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Original Article

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Blood Res 2022; 57(1):

Published online March 31, 2022

https://doi.org/10.5045/br.2021.2021176

© The Korean Society of Hematology

Real-world evidence of levofloxacin prophylaxis in elderly patients with newly diagnosed multiple myeloma who received bortezomib, melphalan, and prednisone regimen

Su-In Kim1#, Sung-Hoon Jung1#, Ho-Young Yhim2, Jae-Cheol Jo3, Ga-Young Song1, Mihee Kim1, Seo-Yeon Ahn1, Jae-Sook Ahn1, Deok-Hwan Yang1, Hyeoung-Joon Kim1, Je-Jung Lee1

Author Info. +

1Department of Hematology-Oncology, Chonnam National University Hwasun Hospital and Chonnam National University Medical School, Hwasun, 2Department of Internal Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School, Jeonju, 3Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea

Correspondence to : Je-Jung Lee, M.D., Ph.D.
Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun 58128, Korea
E-mail: drjejung@chonnam.ac.kr
#These authors contributed equally to this work.

Received: September 24, 2021; Revised: December 3, 2021; Accepted: December 29, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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Background
Although survival outcomes of multiple myeloma (MM) have improved with the development of new and effective agents, infection remains the major cause of morbidity and mortality. Here, we evaluated the efficacy of levofloxacin prophylaxis (in a real-world setting) during bortezomib, melphalan, and prednisone (VMP) therapy in elderly patients with newly diagnosed MM.
Methods
This study retrospectively analyzed the records of patients with newly diagnosed MM treated with the VMP regimen between February 2011 and September 2020 at three institutes of the Republic of Korea.
Results
Of a total of 258 patients, 204 (79.1%) received levofloxacin prophylaxis during VMP therapy. The median number of levofloxacin prophylaxis cycles was 4 (range, 1‒9), but 10 patients did not complete the planned prophylaxis because of side effects. Sixty-six patients (25.5%) experienced severe infections during VMP therapy, most of which (74.7%) occurred within the first four cycles of VMP therapy regardless of levofloxacin prophylaxis status. Early severe infection was significantly associated with poor survival. In multivariate analysis, levofloxacin prophylaxis was significantly associated with a lower risk in early severe infection.
Conclusion
Our findings suggest that levofloxacin prophylaxis should be considered at least during the first four cycles of VMP therapy in elderly patients with newly diagnosed MM.

Keywords Early infection, Prophylaxis, Levofloxacin, Multiple myeloma

Article

Original Article

Blood Res 2022; 57(1): 51-58

Published online March 31, 2022 https://doi.org/10.5045/br.2021.2021176

Copyright © The Korean Society of Hematology.

Real-world evidence of levofloxacin prophylaxis in elderly patients with newly diagnosed multiple myeloma who received bortezomib, melphalan, and prednisone regimen

Su-In Kim1#, Sung-Hoon Jung1#, Ho-Young Yhim2, Jae-Cheol Jo3, Ga-Young Song1, Mihee Kim1, Seo-Yeon Ahn1, Jae-Sook Ahn1, Deok-Hwan Yang1, Hyeoung-Joon Kim1, Je-Jung Lee1

1Department of Hematology-Oncology, Chonnam National University Hwasun Hospital and Chonnam National University Medical School, Hwasun, 2Department of Internal Medicine, Jeonbuk National University Hospital, Jeonbuk National University Medical School, Jeonju, 3Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea

Correspondence to:Je-Jung Lee, M.D., Ph.D.
Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, 322 Seoyangro, Hwasun 58128, Korea
E-mail: drjejung@chonnam.ac.kr
#These authors contributed equally to this work.

Received: September 24, 2021; Revised: December 3, 2021; Accepted: December 29, 2021

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background
Although survival outcomes of multiple myeloma (MM) have improved with the development of new and effective agents, infection remains the major cause of morbidity and mortality. Here, we evaluated the efficacy of levofloxacin prophylaxis (in a real-world setting) during bortezomib, melphalan, and prednisone (VMP) therapy in elderly patients with newly diagnosed MM.
Methods
This study retrospectively analyzed the records of patients with newly diagnosed MM treated with the VMP regimen between February 2011 and September 2020 at three institutes of the Republic of Korea.
Results
Of a total of 258 patients, 204 (79.1%) received levofloxacin prophylaxis during VMP therapy. The median number of levofloxacin prophylaxis cycles was 4 (range, 1‒9), but 10 patients did not complete the planned prophylaxis because of side effects. Sixty-six patients (25.5%) experienced severe infections during VMP therapy, most of which (74.7%) occurred within the first four cycles of VMP therapy regardless of levofloxacin prophylaxis status. Early severe infection was significantly associated with poor survival. In multivariate analysis, levofloxacin prophylaxis was significantly associated with a lower risk in early severe infection.
Conclusion
Our findings suggest that levofloxacin prophylaxis should be considered at least during the first four cycles of VMP therapy in elderly patients with newly diagnosed MM.

Keywords: Early infection, Prophylaxis, Levofloxacin, Multiple myeloma

Fig 1.

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Figure 1.Rates of severe infection by levofloxacin prophylaxis status of patients during bortezomib, melphalan, and prednisone (VMP) therapy.
Blood Research 2022; 57: 51-58https://doi.org/10.5045/br.2021.2021176

Fig 2.

