Post‐marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab

Gonzalez, Veronica D.; Salgueiro, Esther; Jimeno, Francisco J.; Hidalgo, Agustı́n; Rubio, Teresa; Manso, Gloria

doi:10.1002/pds.1587

Cited by 26 publications

(13 citation statements)

References 36 publications

(38 reference statements)

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“…A total of 69 records associated with rituximab therapy were found among almost 50,000 cases registered in the Spanish PV system. Among the AEs reported, leukocyte disorders, dyspnea, hypotension, and pneumonitis are among the most common and similar to the incidence described in pre-approval trials [15]. Finally, late onset neutropenia has also been reported after rituximab's approval.…”

Section: Postmarketing Publicationssupporting

confidence: 56%

Pharmacovigilance of Oncology Biosimilars

Camacho¹,

Pai²

2016

J Pharmacovigil

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Biologicals are critical in cancer medicine. Four of the top ten biological blockbusters worldwide are oncology drugs used for therapeutic or supportive care. The global market for biologic cancer therapies approximately totalled US$ 51.2 billion in 2014 and is expected to reach US$ 66.4 billion in 2019. The patents of most of these top-selling agents will expire by the year 2020 attracting industry to develop biosimilars -agents with high similarity to their biological reference product. Furthermore, manufacturing biosimilars is more cost and time effective than developing their reference products. The cost containments derived from the biosimilars entry to the market are expected to result in considerable societal savings and financial relief to health systems globally. Led by the European Medicines Agency, and the Food and Drug Administration, several other regulatory agencies continue to develop their approval and pharmacovigilance (PV) programs for biosimilars worldwide. Maximizing the safety monitoring and reporting of adverse events (AEs) associated with biosimilars will be critical to rapidly find a place in cancer medicine. Greater efforts to educate patients and healthcare providers to report AEs as well as requesting periodical dissemination and publication of reports by sponsors will be determinant to ensure the post-marketing safety of these agents and gaining the trust of health care providers. This article reviews common and postmarketing AEs associated with the three top cancer biologicals with upcoming expiration patents, their reported AEs during post-marketing surveillance and discusses potential challenges in the PV process of cancer biosimilars.

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Section: Postmarketing Publicationssupporting

confidence: 56%

Pharmacovigilance of Oncology Biosimilars

Camacho¹,

Pai²

2016

J Pharmacovigil

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“…However, side-effects were recorded in phase III controlled trials and post-marketing surveillance programmes, with less severity in RA than in lymphoma [2,9]. Infusion-related reactions (IRRs) occurred in 9-15% of patients.…”

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confidence: 99%

“…Although the rate of delayed neutropenia was slightly increased, the immediate risk of infection, namely pulmonary infection, was not increased, and data were incomplete regarding the risk of delayed infection [11]. Severe delayed lung injury was noted with a rate of occurrence of 0.03% in the review of KIMBY [2] and 0.01% in the Spanish pharmacovigilance database [9]. Of all sideeffects of rituximab, lung disease may have by far the highest reporting odds ratio (ROR; 68.1; 95% confidence interval 23.8-194.9) [9].…”

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confidence: 99%

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Rituximab-induced lung disease: a systematic literature review

Lioté¹,

Lioté²,

Séroussi³

et al. 2009

European Respiratory Journal

153

120

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The anti-CD20 antibody rituximab has been reported to induce a heterogeneous spectrum of lung disorders. The aim of the present study was to critically review data on the clinical presentations, causality assessments and management strategies of lung diseases possibly related to rituximab.A systematic literature review was performed on English-language reports in PubMed until September 2008.Cases of lung diseases ascribed to rituximab (n545) were identified, with three time-to-onset patterns. The most common presentation was acute/subacute hypoxaemic organising pneumonia (n537), starting 2 weeks after the last infusion (often around the fourth cycle) and resolving, in most cases, provided glucocorticoid therapy was given early. Acute respiratory distress syndrome occurred in five patients, within a few hours and usually after the first infusion. In the remaining three patients, macronodular organising pneumonia developed insidiously long after rituximab therapy and responded to steroids. Eight patients died. Based on time to onset, symptoms, and responses to discontinuation and rechallenge with rituximab and other drugs, 13 cases were highly compatible and 32 compatible with rituximab-induced lung disease.Knowledge of these presentations of rituximab-induced lung disease should prove helpful for diagnosis and causality assessment purposes. Time-to-onset data, suggesting different pathogenic mechanisms, support closer clinical and perhaps radiological monitoring between infusions, particularly in patients with a history of reversible respiratory symptoms.

