Single-Agent Pixantrone as a Bridge to Autologous Stem Cell Transplantation in a Patient with Refractory Diffuse Large B-Cell Lymphoma

Appio, Lorena; Landoni, Carlo; Targia, M.L. La; Bertolli, Vanda; Chiarucci, Martina; Crovetti, G; Vassenna, Elisabetta; Serio, Giovanni; Bregni, Marco

doi:10.1159/000458147

Cited by 1,462 publications

(12 citation statements)

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“…Three of the 10 responding patients in the PIXA registry subsequently received stem cell transplant after pixantrone. 18 Further studies evaluating the role of pixantrone in salvage regimens are of interest. The effectiveness of pixantrone in the current registry was also slightly better than in the aforementioned real-life retrospective study conducted in the UK, which reported median OS durations of 3.4 months, and an ORR of 24% (CR 10%; PR 14%), in a patient population similar to the current study.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non‐Hodgkin B‐cell lymphomas

Sancho

Navarro

Campos

et al. 2020

European J of Haematology

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Eur J Haematol. 2020;104:499-508. | 499 wileyonlinelibrary.com/journal/ejh 1 | INTRODUC TI ON Diffuse large B-cell lymphoma (DLBCL) is the most common form of non-Hodgkin lymphoma (NHL); between 30% and 58% of patients with NHL have DLBCL, which has a crude incidence in Europe of 3.81 cases per 100 000. 1,2 The incidence of both NHL and DLBCL varies considerably between European countries, with Italy and Spain having an incidence of NHL higher than the European average. 1-3 First-line therapy for intermediate-or high-risk B-cell NHL is an anthracycline-based regimen in combination with rituximab, such asAbstract Background and objective: Few treatment options exist for patients with relapsed/ refractory (R/R) B-cell non-Hodgkin lymphoma (NHL) who fail first-and second-line therapies. Pixantrone is a novel aza-anthracenedione agent with reduced potential for cardiotoxicity but maintained anti-tumour activity relative to anthracyclines. The current retrospective, observational, real-life study was undertaken in 79 patients who received pixantrone monotherapy for multiply R/R aggressive B-cell NHL in Spain and Italy.Results: Before pixantrone, patients had received a median of 3 prior therapies and 84.6% of them were refractory to the last regimen. Median progression-free survival (mPFS) was 2.8 months (95% confidence interval [CI] 2.1-3.6) and median overall survival (mOS) was 4.0 months (95%CI 5.6-7.9), with an objective response rate (ORR) of 29% (complete remission [CR]: 13.2%, partial remission [PR]: 15.2%). Patients receiving ≥2 cycles of pixantrone showed mPFS and mOS of 3.1 and 6.0 months, respectively, and an ORR of 36.8% (CR: 17.5%, PR: 19.3%). Overall, 63.3% of patients reported ≥1 adverse event (AE), most commonly haematological AEs. One patient developed grade 2 sinus tachycardia. Conclusion:Pixantrone was effective and well tolerated in a real-world population of multiply R/R patients with aggressive B-cell NHL, many of whom had very poor prognostic factors. K E Y W O R D Saggressive B-cell lymphoma, pixantrone, relapse, survival

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Section: Discussionmentioning

confidence: 99%

Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non‐Hodgkin B‐cell lymphomas

Sancho

Navarro

Campos

et al. 2020

European J of Haematology

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“…This is a case report and to be honest with our readers, we must recognize that one swallow does not make a summer. This having been acknowledged, the report by Appio et al [2] raises a number of positive issues. The Pixantrone is a novel anthracenedione, and as such it is popularly referred to as an "anthracycline-like" drug.…”

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confidence: 99%

“…Many doctors actually do not know pixantrone, and if they do, they believe it is one more anthracycline. In this issue of the journal, Appio et al [2] report on a clinical case that clearly shows the might of pixantrone. They describe the case of a 56-year-old NHL patient who relapsed after R-CHOP, underwent second-line salvage therapy with rituximab, dexamethasone, high-dose cytarabine, and cisplatin (or oxaliplatin), but progressed before autologous stem cell transplantation could be performed.…”

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Do You Know Pixantrone?

