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
Year: 2026
Type: article
Abstract: Background: 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. Methods: 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. Results: 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). Conclusions: 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.
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W7224079123