Sustained Improvements in Quality of Life Observed with Bortezomib in Multiple Myeloma

TON - February 2010 Vol 3, No 1 — June 2, 2010

The addition of bortezomib to a standard regimen for patients newly diagnosed with multiple myeloma resulted in sustained im provements in quality of life, compared with the standard two-drug regimen, according to long-term re sults from the landmark Velcade as Initial Standard Therapy in Multiple Myeloma (VISTA) trial, which led to the approval of bortezomib for this indication.

"Since we are considering myeloma as a chronic disease, patients are living longer, and it is important to see we are improving their quality of life as well," said Ravinder Dhawan, PhD, of Johnson & Johnson Pharmaceutical Services, Raritan, New Jersey.

In the phase 3 VISTA trial, 854 patients were randomized to treatment with melphalan and prednisone (MP) or MP plus bortezomib (VMP). The researchers found that VMP was superior to MP across all end points, including response rate, time-to-progression, and overall survival.

"The VISTA trial was extremely important. Two years ago, when the data were presented at ASH, there was a standing ovation. It was a transformational study for newly diagnosed multiple myeloma," he noted.

"We previously reported that achieving a complete response [CR] has a positive impact on health-related quality of life [HRQOL] at the fourth cycle after CR onset," said Dhawan. "This subanalysis evaluated the number of patients who experienced sustained HRQOL improvement after their best tumor response and the overall HRQOL impact in the VMP and MP arms—in other words, once you have a good response, is this response sustainable and is there a benefit in terms of quality of life?"

HRQOL improvements observed after best response achieved
The European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30, an HRQOL questionnaire commonly used in multiple myeloma, was administered at screening, day 1 of each cycle during treatment, and every 8 weeks until progression. Sustained HRQOL improvement was defined as a change in an individual domain or function score of at least five points for two consecutive cycles after achieving a best response. At baseline, all EORTC QLQ-C30 domain and function scores were similar between the two treatment arms.

At the time they achieved their best response, patients receiving bortezomib actually had lower HRQOL scores in six domains, indicating worse health status. These included physical, role, social, emotional, and cognitive function, as well as global health status (although statistical significance was shown only for role function and social function). The VMP arm was numerically superior in nine domains at the time of best response.

But after achieving the best response, a higher percentage of patients in the VMP arm experienced sustained HRQOL improvements, versus those in the MP arm, in all of the 15 EORTC QLQ-C30 scores except for cognitive function, a domain that was essentially the same for each arm, Dhawan reported.

Statistically significant differences were shown for nausea/vomiting, appetite loss, and diarrhea, favoring bortezomib. "Improvement in appetite, for example, was observed in 36% of patients with good responses. And the improvements in nausea and diarrhea remained significant after adjustment for baseline score, score at best response, and type of response," he said. "A trend for higher rates of sustained HRQOL improvement after best response was also observed in many other domains for patients treated with VMP versus MP.

"Although HRQOL decrements were often higher in the bortezomib arm at onset of best response, these data suggest that VMP patients experience substantial and durable HRQOL improvements after they achieve their best response," he concluded.

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