146

543

PROPHYLAXIS OF FEBRILE INFECTIOUS DISEASES IN NEUTROPENIC PATIENTS WITH LUNG CANCER AFTER ANTI- NEOPLASTIC CHEMOTHERAPY.

G.Pallotta.F.De Marinis,M.A.Noseda,M.R.Migliorino. "C.Forlanini"Hospital-3rd Pneumological Division- Rome,Italy. From December 1990 to May '91,40 pts with lung cancer

entered in a randomized trial comparing the efficacy of Pefloxacin (Peflacin*) vs Tymopentine (Sintomoduli- na*),preventing febrile infectious diseases in neutro- penic pts,after antineoplastic chemotherapy. Pts in Arm A received Peflacin,400 mg twice a day, d.3-12 every 21-28 days,and in Arm B,Sintomodulina,50 mg,three times per week,for three months.Of 40 pts who entered in the trial,30 are evaluable.The two Arms are homogeneous for number,PS,age,gender,histologic type,CT regimens,.days of hospitalization and costs of therapy and hospitalization. We evaluated the number of febrile episodes,lenght, body temperature,leukocites nadir,bacterial isolation, we considered a second line antibiotic therapy,with Carbapenem(IMIPEM). Preliminary results:33.3% of febrile episodes in Arm A (32CT cycles,5 SCLC,13 NSCLC) vs 27.2% in Arm B(26 Cycles,3 SCLC,B NSCLC) .

545

INTRAPLEURAL ETOPOSIDE (Etop) IN THE MANAGEMENT OF MALIGNANT PLEURAL EFFUSION.

H. Hoshlnol, S. Tsuchlyat, H. Nakano2, K.Mlnatol, N. FueLi’, A. Taklse2, K. Ezawa2, T. Nomoto2, T. Maklmoto2, Y. TakeI I. Naruse2, S. Watanabe’, H. Kobayashll and Ft. Saltoht ; ‘DEPT. OF INTERNAL MED., NATIONAL NISHIGUNMA HOSPITAL, AND 2FIRST DEPT. OF INTERNAL MED., GUNMA UNIVERSITY, GUNMA, JAPAN.

Malignant pleural effusion is a sfgnificant problem in lung cancer patients (pts). The pharmacology, toxicity, and therapeutic effectiveness of Etop given by the intrapleural route were examined. From April 1988 to December 1988, 11 lung cancer pts with cytologiilly proven, symptomatic, and previously untreated (8 pts) or treated (5 pts) malignant pleural effusions refractory to standard systemic chemotherapy were entered into this study. The median age was 62 years (range: 2892). There were 9 male and 2 female (3 PS2; 5Ps3;3ps4,2stlll8;9stIV,8Ad;2Sq;1 Large;2Small).Adoseof 250mglm2 of Etop was infused into the pleural space after the effusion had been completely drained. No recurrence of the effusion and negative cytology was considered a complete response (CR). A partffl response (PR) was defined as a 90% or greater decrease in the amount of the effusion on serial X-rays. The overall response rate (I CR, 4 PR) at 4 weeks was 48.4 % (5 of 11 pts). The median duration of response was 2.3 I.4 (1.8-l 7.7M). The median survival was 2.7 M (1 .O- 19.2M). Drug levels were followed in plasma up to 24 hr. Phanacokinetfc data were: T1/2cz, 0.33 hr; TlQ3, 7.84 hr; Cmax, 11.73 pf$ml, AUC, t 39.7 fqhr/ml. Ten pts expedenced focal pain but tolerated ft and 1 pt had fever. No pt had grade 3 or 4 hematological toxicity. neurologic toxicity. or alopecia .The administration of Etop was tolerated well. lntrapleural Etop was safe and may play a role in controlling malffnanf effusfons.

544

FEASIBILEY STUDY OF QUALITY OF LIFE (QOL) INSTRUh4ENTS IN JAPANESE PATIENTS WlTH ADVANCED LUNG CANCER

K.E~WI~. M.Fukutani, M.Kmazawa. Y.Tanaka, C.Morioka. Y.Tamura, F.Ito. K.Taiima. S.Tomivama. A.Koiimr H.Okamoto. Y.Ohe. T. Tamwa. Y&s&i. T. shinhi. N.Saiji, Department or Internal hiedicine’ id Thor& Oncology. Division of Biostatistics. National Cancef Center Hospital, 5-l-l. Tsukiji. Chuo- ku, Tokyo, 104 Japan

In Japan there ate some studies on the QOL measurement of patients with cancer, but none of them examined the quality of their instruments. We studied the reliability and validity of the two kinds of self-rating instruments. Form A was made originally in our institute and Form B was translated from FLIC(Functional Living Index Cancer, Schipper 1984) both consist of 22 items. From Apr. till Dec. 1990,79 patients@ts.) with inoperable lung cancer without prior therapy entered this study. Fifty-five were males and 24 females with mean age of 58 yo, 12pt.s. were PS(ECQG)O, 61pts. with PSI and 6pts. with PS2. The internal consistency of the instruments was examined by Cronbach’s alpha. In both Forms alpha showed >.55 except that of physical aspects in Form A. There was a significant correlation between the scores of two Forms in three aspects (Pearson’s correlation, physical, r=.63, psychologicaL.72, totaL.65) but for social scale(t=.48). Factor analysis using the principal component method identified major factors had about 60% of proportion of the total variance in both Form A and B. The factors were mood of pts., anxiety for disease and treatment, relationship to other people and physical capability. In conclusion, this was the fnst study which showed the quality of QOL instrument which had been used in cancer chemotherapy in Japan. A questionnaire translated from FLIC seemed to be applicable in Japanese society which has a different cultural backgroud from Canada, US. and European countries.

Ex@lRIcALANrIBIcYTIcTRSA~FORFKBRILE NEVIXOPENIC PATImS.

A.Kojima, Y.Scejirna, T.Shinkai, K.Fguchi, Y.Sasaki, T.Tamura, Y.Ohe, F.Oshita, T.Miya, H.Okamcto and N.Saijo. Department of Medical Oncology, National Cancer Center Hcspial, Tokyo, Japan

In an ongoing study we randcxnized patients with lung cancer to receive enpiric antibiotic therapy with either Imipenem/Cilastatin(IPM/CS) or IpM/CS plus Amikacin(AMK) for fever(>38"c) and neutrwia(<l,OOO /nnn3) induced by canhination chemotheraw. Antibiotic regimen was as follms;

?xm A: IF'M/CS Zg/day q6h AMK 4OOmg/m2 q12h

Arm B: IPMlc.9 Zglaay q6h Fran June, 1989, to April, 1991, 62 patients entered the trial, 30 receiving IPM/CS plus AMK and 32 IpM/cS. There were nc significant differences in patients's characteristics between the twc groups. 57 of 62 patients were evaluahle, 47(82%) achieved successful out- without need for change of study drug or any additional antibiotics. There were no patients with severe side effects such as seizure, but 17 patients (30%) experienced mesis. Continued study is ongoing at this center to confirm these early results.