Ifenprodil hemitartrate br Treatment compliance rate of Elen
3.2. Treatment compliance rate of Elental®
In the treatment group, the degree of compliance with Elental® was determined based on the patients’ self-reported diaries as the percen-tage of the prescribed dose of Elental® consumed each day. The mean treatment compliance rate in the Elental group was 71.4% ± 22.4%, with a median value of 81.3%.
The incidence of oral mucositis was significantly lower in the treatment group (9.1%) than in the control group (27.3%) (Fig. 2).
3.4. Continuation rate of S-1 and risk factors
Fig. 3 shows the Kaplan-Meier estimates of cumulative S-1 con-tinuation rates according to the treatment and control groups. The treatment group was significantly associated with higher cumulative continuation rates (log-rank P = .047). Each clinicopathological factor was categorized as shown in Table 3, and was analyzed for risk of S-1 continuation. Univariate analyses demonstrated that stomatitis was the only significant risk factor.
All patients in the treatment and control groups were included in the safety analyses (Table 4). There were six Grade 2 adverse events. The incidences of hematological and non-hematological adverse events Surgical Oncology 29 (2019) 97–101
Characteristics of the patients at baseline (before chemotherapy).
Female 3 2
Performance status (ECOG)
Type of gastrectomy
Total 5 3
Laparoscopic 1 3
Lymph Ifenprodil hemitartrate metastasis
Positive 9 11
Stage of disease
were not significantly diﬀerent between the groups.
To our knowledge, this is the first study to show that the elemental diet Elental® is associated with lower incidence and severity of oral mucositis in patients with advanced gastric cancer receiving S-1 ad-juvant chemotherapy.
The mechanism of chemotherapy-induced oral mucositis remains unclear. However, it has been reported that oral glutamine might pre-vent chemotherapy-associated mucositis [9,10]. Moreover, Peterson et al. reported that Saforis™, a sustained-release preparation of gluta-mine, was associated with significantly lower rates of oral mucositis in cancer patients receiving chemotherapy . Glutamine could be im-portant in preventing oral mucositis induced by chemotherapy. How-ever, in general, the systemic administration of L-glutamine alone was not recommended by the Clinical Practice Guidelines for Prevention and Treatment of Mucositis of the Mucositis Study Section of the Multinational Association of Supportive Care in Cancer and the Inter-national Society for Oral Oncology in 2007 . In the present pilot study, we examined whether the elemental diet Elental® (one pack 80 g/ 300 kcal), which contains 1932 mg of L-glutamine, can prevent oral mucositis in patients with advanced gastric cancer during S-1 adjuvant chemotherapy. According to 2 reports, Elental® was associated with reduced incidence and severity of oral mucositis in patients receiving chemotherapy for esophageal cancer and colorectal cancer respectively [7,8]. Our data are in line with these reports.
Fig. 2. Incidence of oral mucositis during study (%).
Fig. 3. Comparison of the S-1 adjuvant chemotherapy continuation rate in the control group and elemental diet treatment group.
After undergoing gastrectomy, patients may be unable to digest food due to depressed gastric reservoir function and gastrointestinal func-tional changes such as insuﬃcient digestion and absorption. Moreover, patients who receive adjuvant chemotherapy are more likely to lose weight due to malnutrition and anorexia caused by chemotherapy-as-sociated gastrointestinal toxicities. Imamura et al. showed that the Elental® treatment group lost significantly less weight compared with the control group after gastrectomy . This study strongly supports our result. We cannot explain the mechanism for the maintenance of body weight, because we did not have enough data. However, it was recently reported that enteral administration of amino acid mixtures was associated with normal amino acid absorption in patients with mucositis . We think that amino acids may be more suitable than proteins for patients with depressed gastric reservoir function and gastrointestinal functional changes.