scholarly journals Clinical and Laboratory Findings in Dogs Undergoing Adjuvant Chemotherapy with Gemcitabine/Carboplatin Combination for Mammary Neoplasia

2021 ◽  
Vol 11 (2) ◽  
pp. 289-299
Author(s):  
Carolina Bistritschan Israel ◽  
Tábata Maués ◽  
Ana Maria Reis Ferreira ◽  
Maria de Lourdes Gonçalves Ferreira
Keyword(s):  
Clinical Trial ◽  
Adjuvant Chemotherapy ◽  
Adverse Events ◽  
Mammary Cancer ◽  
Clinical Signs ◽  
Metastatic Potential ◽  
Prospective Clinical Trial ◽  
Laboratory Findings ◽  
Chemotherapy Protocol ◽  
Mammary Neoplasia

Adjuvant chemotherapy might be indicated in some canine mammary cancer cases due to metastatic potential. In this regard, studies to determine adverse events following chemotherapy protocols are valuable. The purpose of this prospective clinical trial was to evaluate the safety and tolerability of gemcitabine and carboplatin combination in dogs with malignant mammary tumors. For this prospective clinical trial, 21 female dogs mastectomized due to malignant mammary neoplasia underwent adjuvant chemotherapy with gemcitabine (3 mg/kg, 60-minute IV infusion) and carboplatin (10 mg/kg, 20-minute IV infusion) based protocol every 21 days for three cycles. They were monitored periodically for treatment-related adverse events by clinical and laboratory evaluations. A total of 17 (80.9%) dogs developed leukopenia, 10 (47.6%) neutropenia, and 15 (71.4%) thrombocytopenia at least once along with the three chemotherapy cycles. All these hematologic toxicities were grade 1, 2, or 3. Two (9.5%) animals had evidence of gastrointestinal toxicity; however, clinical signs were mild to moderate (grades 1 and 2). No dog had life-threatening adverse events (grade 4) or even died (grade 5) of treatment-related complications. The adjuvant chemotherapy protocol with gemcitabine and carboplatin was well-tolerated and safe in female dogs for mammary cancer treatment with self-limiting hematological and gastrointestinal adverse events.

scholarly journals Single-Arm, Multicenter Phase I/II Clinical Trial for the Treatment of Envenomings by Massive Africanized Honey Bee Stings Using the Unique Apilic Antivenom

2021 ◽  
Vol 12 ◽  
Author(s):  
Alexandre Naime Barbosa ◽  
Rui Seabra Ferreira ◽  
Francilene Capel Tavares de Carvalho ◽  
Fabiana Schuelter-Trevisol ◽  
Mônica Bannwart Mendes ◽  
...  
Keyword(s):  
Mass Spectrometry ◽  
Clinical Trial ◽  
Adverse Events ◽  
Phase I ◽  
Serious Adverse Events ◽  
Clinical Trial Registration ◽  
Laboratory Findings ◽  
Africanized Honey Bee ◽  
Africanized Honeybee ◽  
Hospitalization Period

We evaluated the safety, optimal dose, and preliminary effectiveness of a new-approach Africanized honeybee (Apis mellifera) Antivenom (AAV) in a phase I/II, multicenter, non-randomized, single-arm clinical trial involving 20 participants with multiple stings. Participants received 2 to 10 vials of AAV depending on the number of stings they suffered, or a predefined adjuvant, symptomatic, and complementary treatment. The primary safety endpoint was the occurrence of early adverse reactions within the first 24 h of treatment. Preliminary efficacy based on clinical evolution, including laboratory findings, was assessed at baseline and at various time points over the four following weeks. ELISA assays and mass spectrometry were used to estimate venom pharmacokinetics before, during, and after treatment. Twenty adult participants, i.e., 13 (65%) men and 7 (35%) women, with a median age of 44 years and a mean body surface area of 1.92 m2 (median = 1.93 m2) were recruited. The number of stings ranged from 7 to > 2,000, with a median of 52.5. Symptoms of envenoming were classified as mild, moderate, or severe in 80% (16), 15% (3), and 5% (1) of patients, respectively; patients with mild, moderate, or severe envenoming received 2, 6, and 10 vials of AAV as per the protocol. None of the patients had late reactions (serum sickness) within 30 d of treatment. There was no discontinuation of the protocol due to adverse events, and there were no serious adverse events. One patient had a moderate adverse event, transient itchy skin, and erythroderma. All participants completed the intravenous antivenom infusion within 2 h, and there was no loss to follow-up after discharge. ELISA assays showed venom (melittin and PLA2) concentrations varying between 0.25 and 1.479 ng/mL prior to treatment. Venom levels decreased in all patients during the hospitalization period. Surprisingly, in nine cases (45%), despite clinical recovery and the absence of symptoms, venom levels increased again during outpatient care 10 d after discharge. Mass spectrometry showed melittin in eight participants, 30 d after treatment. Considering the promising safety results for this investigational product in the treatment of massive Africanized honeybee attack, and its efficacy, reflected in the clinical improvements and corresponding immediate decrease in blood venom levels, the AAV has shown to be safe for human use. Clinical Trial Registration: UTN: U1111-1160-7011, identifier [RBR-3fthf8].

scholarly journals Evaluating the use of cytosine arabinoside for treatment for recurrent canine steroid-responsive meningitis-arteritis

2020 ◽  
Vol 187 (1) ◽  
pp. e7-e7
Author(s):  
Christian Günther ◽  
Frank Steffen ◽  
Daniela S Alder ◽  
Laura Beatrice ◽  
Caroline Geigy ◽  
...  
Keyword(s):  
Adverse Events ◽  
Cytosine Arabinoside ◽  
Clinical Remission ◽  
Clinical Signs ◽  
Specific Treatment ◽  
Blood Chemistry ◽  
Immunosuppressive Drugs ◽  
Laboratory Findings ◽  
Treatment Protocols ◽  
Ethical Approval

BackgroundRelapses in steroid-responsive meningitis-arteritis (SRMA) are frequently observed but specific treatment protocols to address this problem are sparsely reported. Standard treatment includes prolonged administration of glucocorticoids as monotherapy or in combination with immunosuppressive drugs. The aim of this study was to assess the safety and efficacy of cytosine arabinoside (CA) in combination with glucocorticoids for treatment of SRMA relapses in 12 dogs on a retrospective basis.MethodsDogs with recurrent episodes of SRMA and treated with a combination of CA and prednisolone were included. Information about clinical course, treatment response and adverse events was collected from medical records. Ethical approval was not required for this study.ResultsTen dogs (10/12) responded well to the treatment with clinical signs being completely controlled. One dog is in clinical remission, but still under treatment. One dog (8%) showed further relapse. Mean treatment period was 51 weeks. Adverse events of variable severity (grade 1–4/5) were documented in all dogs during treatment according to the veterinary cooperative oncology group grading. Three dogs developed severe adverse events. Laboratory findings showed marked changes up to grade 4. Diarrhoea and anaemia were the most often observed adverse events (6), followed by dermatitis (4), alopecia (3) and pneumonia (3). Including blood chemistry changes (13), 50 adverse events were found in total.ConclusionTreatment with CA and glucocorticoids resulted in clinical remission in 10/12 dogs, but a high incidence of adverse events occurred requiring additional measures. All adverse events could be managed successfully in all cases.

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