Cm In Longest Diameter Research Articles

Comparison of two negative pressure ureteral access sheaths combined with day-case flexible ureteroscopy for renal stones randomized trial

To compare the safety and effectiveness of the combination of intelligent intrarenal pressure control platforms and flexible end ureteral access sheath combined with flexible ureteroscopic lithotripsy (FURL) for the treatment of renal stones less than 2 cm with day case mode. From November 2023 to July 2024, a prospective, randomized, double-blind, parallel-controlled study was conducted to recruit 60 patients with upper urinary tract calculi measuring ≤ 2 cm in longest diameter. A total of 60 eligible patients were consecutively enrolled. Based on a pre-generated random number table and allocation scheme using SPSS 27.0, patients were assigned to either the intelligent pressure control group (IFURL, n = 30) or the head bending group (BFURL, n = 30). Blinding measures were implemented for patients, data collectors, statisticians, and analysts, with the allocation results disclosed to the surgeons prior to the start of the procedure in the operating room. The operation duration for IFURL and BFURL was 52.50 (48.00, 60.00) vs. 46.00 (36.00, 56.25), respectively (p = 0.047). Stone free rate (SFR) on the first postoperative day was 73.33% vs. 93.33% for IFURL and BFURL, respectively (p = 0.038). While, SFR was no significant difference between the two groups after two months(90.00% vs. 96.67%, p = 0.301). One patient in IFURL was readmitted after discharge due to fever 2 days post-discharge, and improved after 2 days of anti-infection treatment. One patient in BFURL was readmitted due to lumbar and abdominal pain from urine extravasation, which improved after 3 days of anti-infection treatment. SFR of one-month post-surgery for renal calculi ≤ 2 cm treated with intelligent pressure control and flexible UAS combined with FURL in day surgery mode was similar, with low infection-related complications and rehospitalization rates, showing no statistical difference. However, the overall hospitalization costs for the BFURL was lower than IFURL.

An open-label, multicenter study investigating RP2 oncolytic immunotherapy in combination with second-line systemic atezolizumab combined with bevacizumab in patients with locally advanced unresectable or metastatic hepatocellular carcinoma.

TPS4191 Background: Despite advances in treatment for unresectable hepatocellular carcinoma (HCC), long-term survival rates remain poor. The combination of atezolizumab (Atezo) plus bevacizumab (Bev) is approved as frontline therapy for advanced HCC, but only a minority of patients (pts) respond and secondary resistance usually occurs within months. HCC has an immune-suppressed tumor microenvironment (TME), mediated by activated immune checkpoint signaling and angiogenesis pathways, which may contribute to therapeutic resistance. RP2 is an enhanced potency oncolytic herpes simplex virus type 1 (HSV-1) that expresses the fusogenic gibbon ape leukemia virus glycoprotein with the R sequence deleted (GALV-GP-R–), GM-CSF, and an anti–CTLA-4 antibody-like molecule. The direct oncolytic effect coupled with immune stimulation by RP2 in the TME is intended to provide systemic antitumor activity and synergize with anti–PD-1/PD-L1 agents, such as Atezo. Preclinical data have demonstrated improved distribution of oncolytic HSV within tumors in combination with Bev, supporting the clinical combination of RP2 with Bev. This study will evaluate the safety and efficacy of RP2 combined with Atezo plus Bev as second-line systemic therapy for unresectable and advanced HCC (NCT05733598). Methods: This is an open-label, single arm, phase 2 trial. Up to 30 pts will be enrolled and receive RP2 in combination with Atezo plus Bev. Key inclusion criteria include advanced unresectable HCC with ≥1 measurable tumor of ≥1 cm in longest diameter, Child-Pugh class A, an Eastern Cooperative Oncology Group performance status of 0 to 1, and progression on 1 prior systemic treatment, which must have included a PD-1/PD-L1–directed agent. Key exclusion criteria include untreated/incompletely treated esophageal and/or gastric varices with bleeding or at high risk for bleeding and macroscopic invasion of the tumor into any major blood vessel(s) and/or main bile ducts. Pts will receive intratumoral RP2 Q2W for 4 doses, then Q3W for up to 4 doses. Bev will be given at 10 mg/kg Q2W starting with the first dose of RP2 then at 15 mg/kg Q3W starting with cycle 4; Atezo will be given at 840 mg Q2W for cycles 2 and 3, then at 1200 mg Q3W starting with cycle 4. Pts will receive treatment until confirmed progressive disease, loss of clinical benefit, or unacceptable toxicity. The primary endpoint is overall response rate (ORR), defined as the proportion of pts achieving a best overall response of complete response or partial response per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as modified for this study. Secondary endpoints are safety, ORR using HCC-modified RECIST, duration of response, complete response rate, and progression-free survival. Clinical trial information: NCT05733598 .

An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab plus bevacizumab in patients with locally advanced unresectable or metastatic hepatocellular carcinoma.

