Retrospective multicenter study of elderly patients with platinum-sensitive relapsed ovarian cancer treated with trabectedin and pegylated liposomal doxorubicin (pld) in a real-world setting: a geico study

• Published in: BMC cancer Vol. 24; no. 1; pp. 803 - 11
• Main Authors: Rubio, María Jesús, Manzano, Aránzazu, de Sande, Luis Miguel, Estévez-García, Purificación, Gordon, María Del Mar, de Prado, Diego Soto, de Aranguiz, Blanca Hernando Fernández, Guerra-Alia, Eva M, Carbó-Bagué, Anna, Romero, Ignacio, Corbellas, Miguel, González-Haba, Alba, Robles-Barraza, Carlos E, Martínez-García, Jerónimo, González-Martín, Antonio
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 05.07.2024; BioMed Central; BMC
• Subjects: Age; Aged; Aged patients; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Asthenia; Cancer; Cancer patients; Cancer therapies; Care and treatment; Chemotherapy; Clinical medicine; Clinical trials; Diseases; Dosage and administration; Doxorubicin; Doxorubicin - administration & dosage; Doxorubicin - adverse effects; Doxorubicin - analogs & derivatives; Doxorubicin - therapeutic use; Drug therapy; Elderly; Ethics; Evidence-based medicine; Female; Gynecological cancer; Hematology; Humans; Informed consent; Medical history; Medical prognosis; Neoplasm Recurrence, Local - drug therapy; Neutropenia; Oncology, Experimental; Ovarian cancer; Ovarian Neoplasms - drug therapy; Ovarian Neoplasms - mortality; Ovarian Neoplasms - pathology; Patient outcomes; Patients; Pharmacology, Experimental; Physiological aspects; Platinum; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Polyethylene Glycols - therapeutic use; Population studies; Real-world studies; Relapse; Retrospective Studies; Sensitivity analysis; Serum levels; Survival; Toxicity; Trabectedin; Trabectedin - administration & dosage; Trabectedin - therapeutic use; Treatment Outcome; Womens health; Spain; Taiwan; Real-world studies; Trabectedin; Elderly; Ovarian cancer
• ISSN: 1471-2407; 1471-2407
• DOI: 10.1186/s12885-024-12577-z

Trabectedin in combination with pegylated liposomal doxorubicin (PLD) is approved for the treatment of patients with platinum-sensitive relapsed ovarian cancer. Nevertheless, there is currently limited information regarding this treatment in elderly patients with ovarian cancer in a real-world setting. This observational and multicentric study retrospectively evaluated trabectedin plus PLD in a real-world setting treatment of elderly patients diagnosed with platinum-sensitive relapsed ovarian cancer, treated according to the Summary of Product Characteristics (SmPC) from 15 GEICO-associated hospitals. Patients ≥ 70 years old at the time of treatment initiation and platinum-free intervals ≥ 6 months were considered eligible. Forty-three patients with a median age of 74.0 years were treated between January 1st, 2015, and December 31st, 2019 in 15 Spanish centers. Four patients achieved complete response (9.3%), 14 (32.6%) partial response, and 13 (30.2%) stable disease as the best radiological response. In the analysis of biological overall response according to CA125 serum levels (i.e., Rustin criteria), 14 responded to the treatment (32.6%), 11 responded and normalized (25.6%), three patients stabilized (7.0%) and three progressed (7.0%). Median progression-free survival (PFS) and overall survival (OS) in the study population were 7.7 and 19.5 months, respectively. The most common grade 3/4 adverse events were neutropenia (n = 8, 18.7%) and asthenia (n = 5, 11.6%). This analysis demonstrated that trabectedin combined with PLD is a feasible and effective treatment in elderly patients with platinum-sensitive relapsed ovarian cancer, showing an acceptable safety profile, which is crucial in the palliative treatment of these patients.