[Could Preoperative Conditions Be Preserved or Improved by the Support of Preoperative ONS Administration in Patients with Gastric Cancer?]

INTRODUCTION: In our hospital, we measure the body composition of patients undergoing gastrointestinal surgery. For patients who have a skeletal muscle mass(SMM)of less than 90% of the ideal, we provide them with guidance on having oral nutritional supplements(ONS)and self-exercise therapy. Therefore, we perform operations after taking measures on preserving/improving patient's preoperative conditions. This study was aimed to evaluate the effects on body weight, SMM, and fat mass(FM)in the patients scheduled for gastrectomy. PATIENTS AND METHODS: From January 2017 to December 2020, we retrospectively analyzed 64 gastric cancer patients whose body composition changes were measured at the time of initial diagnosis and immediately before surgery. The body composition was measured by a nutritionist using the BIA method, while the self-exercise therapy was instructed by a rehabilitation therapist. RESULTS: A total of 64 patients were divided into 2 groups: ONS group(36 patients)and Non-ONS group(28 patients). The median preoperative ONS administered to the ONS group was 15 packs. Body weight change showed a significant difference between the 2 groups(+0.73% and -0.91%[p<0.01]in the ONS group and Non-ONS group respectively). SMM change showed no significant difference between the 2 groups(+1.18% and +0.64%[p=0.19]in the ONS group and Non-ONS group respectively). Likewise, FM change showed no significant difference between the 2 groups(-1.08% and -3.50%[p=0.39]in the ONS group and Non-ONS group respectively). CONCLUSION: This study suggested that SMM and FM could be preserved, and body weight could be increased by the support of preoperative ONS administration even in patients with gastric cancer close to having sarcopenia.

Interim analysis of a phase II trial evaluating the safety and efficacy of capecitabine plus oxaliplatin (XELOX) as adjuvant therapy in Japanese patients with operated stage III colon cancer.

PURPOSE: Adjuvant oxaliplatin plus oral capecitabine (XELOX) is recommended for patients with curatively resected colon cancer. However, its safety and tolerability in Asian patients is unclear; therefore, we evaluated the safety and efficacy of adjuvant XELOX in Japanese patients with curatively resected stage III colon cancer (MCSCO-1024) and present the interim safety data. METHODS: This prospective, multi-center, open-label, single-arm phase II study recruited patients with curatively resected stage III colon cancer. The protocol was a 120-min intravenous infusion of oxaliplatin (130 mg/m2) on day 1 and oral capecitabine (2000 mg/m2/day) in two divided doses for 14 days of a 3-week cycle, for a total of eight cycles (24 weeks). The primary endpoint was the 3-year disease-free survival, and secondary endpoints were the treatment completion rate, safety profile (rate and severity of adverse events), and correlation of adverse events, such as peripheral sensory neuropathy (PSN), with the administration period of oxaliplatin, etc. RESULTS: From November 2011 to August 2014 (34 months), 196 patients were enrolled. Safety was analyzed in 190 patients. The median total doses of capecitabine and oxaliplatin were 215,586.9 and 777.2 mg/m2, respectively, while the median relative dose intensities were 82.5 and 76.0%, respectively. The overall treatment completion rate was 73.7%. The most frequent treatment-related adverse event was PSN (88.4%), while the most frequent grade ≥3 treatment-related adverse events were neutropenia (12.6%), PSN (6.3%), diarrhea (4.2%), and thrombocytopenia (4.2%). There were no treatment-related deaths. CONCLUSIONS: Adjuvant XELOX is tolerable for Japanese patients with Stage III colon cancer.

Micrometastasis Volume in Lymph Nodes Determines Disease Recurrence Rate of Stage II Colorectal Cancer: A Prospective Multicenter Trial.

PURPOSE: We reported in a retrospective study that the presence of micrometastasis in lymph nodes, when assessed by carcinoembryonic antigen (CEA)-specific RT-PCR, is a significant prognostic factor in stage II colorectal cancer. The aim of this study was to clarify the clinical value of micrometastasis in a prospective multicenter trial. EXPERIMENTAL DESIGN: From November 2001 to December 2005, a total of 419 colorectal cancer cases were preoperatively registered at a central data center. Of them, 315 node-negative stage II colorectal cancer cases were enrolled. After RNA quality check, 304 colorectal cancer cases were analyzed for CEA mRNA in lymph nodes by both conventional RT-PCR (a band method) and quantitative RT-PCR. Long-term prognosis of the patients was determined by each method. RESULTS: A positive band for CEA mRNA was detected in 73 (24.0%) of 304 patients. Postoperative adjuvant chemotherapy was applied in 31 CEA band-positive cases with an oral 5-fluorouracil derivative HCFU (1-hexylcarbamoyl-5-fluorouracil) for 1 year, whereas chemotherapy was not administered to CEA band-negative group. Multivariate Cox regression analyses revealed that a high micrometastasis volume (high MMV, n = 95) was an independent poor prognostic factor for 5-year disease-free survival (DFS; P = 0.001) and 5-year overall survival (OS; P = 0.016). CONCLUSIONS: This prospective clinical trial demonstrates that micrometastasis volume is a useful marker in identifying patients who are at high or low risk for recurrence of stage II colorectal cancer. Clin Cancer Res; 22(13); 3201-8. ©2016 AACR.