TPS576 Background: Despite advances in treatment for unresectable hepatocellular carcinoma (HCC), long-term survival rates remain poor. The combination of atezolizumab (Atezo) plus bevacizumab (Bev) is approved frontline therapy for advanced HCC, but a minority of patients (pts) respond and secondary resistance usually occurs within months. HCC has an immune-suppressed tumor microenvironment (TME), mediated by activated immune checkpoint signaling and angiogenesis pathways, which may contribute to therapeutic resistance. RP3 is a genetically modified herpes simplex virus type 1 (HSV-1) that expresses the fusogenic gibbon ape leukemia virus glycoprotein with the R sequence deleted (GALV-GP-R–), an anti–CTLA-4 antibody-like molecule, CD40 ligand, and 4-1BB ligand. The direct oncolytic effect coupled with immune stimulation by RP3 in the TME is intended to provide systemic antitumor activity and synergize with anti–PD-1/PD-L1 agents, such as Atezo. Preclinical data have demonstrated improved distribution of oncolytic HSV within tumors in combination with Bev, supporting the clinical combination of RP3 with Bev. This study will evaluate the safety and efficacy of RP3 combined with Atezo plus Bev as first- (1L) and second-line (2L) systemic therapies for unresectable and advanced HCC (NCT05733598). Methods: The 1L and 2L cohorts will each enroll up to 30 pts. Pts in the 1L cohort may not have received prior systemic treatment; pts in the 2L cohort must have progressed on or following 1 prior line of systemic therapy, which must have included a PD-1/PD-L1–directed agent. Key inclusion criteria include advanced unresectable HCC with ≥1 measurable tumor of ≥1 cm in longest diameter, Child-Pugh class A, and an Eastern Cooperative Oncology Group performance status of 0 to 1. Key exclusion criteria include untreated esophageal and/or gastric varices with bleeding or at high risk for bleeding and macroscopic invasion of the tumor into any major blood vessel(s) and/or main bile ducts. Pts with a history of medically refractory hepatic encephalopathy and/or hepato-renal syndrome are also excluded. Pts in the 1L cohort will receive Atezo 1200 mg and Bev 15 mg/kg every 3 weeks (Q3W) together with RP3 intratumorally Q3W for a total of up to 8 doses. Pts in the 2L cohort will receive RP3 every 2 weeks for 4 doses with Bev Q3W starting on cycle (C)1 day (D)1, then RP3 and Bev Q3W for up to 4 more doses with Atezo Q3W being added on C4D1. The primary endpoint is the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Secondary endpoints are safety, ORR using HCC modified RECIST, duration of response, complete response rate, and progression-free survival. Clinical trial information: NCT05733598 .

An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab therapy in patients with locally advanced unresectable or metastatic hepatocellular carcinoma.

TPS4178 Background: Despite advances in treatment for unresectable hepatocellular carcinoma (HCC), long-term survival rates remain poor. The combination of bevacizumab (Bev) and atezolizumab (Atezo) is the preferred frontline therapy for advanced HCC, but a minority of patients (pts) respond, and secondary resistance usually occurs within months. HCC has an immune-suppressed tumor microenvironment, mediated by activated immune checkpoint signaling and angiogenesis pathways, which may contribute to therapeutic resistance. RP3 is a genetically modified herpes simplex virus type 1 (HSV-1) that expresses the fusogenic gibbon ape leukemia virus glycoprotein with the R sequence deleted (GALV-GP-R–), an anti–CTLA-4 antibody-like molecule, CD40 ligand, and 4-1BB ligand. The direct oncolytic effect coupled with immune stimulation by RP3 in the tumor microenvironment is intended to provide systemic antitumor activity and enhance therapeutic response to anti–PD-1/PD-L1 agents, such as Atezo. Preclinical data have demonstrated improved distribution of oncolytic HSV within tumors in combination with Bev, supporting the clinical combination of RP3 with Bev. This study will evaluate the safety and efficacy of RP3 combined with Atezo and Bev as first- (1L) and second-line (2L) systemic therapies for unresectable and advanced HCC. Methods: The 1L and 2L cohorts will each enroll up to 30 pts. Pts in the 1L cohort may not have received prior systemic treatment; pts in the 2L cohort must have progressed on or following one prior line of systemic therapy, which must have included a PD-1/PD-L1−directed agent. Key inclusion criteria include advanced, unresectable HCC with ≥1 measurable tumor of ≥1 cm in longest diameter, Child-Pugh Class A, and Eastern Cooperative Oncology Group performance status of 0−1. Key exclusion criteria include untreated esophageal and/or gastric varices with bleeding or at high risk for bleeding and macroscopic invasion of tumor into any major blood vessel(s) and/or main bile ducts. Pts with a history of medically refractory hepatic encephalopathy and/or hepato-renal syndrome are also excluded. Pts in the 1L cohort will receive 1200 mg Atezo and 15 mg/kg Bev every 3 weeks (Q3W) together with RP3 intratumorally Q3W for a total of up to 8 doses. Pts in the 2L cohort will receive RP3 every 2 weeks for 4 doses with Bev Q3W starting on cycle (C) 1 day (D) 1, then RP3 and Bev Q3W for up to 4 more doses with Atezo Q3W being added on C4D1. The primary endpoint is overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Secondary endpoints are safety, ORR using HCC modified RECIST, duration of response, complete response rate, and progression-free survival. Clinical trial information: NCT05733598 .

An open-label, multicenter study investigating RP3 oncolytic immunotherapy in combination with first- or second-line systemic atezolizumab and bevacizumab therapy in patients with locally advanced unresectable or metastatic hepatocellular carcinoma.

