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Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas

Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas
Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas
Background: The role of prophylactic antibacterial agents after chemotherapy remains controversial.
Methods: We conducted a randomized, double-blind, placebo-controlled trial in patients who were receiving cyclic chemotherapy for solid tumors or lymphoma and who were at risk for temporary, severe neutropenia (fewer than 500 neutrophils per cubic millimeter). Patients were randomly assigned to receive either 500 mg of levofloxacin once daily or matching placebo for seven days during the expected neutropenic period. The primary outcome was the incidence of clinically documented febrile episodes (temperature of more than 38 degrees C) attributed to infection. Secondary outcomes included the incidence of all probable infections, severe infections, and hospitalization but did not include a systematic evaluation of antibacterial resistance.
Results: A total of 1565 patients underwent randomization (784 to placebo and 781 to levofloxacin). The tumors included breast cancer (35.4 percent), lung cancer (22.5 percent), testicular cancer (14.4 percent), and lymphoma (12.8 percent). During the first cycle of chemotherapy, 3.5 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 7.9 percent in the placebo group (P<0.001). During the entire chemotherapy course, 10.8 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 15.2 percent of patients in the placebo group (P=0.01); the respective rates of probable infection were 34.2 percent and 41.5 percent (P=0.004). Hospitalization was required for the treatment of infection in 15.7 percent of patients in the levofloxacin group and 21.6 percent of patients in the placebo group (P=0.004). The respective rate of severe infection was 1.0 percent and 2.0 percent (P=0.15), with four infection-related deaths in each group. An organism was isolated in 9.2 percent of probable infections.
Conclusions: Among patients receiving chemotherapy for solid tumors or lymphoma, the prophylactic use of levofloxacin reduces the incidence of fever, probable infection, and hospitalization. Copyright 2005 Massachusetts Medical Society.
988-998
Cullen, Michael
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Steven, Neil
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Billingham, Lucinda
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Gaunt, Claire
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Hastings, Mark
73ac6df6-8e07-4a29-ac9f-daae9d988048
Simmonds, Peter
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Stuart, Nicholas
fcb422bd-573e-4245-94e7-d4d5af029d1e
Rea, Daniel
b3400f69-815c-4e3d-8413-f929e6731466
Bower, Mark
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Fernando, Indrajit
94b602fc-66f8-4af7-b795-0bf7cf772c80
Huddart, Robert
9b98e268-407a-4dc5-85de-884cadb943a7
Gollins, Simon
ae092a24-b3fb-4d95-b5af-802a14bd79f8
Stanley, Andrew, for the Simple Investigation in Neutropenic Individuals
0b31bedc-76ce-4589-9b46-688853ef2acd
Cullen, Michael
7987e154-38ca-4e64-b957-4c26f98303df
Steven, Neil
42c36dc7-b9d7-460b-aac8-4bbfa89e8584
Billingham, Lucinda
2c62dae2-4d66-4634-bb41-c5484f3d243a
Gaunt, Claire
7ba93c7a-d15f-456c-9fd9-a10e9cbd524b
Hastings, Mark
73ac6df6-8e07-4a29-ac9f-daae9d988048
Simmonds, Peter
27d4c068-e352-4cbf-9899-771893788ade
Stuart, Nicholas
fcb422bd-573e-4245-94e7-d4d5af029d1e
Rea, Daniel
b3400f69-815c-4e3d-8413-f929e6731466
Bower, Mark
0e2581ac-07f9-4c8e-8937-81add8828c88
Fernando, Indrajit
94b602fc-66f8-4af7-b795-0bf7cf772c80
Huddart, Robert
9b98e268-407a-4dc5-85de-884cadb943a7
Gollins, Simon
ae092a24-b3fb-4d95-b5af-802a14bd79f8
Stanley, Andrew, for the Simple Investigation in Neutropenic Individuals
0b31bedc-76ce-4589-9b46-688853ef2acd

Cullen, Michael, Steven, Neil, Billingham, Lucinda, Gaunt, Claire, Hastings, Mark, Simmonds, Peter, Stuart, Nicholas, Rea, Daniel, Bower, Mark, Fernando, Indrajit, Huddart, Robert, Gollins, Simon and Stanley, Andrew, for the Simple Investigation in Neutropenic Individuals (2005) Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. New England Journal of Medicine, 353 (10), 988-998. (doi:10.1056/NEJMoa050078).

Record type: Article

Abstract

Background: The role of prophylactic antibacterial agents after chemotherapy remains controversial.
Methods: We conducted a randomized, double-blind, placebo-controlled trial in patients who were receiving cyclic chemotherapy for solid tumors or lymphoma and who were at risk for temporary, severe neutropenia (fewer than 500 neutrophils per cubic millimeter). Patients were randomly assigned to receive either 500 mg of levofloxacin once daily or matching placebo for seven days during the expected neutropenic period. The primary outcome was the incidence of clinically documented febrile episodes (temperature of more than 38 degrees C) attributed to infection. Secondary outcomes included the incidence of all probable infections, severe infections, and hospitalization but did not include a systematic evaluation of antibacterial resistance.
Results: A total of 1565 patients underwent randomization (784 to placebo and 781 to levofloxacin). The tumors included breast cancer (35.4 percent), lung cancer (22.5 percent), testicular cancer (14.4 percent), and lymphoma (12.8 percent). During the first cycle of chemotherapy, 3.5 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 7.9 percent in the placebo group (P<0.001). During the entire chemotherapy course, 10.8 percent of patients in the levofloxacin group had at least one febrile episode, as compared with 15.2 percent of patients in the placebo group (P=0.01); the respective rates of probable infection were 34.2 percent and 41.5 percent (P=0.004). Hospitalization was required for the treatment of infection in 15.7 percent of patients in the levofloxacin group and 21.6 percent of patients in the placebo group (P=0.004). The respective rate of severe infection was 1.0 percent and 2.0 percent (P=0.15), with four infection-related deaths in each group. An organism was isolated in 9.2 percent of probable infections.
Conclusions: Among patients receiving chemotherapy for solid tumors or lymphoma, the prophylactic use of levofloxacin reduces the incidence of fever, probable infection, and hospitalization. Copyright 2005 Massachusetts Medical Society.

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Published date: 8 September 2005

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Local EPrints ID: 26264
URI: http://eprints.soton.ac.uk/id/eprint/26264
PURE UUID: 7b61e824-c276-4d48-92e6-424025a7a1cc

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Date deposited: 19 Apr 2006
Last modified: 16 Dec 2019 19:22

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Contributors

Author: Michael Cullen
Author: Neil Steven
Author: Lucinda Billingham
Author: Claire Gaunt
Author: Mark Hastings
Author: Peter Simmonds
Author: Nicholas Stuart
Author: Daniel Rea
Author: Mark Bower
Author: Indrajit Fernando
Author: Robert Huddart
Author: Simon Gollins
Author: Andrew, for the Simple Investigation in Neutropenic Individuals Stanley

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