接受围手术期治疗的老年与年轻胃癌患者：CRITICS 试验的结果。
Older versus younger adults with gastric cancer receiving perioperative treatment: Results from the CRITICS trial.
机构信息
Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands.
Department of Radiation Oncology, Netherlands Cancer Institute, Amsterdam, the Netherlands; Department of Radiation Oncology, Universidad de Valparaíso, Valparaíso, Chile.
出版信息
Eur J Cancer. 2020 May;130:146-154. doi: 10.1016/j.ejca.2020.02.008. Epub 2020 Mar 21.
AIM
To evaluate treatment-related toxicity, treatment compliance, surgical complications and event-free survival (EFS) in older (≥70 years) versus younger (<70 years) adults who underwent perioperative treatment for gastric cancer.
METHODS
In the CRITICS trial, 788 patients with resectable gastric cancer were randomised before start of any treatment and received preoperative chemotherapy (3 cycles of epirubicin, cisplatin or oxaliplatin and capecitabine), followed by surgery, followed by either postoperative chemotherapy or chemoradiotherapy (45Gy + cisplatin + capecitabine).
RESULTS
172 (22%) patients were older adults. During preoperative chemotherapy, 131 (77%) older adults versus 380 (62%) younger adults experienced severe toxicity (p < 0.001); older adults received significantly lower relative dose intensities (RDIs) for all chemotherapeutic drugs. Equal proportions of older versus younger adults underwent curative surgery: 137 (80%) versus 499 (81%), with comparable postoperative complications and postoperative mortality. Postoperative therapy after curative surgery started in 87 (64%) older adults versus 391 (78%) younger adults (p < 0.001). Incidence of severe toxicity during postoperative chemotherapy was 22 (54%) in older adults versus 113 (59%) in younger adults (p = 0.541); older adults received significantly lower RDIs for all chemotherapeutic drugs. Severe toxicity rates for postoperative chemoradiotherapy were 22 (48%) older adults versus 89 (45%) for younger adults (p = 0.703), with comparable chemotherapy RDIs and radiotherapy dose. Two-year EFS was 53% for older adults versus 51% for younger adults.
CONCLUSION
Perioperative treatment compliance, especially in the postoperative phase, was poorer in older adults compared with younger adults. As comparable proportions of patients underwent curative surgery, future studies should focus on neo-adjuvant treatment.
TRIAL REGISTRATION
ClinicalTrials.gov identifier: NCT00407186. EudraCT number: 2006-00413032.
目的
评估接受围手术期治疗的老年（≥70 岁）与年轻（<70 岁）成年人的治疗相关毒性、治疗依从性、手术并发症和无事件生存（EFS）。
方法
在 CRITICS 试验中，788 例可切除胃癌患者在开始任何治疗前进行随机分组，并接受术前化疗（3 个周期的表柔比星、顺铂或奥沙利铂和卡培他滨），随后进行手术，然后进行术后化疗或放化疗（45Gy+顺铂+卡培他滨）。
结果
172（22%）例患者为老年人。在术前化疗期间，131（77%）例老年患者与 380（62%）例年轻患者经历严重毒性（p<0.001）；老年患者接受所有化疗药物的相对剂量强度（RDI）明显较低。行根治性手术的老年患者与年轻患者比例相当：137（80%）例与 499（81%）例，术后并发症和术后死亡率相当。根治性手术后开始接受术后治疗的老年患者比例为 87（64%）例，年轻患者为 391（78%）例（p<0.001）。老年患者术后化疗期间严重毒性的发生率为 22（54%）例，年轻患者为 113（59%）例（p=0.541）；老年患者接受所有化疗药物的 RDI 明显较低。老年患者术后放化疗的严重毒性发生率为 22（48%）例，年轻患者为 89（45%）例（p=0.703），化疗 RDI 和放疗剂量相当。老年患者的 2 年 EFS 为 53%，年轻患者为 51%。
结论
与年轻患者相比，老年患者围手术期治疗依从性较差，尤其是在术后阶段。由于接受根治性手术的患者比例相当，未来的研究应侧重于新辅助治疗。
试验注册
ClinicalTrials.gov 标识符：NCT00407186。EudraCT 编号：2006-00413032。
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