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“…Fatal events occurred mostly in patients with pre-existing pulmonary dysfunction, so these patients should be treated with caution, and trastuzumab should be discontinued if severe infusion-related reactions occur. 58,72 A Phase IV trial is currently underway to evaluate the efficacy and safety of trastuzumab in patients with advanced HER-2 gastric cancer.…”

Section: Safety and Tolerabilitymentioning

confidence: 99%

Critical appraisal of trastuzumab in treatment of advanced stomach cancer

Meza–Junco¹,

Au²,

Sawyer³

2011

CMAR

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Advanced or metastatic gastric cancer constitutes the majority of patients in clinical practice. In North America, about 70% of cases are advanced or metastatic when diagnosed, which is higher than the 50% reported in Japan. This difference in presentation is reflected in 5-year overall survival, which is about 20% in North America and 40%-60% in Japan. Despite numerous efforts of randomized studies on advanced gastric cancer, no globally accepted standard regimen has yet been established. Systemic chemotherapy provides palliation and prolongs survival, but the prognosis remains poor. Several monotherapies and combined regimens are currently available and vary around the world. Additionally, several molecular targeting agents are under evaluation in international randomized studies. Human epidermal growth factor receptor-2 (HER-2) is overexpressed or amplified in approximately 22% of patients with gastric cancer. Trastuzumab, a recombinant humanized anti-HER-2 monoclonal antibody, is the first biological therapy that has showed a survival improvement by nearly three months (reduced risk of death by 26%). Therefore, trastuzumab in combination with cisplatin is a reasonable treatment option for patients with advanced gastric cancer who are HER-2 positive. This paper will focus on trastuzumab, its chemical and pharmacological characteristics, and the relevant efficacy, safety, and tolerability studies. Keywords: gastric cancer, HER-2, trastuzumab Management issues in stomach cancerGastric cancer is a cause of considerable morbidity and mortality the second leading cause of cancer-related death, and the third most common malignancy worldwide.1 In the US, it was estimated that there would be 21,000 new cases and 10,570 deaths from gastric cancer in 2010.1 In Japan, there are more than 100,000 new cases diagnosed and 50,000 who die annually.2 In Western countries, most newly diagnosed cases (73%) will present in the advanced stages when gastric cancer is incurable, having a median survival of less than 1 year. Although 52% of gastric cancer cases in Japan are diagnosed at an early stage, this fact may be related to mass screening. 3,4 Fluoropyrimidines, platinums, taxanes, and irinotecan are considered the main active cytotoxic agents for advanced gastric cancer. Palliative chemotherapy for advanced or metastatic gastric cancer offers significant advantages in selected fit patients, including increased survival, symptom control, and quality of life, compared with best supportive care alone. [5][6][7][8][9] Systematic review showed that the overall survival benefit of chemotherapy over best supportive care was six months (hazards ratio [HR] 0.39, 95% confidence interval [CI]: 0.28-0.52). A three-drug regimen including 5-flurouracil, anthracyclines, and cisplatin has showed the best survival results,

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Post‐marketing safety of antineoplasic monoclonal antibodies: rituximab and trastuzumab

Abstract: Our results are consistent with the safety profile of rituximab and trastuzumab observed in large randomised clinical trials.

Cited by 26 publications

References 36 publications

Pharmacovigilance of Oncology Biosimilars

Pharmacovigilance of Oncology Biosimilars

Rituximab-induced lung disease: a systematic literature review

Critical appraisal of trastuzumab in treatment of advanced stomach cancer

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