Publications by authors named "Fanale M"

Purpose: In patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), brentuximab vedotin (BV) as monotherapy or combined with either lenalidomide (Len) or rituximab (R) has demonstrated efficacy with acceptable safety. We evaluated the efficacy and safety of BV + Len + R versus placebo + Len + R in patients with R/R DLBCL.

Methods: ECHELON-3 is a randomized, double-blind, placebo-controlled, multicenter, phase 3 trial comparing BV + Len + R with placebo + Len + R in patients with R/R DLBCL.

View Article and Find Full Text PDF
Article Synopsis
  • Recent treatment options for advanced classical Hodgkin lymphoma have evolved from the longstanding ABVD regimen, with new combinations showing improved survival rates but also increased side effects.
  • A study tested a new treatment protocol (AN+AD) which replaces vinblastine with nivolumab, enrolling patients with treatment-naive stage II bulky or III/IV cHL, leading to promising response rates.
  • At the time of analysis, patients showed an 88% complete response rate and a favorable safety profile, suggesting further investigation into this new combination therapy is necessary.
View Article and Find Full Text PDF

This systematic literature review evaluated frontline treatment burden in pediatric and adolescent/young adult (AYA) patients with high-risk classical Hodgkin lymphoma (cHL) among studies originating from the United States. Data were extracted from 32 publications (screened: total, n = 3115; full-text, n = 98) representing 12 studies (randomized controlled trials [RCTs], n = 2; non-comparative, non-randomized, n = 7; observational, n = 3). High-risk disease definitions varied across studies.

View Article and Find Full Text PDF

We explored patient front-line treatment preferences in newly diagnosed stage III/IV classic Hodgkin lymphoma (cHL). The CONNECT patient survey, administered online from 30 December 2020 to 1 March 2021, examined preferences overall and by age at diagnosis in 182 adult patients diagnosed with stage III/IV cHL within the past 10 years in the United States. At diagnosis, patients' median age was 36 years; 66% of patients were younger (aged 16-41 years) and 34% older (aged 42-85 years).

View Article and Find Full Text PDF
Article Synopsis
  • Primary cutaneous anaplastic large-cell lymphomas (pcALCLs) are a form of cutaneous T-cell lymphoma that consistently express CD30, unlike mycosis fungoides (MF), which shows varied expression.
  • In a study called ALCANZA, patients with pcALCLs or CD30-positive MF treated with brentuximab vedotin (BV) had better outcomes in terms of response rates and longer survival compared to those receiving other standard therapies like methotrexate or bexarotene.
  • The analysis found that in a real-world setting, patients treated with BV showed significantly improved treatment duration, response rates, progression-free survival, and healthcare resource use compared to those receiving other
View Article and Find Full Text PDF

Purpose: As part of the CONNECT study, we evaluated the caregiver role in treatment decision-making when caring for patients with classic Hodgkin lymphoma (cHL) in the USA.

Methods: The CONNECT caregiver survey was administered online December 2020-March 2021 to self-identified adult caregivers of cHL patients recruited from patient referrals and online panels. The caregiver's role in treatment decision-making, health-related quality of life (HRQoL, PROMIS-Global), and work impacts (WPAI:CG) were assessed.

View Article and Find Full Text PDF

To understand US physicians' frontline (1L) treatment preferences/decision-making for stage III/IV classic Hodgkin lymphoma (cHL). Medical oncologists and/or hematologists (≥2 years' practice experience) who treat adults with stage III/IV cHL were surveyed online (October-November 2020). Participants (n = 301) most commonly considered trial efficacy/safety data and national guidelines when selecting 1L cHL treatments.

View Article and Find Full Text PDF

Purpose: To evaluate the use of interim positron emission tomography-computed tomography (PET-CT) scans and Deauville 5-point scale (5PS) score reporting for stage III/IV classic Hodgkin lymphoma (cHL) treated frontline (1L) in community oncology settings.

