s-1-(combination) and Weight-Loss

This randomized Phase III trial will evaluate whether perioperative nutrition enriched with eicosapentaenoic acid can prevent body weight loss after total gastrectomy for gastric cancer. The patients who enroll in this study will be randomly assigned to Group A: no supplementation with oral nutrients (standard diet) or Group B: standard diet with eicosapentaenoic acid-enriched supplementation for 7 days before surgery and for 21 days after surgery. For both groups, patients will undergo total gastrectomy with Roux-en Y reconstruction. The extent of dissection will principally follow the third edition of the Gastric Cancer Treatment Guideline published by the Japanese Gastric Cancer Association. When patients are diagnosed with pathological Stage II or III disease, adjuvant chemotherapy with S-1 will be initiated within 6 weeks after surgery and administered for 1 year. The primary endpoint will be the body weight loss at 1 and 3 months after surgery (double primary endpoints). The secondary endpoints will be the relative performance of the supplement, loss of lean body mass at 1 and 3 months after surgery, the lowest serum albumin level, quality of life, the incidence of surgical morbidity and mortality, and the incidence of surgical site infection.

Topics: Adult; Aged; Anastomosis, Roux-en-Y; Antimetabolites, Antineoplastic; Chemotherapy, Adjuvant; Dietary Supplements; Drug Combinations; Eicosapentaenoic Acid; Female; Gastrectomy; Humans; Japan; Male; Middle Aged; Neoplasm Staging; Oxonic Acid; Perioperative Period; Practice Guidelines as Topic; Quality of Life; Research Design; Stomach Neoplasms; Tegafur; Time Factors; Treatment Outcome; Weight Loss

Postoperative chemotherapy is beneficial for many pancreatic cancer patients. However, some patients require dose reduction or the discontinuation of adjuvant chemotherapy because of adverse treatment-related effects. In this study, we aimed to evaluate two main outcomes. First, we evaluated the clinicopathological factors affecting patient disease-free survival (DFS) and overall survival (OS) following upfront surgery. Second, we evaluated the factors that influence the continuity of adjuvant chemotherapy.. Fifty-four patients with resected pancreatic cancer were enrolled. First, we evaluated the clinicopathological factors affecting postoperative survival using the Kaplan-Meier method and Cox regression method. Next, factors affecting the continuity of adjuvant chemotherapy were analyzed using multiple logistic regression analysis.. Univariate and multivariate analyses revealed that positive LN metastasis (HR (95% CI) 6.329 (2.381-16.95); p < 0.001) and relative dose intensity (RDI) < 80% for adjuvant chemotherapy (HR (95% CI) 5.154 (1.761-15.15); p = 0.003) were independent predictive factors for DFS. Regarding OS, extended dissection of the nerve plexus around the superior mesenteric artery (SMA) (HR (95% CI) 4.504 (1.721-11.76); p = 0.002), positive microscopic surgical margin (HR (95% CI) 5.565 (1.724-17.96); p = 0.004), and adjuvant chemotherapy of RDI < 80% (HR (95% CI) 3.534 (1.135-2.667); p = 0.029) were also independent predictive factors. Moreover, the level of RDI significantly correlated with DFS and OS. Multiple logistic regression analysis revealed that low RDI was significantly associated with postoperative body weight loss (BWL) ≥ 10%.. The following factors were significantly associated with poor survival: extended dissection of the nerve plexus around the SMA, lymph node metastasis, residual tumor, and RDI of the adjuvant chemotherapy. Patient's prognosis with adjuvant chemotherapy of RDI < 80% was worse. BWL ≥10% was the most important factor affecting the continuity of adjuvant chemotherapy. Perioperative nutritional intervention is necessary for patients who receive adjuvant chemotherapy for advanced pancreatic cancer.

Topics: Aged; Chemotherapy, Adjuvant; Deoxycytidine; Drug Combinations; Female; Gemcitabine; Humans; Logistic Models; Lymphatic Metastasis; Male; Middle Aged; Oxonic Acid; Pancreatic Neoplasms; Prognosis; Survival Analysis; Tegafur; Treatment Outcome; Weight Loss

We previously demonstrated that body weight loss (BWL) at one month after gastrectomy, a common finding after surgery for gastric cancer, was an independent risk factor for the continuation of adjuvant chemotherapy with S-1. However, it is unclear whether BWL after gastrectomy leads to poor survival through poor compliance to adjuvant chemotherapy with S-1.. We conducted this follow-up study in the same cohort as our previous study. Overall survival (OS) and recurrence-free survival (RFS) were examined in 103 patients who underwent curative D2 surgery and were pathologically diagnosed with stage II or III gastric cancer, and who received postoperative adjuvant chemotherapy with S-1 between June 2002 and December 2011.. The median follow-up period was 64.3 months. The 5-year OS rate in the patients with a BWL of <15% was 59.9%, while that in the patients with a BWL of ≥15% was 36.4% (p = 0.004). Univariate and multivariate analyses for OS demonstrated that pathological T factor and BWL were significant risk factors. On the other hand, the 5-year RFS rate was 56.4% in the BWL <15% group and 36.4% in the BWL ≥15% group (p = 0.016), while univariate and multivariate analyses for RFS demonstrated that BWL was a marginally significant risk factor.. Severe postoperative BWL, which is closely related with poor S-1 compliance, is an important risk factor for survival. It merits testing if preventing BWL improves survival of gastric cancer patients who receive S-1 adjuvant chemotherapy.

