Bendamustine with dexamethasone in relapsed/ refractory systemic light-chain amyloidosis: Results of a phase II study Journal Article
| Authors: | Lentzsch, S.; Lagos, G. G.; Comenzo, R. L.; Zonder, J. A.; Osman, K.; Pan, S.; Bhutani, D.; Pregja, S.; Sanchorawala, V.; Landau, H. |
| Article Title: | Bendamustine with dexamethasone in relapsed/ refractory systemic light-chain amyloidosis: Results of a phase II study |
| Abstract: | PURPOSE No established treatments exist for relapsed/refractory systemic light-chain (AL) amyloidosis. Bendamustine has shown potential in the treatment of multiple myeloma. We conducted a phase II, multicenter trial to assess the efficacy and safety of bendamustine with dexamethasone (ben-dex) in patients with persistent or progressive AL amyloidosis after $ 1 prior therapy. METHODS The trial enrolled 31 patients who received bendamustine on days 1 and 2 (100 mg/m2 intravenously) with 40 mg of weekly dexamethasone in 28-day cycles until disease progression or up to 6 cycles after complete hematologic response. The primary objective was the rate of partial hematologic response (PR) or better. RESULTS Patients received a median of 4 cycles (range, 2-12 cycles) with 57% of patients achieving a PR or better (11% complete response, 18% very good PR). The overall organ response was 29% among the 24 patients who had measurable organ involvement. Treatment was well tolerated with no grade 5 treatment-related adverse events (AEs). Sixty-five percent of patients had a therapy-related grade 3-4 AE. The most common AEs included myelosuppression, fatigue, and nausea/vomiting. The median overall survival was 18.2 months (95% CI, 11.3 to 43.8 months), and hematologic response was associated with prolonged survival (P = .0291). The median progression-free survival was 11.3 months (95% CI, 5.0 to 15.4 months). CONCLUSION Overall, ben-dex is a viable treatment option with substantial efficacy and limited toxicity for patients with pretreated AL amyloidosis who have limited therapeutic options. This trial was registered at (ClinicalTrials.gov identifier: NCT01222260). © 2020 by American Society of Clinical Oncology. |
| Keywords: | adult; clinical article; treatment response; aged; survival rate; overall survival; lenalidomide; constipation; drug tolerability; fatigue; drug dose reduction; drug efficacy; drug safety; hypertension; side effect; anorexia; treatment indication; edema; progression free survival; bortezomib; infection; multiple cycle treatment; phase 2 clinical trial; anemia; bone marrow suppression; nausea; thrombocytopenia; vomiting; dehydration; clinical assessment; relapse; bendamustine; dexamethasone; melphalan; abdominal pain; chill; dizziness; drug dose escalation; dyspnea; fever; rash; alkaline phosphatase; acute kidney failure; multicenter study; muscle weakness; colitis; lung infection; m protein; atrial fibrillation; hydrochlorothiazide; brain hemorrhage; disease exacerbation; adverse drug reaction; brain natriuretic peptide; hypothermia; hyperhidrosis; kidney dysfunction; troponin; desmopressin; amino terminal pro brain natriuretic peptide; al amyloidosis; faintness; infusion related reaction; human; male; female; priority journal; article; nephrogenic diabetes insipidus; neurogenic diabetes insipidus; relapsed refractory al amyloidosis |
| Journal Title: | Journal of Clinical Oncology |
| Volume: | 38 |
| Issue: | 13 |
| ISSN: | 0732-183X |
| Publisher: | American Society of Clinical Oncology |
| Date Published: | 2020-05-01 |
| Start Page: | 1455 |
| End Page: | 1462 |
| Language: | English |
| DOI: | 10.1200/jco.19.01721 |
| PUBMED: | 32083996 |
| PROVIDER: | scopus |
| PMCID: | PMC7193746 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 June 2020 -- Source: Scopus |
