Erin Zagadailov
Takeda Pharmaceutical Company
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Featured researches published by Erin Zagadailov.
The Lancet | 2017
H. Miles Prince; Youn H. Kim; Steven M. Horwitz; Reinhard Dummer; Julia Scarisbrick; Pietro Quaglino; Pier Luigi Zinzani; Pascal Wolter; Jose A Sanches; Pablo L. Ortiz-Romero; Oleg E. Akilov; Larisa J. Geskin; Judith Trotman; Kerry Taylor; Stéphane Dalle; Michael Weichenthal; Jan Walewski; David E. Fisher; B. Dréno; Rudolf Stadler; Tatyana Feldman; Timothy M. Kuzel; Yinghui Wang; Maria Corinna Palanca-Wessels; Erin Zagadailov; William L. Trepicchio; Wenwen Zhang; Hui-Min Lin; Yi Liu; Dirk Huebner
BACKGROUND Cutaneous T-cell lymphomas are rare, generally incurable, and associated with reduced quality of life. Present systemic therapies rarely provide reliable and durable responses. We aimed to assess efficacy and safety of brentuximab vedotin versus conventional therapy for previously treated patients with CD30-positive cutaneous T-cell lymphomas. METHODS In this international, open-label, randomised, phase 3, multicentre trial, we enrolled adult patients with CD30-positive mycosis fungoides or primary cutaneous anaplastic large-cell lymphoma who had been previously treated. Patients were enrolled across 52 centres in 13 countries. Patients were randomly assigned (1:1) centrally by an interactive voice and web response system to receive intravenous brentuximab vedotin 1·8 mg/kg once every 3 weeks, for up to 16 3-week cycles, or physicians choice (oral methotrexate 5-50 mg once per week or oral bexarotene 300 mg/m2 once per day) for up to 48 weeks. The primary endpoint was the proportion of patients in the intention-to-treat population achieving an objective global response lasting at least 4 months per independent review facility. Safety analyses were done in all patients who received at least one dose of study drug. This trial was registered with ClinicalTrials.gov, number NCT01578499. FINDINGS Between Aug 13, 2012, and July 31, 2015, 131 patients were enrolled and randomly assigned to a group (66 to brentuximab vedotin and 65 to physicians choice), with 128 analysed in the intention-to-treat population (64 in each group). At a median follow-up of 22·9 months (95% CI 18·4-26·1), the proportion of patients achieving an objective global response lasting at least 4 months was 56·3% (36 of 64 patients) with brentuximab vedotin versus 12·5% (eight of 64) with physicians choice, resulting in a between-group difference of 43·8% (95% CI 29·1-58·4; p<0·0001). Grade 3-4 adverse events were reported in 27 (41%) of 66 patients in the brentuximab vedotin group and 29 (47%) of 62 patients in the physicians choice group. Peripheral neuropathy was seen in 44 (67%) of 66 patients in the brentuximab vedotin group (n=21 grade 2, n=6 grade 3) and four (6%) of 62 patients in the physicians choice group. One of the four on-treatment deaths was deemed by the investigator to be treatment-related in the brentuximab vedotin group; no on-treatment deaths were reported in the physicians choice group. INTERPRETATION Significant improvement in objective response lasting at least 4 months was seen with brentuximab vedotin versus physicians choice of methotrexate or bexarotene. FUNDING Millennium Pharmaceuticals Inc (a wholly owned subsidiary of Takeda Pharmaceutical Company Ltd), Seattle Genetics Inc.
Future Oncology | 2015
B. Seal; Sean D. Sullivan; Scott D. Ramsey; Carl V. Asche; Kenneth M. Shermock; S. Sarma; Erin Zagadailov; Eileen Farrelly; Michael Eaddy
AIM To describe treatments and cost of care for prostate cancer (PCa) in hospital-based outpatient and inpatient settings. METHODS Hospital encounters associated with PCa (ICD-9 codes 185, 233.4) and PCa-related treatment in a hospital claims database were included. RESULTS There were 211,440 encounters for PCa between January 2006 and December 2010 (88,151 inpatient and 123,289 outpatient). Average cost per inpatient stay was US
Leukemia & Lymphoma | 2018
Erin Zagadailov; Shelby Corman; V.V. Chirikov; C Johnson; Cynthia Macahilig; Brian Seal; Mehul Dalal; Paul J Bröckelmann; Tim Illidge
12,286 versus US
Leukemia & Lymphoma | 2018
Ashish Gautam; Yanyan Zhu; Esprit Ma; Shih-Yuan Lee; Erin Zagadailov; Jeremy Teasell; Akshara Richhariya; Vijayveer Bonthapally; Dirk Huebner
4364 per outpatient visit. Most common treatment during an inpatient stay and outpatient visit was surgery (57%) and radiation (76%), respectively. A total of 80% of outpatient visits and 69.9% inpatient stays were associated with a single treatment; remaining encounters were associated with ≥2 treatments. CONCLUSION Costs are consistent with previous estimates; however, multimodal therapy is an emerging trend that may be related to greater costs in the future which may also be a challenge for hospital decision makers.
