Brentuximab vedotin and AVD followed by involved-site radiotherapy in early stage, unfavorable risk Hodgkin lymphoma

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 feat...

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Bibliographic Details
Published in:Blood 2016-09, Vol.128 (11), p.1458-1464
Main Authors: Kumar, Anita, Casulo, Carla, Yahalom, Joachim, Schöder, Heiko, Barr, Paul M., Caron, Philip, Chiu, April, Constine, Louis S., Drullinsky, Pamela, Friedberg, Jonathan W., Gerecitano, John F., Hamilton, Audrey, Hamlin, Paul A., Horwitz, Steven M., Jacob, Alexandra G., Matasar, Matthew J., McArthur, Gianna N., McCall, Susan J., Moskowitz, Alison J., Noy, Ariela, Palomba, Maria L., Portlock, Carol S., Straus, David J., VanderEls, Nicholas, Verwys, Stephanie L., Yang, Joanna, Younes, Anas, Zelenetz, Andrew D., Zhang, Zhigang, Moskowitz, Craig H.
Format: Article
Language:English
Subjects:
Adolescent
Adult
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Brentuximab Vedotin
Chemoradiotherapy
Clinical Trials and Observations
Dacarbazine - administration & dosage
Doxorubicin - administration & dosage
Female
Follow-Up Studies
Hodgkin Disease - pathology
Hodgkin Disease - therapy
Humans
Immunoconjugates - administration & dosage
Male
Middle Aged
Neoplasm Staging
Pilot Projects
Prognosis
Vinblastine - administration & dosage
Young Adult
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Summary: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. •BV and AVD followed by ISRT is well tolerated, without significant pulmonary toxicity.•BV and AVD followed by ISRT is an effective therapy for unfavorable-risk early stage HL, including bulky disease.
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2016-03-703470