Sudden cardio-pulmonary toxicity following a single infusion of gemcitabine

Ciotti, R.; Belotti, Giuseppina; Facchi, E.; Cantu, Amanda; d’Amico, Andrea; Gatti, C.

doi:10.1023/a:1008305716918

Cited by 30 publications

(22 citation statements)

References 6 publications

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“…Published literature reports describe apparently similar presentations of gemcitabine-associated lung injury with the terms capillary leak syndrome, 24,26 -30 noncardiogenic pulmonary edema, 16,31,32 interstitial pneumonitis, 16,[33][34][35][36][37][38][39][40][41][42][43][44][45][46][47][48] acute pneumonitis, 49 acute respiratory distress syndrome, 8,36,50,51 acute pulmonary toxicity, 52 or acute lung injury. 16,44,45,36,46,[53][54][55][56] In conclusion, our findings highlight the importance of consideration of the risk of lung injury from drug-drug or drug-radiotherapy interactions in designing novel therapeutic regimens for cancer patients, particularly for drugs with additive or synergistic pulmonary toxicity. The MedWatch program is the mechanism by which healthcare professionals …”

Section: Discussionmentioning

confidence: 71%

Clinical features and correlates of gemcitabine‐associated lung injury

Belknap

Kuzel

Yarnold

et al. 2006

Cancer

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BACKGROUNDGemcitabine is a commonly used chemotherapeutic agent structurally and pharmacologically similar to cytarabine. Recently, instances of severe gemcitabine‐associated lung injury have been reported. Herein, investigators affiliated with the Research on Adverse Drug Events and Reports (RADAR) pharmacovigilance program evaluated clinical characteristics of gemcitabine‐associated severe acute lung injury from clinical trial reports, medical literature case reports, and spontaneous reports to the Food and Drug Administration (FDA) Adverse Event Reporting System (AERS).METHODSClinical data were obtained by reviewing adverse event case reports for gemcitabine‐associated lung injury as reported in the medical literature and in the FDA AERS database. Upper limit estimates of ADE rate were derived from review of published clinical trials reporting gemcitabine‐associated lung injury rates of 10% or higher.RESULTSA total of 178 reports of gencitabine‐associated lung injury were identified; in AERS, there were 55 cases from clinical trials and 92 spontaneous reports. A comprehensive search revealed 31 medical literature reports. Clinical features of gemcitabine‐associated lung injury included dyspnea, fever, pulmonary infiltrate, and cough with recognition of toxicity occurring after a median duration of 48 (range, 1‐529) days after initiation of gemcitabine. The taxanes, docetaxel and paclitaxel, were frequently reported as coadministered therapies. Eleven Phase II or Phase III clinical trials with 317 patients identified gemcitabine‐associated lung injury rates of greater than 10%, with the highest rates (22% and 42%) being observed in Phase III clinical trials where Hodgkin disease patients were treated with a regimen that included gemcitabine and bleomycin.CONCLUSIONSHigh rates of gemcitabine‐associated severe lung injury were observed when gemcitabine was combined with other therapies known to also cause lung injury. Physicians should have a high index of suspicion for this toxicity and report the relevant clinical findings to the FDA's AERS. Cancer 2006. © 2006 American Cancer Society.

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Section: Discussionmentioning

confidence: 71%

Clinical features and correlates of gemcitabine‐associated lung injury

Belknap

Kuzel

Yarnold

et al. 2006

Cancer

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“…There are sporadic reports of pro-arrhythmic cardiac toxicity during gemcitabine use [11] and ventricular arrhythmia [12] and sporadic asymptomatic brady-arrhythmias, but no atrial fibrillation [6] has been reported. A case of a severe cardio-pulmonary toxicity (ARDS and atrial fibrillation) after gemcitabine infusion has been recently described [13] and the authors suggested an inflammatory pathogenetic mechanism mediated by cytokine release resulting in myofibroblasts proliferation and collagen deposits. However, this patient had ARDS and developed a further episode of atrial fibrillation unrelated to gemcitabine infusion.…”

Section: Discussionmentioning

confidence: 99%

Gemcitabine-induced atrial fibrillation: A hitherto unreported manifestation of drug toxicity

et al. 2000

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SummaryBackground: Gemcitabine is an antimetabolic drug for solid tumors. Altough its pharmacokinetics as well as its side-effects are well known, paroxysmal atrial fibrillation associated to the administration of this drug has not yet been described. Patients and methods:We describe the case of a 78-year-old man with pancreatic adenocarcinoma who presented repeated paroxysmal atrial fibrillation episodes 18-24 hours after every gemcitabine infusion which resolved with antiarrhythmic drugs. This clinical history was positive for a remote brief episode of atrial fibrillation, which resolved spontaneously, and the patient had no predisposing factors for supraventricular arrhythmias (systemic hypertension, diabetes or coronary artery disease).Results: Cardiac work-up revealed only a mild mitral-valve

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“…Interestingly, flu-like symptoms and fever have also been reported in 20%-35%, and peripheral edema in up to 20% of the patients treated with gemcitabine [51]. Gemcitabine-induced pulmonary toxicity usually upsurges after a number of repeated drug administrations gradually building up, although occasionally it has also been reported to occur after a single-dose administration [54][55][56]. A small number of NCPE cases associated with the gemcitabine administration have been reported so far.…”

Section: Cytotoxic Drugsmentioning

confidence: 99%

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

Briasoulis

Pavlidis

2001

The Oncologist

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Noncardiogenic pulmonary edema (NCPE) is a rare and less well-recognizable pulmonotoxic syndrome of anticancer therapy than pneumonitis/fibrosis. NCPE is a clinical syndrome characterized by simultaneous presence of severe hypoxemia, bilateral alveolar infiltrates on chest radiograph, and no evidence of left atrial hypertension/congestive heart failure. The diagnosis of drug-related NCPE relies upon documented exclusion of any infectious, metabolic, or cancer-related causes. The Oncologist 2001;6:153-161 www.TheOncologist.com Correspondence: Evangelos Briasoulis, M.D., Medical Oncology Department, Ioannina University, Ioannina, 45110, Greece. Telephone and Fax: 30-651-99394; e-mail: ebriasou@otenet.gr. Received August 15, 2000; accepted for publication November 30, 2000. ©AlphaMed Press 1083-7159/2001 INTRODUCTIONSeveral cancer therapeutic drugs are known to induce pulmonary damage, which may result in a variety of clinicopathologic syndromes with minor to severe clinical consequences [1]. Clinical syndromes associated with drug-induced pulmonary toxicity include pneumonitis/fibrosis, hypersensitivity lung disease, and noncardiogenic pulmonary edema (NCPE)/acute respiratory distress syndrome (ARDS). These syndromes share a similar symptomatology but differ in regard to the time-relation to cancer treatment, the radiographic findings, the duration of pulmonary damage, and the long-term outcome [2]. Non-specific symptomatology of cough, progressive dyspnea, and often a low-grade fever alert clinicians confronted with the diagnostic challenge to recognize subclinical syndromes and differentiate fully developed drug-induced pulmonary reactions from lung injuries caused by infectious, cardiac, and neoplastic causes.

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Sudden cardio-pulmonary toxicity following a single infusion of gemcitabine

Cited by 30 publications

References 6 publications

Clinical features and correlates of gemcitabine‐associated lung injury

Clinical features and correlates of gemcitabine‐associated lung injury

Gemcitabine-induced atrial fibrillation: A hitherto unreported manifestation of drug toxicity

Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy

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