TPS623 Background: Despite advances in treatment for unresectable hepatocellular carcinoma (HCC), long-term survival rates remain poor. The combination of bevacizumab (Bev) and atezolizumab (Atezo) is the preferred frontline therapy for advanced HCC, but a minority of patients (pts) respond, and secondary resistance usually occurs within months. HCC has an immune-suppressed tumor microenvironment, mediated by activated immune checkpoint signaling and angiogenesis pathways, which may contribute to therapeutic resistance. RP3 is a genetically modified herpes simplex virus 1 (HSV-1) that expresses the fusogenic GALV-GP R- protein, an anti–CTLA-4 antibody-like molecule, CD40 ligand, and 4-1BB ligand. The direct oncolytic effect coupled with immune stimulation by RP3 in the tumor microenvironment is intended to provide systemic anti-tumor activity and reverse therapeutic resistance to anti-PD-1/PD-L1 agents. Pre-clinical data has demonstrated improved distribution of oncolytic HSV within tumors in combination with Bev supporting the clinical combination of RP3 with Bev. RP3 combined with anti-PD1 therapy has demonstrated clinical activity and safety in pts with various malignant solid tumors. This study will evaluate the safety and efficacy of RP3 combined with Atezo and Bev as 1st (1L) and 2nd (2L) line systemic therapies for inoperable and advanced HCC. Methods: The 1L and 2L cohorts will each enroll up to 30 pts with advanced, unresectable HCC. Pts in the 1L cohort may not have received prior systemic treatment; pts in the 2L cohort must have progressed on or following one prior line of systemic therapy, which must have included a PD-(L)1 directed agent. Key inclusion criteria include advanced unresectable HCC with at least 1 measurable tumor of ≥1 cm in longest diameter, Childs-Pugh Class A, and ECOG Score of 0 or 1. Important exclusion criteria include untreated esophageal and/or gastric varices with bleeding or at high risk for bleeding, and macroscopic invasion of tumor into major blood vessels and/or main bile ducts. Pts with a history of medically refractory hepatic encephalopathy and/or hepato-renal syndrome are also excluded. Pts in 1L cohort will receive 1200 mg Atezo and 15mg/kg Bev Q3W together with RP3 intratumorally (IT) Q3W for a total of up to 8 doses. In 2L pts will receive RP3 Q2W for 4 doses with Bev Q3W starting on C1D1, then RP3 and Bev Q3W for up to 4 more doses with Atezo Q3W being added on C4D1. The primary endpoint includes overall response rate (ORR) by RECIST v1.1. Secondary endpoints are safety, ORR using HCC mRECIST, duration of response, complete response rate, and progression-free survival.

Prophylactic Radiation Therapy vs. Standard-of-Care for Patients with High-Risk, Asymptomatic Bone Metastases: A Multicenter, Randomized Phase II Trial

<h3>Purpose/Objective(s)</h3> External beam radiotherapy (RT) is standard-of-care (SOC) for pain relief of symptomatic bone metastases. We aimed to test whether radiation for asymptomatic bone metastases prevents skeletal-related events (SRE). <h3>Materials/Methods</h3> We conducted a multicenter, randomized phase 2 trial (NCT03523351) of prophylactic RT to high-risk, asymptomatic bone metastases vs SOC. Patients were eligible if they were at least 18 years old with a metastatic solid tumor malignancy and more than 5 metastatic lesions, including at least one asymptomatic high-risk bone lesion, defined as: bulky disease (≥2cm in longest diameter), junctional spine or posterior spinal element disease, disease involving hip or sacroiliac joint, or disease in long bone involving 1/3-2/3 cortical thickness. Patients were stratified by histology and planned SOC (systemic therapy or observation) and randomly assigned in a 1:1 ratio to RT to all enrolled high-risk bone metastases or SOC alone. The primary outcome of SRE (defined as fracture, cord compression, or intervention with surgery or radiation) was analyzed from randomization to death or 12 months. A sample size of 66 was deemed necessary to achieve 80% power to detect a difference of 30% (experimental arm) versus 60% (SOC arm) using a two-sample, one-sided proportion test with alpha<0.05. We used the log-rank test for time-to-event analyses and Wilcoxon rank sum test to compare hospitalizations, brief pain inventory and quality of life (using EQ-5D-5L) between arms. <h3>Results</h3> Between May 8, 2018 and August 9, 2021, 78 patients with 122 bone metastases were enrolled and randomized to prophylactic RT (n=39) or SOC (n=39). The most common primary cancer types were lung (27%), breast (24%), and prostate (22%). Seventy-one patients (91%) were evaluable for the primary endpoint. At one year, SRE occurred in 1 of 62 lesions (1.6%) in the RT arm and 14 of 49 lesions (29%) in the SOC arm (p<0.001). There was a significant difference in time-to-SRE by type of high-risk feature (p=0.016), with most events occurring in junctional spine and bulky disease. There were significantly fewer patients hospitalized for SRE in the RT arm compared to the SOC arm (4 vs 0, p=0.045). At a median follow-up of 2.4 years, overall survival was significantly longer in the RT arm (HR 0.50, 95% CI 0.28, 0.91; p=0.02). Median OS among 11 patients with an SRE was 1.1 years compared to 1.5 years among 67 patients without an SRE. Pain was reduced at 3 months in the RT arm (p<0.05) compared to the SOC arm. EQ-5D-5L was similar between the groups at all time points. <h3>Conclusion</h3> Radiation delivered prophylactically to asymptomatic, high-risk bone metastases reduced skeletal-related events, meeting the primary endpoint of the study. Importantly, we observed an improvement in overall survival, with potential mechanisms of palliation or debulking warranting further investigation in a phase 3 trial.

