Nation-wide randomized comparative study of doxorubicin,vincristine and prednisolone combination therapy with and without L-asparaginase for adult acute lymphoblastic leukemia |
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| Authors: | Eiichi Nagura Kiyoji Kimura Kazumasa Yamada Kazuo Ota Tadashi Maekawa Fumimaro Takaku Haruto Uchino Toru Masaoka Ichita Amaki Kohei Kawashima Ryuzo Ohno Takeo Nomura Jun-ichi Hattori Setsuko Kawamura Akira Shibata Shigeru Shirakawa Nobuyuki Hamajima |
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| Affiliation: | (1) Department of Internal Medicine, Chubu National Hospital, 36-3, Gengo, Morioka-cho, 474 Obu-shi, Alchi-ken, Japan;(2) Nagoya National Hospital, Nagoya, Japan;(3) Department of Internal Medicine, Branch Hospital, Nagoya University School of Medicine, Nagoya, Japan;(4) Aighi Cancer Center Hospital, Nagoya, Japan;(5) Third Department of Internal Medicine, Gunma University School of Medicine, Maebashi, Japan;(6) Third Department of Internal Medicine, Faculty of Medicine, University of Tokyo, Tokyo, Japan;(7) First Department of Internal Medicine, School of Medicine, Kyoto University, Kyoto, Japan;(8) Fifth Department of Internal Medicine, Center for Adult Disease, Osaka, Japan;(9) First Department of Internal Medicine, Nihon University School of Medicine, Tokyo, Japan;(10) First Department of Internal Medicine, Department of Clinical Laboratory, Nagoya University School of Medicine, Nagoya, Japan;(11) First Department of Internal Medicine, Nagoya University School of Medicine, Nagoya, Japan;(12) Third Department of Internal Medicine, Nippon Medical School, Tokyo, Japan;(13) Third Department of Internal Medicine, Kanazawa University School of Medicine, Kanazawa, Japan;(14) First Department of Internal Medicine, Hirosaki University School of Medicine, Hirosaki, Japan;(15) First Department of Internal Medicine, Niigata University School of Medicine, Niigata, Japan;(16) Second Department of Internal Medicine, Mie University School of Medicine, Tsu, Japan;(17) Department of Public Health, Gifu University School of Medicine, Gifu, Japan |
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| Abstract: | A randomized clinical trial of combination chemotherapy for adult acute lymphoblastic leukemia (ALL) with doxorubicin, vincristine and prednisolone with and withoutL-asparaginase (AdVP vs L-AdVP) was conducted, involving 58 institutions throughout Japan. After reaching complete remission (CR), patients were treated with the same regimen for more than 2 years. Among 166 evaluable cases of the 198 cases enrolled, CR rates were 63.1% (53/84) with AdVP and 64.6% (53/82) with L-AdVP (P=0.837). Median survival times and 7-year survival rates were 12.7 months and 21.2% with AdVP, and 16.0 months and 22.3% with L-AdVP (P=0.955 by generalized Wilcoxon test [GW],P=0.952 by log-rank test [LR]). Median diseasefree survival times and 7-year survival rates were 13.5 months and 23.8% with AdVP and 17.0 months and 30.6% with L-AdVP, showing some increments for L-AdVP but no statistical significance (P=0.141 by GW,P=0.300 by LR). Among the cases of extramurally confirmed FAB subtypes, CR rates were 75.9% (63/83) for the L1 subtype and 51.3% (39/76) for the L2 subtype (P=0.001). As to adverse effects, pancreatitis was complicated more frequently in L-AdVP than in AdVP (P=0.039). Other side effects such as hyperbilirubinemia, diabetes mellitus, diarrhea and hypofibrinogenemia were observed more frequently with L-AdVP, but with no statistical significance. Thus, addition of a single course of L-asparaginase in the induction phase of combination chemotherapy with doxorubicin, vincristine and prednisolone did not significantly enhance the effect of antileukemic treatment of adult ALL.This work was supported by a grant-in-aid from the Japanese Foundation for Multidisciplinary Treatment of Cancer (Co-operative Project no. 2) |
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