120 Background: Triplet regimen, FOLFOXIRI, plus bevacizumab is considered as one of standard first-line treatments in metastatic colorectal cancer (mCRC). On the contrary, FOLFOXIRI plus anti-EGFR antibody has been shown to be a promising regimen with greater depth of response (DpR) in patients with RAS wild-type mCRC from the VOLFI and MACBETH trials (J Clin Oncol 2019, JAMA Oncol 2018). We therefore performed a randomized phase II study, DEEPER trial (JACCRO CC-13) [NCT02515734], to investigate the efficacy and safety of cetuximab (cet) vs. bevacizumab (bev) in combination with modified (m)-FOLFOXIRI in previously untreated mCRC patients with RAS wild-type tumors. We have reported a significantly better DpR of m-FOLFOXIRI plus cet compared to bev as the primary endpoint (Tsuji A, et al. ASCO 2021). Methods: This trial was a randomized phase II trial to evaluate modified (m)-FOLFOXIRI (irinotecan 150 mg/m2, oxaliplatin 85 mg/m2, 5-FU 2400 mg/m2) plus cet vs. bev as initial treatment in terms of DpR during the entire course as the primary endpoint in 360 patients with RAS wild-type mCRC. The aim of the trial was to show that median DpR of cet arm was more than 12.5% higher than bev arm, with a power of 85% at a significance level of 0.05, in per protocol set (PPS) consisted of patients evaluable for the DpR. Secondary endpoints included progression-free survival, overall survival, overall response rate, early tumor shrinkage rate, secondary resection rate, and toxicity. A total of 359 patients were enrolled between July 2015 and June 2019. For the PPS (median age 65y, 64% male, PS0/1: 91%/9%, left/right primary: 84%/16%), 159 and 162 patients were randomly assigned to the cet and bev arms, respectively. Clinical outcomes will be analyzed according to primary tumor sidedness which is included in the stratification factor. Additionally, we will collect data of BRAF status, and analyze the clinical outcomes in mCRC patients with RAS/ BRAF wild-type tumors and/or left-sided tumors. Pre-planned survival analysis will be performed to compare the two treatment arms at the time of 3 years after last patients’ enrollment using a log-rank test. All statistical tests are two-sided, and P values ≤ 0.05 are deemed significant. Statistical analyses will be performed using SAS version 9.4. Clinical trial information: NCT02515734 .
357 Background: Remnant gastric cancer (RGC) is defined as a cancer arising in the remnant stomach after initial gastrectomy, regardless of the previous disease or surgical procedure. Despite growing evidence of the effectiveness of minimally invasive surgery (MIS) for primary gastric cancer, MIS for RGC remains controversial due to the rarity of the disease. This study aimed to evaluate the surgical and oncological outcomes of MIS for radical resection of RGC. Methods: We collected the data of patients with RGC who underwent surgery with curative intent between 2005 and 2020 from 17 institutions in Japan, and performed a propensity score (PS) matching analysis to compare the short- and long-term outcomes of MIS with open surgery. Results: A total of 327 patients were included in this study and 186 patients were analyzed after matching. The risk ratios for overall and severe complications were 0.76 (95% confidence interval [CI]: 0.45–1.27) and 0.65 (95% CI: 0.32–1.29), respectively. The MIS group had significantly less blood loss (50 ml vs. 361 ml, P<0.001) and a shorter hospital stay (13 days vs. 16 days, P=0.009) than the open surgery group, while the operative time was longer in the MIS group (344 min vs. 273 min, P<0.001). The median follow-up duration of this cohort was 4.6 years, and the 3-year overall survival rates were 77.9% in the MIS group and 76.2% in the open surgery group (hazard ratio [HR], 0.78; 95% CI: 0.45–1.36). The 3-year relapse-free survival rates were 71.9% in the MIS group and 62.2% in the open surgery group (HR, 0.71; 95% CI: 0.44–1.16). Locoregional recurrence occurred in three patients (3.2%) in the MIS group and four patients (4.3%) in the open surgery group. There were also no differences in the other patterns of recurrence between the groups. Conclusions: MIS for RGC showed favorable short- and long-term outcomes compared to open surgery. MIS is a promising option for radical surgery for RGC.
Introduction: Hepatic hemangioma has incidence of 0.4% e 20% in general population and conventional ultrasound is often the first diagnostic method, normally as an incidental finding. Second generation contrast-enhanced ultrasound (CEUS) has been used in several areas of hepatology, with similar results on computed tomography and magnetic resonance imaging (MRI) in the diagnosis of hepatic hemangiomas. Objective: Correlation between the perflutren CEUS and MRI in the diagnosis of hepatic hemangiomas. Method: A prospective analysis of 37 patients with 57 nodules identified as incidental findings of routine ultrasound. In 37 patients, was administered perflutren contrast with no adverse effects. The 37 patients underwent MRI. Results: Conventional ultrasound identified nodules in 15 patients with typical characteristics of hemangiomas and 22 patients with nodules with other characteristics. In 35 patients the perflutren CEUS characteristics were compatible with hemangiomas. Correlation between ultrasound and MRI with contrast was 94.5%, and in discordant cases the diagnosis was made by MRI. In nodules with indeterminate characteristics on perflutren CEUS, MRI was repeated in three months, confirming the diagnosis of hepatic hemangioma. In the case with nodule suggestive of malignancy on perflutren CEUS we performed biopsy and confirmed the diagnostic of hepatic hemangioma. The ultrasound contrast advantages of greater access to population and lower costs in relation to MRI.
Conclusion:We suggest a new protocol for liver nodules identified incidentally on conventional ultrasound. In typical hemangiomas, conventional ultrasound would suffice. In cases of non-typical nodules, perflutren CEUS confirms the diagnosis of hepatic hemangioma and closes the diagnostic investigation.
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