The impact of contour maps on estimating the risk of gastrointestinal stromal tumor recurrence: indications for adjuvant therapy: an analysis of the Kinki GIST registry.

INTRODUCTION: Contour maps enable risk classification of GIST recurrence in individual patients within 10 postoperative years. Although contour maps have been referred to in Japanese guidelines, their usefulness and role in determining indications for adjuvant therapy is still unclear in Japanese patients. The aims of this study are to investigate the validity of contour maps in Japanese patients with GIST and explore the new strategy for adjuvant therapy. MATERIALS AND METHODS: A total of 1426 Japanese GIST patients who were registered to the registry by the Kinki GIST Study Group between 2003 and 2012 were analyzed. Patients who had R0 surgery without perioperative therapy were included in this study. The accuracy of contour maps was validated. RESULTS: Overall, 994 patients have concluded this study. Using contour maps, we validated the patients. The 5-year recurrence-free survival rates of patients within the GIST classification groups of 0-10%, 10-20%, 20-40%, 40-60%, 60-80%, 80-90%, and 90-100% were 98.1%, 96.6%, 92.3%, 48.0%, 37.3%, 41.0% and 42.4%, respectively. We confirmed that this classification by contour maps was well reflected recurrence prediction. Further, in the high-risk group stratified by the modified National Institutes of Health consensus criteria (m-NIHC), the 10-year RFS rate was remarkably changed at a cutoff of 40% (0-40% group vs. 40-100% group: 88.7% vs. 50.3%, p < 0.001). CONCLUSION: Contour maps are effective in predicting individual recurrence rates. And it may be useful for the decision of individual strategy for high-risk patients combined with m-NIHC.

Role of reduction gastrectomy in patients with gastric cancer with a single non-curable factor: Supplementary analysis of REGATTA trial.

Background: REGATTA trial failed to demonstrate the survival benefit of reduction gastrectomy in patients with advanced gastric cancer with a single non-curable factor. However, a significant interaction was found between the treatment effect and tumor location in the subset analysis. Additionally, the treatment effect appeared to be different between Japan and Korea. This supplementary analysis aimed to elucidate the effect of reduction surgery based on tumor location and country. Methods: Multivariable Cox regression analyses in each subgroup were performed to estimate the hazard ratio (HRadj), including the following variables as explanatory variables: country, age, sex, incurable factor, cT, cN, primary tumor, performance status, histological type, and macroscopic type. Results: Patients (95 in Japan and 80 in Korea) were randomized to chemotherapy alone (86 patients) or gastrectomy plus chemotherapy (89 patients). The subgroup analysis according to the country revealed a worse overall survival in gastrectomy plus chemotherapy arm in Japan (hazard ratio: 1.32, 95% confidence interval: 0.85-2.05), but not in Korea (hazard ratio: 0.85.95% confidence interval: 0.52-1.40). Overall survival was better in distal gastrectomy plus chemotherapy compared with chemotherapy alone (hazard ratio = 0.69, 95% confidence interval: 0.42-1.13), and worse in total gastrectomy plus chemotherapy compared with chemotherapy alone (hazard ratio = 1.34, 95% CI: 0.93-1.94), which was more remarkable in Korea than in Japan. Conclusions: Primary chemotherapy is a standard of care for advanced gastric cancer; however, the survival benefits from reduction by distal gastrectomy remained controversial.

Effect of the number of cycles of docetaxel + S-1 therapy on long-term survival in adjuvant chemotherapy for stage III gastric cancer. A pooled analysis of the OGSG0604 and OGSG1002 trials.

