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. 2021 Jul 16;5(6):776-784.
doi: 10.1002/ags3.12487. eCollection 2021 Nov.

Effects of an oral elemental nutritional supplement in gastric cancer patients with adjuvant S-1 chemotherapy after gastrectomy: A multicenter, open-label, single-arm, prospective phase II study (OGSG1108)

Hiroshi Imamura  1 , Jin Matsuyama  2 , Kazuhiro Nishikawa  3 , Shunji Endo  4 , Tomono Kawase  1 , Yutaka Kimura  5 , Junichi Fukui  6 , Junji Kawada  7 , Yukinori Kurokawa  8 , Kazumasa Fujitani  7 , Daisuke Sakai  9 , Hisato Kawakami  10 , Toshimasa Tsujinaka  11 , Toshio Shimokawa  12 , Yoshihiro Matsubara  13 , Taroh Satoh  9 , Hiroshi Furukawa  5 ; Osaka Gastrointestinal Cancer Chemotherapy Study Group (OGSG)
Affiliations

Effects of an oral elemental nutritional supplement in gastric cancer patients with adjuvant S-1 chemotherapy after gastrectomy: A multicenter, open-label, single-arm, prospective phase II study (OGSG1108)

Hiroshi Imamura et al. Ann Gastroenterol Surg. .

Abstract

Aim: Post-surgical weight loss influences chemotherapy compliance and may be a risk factor for survival. Intake of an oral elemental nutritional supplement (OENS) can reduce weight loss after gastric cancer (GC) surgery. We assessed whether therapy completion levels would increase in patients receiving postoperative adjuvant chemotherapy in combination with an OENS.

Methods: This was a multicenter, open-label, single-arm, phase II study in GC patients who underwent curative total or distal gastrectomy (TG/DG) and received adjuvant S-1 chemotherapy. The primary endpoint was the S-1 completion rate for 1 year with a relative performance (RP) value of ≥70%; secondary endpoints included factors affecting the completion rate of S-1, RP value after eight S-1 courses, S-1 and OENS persistence rates, nutritional index, OENS compliance, and safety.

Results: In 71 efficacy-evaluable patients, the S-1 completion rate was 69.0% (TG, 68.0%; DG, 69.6%) and the RP value was 87.5 (TG, 89.1; DG, 87.5). Over eight treatment courses, median persistence rates were 89.0% for S-1 and 93.8% for the OENS. The mean OENS compliance was 81.8% at the fourth S-1 course and 52.9% at the eighth course. The incidence of Grade 3 or 4 adverse events was 27.2%, most commonly neutropenia (12.3%).

Conclusions: The completion rate of S-1 for 1 year in patients who could take the OENS exceeded the pre-defined threshold level. Randomized controlled trials are warranted to confirm the role of OENS in adjuvant chemotherapy.

Keywords: adjuvant chemotherapy; gastrectomy; gastric cancer; supplemental nutrition.

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Conflict of interest statement

Ethical considerations: The protocol for this research project has been approved by the suitably constituted ethics committees at each institution and it conforms to the provisions of the Declaration of Helsinki. All patients provided written informed consent. This trial was registered with the University Hospital Medical Information Network Clinical Trials Registry (UMIN000006872). Funding information: This study was financially supported, in part, by EA Pharma Co., Ltd. (Tokyo, Japan). The funding source had no role in the design, conduct, or data analysis of this study. Conflict of Interest: H. I. was supported by grants and personal fees from Taiho pharmaceutical Co. Ltd., outside the submitted work. Y. Ku. was supported by grants and personal fees from Taiho pharmaceutical Co. Ltd., outside the submitted work. D. S. was supported by research funds from Yakult Honsha Co. Ltd., Chugai Pharmaceutical Co. Ltd., Ono Pharmaceutical Co. Ltd., Eli Lilly Japan KK, Daiichi‐Sankyo Co. Ltd., and honoraria from Chugai Pharmaceutical Co. Ltd., Daiichi‐Sankyo Co. Ltd., outside the submitted work. H. K. reports receiving consulting fees from Bristol‐Myers Squibb Co. Ltd., Eli Lilly Japan KK, MSD KK, Ono Pharmaceutical Co. Ltd., Daiichi‐Sankyo Co. Ltd., and Taiho Pharmaceutical Co. Ltd.; honoraria from Bristol‐Myers Squibb Co. Ltd., AstraZeneca KK, Bayer Yakuhin Ltd., Eli Lilly Japan KK, MSD KK, Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Daiichi Sankyo Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Taiho Pharmaceutical Co. Ltd.; lecture fees from Bristol‐Myers Squibb Co. Ltd., Eli Lilly Japan KK, MSD KK, Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., Takeda Pharmaceutical Co. Ltd., and Taiho Pharmaceutical Co., Ltd.; and research funding from Chugai Pharmaceutical Co. Ltd., Taiho Pharmaceutical Co. Ltd, and Eisai Co. Ltd. T. Sa. was supported by grants, personal fees, and other remuneration from Ono Pharmaceutical Co. Ltd., Chugai Pharmaceutical Co. Ltd., and Yakult Honsha Co. Ltd.; grants and personal fees from Elli Lilly Japan KK, MSD KK, Bristol Myers Squib Co. Ltd., Astellas Pharma Inc, and Taiho Pharmaceutical Co. Ltd.; grants from Giliad Sciences KK, Parexel International Inc, and Daiichi Sankyo Co. Ltd.; and personal fees from Takara Bio Inc and Sanofi‐Aventis KK, outside the submitted work. The remaining authors have no conflicts of interest to declare. Author Contributions: Study concept: H. I.; study design: H. I., T. T., T. Sa., Y. Ku., T. Sh., D. S., and H. F.; acquisition of data: J. M., K. N., S. E., T. K., Y. Ki., J. F., J. K., Y. M., and H. I.; statistical analysis of data: T. Sh.; analysis and/or interpretation of data: H. I., T. T., Y. Ku., H. K., K. F., T. Sh., D. S., and T. Sa; drafting the manuscript: H. I.; revising the manuscript critically for important intellectual content: T. T., K. N., Y. Ki., H. K., S. E., Y. Ku., J. M., T. K., J. F., J. K., K. F., D. S., T. Sh., Y. M., T. Sa., and H. F. All authors approved the final version of the manuscript.

Figures

FIGURE 1
FIGURE 1
Patient disposition. GC, gastric cancer. †Adverse events leading to discontinuation were rash, neutrophils decreased, and pyelonephritis. The Registration Center (Cancer medication research group) judged patients' appropriateness for the study
FIGURE 2
FIGURE 2
OENS continuation rate (PPS, N = 71). OENS, oral elemental nutritional supplement; PPS, per protocol set
See this image and copyright information in PMC

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