8711 Nimotuzumab and radiotherapy in children and adolescents with brain stem glioma: preliminary results from a Phase II study

Crombet, Tania; Cabanas, Ricardo; Alert, J; Valdés, José Miguel; González, María; Pedrayes, Jorge L; Rios, M De Los; Leyva, T.; Herrera, Raiza; Ávila, M. Carmen Saborido

doi:10.1016/s1359-6349(09)71685-4

Cited by 3 publications

(5 citation statements)

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“…e most frequent and related adverse events (diarrhea, chills, and tremors) that appeared in this study have been reported in previous studies with the monoclonal in different localizations [11][12][13][14][15][16][17][18][19][20][21][22]. In a phase II carried out by Liang and others, the common acute toxicities during the treatment were esophagitis and blood/bone marrow, dermatological, and gastrointestinal complications.…”

Section: Discussionsupporting

confidence: 60%

“…It can also induce natural killer (NK) cell activation, antibody-dependentcell-mediated cytotoxicity (ADCC), dendritic cell (DC) activation, and upregulation induction of programmed death/ligand 1 (PD-L1) molecule on DCs [9,10]. Evidence of low toxicity and efficacy of nimotuzumab have been previously documented for esophageal cancer [11][12][13][14][15][16] and other indications [17][18][19][20][21][22].…”

Section: Introductionmentioning

confidence: 99%

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Nimotuzumab in the Treatment of Inoperable Esophageal Tumors of Epithelial Origin

Fernández

García

Porras

et al. 2022

Journal of Oncology

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Background. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor. It was approved in Cuba for the indication of inoperable malignant tumors of the esophagus of epithelial origin. The purpose of this study was to evaluate the safety, overall and progression-free survival, clinical response, and quality of life, in adult patients with inoperable esophageal tumors of epithelial origin treated with nimotuzumab in a practical context. Material and Methods. The number of patients who developed adverse events was determined, and the frequency, seriousness, causality, and severity of these adverse events were determined. It also determined the median of survival and progression-free survival and rates at 12 and 24 months and the quality of life. Results. A total of 111 patients were included. The proportion of serious and related AE with the use of nimotuzumab was 1.3%. Most of the related AEs were mild and moderate, and the most frequent AEs were diarrhea, chills, and tremors. New diagnosed patients who received nimotuzumab concurrent with chemotherapy and radiotherapy reached a median OS of 12.2 months (95% CI, 6.9–17.5) and 12- and 24-month survival rates of 51.0% and 17.0%, respectively. Median PFS was 7.8 months (95% CI, 6.2–9.5), and 12- and 24-month PFS rates were 39.3% and 11.2%, respectively. A favorable evolution of the general state of health ( p = 0.03 ) was obtained from the beginning of treatment until month 12, with a significant reduction in the appearance of nausea ( p = 0.009 ), insomnia ( p = 0.04 ), constipation ( p = 0.04 ), eating difficulties ( p = 0.0006 ), and choking when swallowing ( p = 0.0001 ), but increased in dysphagia ( p = 0.02 ). Conclusions. The administration of nimotuzumab was safe in the real-world setting. New diagnosed patients that received nimotuzumab concurrent with chemotherapy and radiotherapy reached a higher overall and progression-free survival and better quality of life than the rest of the patients. Trial registration is RPCEC00000215 (Cuban Registry of Clinical Trials; https://registroclinico.sld.cu/en/home). It is registered prospectively on June 30, 2016.