BACKGROUND: S-1 plus docetaxel (DS) therapy followed by S-1 is the standard of care in Japan in postoperative adjuvant chemotherapy for stage III gastric cancer, but long-term survival and the number of DS cycles required are unclear. The purpose of this study was to investigate the impact of the number of cycles of DS therapy on the 5-year survival in stage III gastric cancer in a pooled analysis of two phase II trials (OGSG0604 and OGSG1002). PATIENTS AND METHODS: Patients with histologically confirmed stage III gastric cancer who underwent gastrectomy with D2 lymphadenectomy were enrolled in this pooled analysis. They received DS therapy for four or eight cycles, followed by S-1 until 1 year postgastrectomy. The 5-year overall survival (OS) and the 5-year disease free survival (DFS) by the landmark analysis was evaluated. RESULTS: In total, 113 patients from the OGSG0604 and OGSG1002 trials were enrolled in this study. The landmark analysis showed a 5-year OS that was better with four to eight cycles of DS therapy than with one to three cycles of DS therapy, with the best 5-year OS of 77.4% (95% confidence interval, 66.5-90.1%) for eight cycles. The 5-year DFS was approximately 66% when four or eight cycles of DS therapy were given. CONCLUSION: Although eight cycles of DS therapy may prolong prognosis, the present study did not provide a clear conclusion as to how many DS therapy cycles are needed to improve prognosis after D2 gastrectomy for stage III gastric cancer. TRIAL REGISTRATION: Registration number: UMIN00000714 and UMIN000004440.

Long-term survival with nivolumab followed by irinotecan after total gastrectomy in alpha-fetoprotein-producing gastric cancer: a case report and review of the literature.

BACKGROUND: Alpha-fetoprotein-producing gastric cancer (AFPGC) is a rare type of aggressive gastric cancer (GC) with a dismal prognosis. We present a patient with AFPGC who achieved long-term survival through a multidisciplinary approach. CASE PRESENTATION: A 67-year-old man with advanced GC was referred to our hospital for systemic chemotherapy. He was diagnosed with cStage IVB AFPGC. During 2nd-line treatment, we could not control bleeding from the GC itself. After complete resection, during chemotherapy, portal venous tumor thrombi (PVTTs) and liver metastases were identified. With nivolumab followed by irinotecan, the PVTTs and liver metastases disappeared. Without immunotherapy and chemotherapy for 23 months, the patient has survived for 48 months so far with no recurrence of GC. CONCLUSION: Long-term survival with AFPGC can be accomplished by using several different approaches, such as surgery, immunotherapy, and chemotherapy.

The Phase II Study of Panitumumab in Chemotherapy-Naïve Frail or Elderly Patients with RAS Wild-type Colorectal Cancer: OGSG 1602 Final Results.

BACKGROUND: We previously reported the response rate of a phase II OGSG1602 study on panitumumab in chemotherapy-naive frail or elderly patients with RAS wild-type unresectable colorectal cancer (CRC) [Terazawa T, Kato T, Goto M, et al. Oncologist. 2021;26(1):17]. Herein, we report a survival analysis. METHODS: Patients aged ≥65 years and considered unsuitable for intensive chemotherapy or aged ≥76 years were enrolled. Primary tumors located from the cecum to the transverse colon were considered right-sided tumors (RSTs); those located from the splenic flexure to the rectum were considered left-sided tumors (LSTs). RESULTS: Among the 36 enrolled patients, 34 were included in the efficacy analysis, with 26 and 8 having LSTs and RSTs, respectively. The median progression-free survival (PFS) and overall survival (OS) were 6.0 [95% CI, 5.4-10.0] and 17.5 months (95% CI, 13.8-24.3), respectively. Although no significant differences existed in PFS between patients with LST and RST {6.6 (95% CI, 5.4-11.5) vs. 4.9 months [95% CI, 1.9-not available (NA), P = .120]}, there were significant differences in OS [19.3 (95% CI, 14.2-NA) vs.12.3 months (95% CI, 9.9-NA), P = .043]. CONCLUSION: Panitumumab showed favorable OS in frail or elderly patients with RAS wild-type CRC and no prior exposure to chemotherapy. Panitumumab may be optimal for patients with LSTs (UMIN Clinical Trials Registry Number UMIN000024528).

TRESBIEN (OGSG 2101): encorafenib, binimetinib and cetuximab for early recurrent stage II/III BRAF V600E-mutated colorectal cancer.

