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Volume 337:1021-1028 October 9, 1997 Number 15 Next

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ABSTRACT

Background All-trans-retinoic acid induces complete remission in acute promyelocytic leukemia. However, it is not clear whether induction therapy with all-trans-retinoic acid is superior to chemotherapy alone or whether maintenance treatment with all-trans-retinoic acid improves outcome.

Methods Three hundred forty-six patients with previously untreated acute promyelocytic leukemia were randomly assigned to receive all-trans-retinoic acid or daunorubicin plus cytarabine as induction treatment. Patients who had a complete remission received consolidation therapy consisting of one cycle of treatment identical to the induction chemotherapy, then high-dose cytarabine plus daunorubicin. Patients still in complete remission after two cycles of consolidation therapy were then randomly assigned to maintenance treatment with all-trans-retinoic acid or to observation.

Results Of the 174 patients treated with chemotherapy, 120 (69 percent) had a complete remission, as did 124 of the 172 (72 percent) given all-trans-retinoic acid (P = 0.56). When both induction and maintenance treatments were taken into account, the estimated rates of disease-free survival at one, two, and three years were 77, 61, and 55 percent, respectively, for patients assigned to chemotherapy then all-trans-retinoic acid; 86, 75, and 75 percent for all-trans-retinoic acid then all-trans-retinoic acid; 75, 60, and 60 percent for all-trans-retinoic acid then observation; and 29, 18, and 18 percent for chemotherapy then observation. By intention-to-treat analysis, the rates of overall survival at one, two, and three years after entry into the study were 75, 57, and 50 percent, respectively, among patients assigned to chemotherapy, and 82, 72, and 67 percent among those assigned to all-trans-retinoic acid (P = 0.003).

Conclusions All-trans-retinoic acid as induction or maintenance treatment improves disease-free and overall survival as compared with chemotherapy alone and should be included in the treatment of acute promyelocytic leukemia.

Source Information

From the Northwestern University Medical School and the Robert H. Lurie Cancer Center of Northwestern University, Chicago (M.S.T.); Dana–Farber Cancer Institute, Boston (J.W.A.); Greenebaum Cancer Center, University of Maryland School of Medicine, Baltimore (C.A.S.); Fred Hutchinson Cancer Research Center, University of Washington, Seattle (F.R.A.); Children's Hospital–Oakland, Oakland, Calif. (J.H.F.); Texas Children's Cancer Center, Houston (A.O.); National Cancer Institute of Canada Clinical Trials Group, Kingston, Ont. (L.S.); University of New Mexico, Albuquerque (C.W.); Roswell Park Memorial Institute, Buffalo, N.Y. (C.D.B.); University of Rochester, Rochester, N.Y. (J.M.R.); and Albert Einstein Cancer Center, Montefiore Medical Center, Bronx, N.Y. (P.H.W.). Presented in part at the 36th meeting of the American Society of Hematology, Seattle, December 1–5, 1995.

Address reprint requests to Dr. Tallman at the Robert H. Lurie Cancer Center of Northwestern University, Division of Hematology–Oncology, Northwestern University Medical School, 233 E. Erie St., Suite 700, Chicago, IL 60611.

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All-trans-Retinoic Acid in Acute Promyelocytic Leukemia
Sanz M. A., Martín G., Díaz-Mediavilla J., Tallman M. S., Appelbaum F. R., Schiffer C. A.
Extract | Full Text  
N Engl J Med 1998; 338:393-394, Feb 5, 1998. Correspondence

