This 3-Drug Combo Improves Survival, But Does it Lower Quality of Life? Investigators Say No

Patients with relapsed or refractory multiple myeloma who had an additional drug added to their treatment did not experience any negative effects on their quality of life.

“Relapsed” refers to a patient whose cancer has reappeared or grown again after a period of remission. “Refractory” is used to describe a person whose cancer cells continued to grow even though they were receiving treatment, or whose response to treatment did not last very long.

Researchers added elotuzumab to a drug combination of lenalidomide and dexamethasone in the phase 3 ELOQUENT-2 trial, and while it was established several years ago that the 3-drug combination was more effective at fighting cancer than lenalidomide and dexamethasone alone, the effect on quality of life had not yet been confirmed. Now, after almost 6 years of follow-up, it has been.

Survival in multiple myeloma has greatly improved in recent years because so many effective drugs have been approved. Now, researchers want to make sure that these patients are not just living longer, but that they are able to enjoy that time, particularly in patients who have received quite a few lines of treatment.

In the trial, 321 patients who had received between 1 and 3 previous lines of treatment were given elotuzumab, lenalidomide, and dexamethasone, and 325 patients were given lenalidomide/dexamethasone alone. After almost 6 years of follow-up, the median overall survival was 48.3 months in patients who received the 3-drug combo, compared with 39.6 months with lenalidomide/dexamethasone alone.

Median overall survival is the length of time from the start of cancer treatment that half of the patients are still alive. In a clinical trial, measuring the median overall survival is one way to see how well a new treatment works.

This means that patients who received elotuzumab had an 18% lower risk of death when the final data were collected.

After the safety and effectiveness of the new drug combination had been established, the researchers could focus on what the people in the trial had to say about the treatment’s effect on their quality of life.

Patients were given questionnaires related to quality of life at various timepoints throughout their treatment. The Brief Pain Inventory–Short Form (BPI-SF), the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 questionnaire (QLQ-C30), and the myeloma-specific module (QLQ-MY20) were all used to measure different aspects of quality of life during and after cancer treatment.

Over time, there were no meaningful differences in average scores between treatment groups, according to any of the questionnaires. This is a good thing, because the investigators did not expect the 3-drug combo to actually improve quality of life; they just wanted to make sure the addition of elotuzumab did not make it any worse.

However, elotuzumab-treated patients who started with moderate or severe pain (score of 5 or higher) actually had lower scores when it came to pain severity.

When patients responded well to cancer treatment, they also tended to have lower pain scores than non-responders, but this was seen at about the same rate in the 2 treatment groups.

According to Dr. David Cella, one of the study’s lead investigators, “These findings complement results from the final overall survival analysis of ELOQUENT-2, which demonstrate a statistically significant and clinically meaningful improvement in overall survival with elotuzumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone.”