This is an excerpt of a story that appeared in MedScape. Read the full article here.
Clinical trials in patients with follicular lymphoma (FL) mandate that patients undergo bone marrow biopsies (BMBs) at baseline and at subsequent points following treatment in order to monitor response. But how necessary are they?
The biopsies are unnecessary in most patients, argue researchers reporting results from a retrospective analysis of 99 patients with FL enrolled across 32 clinical trials at Weill Cornell Medical College. The study found that the mandatory BMBs resulted in response assessment change in at most 1% of patients and so concluded that they were not needed.
"In our patient-centered approach to care, we find that these biopsies are painful and anxiety-provoking. The procedures take time, add to healthcare costs, and are a hindrance for patients to participate in clinical trials," corresponding author, Sarah Rutherford, MD, medical oncologist at Weill Cornell Medicine and New-York Presbyterian, New York City, told Medscape Medical News.
"In routine clinical practice, we do not often do bone marrow biopsies in follicular lymphoma patients. Removal of this barrier can contribute significantly to increasing patient interest in clinical trials, which can provide them access to novel and promising therapies," she added.
The study was published in the British Journal of Haematology.
From the patient's perspective, the BMB can be a traumatic experience. One of Dr Rutherford's patients, Liam C, is 1 of the 99 patients described in this study. He met with Dr Rutherford in November 2015, who, after routine blood work and a BMB, enrolled him in a clinical trial evaluating an investigational drug for FL. Although Liam is doing well after about 2 years of therapy, he vividly recalls his BMB experience.
"Although I knew it was a drill going through my bone, it felt like someone was sawing through it," he said. He explained that there was no topical pain (Liam had chosen local anesthesia), but the pressure of the drill was intense, with bouts of excruciating pain, and his whole body shaking. "I was so aware of the unusual invasion. The vibrations from the drilling were felt through the entire body," he told Medscape Medical News. "I was pragmatic knowing that this was necessary, but I was terrified," he recalled.
Indeed, a study of patients with hematologic malignancies found that 70% of patients experienced pain during a bone marrow biopsy, with 32% reporting pain as severe (Acta Anaesthesiol Scand. 2009;53:354-363).
Having performed many BMBs, Dr Khan acknowledges that patients undergoing the procedure experience pain and anxiety, but she also pointed out that the pain experienced with BMBs depends on several factors, including the time taken over the procedure, physician experience, and the pain experienced in a previous procedure. She indicated that in the hands of an experienced operator, the pain and discomfort experienced can be minimized.
Dr Rutherford provided her own insight. "When a bone marrow biopsy is necessary, we make every effort for it to be as comfortable as possible for the patient. However, both patients and physicians would prefer to avoid the procedures when information obtained from them is not considered significant," she told Medscape Medical News.
Liam is self-educated on his disease and knows his protocol well. "If no decisions are made based on a bone marrow biopsy and the results are not conclusive, why are they necessary?" he asked.
A BMB does not come cheap. In a July 2017 updated list of common hospital costs (not accounting for physician and/or other provider fees), Johns Hopkins Hospital lists the average cost of a bone marrow biopsy at $5,400.