Results of a case-control study suggest a cytoprotective agent can reduce treatment-related gastrointestinal (GI) toxicity in patients with multiple myeloma (MM).
Use of this agent, amifostine, was associated with significantly lower rates of grade 2 or higher oral mucositis, nausea, vomiting, and diarrhea.
Additionally, amifostine did not appear to compromise the anti-myeloma activity of treatment, which consisted of high-dose melphalan (HDM) and autologous hematopoietic stem cell transplant (auto-HSCT).
Ehsan Malek, MD, of Case Western Reserve University in Cleveland, Ohio, and his colleagues reported these findings in Leukemia & Lymphoma.
The researchers compared HDM plus auto-HSCT, with or without pre-treatment amifostine, in previously treated MM patients.
There were 107 patients who received amifostine and 114 who did not. The 107 patients received amifostine at 740 mg/m2, given as a bolus infusion at 24 hours and 15 minutes before HDM.
Baseline characteristics were largely similar in the amifostine and control groups. However, more patients in the amifostine group received a tandem HSCT (17 vs 0), and more patients in the control group had an ECOG performance status of 0 (64.3% vs 43%).
Patients in the amifostine group had a longer median time from diagnosis to first HSCT—10 months (range, 4-39) vs 7 months (range, 1-95).
A majority of patients in both groups were in partial response or better at baseline. However, more patients in the control group had stable disease (6.2% vs 1%) or progressive disease (8% vs 0%).
For all-grade GI toxicities, there was largely no significant difference between the amifostine and control groups. However, patients in the amifostine group had significantly lower rates of grade 2 or higher GI toxicities.
Rates of all-grade GI toxicities in the amifostine and control groups, respectively, were:
- Oral mucositis—53.3% vs 64.0%, P=0.104
- Nausea—90.7% vs 95.6%, P=0.143
- Vomiting—65.4% vs 75.4%, P=0.102
- Diarrhea—93.5% vs 84.2%,P=0.030.
Rates of grade 2 or higher GI toxicities in the amifostine and control groups, respectively, were:
- Oral mucositis—27.1% vs 47.4%, P=0.002
- Nausea—31.8% vs 86.0%, P<0.0001
- Vomiting—18.7% vs 52.6%, P<0.0001
- Diarrhea—56.1% vs 73.7%, P=0.006.
The researchers said amifostine was well tolerated and produced no significant adverse effects.
They also said amifostine had “no discernable effect” on engraftment, progression-free survival, or overall survival.
The median time to neutrophil engraftment was 11 days (range, 9-16) in the control group and 10 days (range, 6-21) in the amifostine group (P=0.011). The median time to platelet engraftment was 18 days (range, 0-26) and 19 days (range, 8-71), respectively (P<0.21).
The median progression-free survival was 40 months in the amifostine group and 32 months in the control group (P=0.012). The median overall survival was 70 months and 67 months, respectively (P=0.84).