A randomized study with or without intensified maintenance chemotherapy in patients with acute promyelocytic leukemia who have become negative for PML-RARα transcript after consolidation therapy: The Japan Adult Leukemia Study Group (JALSG) APL97 study
| Autor: | Yukihiko Kimura, Tomoki Naoe, Akihiro Takeshita, Masako Iwanaga, Norio Asou, Katsuji Shinagawa, Tohru Kobayashi, Masaya Okada, Shigeki Ohtake, Hitoshi Kiyoi, Masatomo Takahashi, Fumiharu Yagasaki, Motohiro Tsuzuki, Mitsuhiro Matsuda, Miki Nishimura, Ryuzo Ohno, Yasukazu Kawai, Kentaro Horikawa, Yuji Kishimoto |
|---|---|
| Rok vydání: | 2007 |
| Předmět: |
Adult
Male Oncology Acute promyelocytic leukemia medicine.medical_specialty Adolescent Oncogene Proteins Fusion medicine.medical_treatment Immunology Tretinoin Biochemistry law.invention Japan Leukemia Promyelocytic Acute Randomized controlled trial law Internal medicine Multicenter trial Antineoplastic Combined Chemotherapy Protocols medicine Humans RNA Neoplasm Survival analysis Aged Chemotherapy Hematology business.industry Remission Induction Cell Biology Middle Aged medicine.disease Survival Analysis Chemotherapy regimen Surgery Leukemia Treatment Outcome Female business |
| Zdroj: | Blood. 110:59-66 |
| ISSN: | 1528-0020 0006-4971 |
| DOI: | 10.1182/blood-2006-08-043992 |
| Popis: | To examine the efficacy of intensified maintenance chemotherapy, we conducted a prospective multicenter trial in adult patients with newly diagnosed acute promyelocytic leukemia treated with all-trans retinoic acid and chemotherapy. Of the 302 registered, 283 patients were assessable and 267 (94%) achieved complete remission. Predicted 6-year overall survival in all assessable patients and disease-free survival in patients who achieved complete remission were 83.9% and 68.5%, respectively. A total of 175 patients negative for PML-RARα at the end of consolidation were randomly assigned to receive either intensified maintenance chemotherapy (n = 89) or observation (n = 86). Predicted 6-year disease-free survival was 79.8% for the observation group and 63.1% for the chemotherapy group, showing no statistically significant difference between the 2 groups (P = .20). Predicted 6-year survival of patients assigned to the observation was 98.8%, which was significantly higher than 86.2% in those allocated to the intensified maintenance (P = .014). These results indicate that the intensified maintenance chemotherapy did not improve disease-free survival, but rather conferred a significantly poorer chance of survival in acute promyelocytic leukemia patients who have become negative for the PML-RARα fusion transcript after 3 courses of intensive consolidation therapy. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|