PURPOSE: To assess the impact on Quality of Life (QoL) of postconsolidation immunotherapy with histamine dihydrochloride (HDC) in combination with interleukin-2 (IL-2) in acute myelogenous leukemia (AML).

PATIENTS & METHODS: A multi-national randomized open-label phase 3 trial recruited 320 AML patients between 1998 and 2000. Patients were enrolled after termination of consolidation therapy, stratified by country and remission status (first or subsequent remission), and randomized to HDC/IL-2 treatment or no treatment (standard-of-care, control). The treatment was self-administered at home and included ten 3-week courses of HDC (0.5 mg sc bid; EpiCept Corporation) plus low-dose recombinant IL-2 (aldesleukin, 18,000 U/kg sc bid; Chiron Corp). Cycles 1–3 comprised 3 wks of treatment followed by 3 wks of rest, whereas in cycles 4–10 the rest periods were 6 wks. As reported previously (

Blood
2006
;
108
:
88
), the trial met the primary endpoint of prolonged leukemia-free survival (LFS) for all patients randomized (P=0.008). Assessment of QoL, a secondary trial endpoint, was performed using the validated EORTC-C30(v2) instrument at 8 pre-defined study visits: baseline; pre- and post-cycles 3, 5, and 8; and at 18 months. Data were analyzed as specified in the EORTC scoring manual for 9 scales (1 global, 5 functional, 3 symptom scales) and 6 single-symptom items. Comparisons were made between and within groups at

  1. baseline vs. each visit,

  2. pre- vs. post-treatment, and

  3. baseline vs. end of treatment (18 months).

RESULTS: At least one questionnaire was completed by 285 patients (89%). Patients in both study arms increased or maintained QoL status from baseline to last evaluation with respect to global health status, physical, cognitive and role functioning, and financial issues, as well as symptoms of fatigue, nausea/vomiting, pain, diarrhea, and dyspnea. Comparisons of pre- vs. post-treatment QoL assessments showed transient increases in fatigue (P=0.008), nausea/vomiting (P=0.006), and appetite loss (P=0.005) in the treatment arm.

CONCLUSION: Post-consolidation immunotherapy with HDC/IL-2 self-administered at home by AML patients was associated with transient gastrointestinal symptoms and fatigue, but did not prevent recovery from induction/consolidation chemotherapy.

Topics:
aldesleukin, histamine, immunotherapy, leukemia, myelocytic, acute, quality of life, fatigue, disease remission, nausea and vomiting, weight measurement scales, chemotherapy regimen

Author notes

Disclosure:Employment: Author DB is employed by EpiCept Corp. Consultancy: Authors Whisnant, Rowe, Hellstrand and Brune are consultants to EpiCept Corp. Financial Information: Author Hellstrand holds patents related to the treatment described in the abstract. Off Label Use: The abstract describes the effect on quality of life of an immunotherapy using two drugs one of which is approved for another indication and the other is not approved, so yes, I guess we do describe off-label use of products.

2007, The American Society of Hematology
2007
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