Carboplatin Alone May Negatively Impact Survival in Patients With Ovarian Cancer

Single-agent carboplatin was less active and resulted in significantly worse survival outcomes compared to a combination of carboplatin and paclitaxel in vulnerable older patients with ovarian cancer, according to data published in JAMA Oncology.

Women who are newly diagnosed with advanced ovarian cancer typically receive a standard chemotherapy regimen of carboplatin and paclitaxel every three weeks; however, vulnerable older patients often require regimen and schedule changes.

“Single-agent carboplatin is probably the most widely used treatment in older patients, but given conflicting results for such an approach, the Fourth Ovarian Cancer Consensus Conference emphasized the need for additional research on treatment modification for older patients,” the study authors wrote.

In this international, randomized clinical trial, 120 women (median age, 80 years) aged 70 years or older with newly diagnosed stage 3/4 ovarian cancer received one of the following treatments for six cycles:

• carboplatin plus paclitaxel every three weeks (40 patients; control group),
• Single-agent carboplatin every three weeks (40 patients; single-agent group) or
• weekly carboplatin plus paclitaxel on days one, eight and 15 every four weeks (40 patients; weekly group)

Researchers assessed feasibility (the ability to complete six cycles without disease progression), premature treatment discontinuation due to side effects or death.

The trial was terminated early due based on a committee’s recommendation, which was based on the fact that single-agent carboplatin led to significantly worse survival. Six treatment cycles were completed in 26 of 40 patients (65%) in the control group, 19 of 40 patients (48%) in the single-agent group and 24 of 40 patients (60%) in the weekly group.

Progression-free survival (time during and after treatment when the patient lives without disease progression) was significantly longer in the control group (12.5 months) compared with the single-agent carboplatin group (4.8 months) and the weekly group (8.3 months). Median overall survival (time from diagnosis or treatment start when patients are still alive) was not reached in the control group (meaning that more than half of patients were alive when this was assessed), was 7.4 months in the single-agent group and was 17.3 months in the weekly group.

Eight patients in the control group, six in the single-agent group and nine in the weekly group discontinued treatment due to toxic effects before completing the six cycles.

Side effects occurred mostly in the single-agent and weekly combination groups (23 of 40 patients in both groups) compared to the control group (17 of 40 patients).

Patients in the single-agent group had a higher incidence of severe or greater thrombocytopenia (low blood platelet level) and anemia compared with the other groups. In addition, the weekly group had a higher incidence of severe or greater neutropenia (low count of white blood cells called neutrophils) versus the other patient groups. Other low-grade side effects such as gastrointestinal effects, neuropathy and alopecia were more commonly seen in the control and weekly groups than the single-agent group. Side effects leading to death were reported in three patients in the control group (two of which were considered treatment related), four patients in the single-agent group and five patients in the weekly group (two of which were considered treatment related).

“Management of vulnerable older patients with ovarian cancer should include, from cancer diagnosis, a personalized plan for oncogeriatric care, including both oncologic and geriatric treatment plans,” the study authors concluded. “If the oncologic plan considers the survival advantage provided by carboplatin-paclitaxel doublets, the geriatric plan must be prioritized in parallel, given the high toxic effects observed in this population, and should address the major components of (the Geriatric Vulnerability Score, including) functionality, malnutrition, mood disorders).”

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