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ATRA plus arsenic trioxide improved quality of life in acute promyelocytic leukemia
Patients with acute promyelocytic leukemia who underwent front-line treatment with all-trans–retinoic acid plus arsenic trioxide demonstrated improved health-related quality of life after induction compared with those treated with all-trans–retinoic acid plus chemotherapy, according to results of a randomized phase 3 trial.
However, the benefits primarily were relevant at the end of induction therapy, and quality-of-life differences between treatment arms were marginal at the end of consolidation, researchers wrote.
The prospective, multicenter, open-label, non-inferiority trial compared the efficacy and toxicity of standard all-trans–retinoic acid (ATRA) plus chemotherapy vs. ATRA plus arsenic trioxide in patients with newly diagnosed, low- or intermediate-risk acute promyelocytic leukemia (APL).
Previously published efficacy results showed ATRA plus arsenic trioxide was noninferior to ATRA plus chemotherapy.
Health-related quality of life served as a secondary endpoint. Researchers used the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30 to assess health-related quality of life at the end of induction, as well as after consolidation therapy.
The analysis included 162 patients aged 18 to 70 years, all of whom received at least one dose of their assigned treatment. Of these patients, 150 were evaluable after induction therapy and 142 patients were evaluable after a third consolidation course. Overall compliance with questionnaire forms was 80.1%.
The most significant difference was observed with regard to severity of fatigue at the end of induction therapy. Researchers observed a mean score difference of -9.3 (95% CI, -17.8 to -0.7) that favored patients assigned ATRA plus arsenic trioxide. After a third consolidation course, severity of fatigue did not vary significantly between treatment arm (P=.66).
Researchers also observed small differences after induction therapy in the severity of nausea/vomiting (mean score difference, -5.1; 95% CI, -9.7 to -0.5), appetite loss (mean score difference, -7.1; 95% CI, -14.6 to 0.5) and constipation (mean score difference, -6.1; 95% CI, -16.3 to 4). All favored patients treated with ATRA plus arsenic trioxide.
The investigators also observed small differences in physical functioning (mean score difference, -5.3; 95% CI, -1.9 to 12.4) and cognitive functioning (mean score difference, -5.9; 95% CI, -1.2 to 12.9), both of which also favored those treated with ATRA plus arsenic trioxide.
However, after a third consolidation course, the only clinically significant difference related to severity of diarrhea (mean score difference, -5.5; 95% CI, -0.4 to 10.6) and favored those assigned ATRA plus chemotherapy.
“Health-related quality-of-life benefits of therapy with ATRA plus arsenic trioxide over standard ATRA plus chemotherapy are mainly relevant at the end of induction therapy,” the researchers concluded. “Our health-related quality-of-life results extend previous clinical findings and can help physicians make more informed treatment decisions on first-line therapy for their newly diagnosed patients with acute promyelocytic leukemia.”
Disclosure: The researchers report honoraria from Teva Pharmaceuticals.