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第22回国際化学療法学会(2001,アムステルダム)

学会場(RAI国際会議場)近くの運河と運河巡りボート

22th International Congress of Chemotherapy
Amsterdam, Holland- June 30 - July 3, 2001

PROPHYLACTIC EFFECT OF LEVOFLOXACIN (LVFX) ON NEUTROPENIC FEVER SECONDARY TO THE CHEMOTHERAPY FOR LUNG CANCER

Sawa, T., Yoshida, T. Sawada, M. , Ishiguro, T. , Gifu Municipal Hospital, Gifu, Japan

Ikoma, T. , Kawada, M. , Gotoh, K. , Fujiwara, H. , Gifu University, Gifu, Japan

We have conducted the comparative study of prophylactic effect of Levofloxacin (LVFX) on neutropenic fever secondary to the chemotherapy for lung cancer. The Aim of this study is to evaluate prophylactic efficacy and cost-benefit of Levofloxacin on neutropenic fever induced by chemotherapy in the patients with non-small cell lung cancer.

Eligibility Criteria was as follows.

1. Histological or cytological confirmed non-small cell lung cancer, and scheduled more than 2 cycles of cisplatin based combination chemotherapy.

2. Age was more than 20, and less than 75 years old.

3. No complication of apparent infection that obstruct to complete chemotherapy.

4. Performance Status (ECOG) 0 to 2.

5. Moderate function of bone marrow, kidney, and liver.

6. Informed consent in person.

7. Possible to continue the oral administration of Levofloxacin during chemotherapy

Method

Sixty-three patients with non-small cell lung cancer were assigned into Levofloxacin -treated (21 patients) and control (42 patients). Patients were treated under the following protocol.

1. Prophylactic G-CSF was inhibited. Only leucopenia or neutropenia more than grade 3 was supported by G-CSF.

2. In Levofloxacin group, 300mg of oral Levofloxacin was daily administered during two cycles of chemotherapy. Another prophylactic antibiotic was inhibited in both groups.

3. Antibiotic was instillated when axillary temperature more than 38℃ or secondary infection was complicated.

4. Next cycle of chemotherapy was inhibited until fever elevation and apparent infections were controlled.

5. Observation of following events was performed. WBC, Nuetrophil, duration of fever elevation, CRP, complicated apparent infection, antibiotics for intravenous use, delay of chemotherapy schedule, cost for neutropenic fever and infection (for

Results were as follows.

One case of Levofloxacin group was dropped out because of difficulty of Levofloxacin administration due to chemotherapy-induced anorexia. Evaluable patients were 42 cases in control and 20 cases in Levofloxacin group.

There were no adverse effects in prophylactic Levofloxacin administration.

The duration of febrile days was significantly shorter in Levofloxacin group than the Control group.

There were no significant difference in Worst CRP, Duration of Antibiotics, and Delay of Schedule between Control and Levofloxacin groups. Secondary infection was confirmed in 3 cases (15.0%) in Levofloxacin group and 18 cases (40.5%) in control group, respectively.

Mean survival time was 24 months in Levofloxacin group and 16 months in control group, which was not significant.

Total costs for neutropenic fever and secondary infection were 262 thousands Japanese yen in Levofloxacin group, 274 thousands Japanese yen in control group, which was no significant difference between 2 groups.

In Conclusion, Oral administration of Levofloxacin is considered to be effective strategy as a prophylactic treatment for neutropenic fever and secondary infection in the limited patients with serious and prolonged neutropenia followed by high-dose combination chemotherapy.

Of course, costs associated with the emergence of resistant organisms during the administration of prophylactic antibiotics must also be considered.

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