A Case of Giant Hepatic Hemangioma (23 cm in Long Diameter) with Severe Malnutrition and Blood Coagulopathy

症例は40歳の女性で，1カ月前から増悪する腹部膨満と右側腹部痛および経口摂取不良のため，近医を受診した．腹部超音波検査で肝右葉を占める巨大肝腫瘍を指摘され，当院へ紹介となった．長期間の経口摂取不良のため重度低栄養状態であり，血液検査にて高度の貧血，フィブリノーゲン値低下，FDPとDダイマー値の著明な上昇を認めた．腹部造影CTと造影MRIから，腫瘍内出血を伴う23×15cmの巨大肝海綿状血管腫と診断した．腫瘍随伴性の栄養障害と凝固機能異常をきたしており，手術適応と判断した．術中の出血コントロール目的に腫瘍の支配血管である右肝動脈に対する塞栓術を術前に施行し，肝右3区域切除術を施行した．術後凝固異常の著明な改善を認め，経口摂取も良好となり，経過良好にて術後11日目に退院となった．術後12カ月現在，血液検査の正常化および栄養状態の改善を認め，無再発経過観察中である．

Phase I study of autolytic immunotherapy of metastatic neuroendocrine tumors using intralesional rose bengal disodium.

4115 Background: Metastatic neuroendocrine neoplasms (mNEN) originating in the gastrointestinal tract are frequently slow growing yet both symptom and disease control remain important. Treatment options include resection, systemic somatostatin analogues (SSA), and systemic peptide receptor radionuclide therapy (PRRT). Additional options are needed; we have explored intralesional (IL) rose bengal disodium (PV-10), an investigational autolytic immunotherapy that can yield immunogenic cell death and disease-specific functional adaptive immunity. Methods: This phase 1 study evaluated safety, tolerability and impact on symptoms and biochemical markers resulting from IL PV-10 administered percutaneously to hepatic lesions in patients (pts) with progressive mNEN not amenable to resection or other potentially curative therapy. Eligible lesion(s) were 1.0 - 3.9 cm in longest diameter with amount of PV-10 administered proportional to size. Cohort 1 (n = 6 pts) received PV-10 to a single lesion per treatment cycle; Cohort 2 (n = 6) could receive injection to multiple lesions per treatment cycle. Pts could receive further PV-10 ≥6 weeks after prior injection. The primary endpoint was safety. Secondary endpoints included objective response rate (ORR) assessed by contrast enhanced CT (RECIST 1.1) and 68Ga-DOTATATE PET, biochemical response (CgA) and patient-reported outcome (EORTC QLQ-C30 and GI.NET21 QOL instruments). Results: Twelve pts were enrolled, 50% male, median age 66 yrs (range 47-79). Primary sites: 7 small bowel, 2 pancreas, 1 caecal, 2 unknown; grade: Gd1 = 5, Gd2 = 7. All pts had received SSA and PRRT as part of previous therapy and all had symptomatic, progressive disease. Median CgA was 1585 (range 35-10370). One lesion was injected per cycle for all 12 pts; none were suitable for multiple injections. One pt received 4 sequential PV-10 treatment cycles, 3 received 2 cycles, and 8 received 1 cycle. Toxicity was consistent with experience in other hepatic malignancies: post-procedure pain was reported by most pts; grade 3 photosensitivity reaction occurred in 1 pt; and grade 1 elevation of hepatic enzymes attributed to PV-10 occurred in 2 pts, resolving by day 7. Additionally, carcinoid flare occurred in 1 pt. ORR of injected lesions was 42%; patient-level disease control was 84%. Estimated PFS was 9.2 months; median OS was 22.5 months. CgA remained stable in 10 pts and upregulation of NK and activated CD4+ T lymphocytes was observed post-injection. QOL data at months 1 and 3 showed stable or improved carcinoid symptoms and global health status in 9 pts. Conclusions: PV-10 elicited no safety concerns with encouraging evidence of both local and systemic disease and symptom control in a heavily pre-treated population. Multiple cycles were delivered safely in suitable patients. Adaptive immune upregulation is consistent with other solid tumors and supports potential systemic benefit. Clinical trial information: NCT02693067.

A Case of a Leiomyosarcoma (16cm in Longer Diameter) of the Chest Radically Resected after Preoperative Chemotherapy

A Case of a Leiomyosarcoma (16cm in Longer Diameter) of the Chest Radically Resected after Preoperative Chemotherapy

Cohort 1 results of a phase I study of autolytic immunotherapy of metastatic neuroendocrine neoplasms using intralesional rose bengal disodium.

