Mm. Oken et al., PROPHYLACTIC ANTIBIOTICS FOR THE PREVENTION OF EARLY INFECTION IN MULTIPLE-MYELOMA, The American journal of medicine, 100(6), 1996, pp. 624-628
PURPOSE: Patients with multiple myeloma are at increased risk for bact
erial infection. During the first 2 months of initial chemotherapy the
rate of infection is twice that experienced during the remainder of t
he disease course. As many as one-third of these early infections are
fatal, and many more prevent adequate administration of chemotherapy.
This study was designed to determine whether the morbidity and mortali
ty of early infection can be prevented by prophylactic administration
of trimethoprim-sulfamethoxazole (TMP-SMX). PATIENTS AND METHODS: Elig
ible patients about to begin chemotherapy for multiple myeloma were ra
ndomly assigned to prophylaxis for 2 months or to no prophylaxis (cont
rol). Antibiotic prophylaxis consisted of TMP-SMX 160/800 mg orally ev
ery 12 hours administered for the first 2 months of initial chemothera
py. All patients were observed for infection for 3 months after the st
art of chemotherapy. RESULTS: Of 57 patients entered into the study, 5
4 were evaluable, representing 13.1 patient-years of observation. The
28 TMP-SMX patients and 26 control patients were comparable in terms o
f chemotherapy regimen, age, gender, stage, and bone marrow function.
Bacterial infection during the 3-month study period occurred in 11 con
trol patients but in only 2 patients assigned TMP-SMX (P = 0.004). Eig
ht severe infections occurred in controls compared with 1 in a TMP-SMX
patient (P = 0.010) leading to 4 and 1 infection deaths, respectively
(P = not significant). Severe infections included 5 pneumonias (3 wit
h sepsis), 2 urinary tract infections with complicating pneumonia or s
epsis, 1 diverticulitis with perforation, and 1 staphylococcal scalded
skin syndrome. None of the 4 nonbacterial infections was severe. The
rate of bacterial infection was 2.43 per patient-year for controls and
0.29 per patient-year for the TMP-SMX group (P = 0.001). Toxicity (sk
in rash 6 patients, nausea 1 patient) was not life-threatening but req
uired discontinuation of TMP-SMX in 25% of patients. CONCLUSION: Admin
istering TMP-SMX for the first 2 months of initial chemotherapy is eff
ective, inexpensive prophylaxis for early bacterial infection in multi
ple myeloma.