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• Baer, M. R., Stewart, C. C., Dodge, R. K., Leget, G., Sule, N., Mrozek, K., Schiffer, C. A., Powell, B. L., Kolitz, J. E., Moore, J. O., Stone, R. M., Davey, F. R., Carroll, A. J., Larson, R. A., Bloomfield, C. D. (2001). High frequency of immunophenotype changes in acute myeloid leukemia at relapse: implications for residual disease detection (Cancer and Leukemia Group B Study 8361). Blood 97: 3574-3580 [Abstract] [Full Text]  
• Miano, J. M., Berk, B. C. (2001). Retinoids: New Insight Into Smooth Muscle Cell Growth Inhibition. Arterioscler. Thromb. Vasc. Bio. 21: 724-726 [Full Text]  
• Lippman, S. M., Lee, J. J., Karp, D. D., Vokes, E. E., Benner, S. E., Goodman, G. E., Khuri, F. R., Marks, R., Winn, R. J., Fry, W., Graziano, S. L., Gandara, D. R., Okawara, G., Woodhouse, C. L., Williams, B., Perez, C., Kim, H. W., Lotan, R., Roth, J. A., Hong, W. K. (2001). Randomized Phase III Intergroup Trial of Isotretinoin to Prevent Second Primary Tumors in Stage I Non-Small-Cell Lung Cancer. JNCI J Natl Cancer Inst 93: 605-618 [Abstract] [Full Text]  
• Chim, C.S., Liang, R., Tam, C.Y.Y., Kwong, Y.L. (2001). Methylation of p15 and p16 Genes in Acute Promyelocytic Leukemia: Potential Diagnostic and Prognostic Significance. JCO 19: 2033-2040 [Abstract] [Full Text]  
• Briasoulis, E., Pavlidis, N. (2001). Noncardiogenic Pulmonary Edema: An Unusual and Serious Complication of Anticancer Therapy. The Oncologist 6: 153-161 [Abstract] [Full Text]  
• Soignet, S. L. (2001). Clinical Experience of Arsenic Trioxide in Relapsed Acute Promyelocytic Leukemia. The Oncologist 6: 11-16 [Abstract] [Full Text]  
• Lehmann, S., Paul, C., Törmä, H. (2001). Retinoid Receptor Expression and Its Correlation to Retinoid Sensitivity in Non-M3 Acute Myeloid Leukemia Blast Cells. Clin. Cancer Res. 7: 367-373 [Abstract] [Full Text]  
• Appelbaum, F. R., Rowe, J. M., Radich, J., Dick, J. E. (2001). Acute Myeloid Leukemia. ASH Education Book 2001: 62-86 [Abstract] [Full Text]  
• Douer, D., Estey, E., Santillana, S., Bennett, J. M., Lopez-Bernstein, G., Boehm, K., Williams, T. (2001). Treatment of newly diagnosed and relapsed acute promyelocytic leukemia with intravenous liposomal all-trans retinoic acid. Blood 97: 73-80 [Abstract] [Full Text]  
• Slovak, M. L., Kopecky, K. J., Cassileth, P. A., Harrington, D. H., Theil, K. S., Mohamed, A., Paietta, E., Willman, C. L., Head, D. R., Rowe, J. M., Forman, S. J., Appelbaum, F. R. (2000). Karyotypic analysis predicts outcome of preremission and postremission therapy in adult acute myeloid leukemia: a Southwest Oncology Group/Eastern Cooperative Oncology Group study. Blood 96: 4075-4083 [Abstract] [Full Text]  
• Brinckerhoff, C. E., Rutter, J. L., Benbow, U. (2000). Interstitial Collagenases as Markers of Tumor Progression. Clin. Cancer Res. 6: 4823-4830 [Abstract] [Full Text]  
• Bruserud, O., Gjertsen, B. T., Huang, T.-s. (2000). Induction of Differentiation and Apoptosis-- A Possible Strategy in the Treatment of Adult Acute Myelogenous Leukemia. The Oncologist 5: 454-462 [Abstract] [Full Text]  
• Ikezoe, T., Daar, E. S., Hisatake, J.-i., Taguchi, H., Koeffler, H. P. (2000). HIV-1 protease inhibitors decrease proliferation and induce differentiation of human myelocytic leukemia cells. Blood 96: 3553-3559 [Abstract] [Full Text]  
• Miano, J. M., Berk, B. C. (2000). Retinoids : Versatile Biological Response Modifiers of Vascular Smooth Muscle Phenotype. Circ. Res. 87: 355-362 [Full Text]  
• Grimwade, D., Biondi, A., Mozziconacci, M.-J., Hagemeijer, A., Berger, R., Neat, M., Howe, K., Dastugue, N., Jansen, J., Radford-Weiss, I., Coco, F. L., Lessard, M., Hernandez, J.-M., Delabesse, E., Head, D., Liso, V., Sainty, D., Flandrin, G., Solomon, E., Birg, F., Lafage-Pochitaloff, M. (2000). Characterization of acute promyelocytic leukemia cases lacking the classic t(15;17): results of the European Working Party. Blood 96: 1297-1308 [Abstract] [Full Text]  
• Camacho, L. H., Soignet, S. L., Chanel, S., Ho, R., Heller, G., Scheinberg, D. A., Ellison, R., Warrell, R. P. Jr (2000). Leukocytosis and the Retinoic Acid Syndrome in Patients With Acute Promyelocytic Leukemia Treated With Arsenic Trioxide. JCO 18: 2620-2625 [Abstract] [Full Text]  