e16694 Background: Metastatic neuroendocrine neoplasms (mNEN’s) originating in the gastrointestinal tract are frequently slow growing yet both symptom and disease control remain important. Treatment options include resection, chemoablation, systemic somatostatin analogues (SSA) or peptide receptor radionuclide therapy (PRRT), but additional options are needed, especially when available options have been exhausted. Intralesional (IL) rose bengal disodium (PV-10), an autolytic immunotherapy under development for solid tumors, is being investigated as a potential option for treatment-refractory patients (pts) with hepatic metastases. Methods: This phase 1 study is evaluating the safety, tolerability and objective response resulting from percutaneous administration of PV-10 in 12 pts with progressive mNEN refractory to SSA and PPRT; pts must have at least one injectable hepatic lesion (1.0-3.9 cm in longest diameter) not amenable to resection or other potentially curative therapy. In Cohort 1 (n = 6) pts received PV-10 to a single hepatic lesion per treatment cycle, and could receive PV-10 to additional uninjected hepatic lesions ≥6 weeks after prior injection. The primary endpoint is safety. Secondary endpoints include objective response rate assessed by independent review of contrast enhanced CT and by 68Ga-DOTATATE PET. Results: Cohort 1 has fully enrolled, with 4 of 6 pts male, median age 65 yrs, range 47-72. Primary sites were: small bowel 3, pancreas 2, caecal 1. NET grade: Gd1 = 5, Gd2 = 1. All pts had progressed on prior SSA and PRRT. Median baseline CgA was 645 (range 30-2819). One pt received 4 PV-10 treatment cycles, 1 received 2 cycles, and 4 received a single cycle. Toxicity was acceptable, including transient pain post procedure, carcinoid flare and nausea. A partial response of injected lesions was observed in 50% of pts (injected lesion progression in 1 pt), with an overall response of stable disease achieved in 84% of pts by RECIST 1.1 (progressive disease in 1 pt). Progression free survival (PFS) was not reached by CT (range 2.4-25.3+ months), and was 6.1 months by PET. Median overall survival (OS) was ≥22.5 months, with three subjects alive at the data cut-off of Jan 2020 (range 18.1-33.8 months). Conclusions: Hepatic IL PV-10 elicited no safety concerns with encouraging evidence of both local response of injected tumors and prolonged systemic disease control in some pts. Enrolment to Cohort 2 is nearing completion where an additional 6 pts may receive injection of multiple lesions per treatment cycle. Clinical trial information: NCT00986661 .

A phase I study of oncolytic immunotherapy of metastatic neuroendocrine tumors using intralesional rose bengal disodium: Cohort 1 results.

4102 Background: Metastatic neuroendocrine neoplasms (mNEN’s) originating in the gastrointestinal tract are frequently slow growing yet both symptom and disease control remain important. Treatment options include resection, chemoablation, systemic somatostatin analogues (SSA) or peptide receptor radionuclide therapy (PRRT), but additional options are needed and one such option is hepatic intralesional (IL) rose bengal disodium (PV-10), an oncolytic immunotherapy under development for solid tumours. Methods: This phase 1 study is evaluating the safety, tolerability and reduction of biochemical markers and symptoms resulting from percutaneous administration of PV-10 in 12 subjects with progressive mNEN with hepatic lesions not amenable to resection or other potentially curative therapy. Target lesion(s) must be 1.0 - 3.9 cm in longest diameter. In Cohort 1 (n = 6) subjects receive PV-10 to a single hepatic lesion per treatment cycle, and can receive PV-10 to additional uninjected hepatic lesions ≥6 weeks after prior injection. Cohort 2 (n = 6) subjects may receive injection of multiple lesions per treatment cycle. The primary endpoint is safety. Secondary endpoints include objective response rate (ORR) assessed by contrast enhanced CT and 68Ga-DOTATATE PET, biochemical response (CgA) and patient-reported outcome (EORTC QLQ-C30 and GI.NET21). Results: Cohort 1 has fully enrolled, with 4 of 6 subjects male, median age 65yrs, range 47-72. Primary sites were: small bowel 3, pancreas 2, caecal 1; grade: Gd1 = 5, Gd2 = 1. All patients received prior SSA and PRRT. Median CgA was 645 (range 30-2819). To date 1 subject has received 4 PV-10 treatment cycles, 1 has received 2 cycles, and 4 have received a single cycle. Toxicity has been acceptable, including pain post procedure, carcinoid flare and nausea. LFT’s have remained stable. Overall QOL score was stable for 5 of 6 subjects. ORR in injected lesions is 50% (progression in 1 subject), with overall disease control of 84%. CgA response: 5 stable, 1 progression. One subject with “carcinoid pellagra” had rash resolution. Response follow-up is ongoing and additional efficacy and functional data will be presented. Conclusions: Hepatic IL PV-10 elicited no safety concerns with encouraging evidence of both local and systemic disease control. Enrolment to Cohort 2 is underway. Clinical trial information: NCT02693067.

Dosimetric comparisons of different hypofractionated stereotactic radiotherapy techniques in treating intracranial tumors > 3 cm in longest diameter.

The authors sought to compare the dosimetric quality of hypofractionated stereotactic radiosurgery in treating sizeable brain tumors across the following treatment platforms: GammaKnife (GK) Icon, CyberKnife (CK) G4, volumetric modulated arc therapy (VMAT) on the Varian TrueBeam STx, double scattering proton therapy (DSPT) on the Mevion S250, and intensity modulated proton therapy (IMPT) on the Varian ProBeam. In this retrospective study, stereotactic radiotherapy treatment plans were generated for 10 patients with sizeable brain tumors (> 3 cm in longest diameter) who had been treated with VMAT. Six treatment plans, 20-30 Gy in 5 fractions, were generated for each patient using the same constraints for each of the following radiosurgical methods: 1) GK, 2) CK, 3) coplanar arc VMAT (VMAT-C), 4) noncoplanar arc VMAT (VMAT-NC), 5) DSPT, and 6) IMPT. The coverage; conformity index; gradient index (GI); homogeneity index; mean and maximum point dose of organs at risk; total dose volume (V) in Gy to the normal brain for 2 Gy (V2), 5 Gy (V5), and 12 Gy (V12); and integral dose were compared across all platforms. Among the 6 techniques, GK consistently produced a sharper dose falloff despite a greater central target dose. GK gave the lowest GI, with a mean of 2.7 ± 0.1, followed by CK (2.9 ± 0.1), VMAT-NC (3.1 ± 0.3), and VMAT-C (3.5 ± 0.3). The highest mean GIs for the proton beam treatments were 3.8 ± 0.4 for DSPT and 3.9 ± 0.4 for IMPT. The GK consistently targeted the lowest normal brain volume, delivering 5 to 12 Gy when treating relatively smaller- to intermediate-sized lesions (less than 15-20 cm3). Yet, the differences across the 6 modalities relative to GK decreased with the increase of target volume. In particular, the proton treatments delivered the lowest V5 to the normal brain when the target size was over 15-20 cm3 and also produced the lowest integral dose to the normal brain regardless of the target size. This study provides an insightful understanding of dosimetric quality from both photon and proton treatment across the most advanced stereotactic radiotherapy platforms.

