Comparing the efficacy and safety of raltitrexed combined with irinotecan administered in different dose-schedule patterns for the second-line treatment of metastatic colorectal cancer: an exploratory, observational post hoc analysis from the prospective SALLY registry cohort.
7 affiliations
- 1Department of Medical Oncology, Key Laboratory of Cancer Prevention and Intervention, Ministry of Education, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
- 2Department of Oncology, Second Hospital of Jiaxing, Jiaxing, China.
- 3Department of Medical Oncology, The First Affiliated Hospital of Bengbu Medical College, Bengbu, China.
- 4Department of Oncology, Shaoxing People's Hospital, Shaoxing, China.
- 5Zhejiang Provincial Clinical Research Center for CANCER, Hangzhou, China.
- 6Cancer Center of Zhejiang University, Hangzhou, China.
- 7Center for Medical Research and Innovation in Digestive System Tumors, Ministry of Education, Hangzhou, China.
Abstract
To date, no randomized controlled trial has compared different dose-schedule patterns of raltitrexed combined with irinotecan for the second-line treatment of metastatic colorectal cancer (mCRC). This study aimed to evaluate the efficacy and safety of raltitrexed combined with irinotecan administered by different dose-schedule patterns as a second-line treatment for mCRC. This was an exploratory, observational post hoc analysis of data from the SALLY study, a prospective, multicenter, noninterventional, real-world trial conducted in China. The core eligibility criteria of the SALLY study were mCRC that had failed to respond to first-line treatments comprising 5-fluorouracil (5-FU) + platinum-based chemotherapy. The regimen was administered every 2 or 3 weeks at the corresponding dose. The treatment frequency was determined by the attending physician. Among the 1,066 enrolled patients in the SALLY study, 618 (58.0%) received treatment every 3 weeks and 441 (41.3%) received treatment every 2 weeks in the full analysis set (FAS). There were no statistically significant differences in progression-free survival (PFS), overall survival (OS), objective response rate (ORR), or disease control rate (DCR) between the two groups in the FAS or in the per-protocol set (PPS). In the every-2-week group, 75.1% of patients experienced treatment-related adverse effects (AEs), compared with 77.5% of patients in the every-3-week group (P=0.38). The incidences of grade 3 or 4 toxicities were 10.9% (48/441) and 14.4% (89/619), respectively (P=0.11). In the second-line treatment of mCRC, the efficacy of irinotecan plus raltitrexed administered every 2 weeks with its corresponding dose did not differ significantly from that administered every 3 weeks.
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BibTeX
@article{yu2026comparing,
title = {{Comparing the efficacy and safety of raltitrexed combined with irinotecan administered in different dose-schedule patterns for the second-line treatment of metastatic colorectal cancer: an exploratory, observational post hoc analysis from the prospective SALLY registry cohort.}},
author = {Nuoya Yu and Ziyan Tong and Yaohua Fan and Zishu Wang and Jianfang Wang and Ying Yuan and Shanshan Weng},
journal = {Journal of gastrointestinal oncology},
year = {2026},
month = oct,
doi = {10.21037/jgo-2026-1127},
url = {https://europepmc.org/article/MED/42996882},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Comparing the efficacy and safety of raltitrexed combined with irinotecan administered in different dose-schedule patterns for the second-line treatment of metastatic colorectal cancer: an exploratory, observational post hoc analysis from the prospective SALLY registry cohort.
AU - Nuoya Yu
AU - Ziyan Tong
AU - Yaohua Fan
AU - Zishu Wang
AU - Jianfang Wang
AU - Ying Yuan
AU - Shanshan Weng
PY - 2026
DA - 2026/10/27
JO - Journal of gastrointestinal oncology
DO - 10.21037/jgo-2026-1127
UR - https://europepmc.org/article/MED/42996882
AB - To date, no randomized controlled trial has compared different dose-schedule patterns of raltitrexed combined with irinotecan for the second-line treatment of metastatic colorectal cancer (mCRC). This study aimed to evaluate the efficacy and safety of raltitrexed combined with irinotecan administered by different dose-schedule patterns as a second-line treatment for mCRC. This was an exploratory, observational post hoc analysis of data from the SALLY study, a prospective, multicenter, noninterventional, real-world trial conducted in China. The core eligibility criteria of the SALLY study were mCRC that had failed to respond to first-line treatments comprising 5-fluorouracil (5-FU) + platinum-based chemotherapy. The regimen was administered every 2 or 3 weeks at the corresponding dose. The treatment frequency was determined by the attending physician. Among the 1,066 enrolled patients in the SALLY study, 618 (58.0%) received treatment every 3 weeks and 441 (41.3%) received treatment every 2 weeks in the full analysis set (FAS). There were no statistically significant differences in progression-free survival (PFS), overall survival (OS), objective response rate (ORR), or disease control rate (DCR) between the two groups in the FAS or in the per-protocol set (PPS). In the every-2-week group, 75.1% of patients experienced treatment-related adverse effects (AEs), compared with 77.5% of patients in the every-3-week group (P=0.38). The incidences of grade 3 or 4 toxicities were 10.9% (48/441) and 14.4% (89/619), respectively (P=0.11). In the second-line treatment of mCRC, the efficacy of irinotecan plus raltitrexed administered every 2 weeks with its corresponding dose did not differ significantly from that administered every 3 weeks.
SN - 2078-6891
SN - 2219-679X
ER -