• Ferrara, F., Morabito, F., Martino, B., Specchia, G., Liso, V., Nobile, F., Boccuni, P., Di Noto, R., Pane, F., Annunziata, M., Schiavone, E. M., De Simone, M., Guglielmi, C., Del Vecchio, L., Lo Coco, F. (2000). CD56 Expression Is an Indicator of Poor Clinical Outcome in Patients With Acute Promyelocytic Leukemia Treated With Simultaneous All-Trans-Retinoic Acid and Chemotherapy. JCO 18: 1295-1300 [Abstract] [Full Text]  
• Jurcic, J. G., DeBlasio, T., Dumont, L., Yao, T.-J., Scheinberg, D. A. (2000). Molecular Remission Induction with Retinoic Acid and Anti-CD33 Monoclonal Antibody HuM195 in Acute Promyelocytic Leukemia. Clin. Cancer Res. 6: 372-380 [Abstract] [Full Text]  
• Slack, J. L., Willman, C. L., Andersen, J. W., Li, Y.-P., Viswanatha, D. S., Bloomfield, C. D., Tallman, M. S., Gallagher, R. E. (2000). Molecular analysis and clinical outcome of adult APL patients with the type V PML-RARalpha isoform: results from Intergroup protocol 0129. Blood 95: 398-403 [Abstract] [Full Text]  
• Wiegman, P. J., Barry, W. L., McPherson, J. A., McNamara, C. A., Gimple, L. W., Sanders, J. M., Bishop, G. G., Powers, E. R., Ragosta, M., Owens, G. K., Sarembock, I. J. (2000). All-trans-Retinoic Acid Limits Restenosis After Balloon Angioplasty in the Focally Atherosclerotic Rabbit : A Favorable Effect on Vessel Remodeling. Arterioscler. Thromb. Vasc. Bio. 20: 89-95 [Abstract] [Full Text]  
• Gorin, N. C., Estey, E., Jones, R. J., Levitsky, H. I., Borrello, I., Slavin, S. (2000). New Developments in the Therapy of Acute Myelocytic Leukemia. ASH Education Book 2000: 69-89 [Abstract] [Full Text]  
• Tallman, M. S., Andersen, J. W., Schiffer, C. A., Appelbaum, F. R., Feusner, J. H., Ogden, A., Shepherd, L., Rowe, J. M., Francois, C., Larson, R. S., Wiernik, P. H. (2000). Clinical description of 44 patients with acute promyelocytic leukemia who developed the retinoic acid syndrome. Blood 95: 90-95 [Abstract] [Full Text]  
• Raimondi, S. C., Chang, M. N., Ravindranath, Y., Behm, F. G., Gresik, M. V., Steuber, C. P., Weinstein, H. J., Carroll, A. J. (1999). Chromosomal Abnormalities in 478 Children With Acute Myeloid Leukemia: Clinical Characteristics and Treatment Outcome in a Cooperative Pediatric Oncology Group Study---POG 8821. Blood 94: 3707-3716 [Abstract] [Full Text]  
• Berry, D. M., Meckling-Gill, K. A. (1999). Vitamin D Analogs, 20-Epi-22-Oxa-24a,26a,27a,-Trihomo-1{alpha},25(OH)2-Vitamin D3, 1,24(OH)2-22-Ene-24-Cyclopropyl-Vitamin D3 and 1{alpha},25(OH)2-Lumisterol3 Prime NB4 Leukemia Cells for Monocytic Differentiation via Nongenomic Signaling Pathways, Involving Calcium and Calpain. Endocrinology 140: 4779-4788 [Abstract] [Full Text]  
• Estey, E. H., Giles, F. J., Kantarjian, H., O'Brien, S., Cortes, J., Freireich, E. J, Lopez-Berestein, G., Keating, M. (1999). Molecular Remissions Induced by Liposomal-Encapsulated All-Trans Retinoic Acid in Newly Diagnosed Acute Promyelocytic Leukemia. Blood 94: 2230-2235 [Abstract] [Full Text]  
• Fenaux, P., Chastang, C., Chevret, S., Sanz, M., Dombret, H., Archimbaud, E., Fey, M., Rayon, C., Huguet, F., Sotto, J.-J., Gardin, C., Makhoul, P. C., Travade, P., Solary, E., Fegueux, N., Bordessoule, D., Miguel, J. S., Link, H., Desablens, B., Stamatoullas, A., Deconinck, E., Maloisel, F., Castaigne, S., Preudhomme, C., Degos, L. (1999). A Randomized Comparison of All Transretinoic Acid (ATRA) Followed by Chemotherapy and ATRA Plus Chemotherapy and the Role of Maintenance Therapy in Newly Diagnosed Acute Promyelocytic Leukemia. Blood 94: 1192-1200 [Abstract] [Full Text]  
• Leachman, S. A., Insogna, K. L., Katz, L., Ellison, A., Milstone, L. M. (1999). Bone Densities in Patients Receiving Isotretinoin for Cystic Acne. Arch Dermatol 135: 961-965 [Abstract] [Full Text]  
• Redner, R. L., Wang, J., Liu, J. M. (1999). Chromatin Remodeling and Leukemia: New Therapeutic Paradigms. Blood 94: 417-428 [Full Text]  
• Jansen, J.H., de Ridder, M.C., Geertsma, W.M.C., Erpelinck, C.A.J., van Lom, K., Smit, E.M.E., Slater, R., Reijden, B.A. v., de Greef, G.E., Sonneveld, P., Lowenberg, B. (1999). Complete Remission of t(11;17) Positive Acute Promyelocytic Leukemia Induced by All-trans Retinoic Acid and Granulocyte Colony-Stimulating Factor. Blood 94: 39-45 [Abstract] [Full Text]  
• Burnett, A. K., Grimwade, D., Solomon, E., Wheatley, K., Goldstone, A. H. (1999). Presenting White Blood Cell Count and Kinetics of Molecular Remission Predict Prognosis in Acute Promyelocytic Leukemia Treated With All-Trans Retinoic Acid: Result of the Randomized MRC Trial. Blood 93: 4131-4143 [Abstract] [Full Text]