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Preoperative chemoradiotherapy in older patients with rectal cancer guided by comprehensive geriatric assessment within a multidisciplinary team-a multicenter phase II trial

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机构: [1]Department of Radiation Oncology, National Cancer Center/National Clini‑cal Research Center for Cancer/Cancer Hospital, Chinese Academy of Medi‑cal Sciences and Peking Union Medical College, Beijing, China [2]Depart‑ment of Radiation Oncology, National Cancer Center/ Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China [3]Department of Colorectal Sur‑gery, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [4]Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospi‑tal, Chinese Academy of Medical Sciences and Peking Union Medical Col‑lege, Beijing, China [5]Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China [6]Department of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China
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关键词: Rectal cancer Preoperative chemoradiotherapy Comprehensive geriatric assessment Geriatric oncology

摘要:
The purpose of this study was to evaluate the safety and efficacy of preoperative concurrent chemoradiotherapy (preCRT) for locally advanced rectal cancer in older people who were classified as "fit" by comprehensive geriatric assessment (CGA).A single-arm, multicenter, phase II trial was designed. Patients were eligible for this study if they were aged 70 years or above and met the standards of "fit" (SIOG1) as evaluated by CGA and of the locally advanced risk category. The primary endpoint was 2-year disease-free survival (DFS). Patients were scheduled to receive preCRT (50 Gy) with raltitrexed (3 mg/m2 on days 1 and 22).One hundred and nine patients were evaluated by CGA, of whom eighty-six, eleven and twelve were classified into the fit, intermediate and frail category. Sixty-eight fit patients with a median age of 74 years were enrolled. Sixty-four patients (94.1%) finished radiotherapy without dose reduction. Fifty-four (79.3%) patients finished the prescribed raltitrexed therapy as planned. Serious toxicity (grade 3 or above) was observed in twenty-four patients (35.3%), and fourteen patients (20.6%) experienced non-hematological side effects. Within a median follow-up time of 36.0 months (range: 5.9-63.1 months), the 2-year overall survival (OS), cancer-specific survival (CSS) and disease-free survival (DFS) rates were 89.6% (95% CI: 82.3-96.9), 92.4% (95% CI: 85.9-98.9) and 75.6% (95% CI: 65.2-86.0), respectively. Forty-eight patients (70.6%) underwent surgery (R0 resection 95.8%, R1 resection 4.2%), the corresponding R0 resection rate among the patients with positive mesorectal fascia status was 76.6% (36/47).This phase II trial suggests that preCRT is efficient with tolerable toxicities in older rectal cancer patients who were evaluated as fit based on CGA.The registration number on ClinicalTrials.gov was NCT02992886 (14/12/2016).© 2024. The Author(s).

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出版当年[2025]版:
大类 | 2 区 医学
小类 | 2 区 老年医学 2 区 老年医学(社科)
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大类 | 2 区 医学
小类 | 2 区 老年医学 2 区 老年医学(社科)
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Q2 GERIATRICS & GERONTOLOGY Q2 GERONTOLOGY

影响因子: 最新[2023版] 最新五年平均 出版当年[2024版] 出版当年五年平均 出版前一年[2023版]

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第一作者机构: [1]Department of Radiation Oncology, National Cancer Center/National Clini‑cal Research Center for Cancer/Cancer Hospital, Chinese Academy of Medi‑cal Sciences and Peking Union Medical College, Beijing, China
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通讯机构: [1]Department of Radiation Oncology, National Cancer Center/National Clini‑cal Research Center for Cancer/Cancer Hospital, Chinese Academy of Medi‑cal Sciences and Peking Union Medical College, Beijing, China [2]Depart‑ment of Radiation Oncology, National Cancer Center/ Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Shenzhen, China [6]Department of Radiation Oncology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China
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