Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma

A. Broccoli; C. Pellegrini; A. Di Rocco; B. Puccini; C. Patti; G. Gini; D. Mannina; M. Tani; C. Rusconi; A. Romano; A. Vanazzi; B. Botto; C. Carlo-Stella; S. Hohaus; P. Musto; P. Mazza; S. Molica; P. Corradini; A. Fama; F. Gaudio; M. Merli; A. Gravetti; G. Gritti; A. Arcari; P. Tosi; A.M. Liberati; A. Pinto; V. Pavone; F. Gherlinzoni; V. Naso; S. Volpetti; L. Trentin; M.C. Goldaniga; M. Bonfichi; A. De Renzo; C. Schiavotto; M. Spina; S. Storti; A.M. Carella; V. Stefoni; L. Argnani; P.L. Zinzani

doi:10.3324/haematol.2017.171355

Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma

A. Broccoli, C. Pellegrini, A. Di Rocco, B. Puccini, C. Patti, G. Gini, D. Mannina, M. Tani, C. Rusconi, A. Romano, A. Vanazzi, B. Botto, C. Carlo-Stella, S. Hohaus, P. Musto, P. Mazza, S. Molica, P. Corradini, A. Fama, F. GaudioM. Merli, A. Gravetti, G. Gritti, A. Arcari, P. Tosi, A.M. Liberati, A. Pinto, V. Pavone, F. Gherlinzoni, V. Naso, S. Volpetti, L. Trentin, M.C. Goldaniga, M. Bonfichi, A. De Renzo, C. Schiavotto, M. Spina, S. Storti, A.M. Carella, V. Stefoni, L. Argnani, P.L. Zinzani

Research output: Contribution to journal › Article › peer-review

Abstract

Between November 2012 and July 2014, in accordance with national law 648/96, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in everyday clinical practice to check whether clinical trial results are confirmed in a real-life context. The primary endpoint of this study was best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of four cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. The overall response rate was 62.5%. At the latest follow up, 15/18 patients are still in complete remission (3 with consolidation). The progression-free survival rate at 24 months was 39.1% and the disease-free survival rate at the same time was 54% (median not reached). All the long-term responders were aged

Original language	English
Pages (from-to)	1931-1935
Number of pages	5
Journal	Haematologica
Volume	102
Issue number	11
DOIs	https://doi.org/10.3324/haematol.2017.171355
Publication status	Published - 2017

Keywords

brentuximab vedotin
adolescent
adult
aged
allogeneic stem cell transplantation
anaplastic large cell lymphoma
Article
blood toxicity
cancer recurrence
cancer survival
clinical article
computer assisted tomography
disease free survival
drug dose reduction
drug efficacy
drug safety
drug tolerability
erythema
female
human
infusion
Italy
male
median survival time
multicenter study
multiple cycle treatment
nausea
neurotoxicity
neutropenia
observational study
overall survival
phase 2 clinical trial (topic)
positron emission tomography
progression free survival
retrospective study
survival rate
treatment response
weakness

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Broccoli, A., Pellegrini, C., Di Rocco, A., Puccini, B., Patti, C., Gini, G., Mannina, D., Tani, M., Rusconi, C., Romano, A., Vanazzi, A., Botto, B., Carlo-Stella, C., Hohaus, S., Musto, P., Mazza, P., Molica, S., Corradini, P., Fama, A., ... Zinzani, P. L. (2017). Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma. Haematologica, 102(11), 1931-1935. https://doi.org/10.3324/haematol.2017.171355

Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma. / Broccoli, A.; Pellegrini, C.; Di Rocco, A.; Puccini, B.; Patti, C.; Gini, G.; Mannina, D.; Tani, M.; Rusconi, C.; Romano, A.; Vanazzi, A.; Botto, B.; Carlo-Stella, C.; Hohaus, S.; Musto, P.; Mazza, P.; Molica, S.; Corradini, P.; Fama, A.; Gaudio, F.; Merli, M.; Gravetti, A.; Gritti, G.; Arcari, A.; Tosi, P.; Liberati, A.M.; Pinto, A.; Pavone, V.; Gherlinzoni, F.; Naso, V.; Volpetti, S.; Trentin, L.; Goldaniga, M.C.; Bonfichi, M.; De Renzo, A.; Schiavotto, C.; Spina, M.; Storti, S.; Carella, A.M.; Stefoni, V.; Argnani, L.; Zinzani, P.L.

