received their first drug treatment for a period of 3 to <6 months, the R/T sequence had a significantly longer median OS (13.7 vs. 10.8 months,p= 0.0069) and a longer median PFS (10.8 vs. 8.5 months,p= 0.0003) than the T/R group. There were no statistically significant differences between groups with first drug treatment durations of <3 months and ≥6 months.Conclusions: Our analysis seems to suggest that the administration of R for a period of 3 to <6 months before that of T can prolong both OS and PFS, as compared to the opposite sequence.
背景：难治性转移性结直肠癌（mCRC）患者很少接受三线或后续治疗。在此背景下，瑞戈非尼（R）和曲氟尿苷/替匹嘧啶（T）是两种重要的新型治疗选择，在总生存期（OS）、无进展生存期（PFS）和疾病控制方面均有统计学显著改善，但具有不同的毒性特征。本研究是我们已发表的大型回顾性研究的亚组分析，旨在评估R和T序贯给药时患者的临床结局。 患者与方法：该研究涉及意大利13个癌症中心，进行了为期10年（2012-2022年）的回顾性观察。在此亚组分析中，我们重点关注首次药物治疗持续时间（<3个月、3至<6个月和≥6个月）与接受瑞戈非尼-曲氟尿苷/替匹嘧啶序贯治疗或相反序贯治疗患者生存结局之间的相关性。 结果：初始研究纳入了866例接受T/R序贯、R/T序贯或单独T或R治疗的mCRC患者。本分析重点评估序贯治疗中首次治疗持续时间对临床结局（OS、PFS）的影响，分别包括T/R序贯组146例患者和R/T序贯组116例患者。根据首次药物治疗持续时间，T/R序贯组的亚组包括：27例（18.4%）接受T治疗<3个月的患者，86例（58.9%）治疗3至<6个月的患者，以及33例（22.6%）治疗≥6个月的患者；在反向序贯组（R作为首次药物）中，亚组包括：18例（15.5%）首次治疗<3个月的患者，62例（53.4%）治疗3至<6个月的患者，以及35例（31.0%）治疗≥6个月的患者。在首次药物治疗持续时间为3至<6个月的患者中，R/T序贯组的中位OS（13.7个月 vs. 10.8个月，p=0.0069）和中位PFS（10.8个月 vs. 8.5个月，p=0.0003）均显著长于T/R组。在首次药物治疗持续时间<3个月和≥6个月的组间，未观察到统计学显著差异。 结论：我们的分析似乎表明，与相反序贯相比，先使用R治疗3至<6个月后再使用T治疗，可能延长OS和PFS。
肿瘤(癌症)患者之家