Nation-wide randomized comparative study of doxorubicin, vincristine and prednisolone combination therapy with and without L-asparaginase for adult acute lymphoblastic leukemia.

Autor:	Nagura, Eiichi, Kimura, Kiyoji, Yamada, Kazumasa, Ota, Kazuo, Maekawa, Tadashi, Takaku, Fumimaro, Uchino, Haruto, Masaoka, Toru, Amaki, Ichita, Kawashima, Kohei, Ohno, Ryuzo, Nomura, Takeo, Hattori, Jun-ichi, Kawamura, Setsuko, Shibata, Akira, Shirakawa, Shigeru, Hamajima, Nobuyuki, Nagura, E, Kimura, K, Yamada, K
Předmět:	ANTINEOPLASTIC agents ASPARAGINASE CHI-squared test CLINICAL trials COMPARATIVE studies DOXORUBICIN LYMPHOBLASTIC leukemia RESEARCH methodology MEDICAL cooperation RESEARCH SURVIVAL analysis (Biometry) VINCRISTINE EVALUATION research RANDOMIZED controlled trials TREATMENT effectiveness DISEASE remission PREDNISOLONE
Zdroj:	Cancer Chemotherapy & Pharmacology; Sep1994, Vol. 33 Issue 5, p359-365, 7p
Abstrakt:	A randomized clinical trial of combination chemotherapy for adult acute lymphoblastic leukemia (ALL) with doxorubicin, vincristine and prednisolone with and without L-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 disease-free 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. [ABSTRACT FROM AUTHOR]
Databáze:	Complementary Index
Externí odkaz:	Zobrazit plný text záznamu Full text from SpringerLink