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Bone marrow biopsy unnecessary for follicular lymphoma clinical trials
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Bone marrow biopsy did not change response assessments after treatment among patients enrolled in clinical trials for follicular lymphoma, which suggests mandatory biopsy is not needed, according to published findings.
The standard in clinical trials for patients with follicular lymphoma is to undergo bone marrow biopsy — a procedure that can be painful, time consuming and costly — twice during the trial.
“Most clinical trials for follicular lymphoma require bone marrow biopsies at baseline. Then, once the patient received treatment and if imaging shows they have a complete response, another biopsy will be conducted in order to confirm the complete response,” Sarah C. Rutherford, MD, hematologist/oncologist at Weill Cornell Medicine and NewYork-Presbyterian, told HemOnc Today. “There are some occasions in which there are other reasons to do a biopsy, such as prolonged low blood counts; however, for the purposes of assessing response, our study argues that we could stop doing these bone marrow biopsies in clinical trials for follicular lymphoma.”
Rutherford and colleagues evaluated data from 99 patients (median age, 61 years; range, 29-87) with newly diagnosed or relapsed/refractory follicular lymphoma treated in 32 clinical trials at Weill Cornell Medicine between 2000 and 2016.
Most patients had advanced disease (n = 95); 34 were newly diagnosed; and 65 had relapsed or refractory disease. Fifty-eight relapsed patients received prior rituximab (Rituxan; Genentech, Biogen).
The 2007 International Working Group revised criteria for response assessment was the most frequently response criteria used in these clinical trials. Analyses included pre- and posttreatment imaging and bone marrow examinations of all patients. The premise of the study was that the only follicular lymphoma patients in whom bone marrow biopsy could affect response assessment are those with positive bone marrows at baseline who have a complete response on post-treatment imaging but residual lymphoma in their bone marrow.
Forty-five patients had positive bone marrow biopsies at baseline. Posttreatment imaging tests showed 12 of these patients had a complete response, 19 had a partial response, five had stable disease and nine had progressive disease.
Eleven of the 12 patients with complete response by imaging criteria had negative posttreatment bone marrow biopsies; one patient did not undergo posttreatment bone marrow biopsy.
Thus, the bone marrow biopsy could possibly have altered response assessment in only one patient (1%; 95% CI, 0-5.5), Rutherford said.
“We only found one patient had bone marrow involvement at the beginning, had complete response to their treatment, and then actually declined a second bone marrow test,” Rutherford said. “The number of patients whose bone marrow biopsies provide useful information is too little to warrant the biopsies be mandatory.”
The researchers found bone marrow biopsies to be “irrelevant” to response assessment for the 54 patients with negative biopsy at baseline. Three of the patients who underwent second bone marrow biopsy showed myelodysplastic syndrome; however, this did not change the patients’ response assessment because two had negative biopsies at baseline and one had follicular lymphoma on posttreatment imaging. The researchers would still recommend doing bone marrow biopsies when clinically indicated as in these cases.
“We are proposing to do a larger study looking at many more patients treated on clinical trials for follicular lymphoma already. We will go back and look at bone marrow biopsy results to see if we can validate our results in a larger study cohort,” Rutherford said. “Our hope is we will be able to confirm our results and take bone marrow biopsy out of the requirements for clinical trials for this patient population.” – by Melinda Stevens
For more information:
Sarah C. Rutherford, MD, can be reached at: Weill Cornell Medicine, Department of Medicine, 1305 York Ave., 7th Floor, New York, NY 10021; email: sar2014@med.cornell.edu.
Disclosure: The researchers report no relevant financial disclosures.
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