Value of contrast-enhanced sonography of small hepatocellular carcinoma with sonazoid prior to radiofrequency ablation.

We aimed to determine the value of contrast-enhanced sonography (CEUS) with Sonazoid prior to percutaneous radiofrequency ablation (RFA) of small (<3 cm) hepatocellular carcinoma (HCC). This prospective study was approved by our institutional review board and informed consent was obtained. The following criteria were used for study enrollment: (1) cirrhotic patients with HCCs found by contrast-enhanced CT or Gd-EOB-DTPA-enhanced MRI; (2) a single HCC <3 cm in longest diameter or multinodular HCCs (<3) with each tumor <3 cm in longest diameter; and (3) indeterminate identification of the index tumor from the surrounding cirrhosis-related pseudolesions on conventional US. Percutaneous RFA was performed under the guidance of CEUS with Sonazoid. The value of CEUS in index tumor detection and targeting was compared with that of concurrently performed conventional US. A total of 38 patients with 43 HCCs (mean size, 1.6 cm; range, 0.5-2.9 cm) were enrolled. The vascular phase of Sonazoid-enhanced ultrasonography showed good tumor enhancement in 30/43 HCCs (70%). The Kupffer phase increased lesion conspicuity and operator's diagnostic confidence in 29 patients with 31 HCCs (31/43, 72%) compared with conventional US. CEUS with Sonazoid is useful for detection and targeting of small HCC prior to RFA. © 2017 Wiley Periodicals, Inc. J Clin Ultrasound 45:383-390, 2017.

Evaluation of the Outcome of Patients with Papillary Thyroid Carcinoma with Surgical Intervention

Background : Papillary Thyroid Carcinoma (PTC) is the most common form of well differentiated thyroid cancer, and constitutes 1% of all solid tissue cancers with a female predominance and surgical intervention helps in removal of the cancer.Methods: A retrospective data analysis was done among 70 papillary thyroid carcinoma patients who had undergone radical thyroidectomy with or without selective lymph node excision in the Department of Breast and Thyroid Surgery at Shandong Provincial Hospital from 2005 to 2012.Results: The study showed a female predominance with a mean age 43.81years. 71.4% cases presented with lymphadenopathy and out of 70 patients, 16 had previous thyroid hormone dysfunction. Radical Thyroidectomy with selected lymph node excision was done in 77.1% cases and the rest had undergone only Radical Thyroidectomy. 44.3% of the tumor was &lt;1cm in longest diameter, 58.6% cases had no lymph node metastasis and 38.6% cases had central lymph node metastasis. Mean survival after surgical management was 5.56 years with a standard deviation of 2.64 years. Only in 4 cases operative or postoperative complications were observed and in a single case we needed to perform reopen surgery. Mean hospital stay was 11days with a standard deviation of 5 days. Distant metastasis was observed only in 2 cases and correspondingly died after 1 year. Radio ablation by using radioactive Iodine (I131) was required in 5 patients and 88.6% required thyroid hormone replacement after surgery.Conclusion: So, surgical management is safe and results in an increased survival with possibility of cure in patients with papillary thyroid carcinoma. Chatt Maa Shi Hosp Med Coll J; Vol.15 (2); Jul 2016; Page 52-56

Robotic Single-Site Myomectomy: Clinical Analysis of 61 Consecutive Cases

Study ObjectivesTo report 61 consecutive cases of successful robotic single-site myomectomy (RSSM), and to evaluate the feasibility and safety of RSSM. DesignRetrospective analysis of 61 cases involving RSSM (Canadian Task Force classification III). SettingDepartment of Obstetrics and Gynecology, College of Medicine, Robot Surgery Center, Ewha Womans University, Seoul, Republic of Korea. PatientsSixty-one patients who underwent RSSM performed by 3 gynecologic surgeons at Ewha Womans University between December 2014 and May 2016. InterventionsWe analyzed the patients' baseline characteristics and surgical variables and the trends in operation-related variables according to surgeon's level of experience with RSSM. Measurements and Main ResultsThere were no cases of conversion to laparotomy or robotic multisite myomectomy. RSSM was successful for multiple uterine myomas up to 12 in number and for large myomas up to 12.8 cm in longest diameter. In terms of myoma location, RSSM was successful for all types of myomas, including subserosal, intramural, and intraligamentary. The mean docking time was 5.45 ± 2.84 minutes (2.0∼12.0 minutes), mean total operation time was 135.98 ± 59.62 minutes (60∼295 minutes), mean estimated blood loss was 182.62 ± 153.02 mL (10∼600 mL), and mean skin incision length was 2.70 ± 0.19 cm (2.4∼3.10 cm). The mean time to postoperative gas passage was 28.71 ± 12.99 hours (3.33∼76.50 hours), and the mean duration of hospitalization was 4.21 ± 0.84 days (3∼6 days). No patient required additional analgesics other than applied intravenous patient-controlled analgesia. The mean change in hemoglobin level was 2.43 ± 0.87 g/dL, and the incidence of postoperative anemia requiring blood transfusion was only 3.3% (2 cases). No intraoperative or perioperative complications were noted. ConclusionRSSM is a feasible and safe procedure even in cases large, multiple, and intramural type myomas. Therefore, this option could be extended to appropriately selected patients.

