研究动态
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生存计划,包括可手术 III 期非小细胞肺癌 (ESPATUE) 随机试验中 10 多年的长期毒性和生活质量发展。

Survivorship program including long-term toxicities and quality-of-life development over 10 years in a randomized trial in operable stage III non-small-cell lung cancer (ESPATUE).

发表日期:2024 Aug 28
作者: Christina Schulte, Thomas Gauler, Christoph Pöttgen, Godehard Friedel, Hans-Georg Kopp, Berthold Fischer, Heinz Schmidberger, Martin Kimmich, Wilfried Budach, Sebastian Cordes, Johannes Wienker, Martin Metzenmacher, Rodrigo Hepp de Los Rios, Werner Spengler, Dirk De Ruysscher, Claus Belka, Stefan Welter, Diana Luetke-Brintrup, Maja Guberina, Filiz Oezkan, Kaid Darwiche, Martin Schuler, Karl-Heinz Jöckel, Clemens Aigner, Georgios Stamatis, Martin Stuschke, Wilfried Ernst Erich Eberhardt
来源: INTERNATIONAL JOURNAL OF CANCER

摘要:

超过 40% 的 III 期非小细胞肺癌 (NSCLC) 患者 (pts) 在多模式治疗后获得 5 年生存期。然而,在进一步的长期随访中,人们对相关的晚期毒性和生活质量(QoL)知之甚少。因此,我们邀请来自随机 III 期试验(Eberhardt 等人,临床肿瘤学杂志 2015)的患者在诊断 10 年后参加结构化生存计划 (SSP),包括随访影像、实验室参数、心脏检查肺部检查、长期毒性评估和生活质量调查问卷。在最初招募的 246 名患者中,161 名被认为在诱导治疗后可能可切除,并被随机分配(A 组:80 名:确定性放化疗;B 组:81 名:确定性手术;85 名因不同原因未随机分配;C 组)。 10 年后仍然活着的 37 名患者中有 31 人同意 SSP(A 中 13 人;B 中 12 人;C 中 6 人)。很少观察到临床相关的长期毒性(3 级和 4 级),没有任何信号支持任何随机分组。此外,来自全球生活质量分析的可用数据没有显示出有利于任何明确的局部区域方法的信号(SSP A 点的平均生活质量:56.41/100,B 点:64.39/100),并且与基线和早期 1 相比没有后期下降。年随访。这是在随机多模式试验中治疗的 III 期 NSCLC 中报告的第一个全面的极晚期生存随访 SSP,它可以作为医生和患者决定局部治疗方案的重要基线信息。© 2024 )。约翰·威利出版的《国际癌症杂志》
Over 40% stage-III non-small-cell lung cancer (NSCLC) patients (pts) experience 5-year survival following multimodality treatment. Nevertheless, little is known about relevant late toxicities and quality-of-life (QoL) in the further long-term follow-up. Therefore, we invited pts from our randomized phase-III trial (Eberhardt et al., Journal of Clinical Oncology 2015) after 10 years from diagnosis to participate within a structured survivorship program (SSP) including follow-up imaging, laboratory parameters, cardio-pulmonary investigations, long-term toxicity evaluations and QoL questionnaires. Of 246 pts initially accrued, 161 were considered potentially resectable following the induction therapy and were randomized (80 to arm A: definitive chemoradiation; 81 to arm B: definitive surgery; 85 not randomized for different reasons; group C). 31 from 37 pts still alive after 10 years agreed to the SSP (13 in A; 12 in B; 6 in C). Clinically relevant long-term toxicities (grade 3 and 4) were rarely observed with no signal favoring any of the randomization arms. Furthermore, available data from the global QoL analysis did not show a signal favoring any definitive locoregional approach (Mean QoL in SSP A pts: 56.41/100, B pts: 64.39/100) and no late decline in comparison to baseline and early 1-year follow-up. This is the first comprehensive SSP of very late survival follow-up reported in stage-III NSCLC treated within a randomized multimodality trial and it may serve as important baseline information for physicians and pts deciding for a locoregional treatment option.© 2024 The Author(s). International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.