Sedation with DEX is effective and safe for patients with gastric tumors who are undergoing ESD.

Objective Recent guidelines have adopted an incidence of febrile neutropenia (FN) threshold of 20% for the use of prophylactic granulocyte colony-stimulating factor (G-CSF). In a Japanese phase II study of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) for Japanese patients with advanced pancreatic cancer, the incidence of FN and severe neutropenia were 24.7% and 77.8%, respectively, without G-CSF prophylaxis. The aim of this retrospective study was to investigate the incidence of FN or severe neutropenia induced by full-dose FOLFIRINOX administration with G-CSF prophylaxis during the first cycle of treatment. Methods Patients with advanced pancreatic cancer who received FOLFIRINOX with G-CSF prophylaxis during the first cycle of treatment from January 2014 to August 2014 were investigated and the frequency of adverse events during the first cycle was measured. Results Among seven patients who received FOLFIRINOX, six patients met the eligibility criteria. The patient characteristics were as follows: median age (range), 57 (50-66); men/women, 3/3; performance status 0/ 1, 2/4. Grade 3/4 hematological adverse events were as follows: leukopenia in 33% of the patients, neutropenia in 33% of the patients, thrombocytopenia in 33% of the patients and FN in 17% of the patients. One patient was heterozygous for the UGT1A1*6 and UGT1A1*28 polymorphisms and experienced FN. Grade3/4 non-hematological adverse events were as follows: anorexia in 33% of the cases and nausea in 50% of the cases. Conclusion Although the present study was retrospective and small, the simultaneous administration of G-CSF might be effective for the prevention of severe neutropenia and FN in patients treated with FOLFIRINOX.

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274 Background: Granulocyte Colony-Stimulating Factors (GCSF) is used as supportive care in cancer management when patients (pts) receive chemotherapy with high risk of febrile neutropenia (FN). Peg-GCSF is unapproved in Japan at the time of Aug 2014. Hence, phase II study of combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) for Japanese pts with advanced pancreatic cancer showed FN; 22% and severe neutropenia; 77.8%. Purpose of this retrospective study was to describe the incidence of FN and severe neutropenia during the first cycle of FOLFIRINOX with prophylactic GCSF (pGSF). Methods: Between January 2014 and August 2014, the pts who received FOLFIRINOX with pGCSF were examined retrospectively. The adverse events and detail of pGCSF administration during first cycle were investigated. Results: Among five pts administered FOLFIRINOX, 4 pts received pGSF in first cycle. All patients received FOLFIRINOX without dose reduction. The patient characteristics were as follows: median age (range), 58 (50-66); male/ female, 3/1; PS 0/1, 1/3. The detail of UTG1A1 (*6/ *28) was as follows: (wild type/ wild type), 2pts; (wild/ hetero), 1pt; (hetero/ hetero), 1pt. Hematological adverse events (grade 1/2/3/4) were as follows: leukopenia (0/1/2/0), neutropenia (0/1/0/1), thrombocytopenia (0/4/0/0), FN (0/0/1/0). The patient who occurred grade4 neutropenia and grade3 febrile neutropenia had UTG1A1 *6 hetero/ *28 hetero. Non-hematological adverse events (grade 1/2/3/4) were as follows: elevated GOT (2/1/0/0), elevated GPT (2/1/0/0), elevated T-Bil (0/0/0/0), anorexia (1/2/1/0), fatigue (2/1/0/0), nausea (0/1/2/0), diarrhea (1/1/0/0). The median starting date of pGSF administration was 4.5 (3-7). The median number of pGSF administration was 7.5 (6-9). Conclusions: Although this was retrospective and small study, pGSF appeared to be effective for prevention of severe neutropenia and FN. Hence pGSF might increase dose intensity of FOLFIRINOX.