Abstract OT3-02-14: A phase 1 study in patients with metastatic breast cancer to evaluate the feasibility of magnetic resonance imaging with ferrumoxytol as a potential biomarker for response to treatment with nanoliposomal irinotecan (nal-IRI, MM-398)

Abstract Background: Nal-IRI (MM-398, nanoliposomal irinotecan) is designed for extended circulation relative to free irinotecan and to exploit leaky tumor vasculature for enhanced drug delivery to tumors. Tumor deposition of nal-IRI and subsequent conversion to SN-38 in both neoplastic cells and tumor associated macrophages (TAM) may positively correlate with response to therapy. In phase I studies of nal-IRI, activity has been shown in metastatic breast cancer (MBC), pancreatic and colorectal cancer. Ferumoxytol (FMX) is an iron-oxide superparamagnetic nanoparticle that has been used off-label for its MRI contrast properties. FMX has long-circulating pharmacokinetics and is taken up by TAMs with similar distribution patterns to nal-IRI in preclinical models. A single site pilot study established the feasibility of performing quantitative FMX MRI. Thirteen patients with advanced cancer (3 with ER/PR+ MBC) were imaged with FMX MRI and treated with nal-IRI. Median tumor lesion FMX uptake in the pilot study was 32.6 and 34.5 μg/mL at 1 h and 24 h, respectively. Lesions with FMX uptake above the median were associated with greater reductions in tumor size following treatment with nal-IRI as determined by CT lesion measurements. The relationship between FMX levels in tumor lesions and nal-IRI activity may serve as a potential biomarker for nal-IRI deposition and response in solid tumors. This study has been expanded to include additional MBC patients to further evaluate the technical feasibility of FMX MRI at multiple study sites, and to evaluate activity of nal-IRI in patients with MBC. Trial Design: Three cohorts of 10 patients with MBC in the following categories will be enrolled: ER and/or PR positive/HER2-negative, triple negative (TNBC) and MBC with brain metastases. An imaging phase will be followed by a treatment phase. The imaging phase consists of a baseline MRI scan, FMX infusion, and follow-up MRI scans at 1-4 and 24 h after infusion. The treatment phase begins 1-6 days after imaging and consists of nal-IRI 80 mg/m2 q2w. A pretreatment biopsy is required for correlative studies. Study Objectives: The primary objective of this multisite expansion is to investigate the feasibility of FMX quantitation in tumor lesions at multiple lesion sites in breast cancer. The secondary objective is to characterize the efficacy of nal-IRI in patients with metastatic breast cancer. Eligibility Criteria: The key inclusion criteria include patients with MBC, ECOG 0 or 1 with adequate bone marrow reserve and no prior topoisomerase 1 inhibitor or anti-VEGF treatment. ER and/or PR positive/HER2-negative and TNBC patients must have had 1-3 prior lines of chemotherapy in the metastatic setting and have at least 2 measurable lesions. Patients with brain metastasis must be neurologically stable and have new or progressive brain metastases after prior radiation therapy with at least one lesion measuring ≥ 1 cm in longest diameter on gadolinium-enhanced MRI. Status: This trial is currently recruiting patients. Citation Format: Sachdev JC, Ramanathan RK, Raghunand N, Anders C, Munster P, Minton S, Northfelt D, Blanchette S, Campbell K, Lee H, Klinz SG, Hendriks BS, Moyo V, Fitzgerald JB, Korn RL. A phase 1 study in patients with metastatic breast cancer to evaluate the feasibility of magnetic resonance imaging with ferrumoxytol as a potential biomarker for response to treatment with nanoliposomal irinotecan (nal-IRI, MM-398). [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT3-02-14.

妊娠を契機に増大したと推測される長径16cm胸壁デスモイド腫瘍の1例

妊娠を契機に増大したと推測される長径16cm胸壁デスモイド腫瘍の1例

A Smartphone App to Assist Scalp Localization of Superficial Supratentorial Lesions—Technical Note

Neuronavigation is an established technology in neurosurgery. In parts of the world and certain circumstances in which neuronavigation is not easily available or affordable, alternative techniques may be considered. An app to assist scalp localization of superficial supratentorial lesions has been introduced, and its accuracy has been compared with established neuronavigation systems. Sina is a simple smartphone app that overlaps the transparent patients' computed tomography/magnetic resonance images on the background camera. How to use Sina intraoperatively is described. The app was used for scalp localization of the center of the lesions in 11 patients with supratentorial pathologies <3 cm in longest diameter and <2 cm from the cortex. After localization of the lesion using Sina, the center of the lesion was marked on the scalp using standard neuronavigation systems and the deviations were measured. Implementation of Sina for intraoperative scalp localization is simple and practical. The center of the lesions localized by Sina was 10.2 ± 2 mm different from localization done by standard neuronavigation systems. When neuronavigation is not easily available or affordable, Sina can be helpful for scalp localization and preoperative planning of the incision for selected supratentorial pathologies.