The BRAF V600E mutation accounts for approximately 5% of colorectal cancer (CRC) cases and is an extremely poor prognostic factor. However, there are no clear recommendations regarding first-line therapy for patients with early recurrent BRAF V600E-mutated CRC, during or after adjuvant chemotherapy. Recently, a novel combination of encorafenib, binimetinib and cetuximab, showed a higher response rate than standard chemotherapy in patients with BRAF V600E-mutated CRC. Here we describe our plan for the TRESBIEN study (OGSG 2101), which is an open-label, multicenter, single-arm, phase II study designed to evaluate whether encorafenib, binimetinib and cetuximab are effective for patients with early recurrent BRAF V600E-mutated colorectal cancer, during or after adjuvant chemotherapy. The planned number of subjects is 25.

An ongoing study to evaluate encorafenib, binimetinib and cetuximab for people with early recurrent BRAF V600E-mutated colorectal cancer. BRAF V600E-mutated colorectal cancer (CRC) is a type of cancer caused by change (mutation) in a gene called BRAF. It is one of the most difficult types of CRC to treat because currently available drugs do not effectively treat the disease. Recently, two novel treatments, encorafenib and cetuximab, have been approved for use together in several countries for the treatment of advanced or metastatic BRAF V600E-mutated CRC. In Japan, these drugs are also approved to be given with another treatment called binimetinib, an approach called triplet therapy. This article describes the ongoing TRESBIEN study that is looking at how effective and how safe triplet therapy is for the treatment of people with early recurrent BRAF V600E-mutated CRC, during or after they have additional (adjuvant) chemotherapy. This study is ongoing, and the researchers are currently recruiting new participants. TRESBIEN will evaluate the percentage of participants whose tumors shrink with triplet therapy. The study will also look at any side effects. Clinical Trial Registration: jRCTs051210152 (ClinicalTrials.gov) (Japan Registry of Clinical Trials https://jrct.niph.go.jp/search?language=en&page=1).

Neoadjuvant docetaxel, oxaliplatin and S-1 therapy for the patients with large type 3 or type 4 gastric cancer (OGSG1902): protocol of a multi-center, phase II study.

BACKGROUND: Large type 3 and type 4 gastric cancers have extremely poor prognoses. To address this, neoadjuvant chemotherapy may be a promising approach. The phase III JCOG0501 study, conducted to confirm the superiority of neoadjuvant S-1 plus cisplatin followed by D2 gastrectomy over upfront surgery, showed no survival benefit for neoadjuvant S-1 plus cisplatin. In Korea, the PRODIGY study, which was a phase III study of neoadjuvant docetaxel plus oxaliplatin plus S-1 (DOS) followed by surgery and adjuvant S-1 versus surgery and adjuvant S-1 for gastric cancer of T2-3N+ or T4Nany, showed that progression-free survival (PFS) was significantly superior in the neoadjuvant DOS arm. Therefore, DOS therapy may be a promising candidate for preoperative chemotherapy for large type 3 or type 4 gastric cancer. METHODS: Preoperative docetaxel 40 mg/m2 and oxaliplatin 100 mg/m2 will be intravenously administered on day1 every three weeks. S-1 will be orally administered 80 mg/m2 on days 1-14 of a 21-day cycle. Patients will receive three courses of treatment and gastrectomy with ≥D2 lymph node dissection. Postoperative S-1 plus docetaxel therapy (DS) will be administered according to the JACCRO GC-07 (START-2) study. The primary endpoint is the 3-year PFS rate. Secondary endpoints include PFS time, overall survival time, pathological response rate, response rate according to RECIST version1.1, proportion of completion of neoadjuvant chemotherapy, R0 resection rate, proportion of completion of surgery, proportion of completion of protocol treatment, proportion of negative conversion of CY, adverse event occurrence rate, and nutritional evaluation. The null hypothesis for the 3-year PFS rate is 45% and the expected value is 60%. The total sample size is 46 considering that the registration period and follow-up period are two and three years, respectively. DISCUSSION: This is a prospective, multicenter, single-arm, open-label, phase II trial assessing the efficacy and safety of preoperative DOS and postoperative DS for large type 3 or type 4 gastric cancer. The results will inform future phase III trials and are expected to lead to new treatment strategies for large type 3 or type 4 gastric cancer. TRIAL REGISTRATION: Registered with Japan Registry of Clinical Trials on October 11, 2019 ( jRCTs051190060 ).

