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Cryoablation of Primary Breast Cancer in Patients Ineligible for Clinical Trials: A Multiinstitutional Study

A recent study evaluated the safety and outcomes of breast cancer cryoablation without surgical excision in patients deemed ineligible for prospective clinical trials. The retrospective study, conducted at seven institutions from January 2000 through August 2021, involved women who underwent cryoablation of biopsy-proven unifocal primary breast cancer with locally curative intent, without surgical excision, outside of a clinical trial. Of the 112 patients included in the final study sample (median age, 71 years), 6.3% had an associated adverse event (AE); the AEs were all mild and involved hypothermia-induced skin damage. In all, 98.2% of the procedures (110/112) were technically successful; two procedures were considered treatment failures. The median time from cryoablation to the first imaging follow-up was 76 days, while the median total follow-up was 2.0 years. During that time, 20% of the patients (22/110) had biopsies for suspicious imaging findings in the ipsilateral breast: 40.9% had benign concordant findings and 54.5% had ipsilateral breast tumor recurrences (IBTR). Of the 12 patients who had IBTR (10.9% overall), seven had a true recurrence and five had new primary disease; three patients had received previous adjuvant or neoadjuvant therapy. The cumulative incidence of IBTR, when factoring in death as a competing risk, was 5.3% at 1 year, 12.2% at 2 years, and 18.2% at 3 years. The researchers conclude: "In select individuals with unfavorable patient or tumor characteristics, breast cancer cryoablation provides a safe alternative to surgery with good outcomes. These findings may be particularly relevant in patients who are also poor surgical candidates."

Cryoablation and Post-Progression Immune Checkpoint Inhibition in Metastatic Melanoma: A Phase II Trial

A non-randomized Phase II single-center study assessed the safety and efficacy of image-guided percutaneous cryoablation and immune checkpoint inhibition (ICI) in PD-1-resistant metastatic melanoma. The study included patients with unresectable melanoma progressing on ICI; 56% were male and the median age at enrollment was 63.5 years. Seventy-eight percent of the patients had an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1, while 22% had an ECOG score of 2. The patients all underwent cryoablation of an enlarging metastasis, with ICI continued for at least two more cycles. For the 17 patients who were treated, ablation sites included enlarged lymph nodes and metastatic tumors in the lung or pleura, soft tissue or bone, adrenal gland, kidney, and liver. Following ablation, 16 patients received two additional doses of post-progression ICI. Overall, the combination treatment was considered safe and feasible, with a 23.5% objective response rate and a 41% disease control rate. The researchers report that "the anti-tumor efficacy of combining cryoablation and post-progression ICI was superior to what would be expected with the use of post-progression ICI alone with an acceptable safety profile," and they recommend additional research into the "synergistic therapeutic approach."

The #HOPE4LIVER Single-Arm Pivotal Trial for Histotripsy of Primary and Metastatic Liver Tumors

In the #HOPE4LIVER trials, researchers assessed the safety and technical success of histotripsy for use against primary or metastatic liver tumors. The parallel trials - conducted in the United States, European Union, and England - were prospective, single-arm studies involving patients with up to three tumors smaller than 3 cm. Patients underwent CT or MRI and clinic visits at 1 week or less before the procedure, at index-procedure, 36 hours or less postprocedure, and 30 days after the procedure. A total of 44 participants (mean age, 64 years) with 49 tumors were treated; 18 had hepatocellular carcinoma and 26 had non-hepatocellular carcinoma liver metastases. The maximum pretreatment tumor diameter was 1.5 cm ± 0.6, while the maximum post-histotripsy treatment zone diameter was 3.6 cm ± 1.4. The performance goal of greater than 70% for the primary technical success endpoint was met, with 95% (42 of 44) of lesions achieving technical success within 36 hours of the procedure. The performance goal of less than 25% for the primary safety endpoint was also met, with a reported procedure-related major complication rate of 7% (3 of 44) within 30 days of the procedure. "In conclusion, this pivotal study confirms the technical success and safety of histotripsy for the noninvasive mechanical destruction of liver tumors," the study authors write. "Pending early clinical adoption, larger trials with longer follow-up in typical candidates for local-regional treatment will provide further outcome data to help define the role of this emerging technology."

Patients With Hepatocellular Carcinoma and Portal Vein Tumour Thrombosis After Successful Downstaging May Be Candidates for Liver Transplantation: A Meta-Analysis

In a letter to the editor, researchers report on a meta-analysis conducted to evaluate the prognosis of patients with hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT) after liver transplantation (LT). A comprehensive literature review identified 14 relevant studies between January 2003 through June 202, with data on 686 patients with HCC and PVTT following LT. At 5 years, pooled survival for all patients was 49%. In the six studies in which 84 patients with HCC and PVTT were successfully downstaged before LT, the pooled survival rate was 63% at 5 years. For individuals who were not downstaged, or not downstaged successfully, the pooled survival rate at 5 years was 41%. The researchers found no publication bias, as measured by Begg's test or Egger's test, and sensitivity analyses — used to evaluate the effect of individual studies on the overall findings — revealed that each study could be deleted once without having a meaningful impact on the total results.

Machine Learning Based on Clinical Information and Integrated CT Radiomics to Predict Local Recurrence of Stage Ia Lung Adenocarcinoma After Microwave Ablation

By developing a machine learning-based model that combined features of clinical and integrated radiomics from preprocedural computed tomography (CT) and CT from immediately after microwave ablation (MWA), researchers were able to more accurately predict the local recurrence of stage Ia lung adenocarcinoma than either technique individually. The researchers tested three machine learning-based models with the data from 360 patients. The patients, who had stage Ia lung adenocarcinoma and were receiving MWA, included 208 in the training set, 90 for the internal test, and 64 for the external test. Using univariate and multivariate analyses, the team identified factors predictive of local recurrence, while integrated radiomics features were taken from pre- and post-MWA CT scans. The t-test and least absolute shrinkage and selection operator were used to select 10 radiomics features. According to the data, an independent clinical predictor was the ablative margin (p = 0.001, odds ratio [OR] = 0.46, 95%CI: 0.29, 0.73). Among the three models evaluated, the combined model had the highest area under the curve value (training: 0.86, 95%CI: 0.81, 0.91; internal test: 0.93, 95%CI: 0.87, 0.98; external test: 0.89, 95%CI: 0.79, 0.96). The findings, say the researchers, could be used to aid in clinical decision-making.

Comparison of Complications in Patients with Ductal Cholangiocarcinoma (CCC) and Patients with Colorectal Liver Metastases (CRLMs) After Portal Vein Embolization (PVE): A Matched Cohort Study

A retrospective analysis compared the safety of portal vein embolization (PVE) for patients with cholangiocarcinoma (CCC) and with colorectal liver metastases (CRLMs). The study included 160 patients (80 with CCC and 80 with CRLMs) who underwent PVE between July 2011 and March 2020. A total of 34 patients experienced complications: 27 "minor" complications that had no effect on subsequent surgical treatment; 4 "intermediate ones that delayed surgery; and 3 "severe" ones that prevented surgery. Biliary drainage occurred an average of 5 days before PVE for patients with CCC. At baseline, bilirubin levels were 1.1 mg/dl in CCC patients and 0.55 mg/dl in CRLMs patients. Patients with CCC were more likely to experience postinterventional infections, according to the researchers. The study identified several significant predictive factors for the occurrence of (minor) complications: the preintervention future liver remnant volume, body mass index, age, chemotherapy before PVE, and severe liver steatosis. The findings, say the researchers, demonstrate that patients with CCC with prior biliary drainage can undergo PVE, with procedural safety comparable to that for CRLM patients.

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