Long-term Outcomes of OGSG1108: A Supplemental Study of Oral Nutritional Supplementation During Adjuvant S-1 Chemotherapy.
The OGSG1108 trial evaluated the effect of oral elemental nutritional supplementation (ONS) on one-year compliance with adjuvant S-1 chemotherapy after gastrectomy for pathological stage II/III gastric cancer. It remains unknown whether intervention with ONS affords survival benefits, along with enhanced compliance with adjuvant chemotherapy.
Two groups of patients registered in the OGSG1108 trial were compared. The on-protocol group included 81 patients with pathological stage II/III gastric cancer and good acceptability (≥60%) in an ONS compliance test, who were eligible for the second registration and received protocol-based treatment with adjuvant S-1 and ONS. The off-protocol group included 24 patients with pathological stage II/III gastric cancer and poor acceptability (<60%) in an ONS compliance test, who were ineligible for the second registration and received optional adjuvant S-1 as an off-protocol treatment. Supplemental data were collected for both groups. Patient characteristics, biochemical and oncological factors, postoperative complications, number of S-1 chemotherapy courses, overall survival (OS), and relapse-free survival (RFS) were compared and prognostic factors were analyzed.
The number of S-1 courses was comparable between the two groups (on-protocol vs. off-protocol: 6.3±2.5 vs. 5.9±3.3). No significant differences were observed in 5-year OS (71.9% vs. 66.7%, p=0.700) or RFS (58.4% vs. 62.5%, p=0.972). A multivariate analysis identified pathological stage and number of S-1 courses as independent prognostic factors, but not acceptability of ONS.
Postoperative intervention with ONS did not seem to improve the prognosis of patients receiving adjuvant S-1 treatment. The number of S-1 courses was a prognostic factor.
Two groups of patients registered in the OGSG1108 trial were compared. The on-protocol group included 81 patients with pathological stage II/III gastric cancer and good acceptability (≥60%) in an ONS compliance test, who were eligible for the second registration and received protocol-based treatment with adjuvant S-1 and ONS. The off-protocol group included 24 patients with pathological stage II/III gastric cancer and poor acceptability (<60%) in an ONS compliance test, who were ineligible for the second registration and received optional adjuvant S-1 as an off-protocol treatment. Supplemental data were collected for both groups. Patient characteristics, biochemical and oncological factors, postoperative complications, number of S-1 chemotherapy courses, overall survival (OS), and relapse-free survival (RFS) were compared and prognostic factors were analyzed.
The number of S-1 courses was comparable between the two groups (on-protocol vs. off-protocol: 6.3±2.5 vs. 5.9±3.3). No significant differences were observed in 5-year OS (71.9% vs. 66.7%, p=0.700) or RFS (58.4% vs. 62.5%, p=0.972). A multivariate analysis identified pathological stage and number of S-1 courses as independent prognostic factors, but not acceptability of ONS.
Postoperative intervention with ONS did not seem to improve the prognosis of patients receiving adjuvant S-1 treatment. The number of S-1 courses was a prognostic factor.
Authors
Yanagimoto Yanagimoto, Tsujinaka Tsujinaka, Kawada Kawada, Motoori Motoori, Matsuyama Matsuyama, Imamura Imamura, Kawabata Kawabata, Inoue Inoue, Ueda Ueda, Demura Demura, Takeno Takeno, Takayama Takayama, Nagai Nagai, Adachi Adachi, Omori Omori, Kurokawa Kurokawa, Endo Endo, Shimokawa Shimokawa, Satoh Satoh,
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