Brentuximab vedotin in relapsed/refractory Hodgkin lymphoma. The Hellenic experience

Abstract

This retrospective study aimed to describe the Hellenic experience on the use of brentuximab vedotin (BV) in relapsed/refractory (R/R) Hodgkin lymphoma (HL) given within its indication. From June 2011 to April 2015, ninety‐five patients with R/R HL, who received BV in 20 centers from Greece, were analyzed. Their median age was 33 years, and 62% were males. Sixty‐seven patients received BV after autologous stem cell transplantation failure, whereas 28 patients were treated with BV without a prior autologous stem cell transplantation, due to advanced age/comorbidities or chemorefractory disease. The median number of prior treatments was 4 and 44% of the patients were refractory to their most recent therapy. The median number of BV cycles was 8 (range, 2‐16), and the median time to best response was the fourth cycle. Fifty‐seven patients achieved an objective response: twenty‐two (23%), a complete response (CR), and 35 patients (37%), a partial, for an overall response rate of 60%. Twelve patients (13%) had stable disease, and the remaining twenty‐six (27%) had progressive disease as their best response. At a median follow‐up of 11.5 months, median progression‐free survival and overall survival were 8 and 26.5 months, respectively. Multivariate analysis showed that chemosensitivity to treatment administered before BV was associated with a significantly increased probability of achieving response to BV (P = .005). Bulky disease (P = .01) and response to BV (P <.001) were significant for progression‐free survival, while refractoriness to most recent treatment (P = .04), bulky disease (P = .005), and B‐symptoms (P = .001) were unfavorable factors for overall survival. Among the 22 CRs, 5 remain in CR with no further treatment after BV at a median follow‐up of 13 months. In conclusion, our data indicate that BV is an effective treatment for R/R HL patients even outside clinical trials. Whether BV can cure a fraction of patients remains to be seen.

Positive impact of brentuximab vedotin on overall survival of patients with classical Hodgkin lymphoma who relapse or progress after autologous stem cell transplantation: A nationwide analysis

“…The results of this study led to the accelerated Food and Drug Administration (FDA) approval of BV in 2011. Although these results have been reproduced by other studies, the impact of BV on the overall survival (OS) of patients with R/R cHL has not been addressed so far . In this study, we present data obtained from 214 patients with R/R HL after auto‐SCT reported in the Greek registry.…”

Targeted Drug Brentuximab Vedotin for Treatment of Relapsed or Refractory Cd30-Positive Hodgkin’s Lymphoma

“…До 5 % пациентов с полным ответом после терапии БВ (от 5 до 11 пациентов [17,18]) остаются в ремиссии без какого-либо последующего ле-чения. В базовом исследовании сообщается о 9 (9 %) таких пациентах [6].…”

“…Показатели эффективности БВ у пациентов с р / р CD30-положительной ЛХ после как минимум 2 линий предшествующей терапии в случаях, когда аутоТГСК и комбинированная химиотерапия не рассматриваются как вариант терапии, из обзора Европейского агентства по лекарственным средствам [27] Показатели Все пациенты (n=59), чел. (%) Наибольшее число публикаций было найдено для сме-шанной популяции -13 публикаций: 10 из них о про-грамме дорегистрационного использования препарата по запросу врача (Named Patient Program, NPP) в разных странах: Франция [16,23,25], Италия [19], Германия [21], Турция [20], Азия [26], Греция [18], в том числе 2 система-тических обзора [11,12], 2 публикации по применению БВ в Италии после окончания NPP [17,22], а также 1 систе-матический обзор и мета-анализ [10]. Все исследования, кроме систематических обзоров, имеют уровень доказа-тельности С как ретроспективные несравнительные иссле-дования.…”

“…Медиана ОВ была достигнута только в греческом исследовании и со-ставила 26,5 мес. [18]. Среднее число циклов БВ составило от 4,5 до 10,5.…”

“…(p<0,021). В греческом исследовании сообщается, что чувствитель-ность к лечению перед БВ увеличивает возможность отве-та на терапию (p=0,005) [18].…”