Minotti

Menna²,

Salvatorelli³

2017

Chemotherapy

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Following approval by the EMA, which maintained a role for pixantrone in a difficult-to-treat condition like r/r NHL, the drug became available in many countries, but its popularity with hematologists remained disappointing to say the least. It goes without too many words that the FDA decision counts, particularly in days when new drugs are running in the pipeline and hold promise for important twists in the field. Many doctors actually do not know pixantrone, and if they do, they believe it is one more anthracycline. In this issue of the journal, Appio et al. [2] report on a clinical case that clearly shows the might of pixantrone. They describe the case of a 56-year-old NHL patient who relapsed after R-CHOP, underwent second-line salvage therapy with rituximab, dexamethasone, high-dose cytarabine, and cisplatin (or oxaliplatin), but progressed before autologous stem cell transplantation could be performed. Third-line therapy with pixantrone and a single dose of rituximab offered a complete response and allowed the doctors to submit the patient to successful highdose chemotherapy, followed by autologous stem cell transplant and involved-field consolidation radiotherapy as appropriate. The patient enjoys a remission longer than a year, and his cardiac function is fully preserved. Thus, pixantrone was an excellent tool to bridge the patient to transplant -not bad for a little-known drug. This is a case report and to be honest with our readers, we must recognize that one swallow does not make a summer. This having been acknowledged, the report by Appio et al.[2] raises a number of positive issues. The Pixantrone is a novel anthracenedione, and as such it is popularly referred to as an "anthracycline-like" drug. Pixantrone has been obtained by extensive chemical modifications of the prototypic anthracenedione, mitoxantrone, and it has been approved by the European Medicines Agency (EMA), but not by the US Food and Drug Administration (FDA), for the treatment of refractory or relapsed non-Hodgkin lymphoma (r/r NHL).For patients with newly diagnosed NHL, frontline therapy rests with an immuno-chemotherapy regimen that is called R-CHOP, where R reads rituximab (an anti-CD20 antibody) and CHOP reads a cocktail of cyclophosphamide, doxorubicin, vincristine, and prednisone. The reasons pixantrone was rejected by the FDA were quite multifaceted. The phase 3 study of pixantrone versus investigator-choice chemotherapeutics for the treatment of patients with r/r NHL recruited much fewer than planned patients, and in addition, only half of the patients were recruited in countries where rituximab was available for combination with CHOP at the time when NHL was diagnosed and CHOP was commenced. Thus, the FDA felt that the registration trial was both underpowered and structurally inadequate to provide a real representation of patients with r/r NHL. Further concerns were due to the incidence of grade 3-4 cardiotoxicity, which seemed to be higher in the pixantrone arm compared to investigator-choice drugs, as if pixantrone retaine...

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“…This report was also informative as alterations of coronary tone have long been known to occur for 5-fluorouracil and other fluoropyrimidines, while disturbances from tubulin-active agents were only partially known or suspected to occur. Appio et al [3] presented clinical insights from a patient treated with pixantrone for refractory/relapsed non-Hodgkin lymphoma. Their report focused primarily on pixantrone efficacy but, given the patient history (prior anthracycline treatment) and the structure of pixantrone (commonly but misleadingly described as an anthracycline-like drug), a major focus was also given to its cardiac safety.…”

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confidence: 99%

Editorial: The Journal <b><i>Chemotherapy</i></b> Is for Cardio-Oncologists Too

Minotti¹

2018

Chemotherapy

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Single-Agent Pixantrone as a Bridge to Autologous Stem Cell Transplantation in a Patient with Refractory Diffuse Large B-Cell Lymphoma

Cited by 1,462 publications

References 16 publications

Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non‐Hodgkin B‐cell lymphomas

Efficacy and safety of pixantrone for the treatment of multiply relapsed or refractory aggressive non‐Hodgkin B‐cell lymphomas

Do You Know Pixantrone?

Editorial: The Journal <b><i>Chemotherapy</i></b> Is for Cardio-Oncologists Too

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