In: Haematologica, Vol. 102, No. 11, 2017, p. 1931-1935.

Research output: Contribution to journal › Article › peer-review

Broccoli, A, Pellegrini, C, Di Rocco, A, Puccini, B, Patti, C, Gini, G, Mannina, D, Tani, M, Rusconi, C, Romano, A, Vanazzi, A, Botto, B, Carlo-Stella, C, Hohaus, S, Musto, P, Mazza, P, Molica, S, Corradini, P , Fama, A, Gaudio, F, Merli, M, Gravetti, A, Gritti, G, Arcari, A, Tosi, P, Liberati, AM, Pinto, A, Pavone, V, Gherlinzoni, F, Naso, V, Volpetti, S, Trentin, L, Goldaniga, MC , Bonfichi, M, De Renzo, A, Schiavotto, C, Spina, M, Storti, S, Carella, AM, Stefoni, V, Argnani, L & Zinzani, PL 2017, 'Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma', Haematologica, vol. 102, no. 11, pp. 1931-1935. https://doi.org/10.3324/haematol.2017.171355

Broccoli, A. ; Pellegrini, C. ; Di Rocco, A. ; Puccini, B. ; Patti, C. ; Gini, G. ; Mannina, D. ; Tani, M. ; Rusconi, C. ; Romano, A. ; Vanazzi, A. ; Botto, B. ; Carlo-Stella, C. ; Hohaus, S. ; Musto, P. ; Mazza, P. ; Molica, S. ; Corradini, P. ; Fama, A. ; Gaudio, F. ; Merli, M. ; Gravetti, A. ; Gritti, G. ; Arcari, A. ; Tosi, P. ; Liberati, A.M. ; Pinto, A. ; Pavone, V. ; Gherlinzoni, F. ; Naso, V. ; Volpetti, S. ; Trentin, L. ; Goldaniga, M.C. ; Bonfichi, M. ; De Renzo, A. ; Schiavotto, C. ; Spina, M. ; Storti, S. ; Carella, A.M. ; Stefoni, V. ; Argnani, L. ; Zinzani, P.L. / Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma. In: Haematologica. 2017 ; Vol. 102, No. 11. pp. 1931-1935.

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title = "Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma",

abstract = "Between November 2012 and July 2014, in accordance with national law 648/96, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in everyday clinical practice to check whether clinical trial results are confirmed in a real-life context. The primary endpoint of this study was best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of four cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. The overall response rate was 62.5%. At the latest follow up, 15/18 patients are still in complete remission (3 with consolidation). The progression-free survival rate at 24 months was 39.1% and the disease-free survival rate at the same time was 54% (median not reached). All the long-term responders were aged ",

keywords = "brentuximab vedotin, adolescent, adult, aged, allogeneic stem cell transplantation, anaplastic large cell lymphoma, Article, blood toxicity, cancer recurrence, cancer survival, clinical article, computer assisted tomography, disease free survival, drug dose reduction, drug efficacy, drug safety, drug tolerability, erythema, female, human, infusion, Italy, male, median survival time, multicenter study, multiple cycle treatment, nausea, neurotoxicity, neutropenia, observational study, overall survival, phase 2 clinical trial (topic), positron emission tomography, progression free survival, retrospective study, survival rate, treatment response, weakness",

author = "A. Broccoli and C. Pellegrini and {Di Rocco}, A. and B. Puccini and C. Patti and G. Gini and D. Mannina and M. Tani and C. Rusconi and A. Romano and A. Vanazzi and B. Botto and C. Carlo-Stella and S. Hohaus and P. Musto and P. Mazza and S. Molica and P. Corradini and A. Fama and F. Gaudio and M. Merli and A. Gravetti and G. Gritti and A. Arcari and P. Tosi and A.M. Liberati and A. Pinto and V. Pavone and F. Gherlinzoni and V. Naso and S. Volpetti and L. Trentin and M.C. Goldaniga and M. Bonfichi and {De Renzo}, A. and C. Schiavotto and M. Spina and S. Storti and A.M. Carella and V. Stefoni and L. Argnani and P.L. Zinzani",

note = "Cited By :1 Export Date: 21 February 2018 CODEN: HAEMA Correspondence Address: Zinzani, P.L.; Institute of Hematology “L. e A. Ser{\`a}gnoli”, University of BolognaItaly; email: pierluigi.zinzani@unibo.it",

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language = "English",

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T1 - Italian real-life experience with brentuximab vedotin: Results of a large observational study of 40 cases of relapsed/refractory systemic anaplastic large cell lymphoma

AU - Broccoli, A.