An Inferiorly Based Rotation Flap for Defects Involving the Lower Eyelid and Medial Cheek.

We report a series of 20 patients who underwent inferiorly based rotation flaps for reconstruction of defects of the medial and infraorbital cheek and lower eyelid following Mohs micrographic surgery for nonmelanoma skin cancer. Defects ranged from 1.2 to 3.2 cm in longest diameter and patients ranged from 27 to 91 years of age. All 20 patients had excellent functional and cosmetic outcome with up to 2-year follow-up and no subsequent surgical or laser revision. There were no instances of partial or complete flap necrosis, hematoma, or ectropion. Our series includes defects that originated on the cheek as far laterally as directly below the lateral canthus, and terminated as far medially as the nasal sidewall. An inferiorly based rotation flap is a viable alternative to a laterally based rotation flap and should be in the armamentarium of reconstructive dermatologic and facial plastic surgeons.

Clinical Outcomes of R-CHOP Chemotherapy Alone Compared with R-CHOP Plus Radiotherapy in Patients with Localized, Non-Bulky Diffuse Large B-Cell Lymphoma

IntroductionAlthough several previous studies addressed the role of radiation in treating localized diffuse large B-cell lymphoma (DLBCL), chemotherapy alone has shown promising efficacy with the emergence of Rituximab. Thus, we evaluated the clinical efficacy outcomes and failure patterns of patients with localized DLBCL according to two different treatment strategies, either 6 or more cycles of R-CHOP chemotherapy alone or 3 or 4 cycles of R-CHOP followed by involved field radiotherapy (IFRT).MethodsA prospectively collected database from 21 tertiary centers participating the Consortium for Improving Survival of Lymphoma (CISL), built up for PROCESS study (NCT01202448) for secondary central nervous system involvement in DLBCL, was recruited for current study in addition to the Asan Medical Center (AMC) Lymphoma Registry. CISL database and AMC lymphoma registry consisted of data from patients with newly diagnosed DLBCL between August 2010 and August 2012, and between February 2004 and February 2012, respectively. Inclusion criteria were localized (stage I or II), non-bulky (<10cm in longest diameter) DLBCL treated with R-CHOP as 1st line chemotherapy, and patients either who received 6 or more cycles of R-CHOP chemotherapy only (R-CHOP alone group) or received 3 or 4 cycles of R-CHOP chemotherapy followed by IFRT (R-CHOP plus RT group). Comparisons of clinicopathologic parameters, clinical outcomes and the patterns of relapse were performed between two groups. The types of relapse were classified as either locoregional or distant, according to whether it involves any separate region from primary sites. Efficacy outcomes included complete response (CR) rate, 2-year overall survival (OS) rate, and 2-year event-free survival (EFS) rate.ResultsA total of 357 patients (CISL prospective cohort: 161 patients, AMC registry: 196 patients) were eligible for the analyses. Two hundred ninety nine patients (83.5%) received 6 or more cycles of R-CHOP chemotherapy alone, and 58 patients (16.2%) underwent 3 or 4 cycles of R-CHOP followed by IFRT. Median age was 54 years (range, 16-87). During the median follow-up of 24 months (range, 4-116 months), 35 patients (9.8%) experienced relapse, and 22 patients (6.1%) died. Two-year OS and EFS rate was 94.7% and 89.9%, respectively, and 345 out of 357 patients (96.6%) achieved CR. Comparing R-CHOP alone to R-CHOP plus RT group, there was no significant difference in clinicopathologic parameters. R-CHOP alone could achieve significantly higher CR rate of 97.7 % than 91.4% of R-CHOP plus RT group (p = 0.030). Two-year OS and EFS were significantly longer in R-CHOP alone group than R-CHOP plus RT group (96.1 vs 89.9 %, p = 0.029 and 91.7% vs 81.8%, p= 0.028) (Figure 1). Relapse rate was significantly lower in R-CHOP alone group compared with R-CHOP plus RT group than group (7.4% vs 22.4%, p=0.001), and distant relapses were also significantly lower (15.5% vs 2.7%, p<0.001). In addition, even only in relapsed patients, R-CHOP alone group showed lower incidence of distant relapses with marginal statistical significance (36.4% vs 69.2 %, p=0.062) (Table 1).ConclusionIn our cohort, R-CHOP alone for six to eight cycles without IFRT could achieve significantly higher 2-year OS and EFS rate as well as CR compared with R-CHOP plus RT group. In addition, the rate of relapse and systemic failure were significantly lower in R-CHOP alone group, which altogether warrant further validation in prospective trial.Table 1Explorative comparison of overall clinical outcomes and patterns of relapse between two subgroups: patients who underwent six or more cycles of R-CHOP chemotherapy alone and who underwent 3 or 4 cycles of R-CHOP followed by IFRTTotal (%)R-CHOP alone group (%)R-CHOP plus RT group (%)P -valueNumber of patients357 (100)299 (83.5)58 (16.2)Treatment responseComplete response345 (96.6)292 (97.7)53 (91.4)0.030Overall response351 (98.3)294 (98.3)57 (98.3)1.000Rate of relapse35 (9.8%)14 (7.4)11 (22.4)< 0.001Median time to relapse (95% CI)11 (7-15)11 (8-14)10 (5-14)0.346Pattern of relapse< 0.001 (0.062)Locoregional14 (4.7) (63.6)4 (6.9) (30.8)Distant8 (2.7) (36.4)9 (15.5) (69.2) [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.