A phase II study of S-1 therapy for patients with advanced and recurrent esophageal cancer resistant or intolerable to fluorouracil, platinum, and taxane therapy (OGSG 1404).

BACKGROUND: Fluorouracil (FU), platinum (PT), and taxane (TAX) therapy was the standard chemotherapy for esophageal squamous cell carcinoma (ESCC) before the era of anti-programmed death-1 antibodies. The aim of this phase II trial was to evaluate the efficacy and safety of S-1 monotherapy for patients with recurrent or metastatic (R/M) ESCC resistant or intolerable to FU, PT, and TAX therapy. METHODS: Eligible patients had R/M ESCC; no prior S-1 use; were intolerant or refractory to prior FU, PT, and TAX therapy; aged ≧ 20 years; and Eastern Cooperative Oncology Group performance status 0 or 1. S-1 was administered orally from days 1 to 28, every 6 weeks until disease progression. The primary endpoint was the disease control rate (DCR) for each patient, assessed by Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary endpoints were overall survival, progression-free survival, time to treatment failure, response rate, and toxicity. RESULTS: Between October 2015 and December 2017, 17 patients were recruited, and the trial was terminated because of slow accrual. The DCR was 46.7%. The response rate was 13.3%. The median progression-free survival was 2.0 months. The median time to treatment failure was 1.9 months. The median overall survival was 8.4 months, and the 1 year overall survival rate was 30.5%. CONCLUSIONS: Although this trial closed early because of slow accrual, we observed modest clinical activity with S-1 in patients with R/M ESCC who could not tolerate or whose tumors were refractory to FU, PT, and TAX therapy.

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).

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.

Comparison of S-1-cisplatin every 5 weeks with capecitabine-cisplatin every 3 weeks for HER2-negative gastric cancer (recurrent after S-1 adjuvant therapy or chemotherapy-naïve advanced): pooled analysis of HERBIS-2 (OGSG 1103) and HERBIS-4A (OGSG 1105) trials.

BACKGROUND: We previously reported the HERBIS-4A phase II trial comparing S-1 plus cisplatin (SP) with capecitabine plus cisplatin (XP) in chemotherapy-naïve patients with HER2-negative advanced gastric cancer (GC). We performed a pooled analysis of HERBIS-4A and HERBIS-2, the phase II trial comparing SP with XP in HER2-negative recurrent GC patients with a recurrence-free interval after S-1 adjuvant therapy of ≥ 6 months. PATIENTS AND METHODS: Patients were randomly assigned to receive either SP [S-1 (40-60 mg twice daily for 21 days) plus cisplatin (60 mg/m2 on day 8), every 5 weeks] or XP [capecitabine (1000 mg/m2 twice daily for 14 days) plus cisplatin (80 mg/m2 on day 1), every 3 weeks]. RESULTS: In the pooled analysis, SP (n = 44-50) showed a longer progression-free survival [6.4 versus 5.1 months; hazard ratio (HR), 0.666; P = 0.062], overall survival (14.8 versus 10.6 months; HR, 0.695; P = 0.099), and time to treatment failure (4.6 versus 3.6 months; HR, 0.668; P = 0.045) as well as a higher disease control rate (86.4% versus 68.1%, P = 0.149) compared with XP (n = 47-51). A significant survival advantage for SP over XP was apparent in patients with a performance status of 0, a differentiated-type tumor histology, or a primary tumor localization to the upper portion of the stomach. CONCLUSION: Our pooled analysis supports the use of SP in the first-line setting for patients with HER2-negative advanced or recurrent GC with a recurrence-free interval of ≥ 6 months. CLINICAL TRIAL REGISTRATION: The HERBIS-2 trial was registered with UMIN-CTR as UMIN000006105.

Differences in disease status between patients with progression after first-line chemotherapy versus early relapse after adjuvant chemotherapy who undergo second-line chemotherapy for gastric cancer: Exploratory analysis of the randomized phase III TRICS trial.

