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Colony stimulating factor for bone marrow transplantation
WS12.9
*9
COLONY STIMULATING FACTOR FOR BONE MARROW TRANSPLANTATION T.Masaoka, K.Motoyoshi, F.Takaku, S.Kato, M. H a r a d a , Y.Kodera, A. K a n a m a r u , R. O h n o , T . I n o u e , Japan BMT-study group. Center for Adult Disease,Osaka A phase II s t u d y o f c o l o n y stimulating factor derived form human urine (M-CSF) was performed for bone marrow transplantation. Steady and rapid recovery of leukocytes and granulocytes was observed. In m o s t p a t i e n t s who received M-CSF f r o m d a y i, l e u k o c y t e s started to i n c r e a s e o n d a y 6, monocytes and granulocytes on day ii. Significant differences in t h e d a y s to r e c o v e r y of l e u k o c y t e s over i000 or for granulocytes over 500 were observed from non randomized control patients. In some patients in which recovery of leukocytes was delayed, CSF also seemed to b e effective for increasing leukocytes from 8 days after the start of administration. There was no significant difference in t h e r a t e of r e l a p s e of leukemia between the two groups. M-CSF seems very promising for treatment of patients after BMT by shortening the period of leukopenia or granulocytopenia.
WS12-10
"1o
~ A N T I h ~ GAFF~ IN RHEJMATOID ARTHRITIS. A DOUHLE-HLIND STUDY COMPARING I~M/NE~ON ( ~ A N T IN~fERFEBDN G A ~ ) WITH PLACHBO. E.M. Veys*, H. Mielants*, G. Verbruggen*, J.P. Grosclaude**, F. Luyten*, W. M e i e r , W. Fiefs***, A.R. Galazka** *Dept. of RheumatoloD-, University Hospital, Ghent, Belgie; **Biogen SA, Geneva, Switzerland; ***Laboratory of Molecular Biolog3", University of Ghent, Belgie. Interferon gamma has principally been studied as an antiproliferative agent. It has been found t o exert a certain anticancer activity of which Immuncmodulation may be an aspect. Low doses of interferon gamma produced consistent increases in natural killer cell activiCy and }~A-DR expression. In the present work, the results of a double-blind stud}, ccmparing recombinant interferon g~na with placebo are reported. Both compounds were administered to rheumatoid arthritis (RA) patients for 6 months. The patients received a subou~aneous injection of I00~ of Irnmuneron or placebo, daily the first 5 da~vs and then twice weekly for 23 weeks. Clinically the patients were evaluated by the same investigator; the laboratory findings and side-effects were assessed by a co-investigator in order to guarantee the double-blind status of the stud},. Twenty-two out of 26 patients who entered the s~ud},, could be evaluated after 24 weeks of trea~nent. Minima/ side-effects were reported. Intragroup statistical evaluation revealed a significant decrease of the render joint index in the active gr~ap. Intergroup variance analysis revealed significant differences in favour of IEW-~ for tender joint score, Lee-index and pain by patient ques'~ionin~. The n~ber of subcutaneous nodules had increased in the placebo group durlng the trial period. Other variables were in favour of Immuneron but variations did not reach statistical significance. S~udies on a larger group of patients are mandatc~%, to confirm these encouraging results. Other schedules are currently being tested.
WS12-11 COMBINATION EFFECT OF HUMAN RECOMBINANT TNF (PT-050) AND ANTITUMOR DRUGS T. T a g u c h i , ~ Y. K i m o t o , : Y. T a n j i , I Y. M a t s u i , 2 K. N a k a t a , ~ Y. S o h m u r ~ a n d S. N a k a m u r a 2 Dept. of Surgery, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan ~ and Research Laboratories, Dainippon Pharmaceutical Co., Ltd., Osaka, Japan 2 The combination effect of P T - 0 5 0 and antitumor drugs was investigated using murine and human tumors transplanted in m i c e . Antitumor effect in t e r m s of t h e i n h i b i t i o n rate of tumor growth and/or the cure rate was augmented when PT-050 was intravenously g i v e n in c o n % b i n a t i o n w i t h mitomycin C, d o x o r u b i c i n or c i s - p l a t i n u m to m i c e b e a r i n g Meth A sarcoma or C o l o n 26 a d e n o c a r c i n o m a . Similar augmentation in a n t i t u m o r activity was observed in n u d e m i c e b e a r i n g human gastric adenocarcinoma (MKN-45) , neuroblastoma (GOTO) o r m e l a n o m a (HMV-2) w h e n P T - 0 5 0 w a s i n t r a v e n o u s l y given with 5-fluorouracil, cyclophosphamide or mitomycin C. These results suggest that the combination use of PT-050 and various antitumor drugs may be w o r t h t r y i n g in a n t i c a n c e r chemotherapy.
