title: Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma.
abstract: This multicenter pilot study assessed the safety and efficacy of brentuximab vedotin (BV) and AVD (adriamycin, vinblastine, and dacarbazine) followed by 30 Gy involved site radiation therapy (ISRT). Patients with newly diagnosed, early stage classical Hodgkin lymphoma (HL) with unfavorable-risk features were treated with 4 cycles of BV and AVD. Patients who achieved a negative positron emission tomography (PET) scan (Deauville score of 1-3) received 30 Gy ISRT. Thirty patients received treatment and were assessable for toxicity. Twenty-nine patients completed 4 cycles of BV + AVD, and 25 patients BV + AVD + 30 Gy ISRT. No clinically significant noninfectious pneumonitis was observed. Serious adverse events (≥grade 3) were reported in 4 patients, including febrile neutropenia, peripheral neuropathy, and hypertension. After 2 and 4 cycles of BV + AVD, 90% (26 of 29) and 93% (27 or 29) of patients achieved a negative PET scan, respectively. Two patients with biopsy-proven primary refractory HL were treated off-study. All 25 patients who completed BV + AVD + ISRT achieved a complete response. With a median follow-up of 18.8 months, by intent to treat, the 1-year progression-free survival is 93.3% (95% confidence interval, 84-102). Overall, the treatment was well-tolerated with no evidence of significant pulmonary toxicity. The majority of patients (≥90%) achieved negative interim PET scans after 2 and 4 cycles of BV + AVD. Excluding the 2 primary refractory patients, all patients are disease free, suggesting that this is a highly active treatment program even in patients with substantial disease bulk. This trial was registered at www.clinicaltrials.gov as #NCT01868451.
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Anita
authors.identifier: 0000-0002-1381-5810
authors.initials: A
authors.lastname: Kumar
authors.affiliation: Wilmot Cancer Institute, University of Rochester, Rochester, NY.
authors.forename: Carla
authors.initials: C
authors.lastname: Casulo
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Joachim
authors.initials: J
authors.lastname: Yahalom
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Heiko
authors.initials: H
authors.lastname: Schöder
authors.affiliation: Wilmot Cancer Institute, University of Rochester, Rochester, NY.
authors.forename: Paul M
authors.initials: PM
authors.lastname: Barr
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Philip
authors.initials: P
authors.lastname: Caron
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: April
authors.initials: A
authors.lastname: Chiu
authors.affiliation: Wilmot Cancer Institute, University of Rochester, Rochester, NY.
authors.forename: Louis S
authors.initials: LS
authors.lastname: Constine
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Pamela
authors.initials: P
authors.lastname: Drullinsky
authors.affiliation: Wilmot Cancer Institute, University of Rochester, Rochester, NY.
authors.forename: Jonathan W
authors.initials: JW
authors.lastname: Friedberg
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: John F
authors.initials: JF
authors.lastname: Gerecitano
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Audrey
authors.initials: A
authors.lastname: Hamilton
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Hamlin
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Steven M
authors.initials: SM
authors.lastname: Horwitz
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Alexandra G
authors.initials: AG
authors.lastname: Jacob
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Matasar
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Gianna N
authors.initials: GN
authors.lastname: McArthur
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Susan J
authors.initials: SJ
authors.lastname: McCall
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Alison J
authors.initials: AJ
authors.lastname: Moskowitz
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Ariela
authors.initials: A
authors.lastname: Noy
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Maria L
authors.initials: ML
authors.lastname: Palomba
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Carol S
authors.initials: CS
authors.lastname: Portlock
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: David J
authors.initials: DJ
authors.lastname: Straus
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Nicholas
authors.initials: N
authors.lastname: VanderEls
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Verwys
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Joanna
authors.initials: J
authors.lastname: Yang
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Anas
authors.initials: A
authors.lastname: Younes
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Andrew D
authors.initials: AD
authors.lastname: Zelenetz
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Zhigang
authors.initials: Z
authors.lastname: Zhang
authors.affiliation: Memorial Sloan Kettering Cancer Center, New York, NY; and.
authors.forename: Craig H
authors.initials: CH
authors.lastname: Moskowitz
mesh_terms: D000293:Adolescent; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000079963:Brentuximab Vedotin; D059248:Chemoradiotherapy; D003606:Dacarbazine / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006689:Hodgkin Disease / Q000473:pathology / Q000628:therapy*; D006801:Humans; D018796:Immunoconjugates / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010865:Pilot Projects; D011379:Prognosis; D014747:Vinblastine / Q000008:administration & dosage; D055815:Young Adult
chemical_list: D018796:Immunoconjugates; D014747:Vinblastine; D003606:Dacarbazine; D000079963:Brentuximab Vedotin; D004317:Doxorubicin