Abstract P080

Brentuximab vedotin monotherapy is a feasible and effective treatment in elderly and frail patients with classical Hodgkin lymphoma: Results of the prospective GHSG-NLG phase II BVB trial.

Background: Standard treatment for classical Hodgkin lymphoma (HL) is poorly tolerated by older patients (pts) with comorbidities or frailty and results are disappointing.

Methods: In the international prospective phase II BVB trial (NCT02191930), we evaluated safety and efficacy of brentuximab vedotin (BV, 1.8 mg/kg every 3 weeks) in previously untreated HL patients aged ≥60 years considered unsuitable for combination chemotherapy. The primary endpoint was objective response rate (ORR) assessed by computed tomography after ≥2 cycles of BV. Secondary endpoints included toxicity, progression-free (PFS) and overall survival (OS). For comparison, we evaluated elderly HL patients from a Norwegian population-based cohort diagnosed 2000-2015.

Results: Between 2015 and 2018, we enrolled 20 pts. Nineteen pts with a median age of 82 years (range 62-88) and a median Cumulative Illness Rating Scale for Geriatrics (CIRSG) score of 8 (range 4-14) were evaluable for toxicity, whereas 18 were evaluable for response. With a median of 6 BV cycles given (range 2-16), grade (G) 3 hematological toxicity occurred in 3 pts, with no G4 reported. G3 or 4 infections were seen in 3 and 1 pts, respectively, while non-hematological G3 or 4 toxicities were noted in 7 and 3 pts, respectively. Four (22%) pts had complete and 7 (39%) had partial response (ORR 61%, 95%CI 31-100). One patient received radiotherapy (RT) in remission. With a median follow-up of 30 months, median PFS was 19 months (95%CI 5-30), and median OS was not reached (Figure A+C). Three-year PFS and OS were 27% (95%CI 6-48) and 56% (95%CI 31-81), respectively. In the retrospective cohort, 49 pts had a median age of 81 years (range 65-92) and a median CIRSG score of 9 (range 0-25). Of these, 31 received various dose-attenuated combination regimens, mostly cyclophosphamide, vincristine and prednisolone (CVP) +/- doxorubicin (CHOP), 6 oral trofosfamide and 5 received other single agent chemotherapy. Median number of cycles for intermittent schedules was 2 (range 1-8). Five pts received additional RT as part of primary treatment and 7 had limited-field RT only. ORR response rate was 47% (95%CI 30-70) and PFS and OS at 3 years 10% (95%CI 2-19) and 12% (95%CI 4-21), respectively (Figure B+D).

Conclusion: BV monotherapy is a tolerated and effective treatment option, and it may improve outcomes compared to conventional therapy in elderly and frail HL patients ineligible for curatively intended combination chemotherapy.

Authors

Alexander Fosså, Daniel Molin, Paul J. Bröckelmann, Gundolf Schneider, Ulf Schnetzke, Johan Linderoth, Peter Kamper, Sirpa M. Leppä, Julia Meissner, Valdete Schaub, Kjersti Lia, Michael Fuchs, Peter Borchmann, Boris Böll