Abstract
We conducted a single-center, prospective clinical trial in which a subcutaneous bortezomib (Bor) regimen [1.6 mg/m2 per month (BD 1.6 mg/m2 therapy)] was administered to 22 multiple myeloma patients. All patients had been treated sufficiently with once-monthly subcutaneous Bor injections (BD 1.3 mg/m2therapy). Of the 22 patients, 13 had IgG-, 2 had IgA-, and 7 had Bence-Jones protein (BJP)-type multiple myeloma. The observation period for therapeutic effect determination ranged from 84 to 412 days (median: 400 days). Therapeutic effects were investigated in 15 patients during the increase in Bor from 1.3 to 1.6 mg/m2, and none achieved complete remission (CR), very good partial remission (VGPR), or partial remission (PR). Given the small number of patients, a significant conclusion must be reached carefully. However, the chance of stronger success with increases in Bor is low for patients who have already undergone long-term 1.3 mg/m2 Bor treatment. Furthermore, non-hematological toxicity was seen in 12 of 22 patients, so increasing Bor to 1.6 mg/m2 should be considered carefully. However, the statuses of patients in this study suggest that once-monthly Bor could inhibit disease progression. In future we should investigate low-frequency Bor maintenance therapy.
Highlights
We investigated the maximum tolerated dose and dose-limiting toxicity in 3 phase 1 trials involving a total of 123 patients with hematopoietic malignancies and various solid tumors [1]-[3]
Adverse events were evaluated in all patients, including those with Bence-Jones protein (BJP)-type multiple myeloma
We found no reports that directly compared Bor doses of 1.3 mg/m2 and 1.6 mg/m2, and few reports investigated the boosting effect of increasing the Bor dose in patients receiving long-term1.3 mg/m2 Bor therapy or once-monthly Bor administrations as maintenance therapy
Summary
We investigated the maximum tolerated dose and dose-limiting toxicity in 3 phase 1 trials involving a total of 123 patients with hematopoietic malignancies and various solid tumors [1]-[3]. It was decided to recommend a dosing schedule in which 1.3 mg/m2 of bortezomib (Bor) is administered twice a week for 2 weeks, followed by a 10-day washout period. (2015) The Efficacy and Safety of a 1.6 mg/m2 Increase in a Bortezomib Regimen. Suzuki myeloma via subcutaneous injections administered once or twice weekly. Several trials involving increased amounts of Bor have been conducted [4]-[6], there have been no reports of long-term, once-monthly 1.3 mg/m2 of Bor administration as maintenance therapy. We could find no examples in the literature that evaluated the efficacy and safety of increasing the Bor dose to 1.6 mg/m2 in such patients. To date there have been no reports in which subcutaneous Bor injections were administered at a once-monthly dosage of 1.6 mg/m2
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