[Adjuvant chemotherapy with FOLFOX4 regimen after curative resection of liver metastases from colorectal cancer].

Only a partial benefit of adjuvant chemotherapy administered after curative resection of colorectal cancer (CRC) metastases has been demonstrated. We report here our experience of 7 cases that were administered FOLFOX4 regimen as adjuvant chemotherapy after a curative resection of liver metastases from CRC. Five patients received 6 cycles of FOLFOX4 after prophylactic hepatic arterial infusion of 5-FU, and 2 remaining patients simply received 8 cycles of FOLFOX4. All patients completed the planned cycles of FOLFOX4 without any dose reduction of oxaliplatin. No patients developed a severe adverse effect greater than grade 2 except for grade 3 neutropenia observed in 4 cases. Although lung metastases occurred in 2 cases 28.1 and 21.3 months after liver resection, respectively, all patients are alive after a median follow up of 23.5 months. Our experience indicates that adjuvant chemotherapy with six to eight cycles of FOLFOX4 regimen is safe with a high dose intensity of oxaliplatin and expected to provide a survival benefit.

[A complete response of locally-advanced poorly differentiated adenocarcinoma of the rectum to pre-operative chemo-radiation therapy].

A 71-year-old woman with peri-anal pain and anal bleeding was found to have a tumor in lower rectum in colonoscopic examination, which was histologically diagnosed as poorly differentiated adenocarcinoma. Computed tomography and magnetic resonance imaging showed a tumor 5 cm in diameter deeply infiltrating mesorectum, and swelling of intra-pelvic lymph nodes. At the first operation, infiltration of the tumor was so deep that a complete surgical resection was considered to be difficult, and only a sigmoid colostomy construction was done. After chemo-radiation therapy of 50.4 Gy and 5-FU plus levofolinate calcium (Isovorin) infusion, the tumor was reduced in size and lymph nodes were extremely decreased. The patient underwent an abdominoperinial resection 6 weeks after the end of chemo-radiation, and pathological examination revealed a complete replacement of tumor with necrosed tissue, and no viable tumor cell was found. Poorly differentiated adenocarcinoma of the colon is reported to be highly malignant and associated with poor prognosis. Preoperative chemo-radiation therapy can be a promising candidate for adjuvant treatment of locally-advanced poorly differentiated adenocarcinoma of the rectum.

Adjuvant hepatic arterial infusion after curative resection of colorectal liver metastases using removable intra-arterial catheters with shape-memory alloy.

BACKGROUND AND OBJECTIVES: Although there are some reports that adjuvant hepatic arterial infusion (HAI) chemotherapy reduces the hepatic recurrence following curative resection of colorectal liver metastases, problems of indwelling catheters after chemotherapy cessation remains unsolved. The usefulness of adjuvant HAI was investigated using a removable port-catheter system. METHODS: Spiral catheterstrade mark were attempted to be placed in 17 patients who underwent curative hepatectomy. The catheter contains a special shape-memory alloy at its tip, which allows stable fixation to the vascular wall without coiling so the catheter can be removed if necessary. 5-fluorouracil (5-FU) in total dose of 12 g was intra-arterially administered. RESULTS: W spiral catheterstrade mark were successfully placed in the hepatic artery by percutaneous approach in 82% of the patients. All patients underwent scheduled chemotherapy without serious adverse events. Reservoir-catheter system was removed easily and uneventfully after discontinuation of the chemotherapy. 3D-CT angiography revealed that the hepatic artery was well preserved with short-term chemotherapy. Postoperative hepatic recurrence was observed only in 18% of the patients with the median follow-up time of 19.9 months. CONCLUSIONS: Prophylactic 5-FU HAI using W spiral cathetertrade mark and subsequent catheter extirpation is a promising strategy following curative resection of colorectal liver metastases.