Topics: Aged; Antimetabolites, Antineoplastic; Chemotherapy, Adjuvant; Drug Combinations; Female; Follow-Up Studies; Gastrectomy; Humans; Male; Middle Aged; Multivariate Analysis; Oxonic Acid; Postoperative Period; Risk Factors; Stomach Neoplasms; Survival Rate; Tegafur; Treatment Outcome; Weight Loss

Eicosapentaenoic acid-enriched oral nutritional supplements (Prosure®; Abbott Japan, Tokyo, Japan) may attenuate surgical stress and catabolism after gastric cancer surgery. The present study aimed to evaluate the effects of Prosure® on body weight loss( BWL) and compliance with S-1 adjuvant chemotherapy after gastrectomy.. Patients who underwent curative total gastrectomy for gastric cancer were selected to undergo adjuvant S-1 chemotherapy at Kanagawa Cancer Center between December 2010 and October 2011. The patients received a normal postgastrectomy diet and two 240 mL packs of Prosure® for 21 postoperative days. BWL was defined as %BWL and calculated as %BWL=(preoperative body weight-1-month postoperative body weight)×100/preoperative body weight. Time to S-1 treatment failure was calculated.. Five patients were enrolled in this study. The median age was 62.0 years. One patient was male, and 4 were female. The 1-month postoperative BWL was 92.1%. Compared to our previous report, a 20% risk reduction was observed in this study (Prosure® group vs control group, 92.1% vs 89.7%). Moreover, all the patients continued with the S-1 adjuvant chemotherapy for longer than 6 months.. Prosure® may inhibit BWL at 1 month after gastrectomy. Moreover, Prosure® improved the patients' compliance with the adjuvant chemotherapy after gastrectomy.

Topics: Chemotherapy, Adjuvant; Drug Combinations; Eicosapentaenoic Acid; Enteral Nutrition; Female; Gastrectomy; Humans; Male; Middle Aged; Oxonic Acid; Stomach Neoplasms; Tegafur; Weight Loss

Compliance of S-1 adjuvant chemotherapy is not high. The aim of the present study is to clarify risk factors for continuation of S-1 after gastrectomy.. This retrospective study selected patients who underwent curative D2 surgery for gastric cancer, were diagnosed with stage 2/3 disease, creatinine clearance more than 60 ml/min, and received adjuvant S-1 at our institution between June of 2002 and December of 2011. Time to S-1 treatment failure (TTF) was calculated.. A total of 103 patients were selected for the present study. When TTF curve stratified by each clinical factor was compared by the log-rank test, body weight loss (BWL) of 15 % was regarded as a critical point. Both univariate and multivariate Cox proportional hazard analyses demonstrated that BWL was the significant independent risk factor. Moreover, BWL remained a significant factor in both the univariate and multivariate analyses in the subset excluding 8 patients who discontinued S-1 because of recurrence. The 6-month continuation rate was 66.4 % in the patients with BWL < 15 and 36.4 % in patients with BWL ≥ 15 % (P = .017).. BWL was the most important risk factor for the compliance of adjuvant chemotherapy with S-1 in the patients with stage 2/3 gastric cancer who underwent D2 gastrectomy. To improve drug compliance that leads to survival, it is a key to maintain body weight before starting S-1 adjuvant. Our study emphasizes the requirement for adequate studies of perioperative nutritional intervention in patients who receive gastrectomy for advanced gastric cancer.

Topics: Adenocarcinoma; Adult; Aged; Aged, 80 and over; Antimetabolites, Antineoplastic; Chemotherapy, Adjuvant; Drug Combinations; Female; Follow-Up Studies; Gastrectomy; Humans; Kaplan-Meier Estimate; Male; Medication Adherence; Middle Aged; Multivariate Analysis; Oxonic Acid; Risk Factors; Stomach Neoplasms; Tegafur; Weight Loss

Body weight loss is a common outcome in patients with gastric cancer who have undergone gastrectomy. However, the rate of body weight loss after surgery is unknown.. In this retrospective study, we selected patients who underwent radical gastrectomy for gastric cancer and were diagnosed with Stage II or III disease. Further, we compared the body weight loss after surgery between patients in the surgery alone group and the S-1 adjuvant chemotherapy group.. We evaluated 163 patients, of which 81 underwent only surgery, and 82 underwent surgery followed up with S-1 adjuvant chemotherapy. The body weight loss rate at 1, 3, and 6 months in the surgery alone group were 93.1%, 92.9%, and 94.9%, while those in the S-1 adjuvant group were 92.9%, 90.4%,and 91.9%, which was a significant difference.. Body weight loss after gastrectomy was higher in the S-1 adjuvant group than in the surgery alone group. Further, nutritional support is required for these patients to maintain body weight after surgery.

Topics: Aged; Antimetabolites, Antineoplastic; Chemotherapy, Adjuvant; Drug Combinations; Gastrectomy; Humans; Middle Aged; Oxonic Acid; Stomach Neoplasms; Tegafur; Weight Loss