Methods: This retrospective, observational study included adults with stage III/IV cHL initiating 1L doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD), brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine, or an escalated dosing regimen of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone within the US Oncology Network between January 2017 and October 2019. Data were collected from electronic health records and chart reviews and summarized descriptively.

View Article and Find Full Text PDF

In newly diagnosed stage III/IV classic Hodgkin lymphoma (cHL), A+AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine) improved overall survival (OS) versus ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine). As clinical trial and real-world populations may differ, real-world treatment characteristics and OS (rwOS) were assessed for patients with stage III/IV cHL treated with frontline ABVD. This retrospective, observational analysis of deidentified electronic health record data (1/1/2011-8/31/2020) evaluated baseline disease and clinical characteristics, treatment patterns, and rwOS in patients with stage III/IV cHL treated with frontline ABVD.

View Article and Find Full Text PDF

The six-year ECHELON-1 update showed a survival advantage for frontline (1 L) A + AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine) vs ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine) for stage III/IV classic Hodgkin lymphoma (cHL). As clinical trials have limited ability to track patients for extended periods, we developed an oncology simulation model using ECHELON-1 data to estimate population-based cHL outcomes in the US over 10 years (through 2031). The model included a scenario without (64.

View Article and Find Full Text PDF

Background: Since Food and Drug Administration approval of brentuximab vedotin in combination with cyclophosphamide, doxorubicin, and prednisone (A + CHP) as initial therapy for previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL), there has been limited research on real-world patient characteristics, treatment patterns, and clinical outcomes.

Methods: We retrospectively analyzed claims of patients with PTCL treated with frontline A + CHP or CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone) using the Symphony Health Solutions database. Adults with International Classification of Diseases-9/10 PTCL diagnosis codes who initiated A + CHP or CHOP between November 2018 and July 2021 were included.

View Article and Find Full Text PDF

Purpose: We surveyed oncologists who treat classic Hodgkin lymphoma (cHL) as part of the CONNECT study to understand the treatment decision-making process, including the impact of positron emission tomography/computed tomography (PET/CT) imaging.

Methods: US physicians self-identifying as oncologists, hematologists, or hematologists/oncologists with ≥2 years of practice experience who treated ≥1 adult with stage III/IV cHL in the frontline setting in the last year were surveyed (October 19-November 16, 2020). Physician demographics, guideline adherence, and PET/CT utilization, interpretation, and access barriers were assessed.

View Article and Find Full Text PDF

Purpose: Chemoimmunotherapy for patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) is largely unchanged for decades. Both preclinical models and clinical data suggest the combination of lenalidomide and ibrutinib may have synergy in DLBCL, particularly in the non-germinal center B-cell-like subset.

Methods: We enrolled 60 patients with newly diagnosed non-germinal center B-cell-like DLBCL in this investigator-initiated, single-arm phase II trial of rituximab, lenalidomide, and ibrutinib (RLI) with the sequential addition of chemotherapy (ClinicalTrials.

View Article and Find Full Text PDF

Peripheral T-cell lymphomas (PTCLs) are a heterogeneous group of aggressive non-Hodgkin lymphomas, the majority of which have high relapse rates following standard therapy. Despite use of consolidative stem cell transplant (SCT) following frontline therapy, there remains no consensus on its utility. The double-blind randomized phase 3 ECHELON-2 study (#NCT01777152; clinicaltrials.

View Article and Find Full Text PDF

Background: For patients with peripheral T-cell lymphoma (PTCL), outcomes using frontline treatment with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) or CHOP-like therapy are typically poor. The ECHELON-2 study demonstrated that brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A+CHP) exhibited statistically superior progression-free survival (PFS) per independent central review and improvements in overall survival versus CHOP for the frontline treatment of patients with systemic anaplastic large cell lymphoma or other CD30-positive PTCL.

Patients And Methods: ECHELON-2 is a double-blind, double-dummy, randomized, placebo-controlled, active-comparator phase III study.

