2018•Journal of Clinical OncologyRequires access
Long-term follow-up of brentuximab vedotin ± dacarbazine as first line therapy in elderly patients with Hodgkin lymphoma.
Jonathan W. Friedberg, Andres Forero‐Torres, Beata Holkova, Jerome H. Goldschmidt, Ralph Vincent Boccia, Rodolfo Eduardo Bordoni, Vivian Jean M. Cline, Dipti Patel‐Donnelly, Patrick J. Flynn, Gregg A. Olsen, Robert W. Chen, Faith C. Galderisi, Yinghui Wang, Jeff Porter Sharman, Christopher A. Yasenchak
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Abstract
7542 Background: Elderly patients (pts) with Hodgkin lymphoma (HL) have few treatment (tx) options and poor outcomes compared to younger pts. This phase 2, frontline, open-label trial studied brentuximab vedotin monotherapy (BV; ADCETRIS) and BV+dacarbazine (DTIC) in these pts (NCT01716806). We previously reported high response rates (92% and 100%, respectively) and complete remission rates (73% and 62%, respectively) as well as manageable safety profiles (Forero-Torres 2015, Friedberg 2017). Methods: Twenty-seven pts ≥ age 60 with classical HL not eligible for standard tx received 1.8 mg/kg BV; then 22 others received 1.8 mg/kg BV+375 mg/m2 DTIC (12 cycles), then BV. Radiographic scans were done at Cycles 2, 4, 8, 12, 16 (for continued BV), end of tx, then per standard of care. Follow-up visits were every 3 months (mos). Results: Survival and peripheral neuropathy (PN) results are presented below. BV+DTIC resulted in 3-year (yr) PFS and OS rates of 52% and 90%, respectively, while BV alone rates were 34% and 71%. Most pts had tx-emergent PN and had either complete resolution or some resolution/improvement. Nearly all ongoing PN was Grade 1/2; 1 pt had ongoing Grade 3 PN. Conclusions: BV alone and BV+DTIC appear to induce long-term remissions for a subset of elderly HL pts. The addition of DTIC appears to increase durability of response and survival although not statistically assessed. PN resolution/improvement was observed for the majority of pts. These durable responses suggest that BV+DTIC may be an induction option for frail, elderly pts ineligible for standard tx. Clinical trial information: NCT01716806. BV (N = 27) BV+DTIC (N = 22) Median observation time from first dosea, mos (range) 42.6 (4.6, 56.3) 37.8 (14.8, 44.8) Median PFSa, mos (range) 10.5 (2.6+, 52.2+) NR (4.2+, 39.6+) 3-yr PFS ratea (95% CI) 34% (16%, 53%) 52% (26%, 73%) Median OS, mos (range) NR (4.6+, 56.3+) NR (6.7+, 44.8+) 3-yr OS rate (95% CI) 71% (49%, 85%) 90% (65%, 97%) Tx-emergent PN, n (%) 24 (89%) 19 (86%) Complete resolution, n/N (%) 9/24 (38%) 5/19 (26%) Some resolution/improvementb, n/N (%) 9/24 (38%) 8/19 (42%) Median time to resolution/improvement, weeks 12.6 4.9 Ongoing Grade 1/2, n/N (%) 14/15 (93%) 14/14 (100%)