Safety and Efficacy Analysis of Lurbinectedin in Patients With Advanced Ovarian Tumors

In a new assessment of the CORAIL study, Alexandra Leary, MD, from the Gustave Roussy Cancer Campus, and colleagues sought to find the safety profile of lurbinectedin for the treatment of solid tumors. The CORAIL study was a randomized phase III study that compared lurbinectedin to pegylated liposomal doxorubicin/topotecan in patients that had a form of ovarian cancer that was platinum resistant.

In the CORAIL study, 219 patients were treated with one dose of lurbinectedin (3.2 mg) in two arms. Treatment was discontinued if there was significant disease progression or high toxicity levels, or if the patient decided to discontinue treatment. The researchers monitored patients’ safety levels throughout the study and 30 days after or until a patient started a new therapy. They also performed weekly analyses for safety by looking at patients’ laboratory abnormalities in their results and checking for any adverse events.

In their results, researchers found that most patients discontinued treatment because of disease progression. Patients received treatment for a median of 13.3 weeks. The most common adverse events in this study were fatigue and gastrointestinal disorders. However, 4 patients did report experiencing musculoskeletal events. Under 1% of patients reported experiencing grade 4 anemia. Hematological toxicities was one of the most common adverse events, with 11% reporting neutropenia and 3% reporting febrile neutropenia and thrombocytopenia. Only 5 patients discontinued treatment due to hematological toxicities. Overall, the rate of discontinuation due to an adverse event occurring was 6%. Deaths that were related to treatment or were unknown occurred in 7 patients and were due to pneumonia (n = 2), sepsis (n = 2), lung infection (n = 1), cardiorespiratory arrest (n = 1), or pulmonary arterial hypertension (n = 1). Of these patients, 3 had ovarian cancer. The researchers found that age or exposure to lurbinectedin had no statistically significant effect on the drug’s overall safety levels.

“The incidence of severe haematological abnormalities decreased after the second treatment cycle,” the authors wrote. “Transaminase increases, fatigue, gastrointestinal disorders and decreased appetite were the non-haematological abnormalities and toxicities most commonly found during lurbinectedin treatment; most episodes of these events were mild or moderate.”

In conclusion, Dr Leary and colleagues confirmed that lurbinectedin is safe for use in patients with ovarian tumors that are in an advanced stage. Their conclusions align with similar results found in previous studies, such as the CORAIL study and the FDA’s conclusions on safety levels. The most common toxicity was found to be transient and reversible myelosuppression.

Reference:

Leary A, Oaknin A, Trigo JM, et al. Pooled Safety Analysis of Single-Agent Lurbinectedin in Patients With Advanced Solid Tumours. Eur J Cancer. 2023;192:113259-113259. doi:10.1016/j.ejca.2023.113259