{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,8]],"date-time":"2026-01-08T08:37:34Z","timestamp":1767861454995,"version":"3.49.0"},"reference-count":54,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"21","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2009,7,20]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> To assess efficacy and safety of single-agent bortezomib in previously untreated patients with multiple myeloma, investigate prevalence of baseline and treatment-emergent polyneuropathy, and identify molecular markers associated with response and neuropathy. <\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and Methods<\/jats:title><jats:p> Patients received bortezomib 1.3 mg\/m<jats:sup>2<\/jats:sup> on days 1, 4, 8, and 11, for up to eight 21-day cycles. A subset of patients underwent neurophysiologic evaluation pre- and post-treatment. Bone marrow aspirates were performed at baseline for exploratory whole-genome analyses. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Among 64 patients, 41% had partial response or better, including 9% complete\/near-complete responses; median duration of response was 8.4 months. Response rates did not differ in the presence or absence of adverse cytogenetics. After median follow-up of 29 months, median time to progression was 17.3 months. Median overall survival had not been reached; estimated 1-year survival was 92%. Thirty-two patients successfully underwent optional stem-cell transplantation. Bortezomib treatment was generally well tolerated. At baseline, 20% of patients had sensory polyneuropathy. Sensory polyneuropathy developed during treatment in 64% of patients (grade 3 in 3%), but proved manageable and resolved in 85% within a median of 98 days. Neurologic examination, neurophysiologic testing, and measurements of epidermal nerve fiber densities in 35 patients confirmed pretreatment sensory neuropathy in 20% and new or worsening neuropathy in 63%. Pharmacogenomic analyses identified molecular markers of response and treatment-emergent neuropathy, which will require future study. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Single-agent bortezomib is effective in previously untreated myeloma. Baseline myeloma-associated neuropathy seems more common than previously reported, and bortezomib-associated neuropathy, although a common toxicity, is reversible in most patients. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2008.18.3087","type":"journal-article","created":{"date-parts":[[2009,6,16]],"date-time":"2009-06-16T01:44:52Z","timestamp":1245116692000},"page":"3518-3525","source":"Crossref","is-referenced-by-count":229,"title":["Single-Agent Bortezomib in Previously Untreated Multiple Myeloma: Efficacy, Characterization of Peripheral Neuropathy, and Molecular Correlations With Response and Neuropathy"],"prefix":"10.1200","volume":"27","author":[{"given":"Paul G.","family":"Richardson","sequence":"first","affiliation":[{"name":"From the Dana-Farber Cancer Institute; Beth Israel Deaconess Medical Center; Massachusetts General Hospital; Millennium Pharmaceuticals; Brigham and Women's Hospital, Boston, MA; Roswell Park Cancer Institute, Buffalo; Memorial Sloan-Kettering Cancer Center, New York, NY; 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