Gemcitabine and bendamustine is a safe and effective salvage regimen for patients with recurrent/refractory Hodgkin lymphoma: Results of a phase 1/2 study.

Abstract

BACKGROUND:

Both gemcitabine and bendamustine have been evaluated in patients with recurrent/refractory Hodgkin lymphoma but to the authors' knowledge not as a doublet. The authors completed a phase 1/2 trial to identify the optimal dose and frequency of administration and to assess the efficacy of this combination in patients with recurrent/refractory Hodgkin lymphoma.

METHODS:

Patients were treated up to a maximum dose of gemcitabine (1000 mg/m2 on day 1) and bendamustine (120 mg/m2 on days 1 and 2), which was determined to be the recommended phase 2 dose, administered every 21 days for up to 6 cycles. Patients could discontinue study therapy after 2 cycles to proceed with autologous or allogeneic stem cell transplantation.

RESULTS:

No dose-limiting toxicities were identified, but 4 patients experienced grade 3 to 5 pulmonary adverse events (toxicity was graded according to Common Terminology Criteria for Adverse Events [version 4]). A total of 26 patients were enrolled having completed a median of 4 prior lines of therapy (range, 1-7 lines), including 13 patients at the recommended phase 2 dose, in whom the overall response rate was 69% and the complete response rate was 46%. The median progression-free survival for the phase 2 patients was 11 months (95% CI, 3 months to not reached), and the median overall survival for this group had not been reached at the time of last follow-up (95% CI, 4 months to not reached).

CONCLUSIONS:

This doublet was found to be tolerable and effective, but patients must be monitored closely for pulmonary toxicity. The authors currently are evaluating this doublet in combination with nivolumab.

• Authors: Jonathon B Cohen, Lai Wei, Kami J Maddocks, Beth Christian, Leonard T Heffner, Amelia A Langston, Mary Jo Lechowicz, Pierluigi Porcu, Christopher R Flowers, Steven M Devine, Kristie A Blum
• Journal: Cancer (Cancer) Vol. 126 Issue 6 Pg. 1235-1242 (03 15 2020) ISSN: 1097-0142 [Electronic] United States
• PMID: 31821549 (Publication Type: Clinical Trial, Phase I, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 American Cancer Society.

Chemical References

• Antibiotics, Antineoplastic
• Deoxycytidine
• Bleomycin
• Bendamustine Hydrochloride
• Gemcitabine

Topics

• Adult
• Aged
• Antibiotics, Antineoplastic (administration & dosage, adverse effects)
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bendamustine Hydrochloride (administration & dosage, adverse effects)
• Bleomycin (administration & dosage, adverse effects)
• Deoxycytidine (administration & dosage, adverse effects, analogs & derivatives)
• Drug Administration Schedule
• Drug Resistance, Neoplasm
• Female
• Hodgkin Disease (drug therapy)
• Humans
• Male
• Middle Aged
• Progression-Free Survival
• Recurrence
• Salvage Therapy (methods)
• Young Adult
• Gemcitabine