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Figure 2.Kaplan-Meier curves for progression-free survival (PFS) and overall survival (OS) in all patients (A, B) and those who experienced early severe infections (C, D).
Blood Research 2022; 57: 51-58https://doi.org/10.5045/br.2021.2021176

Table 1 . Baseline clinical characteristics of all patients (N=258)..

Variables
Median age, years (range)72 (64–86)
≥75-year, N (%)81 (31.4)
Male, N (%)135 (52.3)
ECOG PS ≥2, N (%)75 (29.1)
Immunoglobulin (Ig) type, N (%)
IgG153 (59.3)
IgA65 (25.2)
IgM3 (1.2)
Light chain only34 (13.2)
Missing3 (1.2)
International Staging System, N (%)
I41 (15.9)
II91 (35.3)
III124 (48.1)
Missing2 (0.8)
ACCI, N (%)
244 (17.1)
393 (36.0)
467 (26.0)
5 or more54 (20.9)
Immunoparesisa), N (%)193 (74.8)
LDH > (1 ULN), N (%)53 (20.5)
GFR <30 mL/min/1.73 m257 (22.1)
ANC <1,000×109/L, N (%)11 (4.3)
ALC <800×109/L, N (%)27 (10.5)
Cytogenetics, N (%)
High38 (14.7)
Standard174 (67.4)
Not evaluable46 (17.8)

a)Immunoparesis is defined as suppression in the levels of 1 or 2 uninvolved immunoglobulin..

Abbreviations: ACCI, Age-adjusted Charlson Comorbidity Index; ALC, absolute lymphocyte count; ANC, absolute neutrophil count; ECOG, Eastern Cooperative Oncology Group; GFR, glomerular filtration rate; LDH, lactate dehydrogenase; N, number; PS, performance status; ULN, upper limit of normal value..

Table 2 . Summary of severe infections developed during bortezomib, melphalan, and prednisone therapy..

Type of infection, N (%)
Respiratory55 (69.6)
Urinary tract5 (6.3)
Gastrointestinal10 (12.6)
Hepatobiliary4 (5.1)
Sepsis/bacteremia1 (1.3)
Skin/soft tissue2 (2.5)
Joint1 (1.3)
Unknown1 (1.3)
Pathogenic microorganism, N (%)
Streptococcus pneumoniae2 (2.5)
Klebsiella pneumonia2 (2.5)
Escherichia coli3 (3.8)
Staphylococcus aureus, methicillin-susceptible1 (1.3)
Nocardia farcinica1 (1.3)
Bacillus species1 (1.3)
Burkholderia1 (1.3)
Enterococcus faecalis1 (1.3)
Influenza type A5 (6.3)
Influenza type B1 (1.3)
Respiratory syncytial virus1 (1.3)
Candida krusei1 (1.3)
Pneumocystitis jiroveci1 (1.3)
Clostridium difficila)2 (2.5)
Unknown56 (70.8)

a)Two cases in the levofloxacin prophylaxis group..

Table 3 . Univariate and multivariate analyses of risk factors in early severe infection during bortezomib, melphalan, and prednisone therapy..

VariableUnivariate analysisMultivariate analysis
Infection rate, N (%)POR (95% CI)POR (95% CI)
Age ≥75 years21 (25.9)0.1481.586 (0.847–2.970)
Gender
Female24 (19.5)0.6960.886 (0.483–1.625)
ECOG PS ≥221 (28.0)0.0581.835 (0.975–3.453)0.4691.298 (0.64–2.626)
Immunoparesis
Yes41 (21.2)0.9381.030 (0.487–2.176)
ACCI ≥428 (23.1)0.3321.349 (0.736–2.471)
ISS III25 (20.2)0.9540.982 (0.534–1.806)
CrCl <30 mL/min12 (21.1)0.9141.041 (0.505–2.145)
LDH
High15 (28.3)0.0931.809 (0.900–3.636)0.1001.868 (0.888–3.929)
Sb2MG ≥5.5 mg/L27 (21.4)0.7311.112 (0.608–2.035)
Serum albumin
<3.5 g/dL38 (29.9)<0.0013.302 (1.709–6.378)0.0022.962 (1.495–5.871)
ANC <1,000/mL3 (27.3)0.5721.478 (0.378–5.772)
ALC <800/mL5 (18.5)0.7830.866 (0.312–2.407)
Hemoglobin ≤11 g/dL46 (22.0)0.2281.693 (0.713–4.019)
Spinal fracture
Yes28 (23.3)0.3601.327 (0.724–2.434)
Best response
≥VGPR14 (12.3)0.0030.377 (0.193–0.736)0.0160.417 (0.205–0.847)
TMP-SMX use
Yes24 (24.7)0.1951.496 (0.812–2.759)
Levofloxacin
Yes36 (17.6)0.0250.466 (0.237–0.919)0.0400.461 (0.220–0.964)

Abbreviations: ACCI, Age-adjusted Charlson Comorbidity Index; ALC, absolute lymphocyte count; ANC, absolute neutrophil count; CrCl, creatinine clearance; ECOG, Eastern Cooperative Oncology Group; ISS, International Staging System; LDH, lactate dehydrogenase; PS, performance status; Sb2MG, serum b2-microglobulin; TMP-SMX, trimethoprim-sulfamethoxazole; VGPR, very good partial response..
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