105
*9
COLONY STIMULATING FACTOR FOR BONE MARROW TRANSPLANTATION T.Masaoka, K.Motoyoshi, F.Takaku, S.Kato, M. H a r a d a , Y.Kodera, A. K a n a m a r u , R. O h n o , T . I n o u e , Japan BMT-study group. Center for Adult Disease,Osaka A phase II s t u d y o f c o l o n y stimulating factor derived form human urine (M-CSF) was performed for bone marrow transplantation. Steady and rapid recovery of leukocytes and granulocytes was observed. In m o s t p a t i e n t s who received M-CSF f r o m d a y i, l e u k o c y t e s started to i n c r e a s e o n d a y 6, monocytes and granulocytes on day ii. Significant differences in t h e d a y s to r e c o v e r y of l e u k o c y t e s over i000 or for granulocytes over 500 were observed from non randomized control patients. In some patients in which recovery of leukocytes was delayed, CSF also seemed to b e effective for increasing leukocytes from 8 days after the start of administration. There was no significant difference in t h e r a t e of r e l a p s e of leukemia between the two groups. M-CSF seems very promising for treatment of patients after BMT by shortening the period of leukopenia or granulocytopenia.
WS12-10
"1o
~ A N T I h ~ GAFF~ IN RHEJMATOID ARTHRITIS. A DOUHLE-HLIND STUDY COMPARING I~M/NE~ON ( ~ A N T IN~fERFEBDN G A ~ ) WITH PLACHBO. E.M. Veys*, H. Mielants*, G. Verbruggen*, J.P. Grosclaude**, F. Luyten*, W. M e i e r , W. Fiefs***, A.R. Galazka** *Dept. of RheumatoloD-, University Hospital, Ghent, Belgie; **Biogen SA, Geneva, Switzerland; ***Laboratory of Molecular Biolog3", University of Ghent, Belgie. Interferon gamma has principally been studied as an antiproliferative agent. It has been found t o exert a certain anticancer activity of which Immuncmodulation may be an aspect. Low doses of interferon gamma produced consistent increases in natural killer cell activiCy and }~A-DR expression. In the present work, the results of a double-blind stud}, ccmparing recombinant interferon g~na with placebo are reported. Both compounds were administered to rheumatoid arthritis (RA) patients for 6 months. The patients received a subou~aneous injection of I00~ of Irnmuneron or placebo, daily the first 5 da~vs and then twice weekly for 23 weeks. Clinically the patients were evaluated by the same investigator; the laboratory findings and side-effects were assessed by a co-investigator in order to guarantee the double-blind status of the stud},. Twenty-two out of 26 patients who entered the s~ud},, could be evaluated after 24 weeks of trea~nent. Minima/ side-effects were reported. Intragroup statistical evaluation revealed a significant decrease of the render joint index in the active gr~ap. Intergroup variance analysis revealed significant differences in favour of IEW-~ for tender joint score, Lee-index and pain by patient ques'~ionin~. The n~ber of subcutaneous nodules had increased in the placebo group durlng the trial period. Other variables were in favour of Immuneron but variations did not reach statistical significance. S~udies on a larger group of patients are mandatc~%, to confirm these encouraging results. Other schedules are currently being tested.
WS12-11 COMBINATION EFFECT OF HUMAN RECOMBINANT TNF (PT-050) AND ANTITUMOR DRUGS T. T a g u c h i , ~ Y. K i m o t o , : Y. T a n j i , I Y. M a t s u i , 2 K. N a k a t a , ~ Y. S o h m u r ~ a n d S. N a k a m u r a 2 Dept. of Surgery, Research Institute for Microbial Diseases, Osaka University, Osaka, Japan ~ and Research Laboratories, Dainippon Pharmaceutical Co., Ltd., Osaka, Japan 2 The combination effect of P T - 0 5 0 and antitumor drugs was investigated using murine and human tumors transplanted in m i c e . Antitumor effect in t e r m s of t h e i n h i b i t i o n rate of tumor growth and/or the cure rate was augmented when PT-050 was intravenously g i v e n in c o n % b i n a t i o n w i t h mitomycin C, d o x o r u b i c i n or c i s - p l a t i n u m to m i c e b e a r i n g Meth A sarcoma or C o l o n 26 a d e n o c a r c i n o m a . Similar augmentation in a n t i t u m o r activity was observed in n u d e m i c e b e a r i n g human gastric adenocarcinoma (MKN-45) , neuroblastoma (GOTO) o r m e l a n o m a (HMV-2) w h e n P T - 0 5 0 w a s i n t r a v e n o u s l y given with 5-fluorouracil, cyclophosphamide or mitomycin C. These results suggest that the combination use of PT-050 and various antitumor drugs may be w o r t h t r y i n g in a n t i c a n c e r chemotherapy.
105