Five-year results of brentuximab vedotin in patients with relapsed or refractory systemic anaplastic large cell lymphoma

This pivotal phase 2 study evaluated the safety and efficacy of brentuximab vedotin in patients with relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). After a median observation period of approximately 6 years from first treatment, we examined the durability of remission,...

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Vydáno v:Blood Ročník 130; číslo 25; s. 2709
Hlavní autoři: Pro, Barbara, Advani, Ranjana, Brice, Pauline, Bartlett, Nancy L, Rosenblatt, Joseph D, Illidge, Tim, Matous, Jeffrey, Ramchandren, Radhakrishnan, Fanale, Michelle, Connors, Joseph M, Fenton, Keenan, Huebner, Dirk, Pinelli, Juan M, Kennedy, Dana A, Shustov, Andrei
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States 21.12.2017
Témata:
Adolescent
Adult
Aged
Brentuximab Vedotin
Disease Progression
Disease-Free Survival
Female
Humans
Immunoconjugates - adverse effects
Immunoconjugates - therapeutic use
Longitudinal Studies
Lymphoma, Large-Cell, Anaplastic - complications
Lymphoma, Large-Cell, Anaplastic - drug therapy
Lymphoma, Large-Cell, Anaplastic - pathology
Male
Middle Aged
Peripheral Nervous System Diseases - etiology
Remission Induction
Salvage Therapy - methods
Stem Cell Transplantation
Survival Analysis
Treatment Outcome
Young Adult
ISSN:1528-0020, 1528-0020
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Popis
Shrnutí:This pivotal phase 2 study evaluated the safety and efficacy of brentuximab vedotin in patients with relapsed or refractory (R/R) systemic anaplastic large cell lymphoma (ALCL). After a median observation period of approximately 6 years from first treatment, we examined the durability of remission, progression-free survival (PFS), overall survival (OS), and safety outcomes of patients treated on this trial. Among all enrolled patients (n = 58), no progressions were observed beyond 40 months, and median OS was not reached. Patients with a complete response (CR), as assessed by the investigator (38 of 58, 66%), continued to demonstrate improved outcomes with neither median OS nor PFS reached. Of the 38 CR patients, 16 received a consolidative stem cell transplant (SCT) with median PFS not reached. Among patients who were on-study and in remission at study closure, 16 patients had not received any new treatment after single-agent brentuximab vedotin other than consolidative SCT. Among this subset of 16 patients, 8 received SCT, and the remaining 8 patients (14% of all enrolled patients) remained in sustained remission without consolidative SCT or any new anticancer therapy. Thirty-three patients experienced peripheral neuropathy, among whom, the majority (30 of 33, 91%) had experienced resolution or improvement at their last assessment. These final results, which demonstrated a high rate of peripheral neuropathy resolution, and durable remissions in a subset of patients with relapsed or refractory systemic ALCL, provide evidence that single-agent brentuximab vedotin may be a potentially curative treatment option. This trial was registered at www.clinicaltrials.gov as #NCT00866047.
Bibliografie:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ISSN:1528-0020
1528-0020
DOI:10.1182/blood-2017-05-780049