Cardiac safety of trabectedin monotherapy or in combination with pegylated liposomal doxorubicin in patients with sarcomas and ovarian cancer
| Autor: | Shreyaskumar Patel, Tracy McGowan, Spyros Triantos, Margaret von Mehren, Scott M. Schuetze, Roland Elmar Knoblauch, Waleed Shalaby, Peter Hu, Brian A. Van Tine, Bradley J. Monk, Robert L. Coleman, Thomas J. Herzog, Robin L. Jones, George D. Demetri |
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| Rok vydání: | 2021 |
| Předmět: |
Male
cardiac toxicity 0301 basic medicine Oncology Cancer Research Multivariate analysis medicine.medical_treatment Soft Tissue Neoplasms patient outcomes chemotherapy Ventricular Function Left Polyethylene Glycols 0302 clinical medicine Antineoplastic Combined Chemotherapy Protocols Child RC254-282 Trabectedin Original Research Aged 80 and over Ovarian Neoplasms Age Factors Neoplasms. Tumors. Oncology. Including cancer and carcinogens Heart Sarcoma Middle Aged Dacarbazine Cardiovascular Diseases 030220 oncology & carcinogenesis Female medicine.drug Adult medicine.medical_specialty Adolescent Anthracycline anthracycline soft tissue sarcomas Young Adult 03 medical and health sciences Clinical Trials Phase II as Topic Internal medicine Product Surveillance Postmarketing medicine Humans Radiology Nuclear Medicine and imaging Medical history Adverse effect Antineoplastic Agents Alkylating Aged Retrospective Studies Chemotherapy business.industry Clinical Cancer Research Stroke Volume medicine.disease Cardiotoxicity 030104 developmental biology Clinical Trials Phase III as Topic Doxorubicin Relative risk Multivariate Analysis Neoplasm Recurrence Local business Ovarian cancer |
| Zdroj: | Cancer Medicine, Vol 10, Iss 11, Pp 3565-3574 (2021) Cancer Medicine |
| ISSN: | 2045-7634 |
| DOI: | 10.1002/cam4.3903 |
| Popis: | Background As with other alkylating agents, cardiac dysfunction can occur with trabectedin therapy for advanced soft tissue sarcomas (STS) or recurrent ovarian cancer (ROC) where treatment options for advanced disease are still limited. Cardiac safety for trabectedin monotherapy (T) for STS or in combination with pegylated liposomal doxorubicin (T+PLD) for ROC was evaluated in this retrospective postmarketing regulatory commitment. Methods Patient data for multiple cardiac‐related treatment‐emergent adverse events (cTEAEs) were evaluated in pooled analyses of ten phase 2 trials, one phase 3 trial in STS (n = 982), and two phase 3 trials in ROC (n = 1231). Results Multivariate analyses on pooled trabectedin data revealed that cardiovascular medical history (risk ratio [RR (95% CI)]: 1.90 [1.24‐2.91]; p = 0.003) and age ≥65 years (RR [95% CI]: 1.78 [1.12‐2.83]; p = 0.014) were associated with increased risk for cTEAEs. Multivariate analyses showed increased risk of experiencing cTEAEs with T+PLD compared to PLD monotherapy (RR [95% CI]: 2.70 [1.75‐4.17]; p Cardiac safety for trabectedin monotherapy advanced soft tissue sarcomas (STS) or in combination with pegylated liposomal doxorubicin (T+PLD) for recurrent ovarian cancer (ROC) was evaluated in pooled analyses of 10 phase 2 trials, one phase 3 trial in STS (n = 982), and two phase 3 trials in ROC (n = 1231). Cardiovascular medical history, age ≥65 years, and prior use of anthracyclines were associated with increased risk for cTEAEs. For patients with STS or ROC who still have limited treatment options, trabectedin may be initiated after carefully considering benefit versus risk. |
| Databáze: | OpenAIRE |
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