Preoperative Chemoradiotherapy in Older Patients with Rectal Cancer Guided by Comprehensive Geriatric Assessment Within a Multidisciplinary Team-a Multicenter Phase II Trial

Overview

Journal BMC Geriatr

Publisher Biomed Central

Specialty Geriatrics

Date 2024 May 21

PMID 38773457

Authors

Wen-Yang Liu

Yuan Tang

Ning Li

Yu Tang

Yun-Jie Cheng

Lin Yang

Hui Fang

Ning-Ning Lu

Shu-Nan Qi

Bo Chen

Shu-Lian Wang

Yong-Wen Song

Yue-Ping Liu

Ye-Xiong Li

Zheng Liu

Jian-Wei Liang

Wei Pei

Xi-Shan Wang

Hai-Zeng Zhang

Jun Wang

Hai-Tao Zhou

Jing Jin

Affiliations

Soon will be listed here.

Abstract

Background: 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).

Methods: 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).

Results: 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).

Conclusion: 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.

Trial Registration: The registration number on ClinicalTrials.gov was NCT02992886 (14/12/2016).

Citing Articles

Landscape of Biomarkers and Pathologic Response in Rectal Cancer: Where We Stand?.

Ocanto A, Teja M, Amorelli F, Counago F, Gomez Palacios A, Alcaraz D Cancers (Basel). 2024; 16(23).

PMID: 39682232 PMC: 11640609. DOI: 10.3390/cancers16234047.

Comprehensive geriatric assessment guided radiotherapy in elderly patients with locally advanced rectal cancer-exploratory results on nonoperative cohort of a multicenter prospective study.

Yang Y, Tang Y, Li N, Tang Y, Cheng Y, Yang L Ther Adv Med Oncol. 2024; 16:17588359241296386.

PMID: 39563720 PMC: 11574900. DOI: 10.1177/17588359241296386.

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