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Low-Dose Interleukin-2 Immunotherapy Does Not Improve Outcome of Patients Age 60 Years and Older With Acute Myeloid Leukemia in First Complete Remission: Cancer and Leukemia Group B Study 9720
- Source :
- Journal of Clinical Oncology. 26:4934-4939
- Publication Year :
- 2008
- Publisher :
- American Society of Clinical Oncology (ASCO), 2008.
-
Abstract
- PurposeCancer and Leukemia Group B (CALGB) 9720 evaluated subcutaneous low-dose recombinant interleukin-2 (rIL-2) maintenance immunotherapy as a strategy for prolonging remission in older patients with acute myeloid leukemia (AML).Patients and MethodsAML patients age 60 years and older in first complete remission after induction and consolidation chemotherapy were randomly assigned to no further therapy or a 90-day regimen of 14-day cycles of low-dose rIL-2, aimed at expanding natural killer (NK) cells, followed by 3-day higher doses aimed at activating cytotoxicity of expanded NK cells to lyse residual AML cells. All randomly assigned patients were included in an intention-to-treat analysis.ResultsA total of 163 (64%) of 254 patients who completed induction and consolidation chemotherapy on CALGB 9720 were randomly assigned to rIL-2 (n = 81) or no further therapy (n = 82); the most common reasons for lack of random assignment were patient refusal and relapse. Fifteen patients randomly assigned to rIL-2 never initiated it because of refusal, intercurrent medical problems, or relapse, and 24 patients initiated rIL-2 but stopped early because of toxicity or relapse. Grade 4 toxicities during rIL-2 therapy included thrombocytopenia (65%) and neutropenia (64%), and grade 3 toxicities included anemia (33%), infection (24%) and malaise/fatigue (14%). Forty-two patients (52%) randomly assigned to rIL-2 completed the full 90-day course. Patients in both arms had similar distributions of both disease-free (combined median = 6.1 months; P = .47) and overall survival (combined median = 14.7 months; P = .61) after random assignment. Moreover, the 42 patients who completed all planned therapy did not show prolongation of disease-free or overall survival.ConclusionLow-dose rIL-2 maintenance immunotherapy is not a successful strategy in older AML patients.
- Subjects :
- Male
Cancer Research
medicine.medical_specialty
Myeloid
Antineoplastic Agents
Neutropenia
Disease-Free Survival
Leukemia and Bone Marrow Transplantation
Internal medicine
Antineoplastic Combined Chemotherapy Protocols
medicine
Humans
Survival rate
Aged
business.industry
Remission Induction
Myeloid leukemia
Cancer
Consolidation Chemotherapy
Middle Aged
medicine.disease
Drug Resistance, Multiple
Surgery
Survival Rate
Leukemia, Myeloid, Acute
Leukemia
Regimen
Treatment Outcome
medicine.anatomical_structure
Oncology
Drug Resistance, Neoplasm
Interleukin-2
Female
Immunotherapy
business
Subjects
Details
- ISSN :
- 15277755 and 0732183X
- Volume :
- 26
- Database :
- OpenAIRE
- Journal :
- Journal of Clinical Oncology
- Accession number :
- edsair.doi.dedup.....113bb2d7aa1cb39b9b01cfe6b1a3dff5