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Barr, Paul M; Robak, Tadeusz; Owen, Carolyn; Tedeschi, Alessandra; Bairey, Osnat; Bartlett, Nancy L; Burger, Jan A; Hillmen, Peter; Coutre, Steven; Devereux, Stephen; Grosicki, Sebastian; McCarthy, Helen; Li, Jianyong; Simpson, David; Offner, Fritz; Moreno, Carol; Zhou, Cathy; Styles, Lori; James, Danelle; Kipps, Thomas J; Ghia, Paolo
Haematologica (Roma), 09/2018, Letnik: 103, Številka: 9Journal Article
Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic leukemia. Extended analysis of RESONATE-2 was conducted to determine long-term efficacy and safety of ibrutinib in older patients with chronic lymphocytic leukemia. A total of 269 patients aged ≥65 years with previously untreated chronic lymphocytic leukemia without del(17p) were randomized 1:1 to ibrutinib (n=136) or chlorambucil (n=133) on days 1 and 15 of a 28-day cycle for 12 cycles. Median ibrutinib treatment duration was 28.5 months. Ibrutinib significantly prolonged progression-free survival chlorambucil (median, not reached 15 months; hazard ratio, 0.12; 95% confidence interval, 0.07-0.20; <0.0001). The 24-month progression-free survival was 89% with ibrutinib (97% and 89% in patients with del11q and unmutated immunoglobulin heavy chain variable region gene, respectively). Progression-free survival rates at 24 months were also similar regardless of age (<75 years 88%, ≥75 years 89%). Overall response rate was 92% (125/136). Rate of complete response increased substantially from 7% at 12 months to 18% with extended follow up. Greater quality of life improvements occurred with ibrutinib chlorambucil in Functional Assessment of Chronic Illness Therapy-Fatigue ( =0.0013). The most frequent grade ≥3 adverse events were neutropenia (12%), anemia (7%), and hypertension (5%). Rate of discontinuations due to adverse events was 12%. Results demonstrated that first-line ibrutinib for elderly patients with chronic lymphocytic leukemia provides sustained response and progression-free survival benefits over chemotherapy, with depth of response improving over time without new toxicity concerns. This trial was registered at and .
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Dostop do baze podatkov JCR je dovoljen samo uporabnikom iz Slovenije. Vaš trenutni IP-naslov ni na seznamu dovoljenih za dostop, zato je potrebna avtentikacija z ustreznim računom AAI.
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Vir: Osebne bibliografije
in: SICRIS
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