Timely adjuvant chemotherapy improves outcome in dogs with non‐metastatic splenic hemangiosarcoma undergoing splenectomy

Faroni, Eugenio; Sabattini, Silvia; Guerra, Dina; Iannuzzi, Chiara; Chalfon, Carmit; Agnoli, Chiara; Stefanello, Damiano; Polton, Gerry; Ramos, Sofia; Aralla, Marina; Ciaccini, Raffaele; Foglia, Armando; Okonji, Samuel; Marconato, Laura

doi:10.1111/vco.12875

Cited by 4 publications

(2 citation statements)

References 34 publications

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“…9 Early detection (whether in the preclinical period or at an earlier stage of disease) has been extensively documented to improve outcomes for many cancer types in humans 26 as well as in dogs. [27][28][29][30][31][32][33][34][35][36][37][38][39][40][41][42][43][44][45][46] A significant concern with all types of cancer screening is the potential for a large number of false positive results, which could lead to unnecessary procedures and expense as well as emotional distress. 5 The high PPV prospectively observed in this study provides reassurance that most OncoK9® CSD results in a high-risk cancer screening population are in fact true positives, and cancer will be found if an adequate confirmatory evaluation is performed.…”

Section: Discussionmentioning

confidence: 99%

Study Design and Interim Analysis of the Cancer Lifetime Assessment Screening Study in Canines (CLASSiC): The First Prospective Cancer Screening Study in Dogs Using Next-Generation Sequencing-Based Liquid Biopsy

Flory,

Gray,

McLennan

et al. 2024

Preprint

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OBJECTIVE The Cancer Lifetime Assessment Screening Study in Canines (CLASSiC) is a prospective, longitudinal cancer screening study, in which enrolled dogs are screened for cancer with physical exams and next-generation sequencing-based liquid biopsy testing on a serial basis. The goals of the first interim analysis, presented here, are to assess the benefits of using the OncoK9® liquid biopsy test as a cancer screening tool in a prospective clinical setting, and to demonstrate test performance for cancer detection, including preclinical detection. SUBJECTS 726 presumably cancer-free client-owned dogs were prospectively enrolled in the study across 24 clinical sites in the US and Canada. Most subjects were at high risk of cancer at the time of enrollment based on age and/or breed. 419 dogs that were enrolled for at least one year and had at least two cancer screening study visits, or that had received a definitive or presumptive diagnosis of cancer up to the time of the interim analysis, were included in the analysis. METHODS Clinical data and a blood sample were collected at each study visit (once or twice per year and when cancer was clinically suspected). Cell-free DNA extracted from plasma was tested by OncoK9® using next-generation sequencing (NGS) technology. RESULTS 417 dogs were eligible for inclusion in the interim analysis and had classifiable outcomes, with a mean on-study duration of 422 days. Of these, 51 dogs were newly diagnosed with cancer (37 definitive, 14 presumptive), translating to a 12% (51/417) observed incidence over the study period; the liver, skin, bone, heart, spleen, lung, and lymph node(s) were the most common anatomic locations for disease. The prospectively observed sensitivity (detection rate) of the test was 56.9% (95% CI: 42.3-70.4%) with a specificity of 98.9% (95% CI: 97.0-99.6%). The prospectively observed positive predictive value was 87.9% (95% CI: 70.9-96.0%) and the negative predictive value was 94.3% (95% CI: 91.3-96.3%). NGS-based liquid biopsy doubled the overall number of cancer cases detected in this study population (from 25 to 51); remarkably, the detection rate for preclinical cancer was increased 4.6-fold from 12% (6/51) by routine care alone to 55% (28/51) by combining routine care with OncoK9® testing. CLINICAL RELEVANCE CLASSiC is the first study to prospectively document the incidence of cancer in a predominantly high-risk canine population, and to prospectively demonstrate that the addition of NGS-based cancer screening to regularly scheduled wellness visits has the potential to substantially increase preclinical cancer detection in this population.

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Section: Discussionmentioning

confidence: 99%

Study Design and Interim Analysis of the Cancer Lifetime Assessment Screening Study in Canines (CLASSiC): The First Prospective Cancer Screening Study in Dogs Using Next-Generation Sequencing-Based Liquid Biopsy

Flory,

Gray,

McLennan

et al. 2024

Preprint

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“…For dogs with splenic hemangiosarcoma treated with surgery alone, survival times are typically less than 2-3 months [3,4]. The administration of adjuvant chemotherapy aims to increase progression-free survival, and the existing literature indicates better survival for dogs undergoing a combinatorial approach, with reported median survival times of 5-8 months for dogs with non-metastatic hemangiosarcoma [1,[4][5][6]. Due to the unfavorable anatomic location, cardiac hemangiosarcomas are almost always inoperable.…”

Section: Introductionmentioning

confidence: 99%

A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy

Marconato,

Tiraboschi,

Aralla

et al. 2023

Cancers

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To test the antitumor effect and safety of peptide-based anticancer vaccination in dogs with hemangiosarcoma undergoing the standard of care (SOC; surgery and doxorubicin), canine hemangiosarcoma cells were infected with Salmonella typhi Ty21a to release immunogenic endoplasmic reticulum stress-related peptides into the extracellular milieu via CX43 hemichannels opening. The infected tumor cell secretome constituted the vaccine. Following the SOC, dogs with biologically aggressive hemangiosarcoma were vaccinated a total of five times, once every 3 weeks, and were followed up with serial imaging. A retrospective population of dogs undergoing the SOC alone served as controls. The primary endpoints were the time to progression (TTP) and overall survival (OS), and the secondary endpoints were toxicity and immune responses. A total of 28 dogs were vaccinated along with the SOC, and 32 received only the SOC. A tumor-specific humoral response along with a vaccine-specific T-cell response was observed. Toxicity did not occur. The TTP and OS were significantly longer in vaccinated versus unvaccinated dogs (TTP: 195 vs. 160 days, respectively; p = 0.001; OS: 276 vs. 175 days, respectively; p = 0.002). One-year survival rates were 35.7% and 6.3% for vaccinated and unvaccinated dogs, respectively. In dogs with hemangiosarcoma undergoing the SOC, the addition of a peptide-based vaccine increased the TTP and OS, while maintaining a safe profile. Moreover, vaccinated dogs developed a tumor-specific response, supporting the feasibility of future phase three studies.

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Hemolymphatic

2024

Clinical Atlas of Small Animal Cytology and Hematology

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Timely adjuvant chemotherapy improves outcome in dogs with non‐metastatic splenic hemangiosarcoma undergoing splenectomy

Cited by 4 publications

References 34 publications

Study Design and Interim Analysis of the Cancer Lifetime Assessment Screening Study in Canines (CLASSiC): The First Prospective Cancer Screening Study in Dogs Using Next-Generation Sequencing-Based Liquid Biopsy

Study Design and Interim Analysis of the Cancer Lifetime Assessment Screening Study in Canines (CLASSiC): The First Prospective Cancer Screening Study in Dogs Using Next-Generation Sequencing-Based Liquid Biopsy

A Phase 2, Single-Arm, Open-Label Clinical Trial on Adjuvant Peptide-Based Vaccination in Dogs with Aggressive Hemangiosarcoma Undergoing Surgery and Chemotherapy

Hemolymphatic

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