BACKGROUND: Second-line chemotherapy (SLC) improves survival in advanced gastric cancer (AGC). Patients receiving SLC are categorized into two disease status groups: tumour progression after first-line chemotherapy and early recurrence after adjuvant chemotherapy. Differences between these groups have not yet been clarified. PATIENTS AND METHODS: A total of 163 eligible patients registered in the randomized phase III TRICS trial evaluating SLC for patients with AGC was classified into the progressive disease (PD) group (n = 55) or the early relapse (ER) group (n = 108). We compared overall survival (OS), progression-free survival (PFS), overall response rate (ORR), and safety. Adjusted OS and adjusted PFS were estimated using inverse probability of treatment weighting (IPTW). RESULTS: The ER group had a lower median age than the PD group (66 vs. 72 years; P = 0.016), performance status (PS) 0 was more frequently seen in the ER group (87% vs. 71%; P = 0.012). The adjusted median OS was 13.7 months in the ER group and 13.6 months in the PD group (IPTW hazard ratio [HR]: 1.023; P = 0.854). The adjusted median PFS was 4.9 months in the ER group and 4.4 months in the PD group (IPTW HR: 0.707; P = 0.004). ORR was significantly better in the ER group than the PD group (21.3% vs. 4.9%; P = 0.020). No significant differences were observed in the incidence of adverse events. CONCLUSIONS: ER was associated with improved PFS and better ORR than PD, although no difference in survival was demonstrated. From the viewpoint of treatment outcome, it seems appropriate to treat patients with ER in the same way as patients with PD. CLINICAL TRIAL REGISTRATION: UMIN 000002571.

[A Case of Superficial-Type Gastric Cancer with Metastatic Ovarian Cancer Diagnosed by Exploratory Laparotomy].

Here, we report a case of superficial-type gastric cancer with metastatic ovarian cancer(Krukenberg tumor)diagnosed by exploratory laparotomy. Chemotherapy was initiated at an early stage in this patient. A 43-year-old woman with superficialtype gastric cancer(0-Ⅱb plusⅡa), an ovarian tumor, and a solitary sclerotic bone lesion underwent exploratory laparotomy and bilateral salpingo-oophorectomy. Pathological findings showed that the resected ovarian tumor specimen contained the same type of signet ring cell carcinoma as the biopsy gastric cancer specimen; hence, the patient was diagnosed with superficial- type gastric cancer with metastatic ovarian cancer. She was treated with first-line chemotherapy(capecitabine plus oxaliplatin)15 days after exploratory laparotomy, followed by second-line chemotherapy(ramucirumab plus paclitaxel), thirdline chemotherapy(nivolumab), and fourth-line chemotherapy(irinotecan). Twenty-two months after the start of first-line chemotherapy, she finally died due to bone metastasis.

[Long-Term Survival of a Patient with Metastatic Ovarian Cancer and Local Recurrence of Rectal Cancer].

A 60s woman with upper rectal cancer underwent low anterior resection; the patient was diagnosed with pSSN1, Stage Ⅲa cancer. She received adjuvant therapy with UFT. Three years after the primary resection, metastasis to the right ovary and local recurrence were diagnosed. She was treated with CAPOX plus bevacizumab(Bev), capecitabine, FOLFIRI, and irinotecan plus S-1. Because only the ovarian metastasis increased rapidly, we were able to perform surgery and R0 resection. Two years after resection, local recurrence became apparent, and chemotherapy was reinitiated. After treating the patient with chemotherapy and chemo-radiation therapy for 2 years, R0 resection was performed. Twelve years after primary tumor resection and 9 years after primary resection, we observed recurrence-free survival.

[A Successful Management of Thrombocytopenia Due to Multiple Lung Metastasis of Intrahepatic Cholangiocarcinoma Using Laparoscopic Splenectomy-A Case Report].

