Ewa Paszkiewicz-Kozik1, Agata Tyczynska2, Martyna Kotarska1, Marcin Szymanski1, Lukasz Targonski1, Joanna Drozd-Sokolowska3, Justyna Rybka4, Elzbieta Wojciechowska-Lampka1, Joanna Tajer1, Lidia Poplawska1, Joanna Romejko-Jarosinska1, Michal Osowiecki1, Sebastian Rybski1, Jan Zaucha2, Jan Walewski1
1 Maria Sklodowska-Curie Institute and Oncology Center, Warsaw, Poland, 2 Medical University of Gdansk, Gdansk, Poland, 3 Medical University of Warsaw, Warsaw, Poland, 4 Wroclaw Medical University, Wroclaw, Poland
Background: Bendamustine (B) and Gemcitabine (G) are active agents in rHL with complete response (CR) rates of around 70% (Santoro et al JCO 2016). We report here on the early results of a pilot prospective, multicenter study by PLRG of BGD chemotherapy followed by ASCT as a salvage for rHL after ABVD failure.
Patients and Methods: Patients with rHL who were eligible for ASCT received BGD regimen of bendamustine 90 mg/m2 iv, days 1, 2, gemcytabine 800 mg/m2 iv, days 1, 4, dexamethasone 20 to 40 mg iv/po days 1–4, q3 weeks for up to 4 cycles.
Response to therapy was evaluated with PET-CT after second cycle and before ASCT according to RECIL criteria (Younes A et al. Ann Oncol 2017). Stem-cell collection was done between 1st and 3rd BGD cycle. Patients in CR proceeded to ASCT. The primary endpoint was progression-free survival (PFS) after completion of BGD and ASCT.
The secondary endpoints were: CR rate at the time of ASCT, cell mobilization rate (MR) and toxicity. Overall survival (OS) will be evaluated in longer follow up.
Results: 30 pts were enrolled, 15 male, median age 28 (range 22–67). 23 pts (77%) were primary refractory, 7 relapsed more than 1 year after the first-line treatment. Patients received 2 (n = 9), 3 (n = 9), or 4 (n = 10) cycles of BGD. 2 patients discontinued BGD after 1st cycle due to skin reaction and received subsequent ICE before ASCT. Response rates after 2 cycles were: CR 70% (21/30), PR 17% (5/30), PD 10% (3/30). PR converted to CR after additional 2 BGD cycles in all cases. 27 patients were successfully mobilized for stem-cell collection without plerixafor. 26 pts with CR (86%) by PET/CT proceeded to ASCT. Median follow-up is 12.2 months. 1-year PFS 68%(49% - 87%) CI.
Grade ≥ 3 adverse events included pneumonia (10%), skin toxicity (10%), nausea (10%), fever (7%).
Conclusion: Early results of BGD/ASCT treatment in patients with mostly refractory HL are encouraging with CR rate of 86% before ASCT. BGD is effective mobilization regimen and has acceptable toxicity. These preliminary results support a prospective study which is currently ongoing.