AU - Pellegrini, C.

AU - Di Rocco, A.

AU - Puccini, B.

AU - Patti, C.

AU - Gini, G.

AU - Mannina, D.

AU - Tani, M.

AU - Rusconi, C.

AU - Romano, A.

AU - Vanazzi, A.

AU - Botto, B.

AU - Carlo-Stella, C.

AU - Hohaus, S.

AU - Musto, P.

AU - Mazza, P.

AU - Molica, S.

AU - Corradini, P.

AU - Fama, A.

AU - Gaudio, F.

AU - Merli, M.

AU - Gravetti, A.

AU - Gritti, G.

AU - Arcari, A.

AU - Tosi, P.

AU - Liberati, A.M.

AU - Pinto, A.

AU - Pavone, V.

AU - Gherlinzoni, F.

AU - Naso, V.

AU - Volpetti, S.

AU - Trentin, L.

AU - Goldaniga, M.C.

AU - Bonfichi, M.

AU - De Renzo, A.

AU - Schiavotto, C.

AU - Spina, M.

AU - Storti, S.

AU - Carella, A.M.

AU - Stefoni, V.

AU - Argnani, L.

AU - Zinzani, P.L.

N1 - Cited By :1 Export Date: 21 February 2018 CODEN: HAEMA Correspondence Address: Zinzani, P.L.; Institute of Hematology “L. e A. Seràgnoli”, University of BolognaItaly; email: pierluigi.zinzani@unibo.it

PY - 2017

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N2 - Between November 2012 and July 2014, in accordance with national law 648/96, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in everyday clinical practice to check whether clinical trial results are confirmed in a real-life context. The primary endpoint of this study was best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of four cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. The overall response rate was 62.5%. At the latest follow up, 15/18 patients are still in complete remission (3 with consolidation). The progression-free survival rate at 24 months was 39.1% and the disease-free survival rate at the same time was 54% (median not reached). All the long-term responders were aged

AB - Between November 2012 and July 2014, in accordance with national law 648/96, brentuximab vedotin was available in Italy for patients with relapsed systemic anaplastic large cell lymphoma outside a clinical trial context. A large Italian observational retrospective study was conducted on the use of brentuximab vedotin in everyday clinical practice to check whether clinical trial results are confirmed in a real-life context. The primary endpoint of this study was best response; secondary endpoints were the overall response rate at the end of the treatment, duration of response, survival and safety profile. A total of 40 heavily pretreated patients were enrolled. Best response was observed after a median of four cycles in 77.5%: globally, 47.5% patients obtained a complete response, 64.2% in the elderly subset. The overall response rate was 62.5%. At the latest follow up, 15/18 patients are still in complete remission (3 with consolidation). The progression-free survival rate at 24 months was 39.1% and the disease-free survival rate at the same time was 54% (median not reached). All the long-term responders were aged

KW - brentuximab vedotin

KW - adolescent

KW - adult

KW - aged

KW - allogeneic stem cell transplantation

KW - anaplastic large cell lymphoma

KW - Article

KW - blood toxicity

KW - cancer recurrence

KW - cancer survival

KW - clinical article

KW - computer assisted tomography

KW - disease free survival

KW - drug dose reduction

KW - drug efficacy

KW - drug safety

KW - drug tolerability

KW - erythema

KW - female

KW - human

KW - infusion

KW - Italy

KW - male

KW - median survival time

KW - multicenter study

KW - multiple cycle treatment

KW - nausea

KW - neurotoxicity

KW - neutropenia

KW - observational study

KW - overall survival

KW - phase 2 clinical trial (topic)

KW - positron emission tomography

KW - progression free survival

KW - retrospective study

KW - survival rate

KW - treatment response

KW - weakness

U2 - 10.3324/haematol.2017.171355

DO - 10.3324/haematol.2017.171355

M3 - Article

VL - 102

SP - 1931

EP - 1935

JO - Haematologica

JF - Haematologica

SN - 0390-6078

IS - 11

ER -