We report a case of multiple lung metastasis of intrahepatic cholangiocarcinoma treated with chemotherapy, in which laparoscopic splenectomy was effective for thrombocytopenia. A 74-year-old woman was diagnosed with multiple lung metastasis of intrahepatic cholangiocarcinoma 6 years after partial liver resection(S3). She was undergoing treatment for post-transfusion hepatitis C infection since the age of 46 years and developed thrombocytopenia due to splenomegaly. The previous hospital determined that there was no indication for chemotherapy due to thrombocytopenia. Elective laparoscopic splenectomy resulted in an increase in the platelet count and facilitated the initiation of gemcitabine(GEM)and cisplatin (CDDP)combination chemotherapy. The patient has maintained a good treatment course without interruption due to thrombocytopenia during chemotherapy. In advanced cancer patients with thrombocytopenia complication due to splenomegaly, laparoscopic splenectomy may offer an effective auxiliary means for the safe implementation of chemotherapy.

[A Case of Liver Metastasis of Distal Bile Duct Cancer].

A 60-year-old female visited our hospital due to anorexia and jaundice in March 2016. She underwent pancreatoduodenectomy( PD)and was diagnosed with distal bile duct cancer. The histopathological diagnosis was distal bile duct cancer, tub2, pT3aN1M0, pStage ⅡB. Postoperatively, she received S-1 therapy as adjuvant chemotherapy. One year after surgery, abdomi- nal enhanced CT and EOB-MRI revealed a liver metastasis(S3; 20mm). After 4courses of gemcitabine(GEM)/cisplatin(CDDP) combination therapy, there was no new lesion; thus, we performed partial hepatectomy(S3)in July 2017. The histopathology findings revealed well differentiated adenocarcinoma that was similar to the primary lesion, and the tumor was confirmed as a recurrence of bile duct cancer. She remains alive without second recurrence for 2 years since the tumor resection(about 3 years since PD). Surgical intervention might be beneficial in selected patients with recurrent bile duct cancer.

[Analysis of Early Palliative Care for Patients with Gastric Cancer].

BACKGROUND: Palliative care delivered to cancer patients late in the course of disease are inadequate to improve advance care planning and quality of life; thus, early palliative care is recommended. We retrospectively analyzed early palliative care delivered to patients with gastric cancer. METHOD: Forty-nine gastric cancer patients who underwent surgery and had received interdisciplinary care from the first visit(early palliative care)were assessed for physical and psychosocial symptoms. RESULTS: All patients were followed up continuously by a nurse certified in palliative care support to provide quality patient-centered care from the beginning(advance care planning). Four patients had experienced relapse, and 3 older patients had decided not to receive chemotherapy following their advance care planning. However, all 4 patients were admitted to a palliative care unit without barriers. CONCLUSION: Early palliative care might lead patients to have advance care planning, and a better quality of life.

Meta-analysis of two randomized phase III trials (TCOG GI-0801 and ECRIN TRICS) of biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer.

BACKGROUND: Biweekly irinotecan (CPT-11) plus cisplatin (CDDP) combination (BIRIP) and CPT-11 alone are both expectable options for treating advanced gastric cancer (AGC) in a second-line setting. We conducted a meta-analysis to compare the efficacy and safety of these two regimens in patients enrolled two randomized phase III trials. PATIENTS AND METHODS: Individual patient-level data from two randomized phase III trials were collected for this study. In both trials, patients with AGC refractory to S-1-based chemotherapy were randomly allocated to BIRIP (CPT-11, 60 mg/m2; CDDP, 30 mg/m2, q2w) or to CPT-11 (150 mg/m2, q2w). RESULTS: Cumulative data from 290 eligible patients were evaluated. The OS was 12.3 months [95% confidence interval (CI) 10.5-14.1] in the BIRIP group and 11.3 months (95% CI 10.0-13.2) in the CPT-11 group (hazard ratio 0.87; 95% CI 0.68-1.12, P = 0.272), while PFS was significantly longer in the BIRIP group (4.3 months [95% CI 3.5-5.1]) than in the CPT-11 group (3.3 months [2.9-4.1]; HR 0.77; 95% CI 0.61-0.98, P = 0.035). The response rate was 20.5% in the BIRIP group and 16.0% in the CPT-11 group (P = 0.361). However, the disease control rate was significantly better in the BIRIP group (72.1%) than in the CPT-11 group (59.2%) (P = 0.032). The two groups did not differ significantly in the incidences of grade 3 or worse adverse events. CONCLUSIONS: Both BIRIP and CPT-11 may be good therapeutic options for patients with AGC as second-line treatment. CLINICAL TRIAL REGISTRATION: UMIN 000025367.

