Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study

Santoro, Armando; Mazza, Rita; Pulsoni, Alessandro; Re, Alessandro; Bonfichi, Maurizio; Zilioli, Vittorio Ruggero; Salvi, Flavia; Merli, Francesco; Anastasia, Antonella; Luminari, Stefano; Annechini, Giorgia; Gotti, Manuel; Peli, Annalisa; Liberati, Anna Marina; Renzo, Nicola Di; Castagna, Luca; Giordano, Laura; Carlo‐Stella, Carmelo

doi:10.1200/jco.2016.66.4466

Cited by 85 publications

(98 citation statements)

References 29 publications

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“…Although the ORR of 83% was superior to that reported in the current study, this population was limited to patients who had received only 1 prior line of therapy and who had not undergone ASCT. The 2‐year PFS and OS rates after ASCT in the study by Santoro et al were >80%, which is comparable to the current study findings in the limited cohort of patients who completed ASCT. We also recognized that both Santoro et al and the current study used response criteria that were published prior to the currently used Lugano classification.…”

Section: Discussionsupporting

confidence: 89%

“…Santoro et al published the results of a phase 2 study of gemcitabine, bendamustine, and vinorelbine as pretransplantation salvage in 59 patients . Although the ORR of 83% was superior to that reported in the current study, this population was limited to patients who had received only 1 prior line of therapy and who had not undergone ASCT.…”

Section: Discussioncontrasting

confidence: 53%

“…Gemcitabine commonly is used in the management of patients with recurrent/refractory Hodgkin lymphoma both before and after autologous stem cell transplantation (ASCT) . Although its single‐agent overall response rate (ORR) is only 39% with a median duration of response of 6.7 months, its use in combination with other chemotherapies has resulted in high response rates and prolonged remissions, with responding patients often undergoing successful ASCT .…”

Section: Introductionmentioning

confidence: 99%

“…In a single‐arm, phase 2 study of bendamustine alone at a dose of 120 mg/m 2 in a 28‐day cycle, approximately 53% of 36 enrolled patients achieved a response, with a CR rate of 33% and a median response duration of 5 months . In a phase 2 study of bendamustine, gemcitabine, and vinorelbine, 59 patients received up to 4 cycles of therapy prior to a planned ASCT, and the ORR was 83%; 43 of 49 patients proceeded as planned to ASCT . The 2‐year PFS rate was 62%.…”

Section: Introductionmentioning

confidence: 99%

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

Cohen

Wei

Maddocks

et al. 2019

Cancer

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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.

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Section: Discussionsupporting

confidence: 89%

Section: Discussioncontrasting

confidence: 53%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Cohen

Wei

Maddocks

et al. 2019

Cancer

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“…Recently, the combination of bendamustine, gemcitabine and vinorelbine (BeGeV regimen) has been successfully tested in 59 patients with relapsed or refractory HL (46% with primary refractory disease and 37% with a CR lasting less than 1 year) in a phase 2 trial (Santoro et al , ). After 4 cycles of treatment, 43 patients (73%) achieved a CR and 6 patients (10%) a partial response (PR), with grade 3–4 thrombocytopenia and neutropenia experienced in 13·5% of patients each, thus enabling safe outpatient administration.…”

Section: The Pre‐autologous Setting: Boosting Responses Before Transpmentioning

confidence: 99%

The role of transplantation in Hodgkin lymphoma

Broccoli

Zinzani

2018

Br J Haematol

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Summary Autologous stem cell transplantation is the standard salvage strategy for young and fit patients with Hodgkin lymphoma failing induction therapy, and is effective in nearly 50% of cases. The quality of response at transplantation is the most relevant prognostic aspect, as patients in complete response can obtain better outcomes. Therefore, first‐line salvage treatments applied before transplantation need to produce high quality responses without excessive myelotoxicity and without affecting peripheral blood stem cell mobilisation. In this sense, the incorporation of new agents active in Hodgkin lymphoma, such as brentuximab vedotin and anti‐programmed death 1 antibodies, in conventional regimens, may help to enhance complete remission rates. Working on conditioning regimen and applying a post‐autologous consolidation treatment (for example with brentuximab vedotin) are two ways for improving transplant outcomes, particularly in patients displaying high‐risk features for early relapse or progression. Allogeneic transplantation maintains its curative potential also in the era of new drugs, although its most correct timing and the most suitable sequence of post‐autologous salvage treatments still remain to be determined.

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Checkpoint inhibitor‐based salvage regimens prior to autologous stem cell transplant improve event‐free survival in relapsed/refractory classic Hodgkin lymphoma

et al. 2023

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Clinical trials of novel salvage therapies have encouraging outcomes for relapsed/refractory transplant‐eligible classic Hodgkin lymphoma (R/R cHL) but comparison with conventional chemotherapy is lacking. Herein, we report the final analysis of a multicenter retrospective cohort of R/R cHL assessing outcomes by type of salvage therapy before autologous stem cell transplant (ASCT). R/R cHL patients who underwent ASCT at 14 institutions across the United States were included. Outcomes were compared among patients receiving conventional chemotherapy, brentuximab vedotin (BV) + chemotherapy, BV alone, and a checkpoint inhibitor (CPI)‐based regimens before ASCT. Study endpoints included event‐free survival (EFS), progression‐free survival (PFS), and overall survival (OS). All endpoints are defined from relapse. Of 936 patients, 728 received conventional chemotherapy, 73 received BV + chemotherapy, 70 received BV alone, and 65 received CPI‐based regimens prior to ASCT. When adjusted for time to relapse, pre‐ASCT response and use of BV maintenance, patients receiving CPI‐based regimens had superior 2‐year EFS compared to conventional chemotherapy, BV + chemotherapy, and BV alone (79.7, 49.6, 62.3, and 36.9%, respectively, p < .0001). Among 649 patients transplanted after 1 line of salvage therapy, CPI‐based regimens were associated with superior 2‐year PFS compared to conventional chemotherapy (98% vs. 68.8%, hazard ratio: 0.1, 95% confidence interval: 0.03–0.5, p < .0001). OS did not differ by pre‐ASCT salvage regimen. In this large multicenter retrospective study, CPI‐based regimens improved EFS and PFS compared to other salvage regimens independent of pre‐ASCT response. These data support earlier sequencing of CPI‐based regimens in R/R cHL in the pre‐ASCT setting.

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Bendamustine in Combination With Gemcitabine and Vinorelbine Is an Effective Regimen As Induction Chemotherapy Before Autologous Stem-Cell Transplantation for Relapsed or Refractory Hodgkin Lymphoma: Final Results of a Multicenter Phase II Study

Abstract: This phase II study demonstrates that BeGEV is an effective salvage regimen able to induce CR in a high proportion of patients with relapsed or refractory HL before ASCT. These data provide a strong rationale for further development of the BeGEV regimen.

Cited by 85 publications

References 29 publications

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

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

The role of transplantation in Hodgkin lymphoma

Checkpoint inhibitor‐based salvage regimens prior to autologous stem cell transplant improve event‐free survival in relapsed/refractory classic Hodgkin lymphoma

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