ICYMI: Trabectedin for Ovarian Cancer Did Not Meet its Primary Endpoint

 

Findings from the MITO23 Trial investigating the outcome of the chemotherapy drug trabectedin against physician’s choice to treat BRCA-mutated patients with ovarian cancer were presented at ASCO’s 2022 Annual Meeting according to a recent account in Cancer Therapy Advisor.

Trabectedin (Yondelis), an antitumor chemotherapy drug, is designed to treat ovarian cancer and soft-tissue sarcoma.

Two hundred and forty-four patients (median age 60) enrolled in the open-label trial (ID: NCT02903004). These patients had been treated previously for recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. They had all responded to a minimum of two lines of platinum-based chemotherapy.

Cancers are classified first by the type of tissue in which it originates and second by the location in the body where it first developed.

The NIH suggests that eighty to ninety percent of cancer cases are associated with epithelial tissues found in our skin and throughout our bodies. This includes the linings and covering of organs and internal passageways.

Both trabectedin and physician’s choice chemotherapy were randomly assigned to two groups consisting of 122 patients each. The chemotherapy was divided again among the 122 patients with chemotherapy drugs such as:

  • Carboplatin
  • Paclitaxel
  • Pegylated liposomal doxorubicin
  • Gemcitabine
  • Topotecan

Interim Results Are In

The majority of participants had endometrioid cancer and the most common type of ovarian cancer called high-grade serous carcinoma. Seventy-five percent of participants were classified as stage III.

Approximately thirty-four percent of participants had a mutation in the BRCA1 gene increasing their risk for certain cancers.

Fourteen percent presented with BRCA2 mutations also increasing their risk of breast cancer. BRCA 1 is found on chromosome 17 while BRCA2 is found on chromosome 13.

Both genes increase the risk of pancreatic and ovarian cancer.

The research team reported that trabectedin did not show a noticeable difference between progression-free survival or overall survival. The same held true for physician’s choice.

Overall survival was the primary endpoint. At an eighteen-month follow-up, trabectedin showed a 15.8 month overall survival while the physician’s choice came through with a 17.9 month survival. The median progression-free survival was almost identical as was the overall response, and especially the duration of response.

There were no exceptional outcomes to be reported for trabectedin.

An exploratory examination was conducted comparing trabectedin with both non-platinum chemotherapy and platinum chemotherapy again without a significant difference.

Adverse Events

It was reported that over ninety percent of participants in both treatment arms had an adverse event. Although there were no fatal adverse events (AEs) there were grade three or four AEs reported in fifty percent of the physician’s choice group and seventy-one percent reported in the trabectedin arm.

 

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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