Sarcopenia Is Associated With Impaired Overall Survival After Gastrectomy for Elderly Gastric Cancer.

BACKGROUND/AIM: The aim of this study was to evaluate the impact of sarcopenia diagnosed by the European Working Group on Sarcopenia in Older People (EWGSOP) algorithm on long-term outcome after gastrectomy. PATIENTS AND METHODS: A total of 90 elderly gastric cancer patients without distant metastasis aged 65 years or older who underwent gastrectomy at the Osaka National Hospital between July 2012 and January 2015 were included in the current analysis. RESULTS: The sarcopenic group (n=19) had a poorer overall survival (OS) (p<0.0001) compared to the non-sarcopenic group (n=79). OS after recurrence was also worse in the sarcopenic group. Multivariate analysis indicated that sarcopenia was an independent risk factor for worse OS after gastrectomy (hazard ratio(HR)=2.92; 95% confidence interval(CI)=1.15-7.75; p=0.025), along with N stage ≥2, age ≥75 years, and presence of severe postoperative complications. CONCLUSION: Sarcopenia is a potential target for preoperative intervention in elderly gastric cancer patients to improve prognosis after gastrectomy. (UMIN-CTR: R000041532).

The Risk Factor of Anastomotic Hypoperfusion in Colorectal Surgery.

BACKGROUND: Inadequate blood flow is an important risk factor for anastomotic leakage. Indocyanine green (ICG) fluorescence imaging allows intraoperative assessment of intestinal blood flow. This study determined the risk factor of anastomotic hypoperfusion in colorectal surgery using ICG fluorescence imaging. METHODS: This study included 74 consecutive patients who underwent colorectal surgery between April 2017 and March 2018. ICG was injected intravenously after dividing the mesentery and central vessels along the planned transection line, but before completing the anastomosis. Intraoperative blood flow was evaluated using ICG fluorescence imaging. With regard to the patient-, tumor-, and surgery-related factors, anastomotic perfusion was evaluated based on the changed transection line and prolonged (more than 60 s) perfusion time. RESULTS: Intraoperative ICG fluorescence imaging was performed in all patients, and no adverse events were associated with ICG injection. Based on the perfusion assessment, we changed the transection line in six patients (8.1%). The prolonged perfusion time was observed in nine patients (12.2%). The postoperative course was uneventful in 63 (85.1%) patients, but one patient (1.4%) had postoperative anastomotic leakage. The changed transection line was significantly associated with anticoagulation therapy (P = 0.029). Well-known risk factors, including surgical site, sex, smoking, blood loss, operative time, and preoperative chemoradiotherapy, were not related to the changed transection line. Prolonged ICG perfusion time was not associated with any patient-, tumor-, or surgery-related factors. CONCLUSIONS: The evaluation of intraoperative blood flow using ICG fluorescence imaging may be able to detect anastomotic hypoperfusion, and anticoagulation therapy is a risk factor of anastomotic hypoperfusion in colorectal surgery.

[A Case of Recurrent Gastric Cancer Successfully Treated by S-1 Chemotherapy].

We report a case of recurrent gastric cancer that was successfully treated by S-1 chemotherapy.An 81-year-old woman with advanced gastric cancer[L Less, Type 2, cT4a(SE), cN0H0P0M0, cStageⅡB]underwent distal gastrectomy.Abdominal CT performed 6 months after surgery revealed a low-density area in the liver.She was diagnosed with liver metastasis and started receiving S-1 chemotherapy.The liver metastasis achieved complete response, so S-1 chemotherapy was discontinued 12 months after recurrence.Abdominal CT performed 9 months after the discontinuation of S-1 chemotherapy revealed multiple low-density areas in the liver.She started receiving S-1 chemotherapy again, but S-1 chemotherapy was discontinued because of side effects after 2 courses.The patient died 24 months after receiving S-1 chemotherapy.