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Section: Discussionsupporting

confidence: 60%

Section: Introductionmentioning

confidence: 99%

Nimotuzumab in the Treatment of Inoperable Esophageal Tumors of Epithelial Origin

Fernández

García

Porras

et al. 2022

Journal of Oncology

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“…Two other ongoing Phase II clinical trials are testing the safety and efficacy of nimotuzumab in combination with different cytotoxic regimens in DIPG 35,44. A Phase II multinational study is being conducted in Cuba and Brazil to evaluate the safety and efficacy of nimotuzumab in combination with radiotherapy (Table 2).…”

Section: Clinical Experience Of Nimotuzumab In Combination With Radiomentioning

confidence: 99%

“…A Phase II multinational study is being conducted in Cuba and Brazil to evaluate the safety and efficacy of nimotuzumab in combination with radiotherapy (Table 2). 44 So far, nine patients have been evaluated. Despite the small number of patients under evaluation, six evaluable patients were reported with stabilized disease after 24 weeks of treatment.…”

Section: Clinical Experience Of Nimotuzumab In Combination With Radiomentioning

confidence: 99%

Nimotuzumab as a radiosensitizing agent in the treatment of high grade glioma: challenges and opportunities

Diaz-Miqueli¹,

Martínez²

2013

OTT

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Nimotuzumab is a humanized monoclonal antibody that binds specifically to human epidermal growth factor receptor, blocking receptor activation. Evidence of its radiosensitizing capacity has been widely evaluated. This article integrates published research findings regarding the role of nimotuzumab in the treatment of high grade glioma in combination with radiotherapy or radiochemotherapy in adult and pediatric populations. First, the mechanisms of action of nimotuzumab and its current applications in clinical trials containing both radiation and chemoradiation therapies are reviewed. Second, a comprehensive explanation of potential mechanisms driving radiosensitization by nimotuzumab in experimental settings is given. Finally, future directions of epidermal growth factor receptor targeting with nimotuzumab in combination with radiation containing regimens, based on its favorable toxicity profile, are proposed. It is hoped that this review may provide further insight into the rational design of new approaches employing nimotuzumab as a useful alternative for the therapeutic management of high grade glioma.

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“…About two thirds of the 600 patients that have been treated in Cuba since 2002 have received more than six doses of the antibody (200 mg for adult, 150 mg for children), including about 50 patients that have been treated with more than 30, bi-weekly doses during more than one year [50]. In particular, two children with brain stem glioma tumors have received more than 100 doses of Nimotuzumab, continuously for more than three years, without showing adverse effects (Figure 1).…”

Section: Diverging From the Cytotoxic Paradigm In Anti-egfr Therapiesmentioning

confidence: 99%

EGFR-Targeting as a Biological Therapy: Understanding Nimotuzumab’s Clinical Effects

Pérez

Moreno

Garrido

et al. 2011

Cancers

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Current clinical trials of epidermal growth factor receptor (EGFR)-targeted therapies are mostly guided by a classical approach coming from the cytotoxic paradigm. The predominant view is that the efficacy of EGFR antagonists correlates with skin rash toxicity and induction of objective clinical response. Clinical benefit from EGFR-targeted therapies is well documented; however, chronic use in advanced cancer patients has been limited due to cumulative and chemotherapy-enhanced toxicity. Here we analyze different pieces of data from mechanistic and clinical studies with the anti-EGFR monoclonal antibody Nimotuzumab, which provides several clues to understand how this antibody may induce a biological control of tumor growth while keeping a low toxicity profile. Based on these results and the current state of the art on EGFR-targeted therapies, we discuss the need to evaluate new therapeutic approaches using anti-EGFR agents, which would have the potential of transforming advanced cancer into a long-term controlled chronic disease.

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8711 Nimotuzumab and radiotherapy in children and adolescents with brain stem glioma: preliminary results from a Phase II study

Cited by 3 publications

References 0 publications

Nimotuzumab in the Treatment of Inoperable Esophageal Tumors of Epithelial Origin

Nimotuzumab in the Treatment of Inoperable Esophageal Tumors of Epithelial Origin

Nimotuzumab as a radiosensitizing agent in the treatment of high grade glioma: challenges and opportunities

EGFR-Targeting as a Biological Therapy: Understanding Nimotuzumab’s Clinical Effects

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