View Article and Find Full Text PDF

Peripheral T-cell lymphomas (PTCL) are a unique subset of lymphomas with a poor prognosis due to limited treatment options. We performed a phase 1 study of carfilzomib in patients with relapsed/refractory PTCL to determine the safety profile and the maximum tolerated dose (MTD) of this agent. The study was a classical 3 + 3 phase 1 design with intra-patient dose escalation allowed beginning on day 8 of cycle 1 and subsequently.

View Article and Find Full Text PDF

Background: Despite advances in the treatment of Hodgkin lymphoma with the introduction of PET-adapted regimens, practical challenges prevent more widespread use of these approaches. The ECHELON-1 study assessed the safety and efficacy of front-line A+AVD (brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine) versus ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) in patients with stage III or IV classical Hodgkin lymphoma. The primary analysis showed improved modified progression-free survival with A+AVD.

View Article and Find Full Text PDF

Purpose: Preclinical and early clinical data suggested that combining histone deacetylase (HDAC) and mTOR inhibitors can synergistically inhibit Hodgkin lymphoma.

Patients And Methods: During the dose-escalation study (ClinicalTrials.gov number: NCT01087554) with the HDAC inhibitor vorinostat and the mTOR inhibitor sirolimus (V+S), a patient with Hodgkin lymphoma refractory to nine prior therapies demonstrated a partial response (PR) lasting for 18.

View Article and Find Full Text PDF

R-FND (rituximab, fludarabine, mitoxantrone, and dexamethasone) can induce molecular remissions in indolent lymphoma. The addition of yttrium ibritumomab tiuxetan (YIT) radioimmunotherapy following first-line induction treatment in patients with advanced follicular lymphoma (FL) may improve remission rates. We now report 10-year follow-up results from our sequential treatment approach with an abbreviated regimen of R-FND followed by YIT consolidation and rituximab maintenance.

View Article and Find Full Text PDF

Purpose: Burkitt lymphoma is an aggressive B-cell lymphoma curable with dose-intensive chemotherapy derived from pediatric leukemia regimens. Treatment is acutely toxic with late sequelae. We hypothesized that dose-adjusted etoposide, doxorubicin, cyclophosphamide, vincristine, prednisone, and rituximab (DA-EPOCH-R) may obviate the need for highly dose-intensive chemotherapy in adults with Burkitt lymphoma.

View Article and Find Full Text PDF

Objectives: To evaluate the cost-effectiveness of brentuximab vedotin (Adcetris) in combination with cyclophosphamide, doxorubicin, and prednisone (A+CHP) in the first-line setting for CD30-expressing peripheral T-cell lymphoma (PTCL).

Study Design: An economic model was developed using clinical and quality-of-life (QOL) data from the ECHELON-2 trial, in which A+CHP demonstrated significant improvement in progression-free survival (PFS) and overall survival (OS) versus cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP).

Methods: A partitioned survival model, consisting of 3 health states (PFS, postprogression survival, and death), was constructed from a US payer perspective over a lifetime time horizon.

View Article and Find Full Text PDF

CD5+ diffuse large B-cell lymphoma (DLBCL), NOS represents a distinct subset of DLBCL associated with poorer outcomes and extranodal disease. We analyzed characteristics and outcomes for 102 CD5+ DLBCL patients diagnosed between 2001-2016. The majority had poor-risk disease based on R-IPI scores; 80% had extranodal disease at diagnosis.

View Article and Find Full Text PDF

In KEYNOTE-087, pembrolizumab had a 69% overall response rate and acceptable safety in patients with relapsed/refractory classical Hodgkin lymphoma (rrHL). We assessed health-related quality of life (HRQoL) in KEYNOTE-087. The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and the EuroQoL Five Dimensions Questionnaire 3-level version (EQ-5D) were administered to 206 patients across three cohorts defined by lymphoma progression after: (1) autologous stem cell transplantation (ASCT) and subsequent brentuximab vedotin (BV) ( = 69); (2) salvage chemotherapy and BV ( = 79); and (3) ASCT without post-transplantation BV ( = 58).

View Article and Find Full Text PDF