Background/Aim: To prospectively evaluate the efficacy and safety of the BNT162b2 vaccine in solid cancer patients undergoing systemic chemotherapy (n=63). Patients and Methods: COVID-19 anti-spike protein antibody levels were measured before the first BNT162b2 vaccination, just before the second BNT162b2 vaccination, one month after the second BNT162b2 vaccination, and 3 months after the second BNT162b2 vaccination. Anti-spike protein antibody seropositivity was set at ≥0.8 U/ml. Results: Colorectal cancer was the most commonly observed primary disease (36.5%). ECOG-PS 0 was observed in the majority (52.4%) of patients. The overall response rate and the median (range) anti-spike protein antibody levels in the whole cohort at 3 months after the second BNT162b2 vaccination were 98.4% (62/63) and 206 (0.4-3,813) U/ml. None of the patients required postponement or discontinuation of systemic chemotherapy because of an adverse reaction. Conclusion: The BNT162b vaccine in solid cancer patients undergoing systemic chemotherapy is effective and safe.The COVID-19 pandemic is still ongoing, and antibody acquisition against COVD-19 through vaccination is necessary for infection control (1, 2). Currently, several COVID-19 vaccines are under development worldwide (3,4). Three types of COVID-19 vaccines [Pfizer (BNT162b2), Moderna (mRNA-1273), and AstraZeneca (ChAdOx1 nCov19)] are currently approved in Japan, all of which have shown high efficacy (94-95%) in preventing the onset of symptomatic .The Pfizer BNT162b2 vaccine is a lipid nanoparticleformulated, nucleoside-modified RNA (mRNA) vaccine encoding a prefusion-stabilized, membrane-anchored severe acute respiratory syndrome coronavirus 2 full-length spike protein (8). In Japan, the BNT162b2 mRNA vaccine was approved by the regulatory authorities in February 2021, with priority vaccination for healthcare workers. Priority vaccination for the elderly and patients with underlying diseases had also been initiated in April 2021. Reports have begun to emerge from both Japan and overseas on the rate of antibody acquisition and reduction of COVID-19 infection rates through vaccination for COVID-19 in healthy subjects (8-11). On the other hand, cancer patients have a significantly higher incidence, severity, and mortality rate of COVID-19 infection, and patients with solid tumors are also priority 2780

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In pathological stage (pStage) II colon cancer, factors such as T stage (T) are high-risk features (HRF) for recurrence. The SACURA trial showed that tumor budding (BD) grade was also associated with recurrence: the 5-year recurrence-free survival (RFS) rate was lower in patients in the BD3 group compared with that of other groups. Interestingly, the BD3 group had a higher proportion of patients with T4. We investigated the prognostic association between T4 and BD3 for recurrence in pStage II colorectal cancer (pII-CRC) with HRF. We analyzed pII-CRC patients with HRF between 2013–2018 at our hospital, Japan. Inclusion criteria were as follows: ≥1 HRF [<12 lymph nodes examined (<12LN), lymph/vascular-invasion, perineural-invasion, T, BD, and histologic-type]. We primarily analyzed the relationship between each factor and RFS. Among 2,920 pII-CRC patients, 448 had HRF. Of these, 43 (9.6%) had T4 and 236 (52.7%) had BD3. On initial analysis, <12LN (P=0.0412), tumor location (P=0.0023), T4 (P=0.0023), and BD3 (P=0.0396) were independent prognostic factors for RFS. Among 257 patients with BD3 and/or T4, the 5-year RFS rates were 81.3%, 74.6%, and 66.2% for patients with BD3 (214 patients), T4 (22 patients), and BD3 plus T4 (21 patients), respectively (hazard ratio 3.08, P=0.0079). pII-CRC patients with BD3 plus T4 had poorer prognosis than those with other factors.

Responses to CT were reported according to RECIST 1.1. Adverse events were classified based on CTCAE v 4.0. Results: Between October 2016 and May 2017, 13 patients with refractory mCRC were treated with this investigational combination. The median age was 47 years (range, 32-65); 10 males and 3 females; ECOG PS 0-1/2, 12/1; site of primary tumor rectum/colon, 8/5. Median baseline serum CEA was 78 ng/ml (range, 18-836). The most common site of metastases was liver (n ¼ 7) followed by peritoneum (n ¼ 5), lungs (n ¼ 3) and nonregional lymph-nodes (n ¼ 3); number of involved metastatic sites 1-2/3, 8/5. After 6 cycles of CT, overall response rate and disease control rate was 15.4% and 84.6% respectively (CR ¼ 0, PR ¼ 2 pts, SD ¼ 9 pts); approximately 69% of patients experienced a 50% decline in serum CEA level. At a median follow-up of 5.5 months (range, 4-8), 7 patients had disease progression and kept on best supportive care; 6 patients were still on study drugs; and all 13 patients were alive. Median progression-free survival was 4.5 months (95%CI 3.8-5.2), from the initiation of ATO plus FOLFIRI. The toxicities were as follows: Grade 1/2 toxicity: fatigue (4 pts.), constipation (1), nausea and vomiting (1). Grade 3 toxicity: fatigue (3), neutropenia (2), diarrhea (2), QTc prolongation (1). No patient experienced grade 4 toxicities. Conclusions: The addition of ATO 0.15 mg/kg/day on days 1 to 2, to standard FOLFIRI regimen as second-line CT in patients with refractory mCRC offers an encouraging anti-tumor effect at the cost of manageable toxicity.Legal entity responsible for the study: