Incidence of hospitalisations in both groups

Incidence of documented infections

Documented Infections0

2

4

6

8

10

12

14

16

18

20

18%

2%

Group A

Group B

Nu

mb

er o

f p

atie

nts

#

60%

20%

10%10%

E.coli

Acinetobacter

Klebsiella

Salmonella

Hospitalisation0

5

10

15

20

25

48%

18%

Group A

Group B

Nu

mb

er o

f p

atie

nts #

#

Abstract Problem statement: Patients on cancer chemotherapy are at substantial risk of developing infection-related mortalities, yet the use of prophylactic antimicrobials continues to be a controversial issue. Fluoroquinolones have been considered for prophylaxis; however, emergence of resistance, high cost, and limited literature support are the main arguments against their use.Objectives: To evaluate the effect of antimicrobial prophylaxis in cancer chemotherapyDesign: Prospective, randomized, open label, controlled studySetting: This study was conducted in the Oncology Department, CMC LudhianaStudy population: 100 patients diagnosed with any solid cancer were enrolled after ethical clearance. They were randomly divided into two groups, A and B. Both groups were comparable in demographic and medical profiles. Mean age was 55.76±1.7 years and 57.04±1.77 years in groups A and B, respectively. The majority of patients (64%) were female with carcinoma breast being the commonest tumor. Most patients were from the lower and middle socioeconomic strata.Intervention: Group A received cancer chemotherapy alone. Group B received prophylactic levofloxacin with each chemotherapy cycle. Follow-up for all patients was 6 weeks, post-chemotherapy.Outcome measure(s): Each patient was analyzed for febrile episodes, documented infections, hospitalizations, and costs incurred.Results: The number of febrile episodes was significantly higher in group A. The relative risk of a clinically documented febrile episode was 0.22 (95% confidence interval 0.08–0.56, p<0.001), indicating a 78% reduction in the risk of fever during the first cycle with the use of levofloxacin therapy, as compared with control group. Documented infections were more common in group A (relative risk 0.11, 95% confidence interval 0.01–0.84, p<0.05). Resistance to levofloxacin was reported in one patient. 48% patients were hospitalized in group A and 18% in group B (relative risk 2.67, 95% confidence interval 1.38–5.15, p<0.01). Average hospitalization was 3.8±0.73 days in group A vs. 1.56±0.56 days in group B (p<0.05). Net decrease in the cost of treatment was a major advantage of using antimicrobial prophylaxis. The total cost of treatment was $9,715.80 and $3,194.54 in groups A and B, respectively. Average cost of treatment per patient per day in two groups was $27.98±4.85 vs. $8.20±2.19 (p<0.001).Conclusion: Our study provides ample evidence that antimicrobial prophylaxis is beneficial to patients receiving cancer chemotherapy because it decreases the morbidity, in terms of febrile episodes, infections, and hospitalizations, and it also reduces the cost of treatment. A larger sample size and blinded approach may further validate our results.Funding source(s): The study is a dissertation research topic and no funding was received.

Introduction Bacterial infections are a major cause of morbidity and mortality in patients receiving cancer chemotherapy for malignancies.

Pooled results from randomized controlled trials show that antimicrobial prophylaxis when started during cancer chemotherapy or at onset of neutropenia reduces all-cause mortality.

Fluoroquinolones are currently the primary antimicrobials used for prophylaxis. When quinolones are used as prophylaxis, the rate of gram negative bacteremia is reduced.

The emergence of multidrug resistant strains in the population of cancer patients who are given prophylactic quinolones for the prevention of gram-negative sepsis is of great concern.

AimTo study the effect of prophylactic fluoroquinolone antimicrobials with cancer chemotherapy in preventing infections and hospitalizations.

Materials and Methods This study was conducted in the Outpatients and Inpatients visiting the Medical Oncology and Haemato-Oncology Departments, Christian Medical College and Hospital, Ludhiana.

It was an open, prospective, randomised research conducted on 100 patients receiving cancer chemotherapy.

Inclusion criteria:Age 18 years and above.Patients with a diagnosis of solid tumors and lymphomas

Materials and Methods (Cont’d)Exclusion criteria:Patients with leukaemias.Hypersensitivity to fluoroquinolone.Patients treated with antibiotic therapy in the previous four weeks.Patients with fever of infectious origin or a documented infection at the time of enrolment.Pregnancy/Lactation.

ResistanceOne case of Levofloxacin resistance in Gp B.The impact of resistance to prophylactic antimicrobial therapy can only be ascertained upon studies using larger sample size.

Cost Analysis

Materials and Methods (Cont’d)Primary parameters:Number of Febrile episodes as defined.Number of Documented infections.Number of Hospitalizations.Secondary parameters:Development of resistance as per culture/sensitivity reports.The Eastern Cooperative Oncology Group (ECOG) Performance grade.Cost analysis

If infection was suspected, samples were obtained for microbiologic cultures and empirical antibacterial therapy was initiated. Bacteria susceptibility was evaluated according to the Kirby-Bauer method.

Statistical analysis: The data was analysed by using Chi-square test and Student t-test. (p<0.05 significant).

PROPHYLACTIC ANTIMICROBIALS: TRIUMPH OVER CANCER CHEMOTHERAPY COMPLICATIONS?Authors: Jyotika Singh, M Joseph John, Dinesh K Badyal.

Instituition: Christian Medical College and Hospital, Ludhiana, Punjab, India.

Group A

Chemotherapy

Follow up six weeks after

the last cycle

Group B

Chemotherapy + Fluoroquinolones

Events Group Ano. of

patients(%)

Group Bno. of

patients(%)

Relative Risk (95%CI)

Events occurring in first cycleNeutropenia Yes NoFebrile episode Yes No

12(24%)38(76%)

18(36%)32(64%)

1(2%) #49(98%)

4(8%)) ##

46(92%)

0.08(0.01-0.62) 0.22(0.08-0.56)

Events occurring at least once in any cycleNeutropenia Yes NoFebrile episode Yes No

6(12%)

44(88%)

20(40%)30(60%)

2(4%)

48(96%)

7(14%) #43(86%)

0.33(0.07-1.57)

0.35(0.16-0.75)

Prophylactic fluoroquinolones

significantly ameliorate the

incidence of febrile episodes, infections, hospitalisations and reduces the cost of

treatment when given with cancer

chemotherapy.

Ca Breast

Ca Lung Ca Ovary

0

2

4

6

8

10

12

14

16 30%

16%

20%20%

14%

10%

Group A

Group B

Num

ber

of p

atie

nts

Ca - Carcinoma

0 1 2 3 4 50%5%

10%15%20%25%30%35%40%45% Group A

Group B

ECOG Grade before enrollment

0 1 2 3 4 50

10

20

30

40

50

60

70

Group A

ECOG Grade at the end of follow-up

Group A

Group B

Hospitalisation Duration of Hospital stay (days) Total expenditure of 50 patients Average cost per day

24(48%)

3.80±0.73

$9,715.80 $27.98±4.85

9(18%)

1.56±0.56 #

$3,194.54

$8.20±2.19

##

ResultsCancer distribution in both groups Culture proven bacterial isolates

0 1 2 3 4 5 6 At fol-low up

0

1000

2000

3000

4000

5000

6000

Absolute neutrophil count (Mean±SE) in different cancer

chemotherapy cycles in both groups

Group A

Group B

Chemotherapy cycles

Abso

lute

neu

trop

hil c

ount

#

ECOG status

#p<0.05 as compared to Group A## p<0.01 as compared to Group A