A cross-sectional study of treatment practices for 7635 patients with multiple myeloma across several European countries suggests considerable consistency in agents used as first-line and second-line treatments. The treatments utilized at later points, however, appear to be more varied, with bortezomib prescribed in nearly half of patients for second-line and third-line therapies.1
“With recent approvals of anti-myeloma drugs and others coming soon, it is interesting to assess our clinical practices, and to compare them with our colleagues both within our own country and across Europe,” study author Marc Raab, MD, of the department of medicine V, Heidelberg University Hospital and German Cancer Research Centre in Germany, told Cancer Therapy Advisor.
According to Dr Raab, the investigation showed that a surprisingly low proportion of patients appear to be treated in clinical trials. This suggests a need for an improved method of encouraging patients to enter clinical trials. He and his colleagues contend that these real-world data provide useful information, both for designing clinical trials and for evaluating the benefits and risks of new and existing agents.
The researchers conducted an observational chart review of 435 European physicians (in Belgium, France, Germany, Italy, Spain, Switzerland, and the UK) that included 7635 patients, who were seen during a 2-to-4 week observation period, regardless of treatment status. They found that 47% of patients were undergoing anti-tumor drug treatment, 42% had previously received at least 1 line of treatment, and 12% had never received anti-tumor drug treatment.
When the investigators reviewed data from patients treated only by oncologists, onco-hematologists, or internists, they found that 95% received (or were expected to receive) at least 1 line of anti-tumor drug treatment. Of these patients, 61% received at least 2 lines of therapy and 38% received at least 3 lines of therapy.
The most commonly used induction therapies contained bortezomib (48%), except in the UK. Lenalidomide was the most commonly used first-line maintenance therapy (45%), for 60% of patients as a second-line agent, and for 52% as a third-line agent. Bortezomib retreatment was prescribed for 47% of patients who received it as a first-line agent.
“These results show how heterogeneous treatments for relapsed patients previously treated with a proteasome inhibitor (PI) and an immunomodulatory drug (IMID) already are, and reflect upon how the new treatment options arriving in this setting are likely to continue to affect the way multiple myeloma is managed,” Dr Raab told Cancer Therapy Advisor.
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Rachid Baz, MD, associate member and director of clinical research in the department of malignant hematology at Moffitt Cancer Center in Tampa, Florida, said the treatment for myeloma is evolving rapidly, and in 2015, 4 therapeutic agents were approved by the U.S. Food and Drug Administration (FDA). “There is not just 1 standard of care approach to the disease. The choice of therapy depends on several factors, including disease-related factors, patient demographics and comorbidities, patient preference, and access to therapeutic agents,” Dr Baz told Cancer Therapy Advisor. “Access to novel therapies is not guaranteed after approval by regulatory authorities, and is further complicated by reimbursement and financial considerations that could further limit the availability of novel agents to patients.”
He noted that while clinical trials can help to elucidate the evidence underlying treatment guidelines, clinical trials may not always generalize to all myeloma patients. This is because patients were excluded from clinical trial participation if they had renal failure. Elderly patients were also under-represented in clinical trials.
“Real-world practice patterns are able to paint a more realistic picture of the treatment paradigm of a disease outside the very controlled scope of a clinical trial. Such patterns may help define areas of further research, or areas where improving access to novel agents could have an important impact,” said Dr Baz.
1. Raab MS, Cavo M, Delforge M, et al. Multiple myeloma: practice patterns across Europe. Br J Haematol. doi: 10.1111/bjh.14193 [Epub ahead of print].