British Journal of Haematology | 2018
Paul J. Bröckelmann; Suzanne McMullen; J Ben Wilson; Kerstin Mueller; Sarah Goring; Aspasia Stamatoullas; Erin Zagadailov; Ashish Gautam; Dirk Huebner; Mehul Dalal; Tim Illidge
Abstract This retrospective study compared effectiveness of (brentuximab vedotin) BV to other chemotherapies in patients with rrHL following an autologous stem cell transplant (ASCT). Data originated from a medical chart review of patients treated in real-world clinical settings at 50 sites in the United Kingdom and Germany. Inverse probability of treatment weights based on propensity scores were used to adjust for differences in baseline characteristics between treatment groups. Among 312 rrHL patients included, 196 received BV and 116 received physicians’ choice chemotherapy. Median PFS was significantly longer (27.0 months vs. 13.4 months; p = .0144) and 12-month OS survival greater (78.1% vs. 65.9%; p = .0129) with BV compared to chemotherapy. Documented adverse events included leukopenia (12.8%) and peripheral neuropathy (8.7%) for BV and leukopenia (12.1%), anemia (5.2%) and diarrhea (5.2%) for chemotherapy. In this real-world study, rrHL patients treated for relapse after ASCT with BV had longer median PFS and 12-month OS than patients receiving chemotherapy.
European Journal of Haematology | 2017
Paul J Bröckelmann; Erin Zagadailov; Shelby Corman; V.V. Chirikov; C Johnson; Cynthia Macahilig; Brian Seal; Mehul Dalal; Tim Illidge
Abstract The number needed to treat (NNT) with brentuximab vedotin consolidation therapy post-autologous stem cell transplant (ASCT) versus placebo in the phase 3 AETHERA trial to avoid one additional event of disease progression/death was evaluated. AETHERA included 329 Hodgkin lymphoma patients at increased risk of progression post-ASCT who received brentuximab vedotin 1.8 mg/kg (n = 165) or placebo (n = 164) on day 1 of each 21-d cycle (up to 16 cycles). Over 60 months, the NNT with brentuximab vedotin ranged from 4.08 to 7.79 for the intent-to-treat population, 3.18–6.07 for patients with ≥2 risk factors, and 2.98–5.65 for patients with ≥3 risk factors. At various time points, and dependent on the risk group, 3–8 patients would need to be treated with brentuximab vedotin consolidation therapy to prevent a disease progression/death, compared with placebo. Patients with increased risk of relapse may benefit most from brentuximab vedotin.
Journal of Clinical Oncology | 2016
Ashish Gautam; Dirk Huebner; Yanyan Zhu; Esprit Ma; Shih-Yuan Lee; Erin Zagadailov; Jeremy Teasell; Akshara Richhariya; Vijayveer Bonthapally
First‐line treatments for classical Hodgkin lymphoma (HL) include ABVD (adriamycin, bleomycin, vinblastine, dacarbazine) and BEACOPPescalated (escalated dose bleomycin, etoposide, adriamycin, cyclophosphamide, vincristine, procarbazine, prednisone). To further improve overall outcomes, positron emission tomography‐driven strategies and ABVD or BEACOPP variants incorporating the antibody‐drug conjugate brentuximab vedotin (BV) or anti‐PD1 antibodies are under investigation in advanced‐stage patients. The present study aimed to elicit preferences for attributes associated with ABVD, BEACOPPescalated and BV‐AVD (BV, adriamycin, vinblastine and dacarbazine) among patients and physicians. Cross‐sectional online discrete choice experiments were administered to HL patients (n = 381) and haematologists/oncologists (n = 357) in France, Germany and the United Kingdom. Included attributes were progression‐free survival (PFS), overall survival (OS), and the risk of neuropathy, lung damage, infertility and hospitalisation due to adverse events. Whereas 5‐year PFS and OS were the most important treatment attributes to patients, the relative importance of each attribute and preference weights for each level varied among physicians according to the description of the hypothetical patient for whom treatment was recommended. PFS and OS most strongly influenced physicians’ recommendations when considering young female patients who did not want children or young male patients. Infertility was more important to physicians’ treatment decision than PFS when considering young women with unknown fertility preferences, whereas hospitalisations due to adverse events played the largest role in treatment decisions for older patients.
Blood | 2016
Youn H. Kim; Sean Whittaker; Steven M. Horwitz; Madeleine Duvic; Reinhard Dummer; Julia Scarisbrick; Pietro Quaglino; Pier Luigi Zinzani; Pascal Wolter; Yinghui Wang; Maria Corinna Palanca-Wessels; Erin Zagadailov; William L. Trepicchio; Yi Liu; M. Little; H. Miles Prince
Brentuximab vedotin (BV) is an anti‐CD30 antibody‐drug conjugate licensed for the treatment of relapsed/refractory Hodgkin lymphoma (rrHL) following autologous stem cell transplant (ASCT) or at least two prior therapies when ASCT or multiagent chemotherapy is not an option. The objective of this study was to describe real‐world outcomes with BV in patients with rrHL considered ASCT ineligible or who refuse ASCT.
Applied Health Economics and Health Policy | 2014
B. Seal; Sean D. Sullivan; Scott D. Ramsey; Carl V. Asche; Ken Shermock; S. Sarma; Erin Zagadailov; Eileen Farrelly; Michael Eaddy
20 Background: AETHERA (NCT01100502) is a randomized Phase 3 study of BV and best supportive care (BSC) vs placebo (PBO) and BSC in the treatment of pts at risk of residual HL post-ASCT. BV consolidation therapy post-ASCT significantly improved progression-free survival (PFS) by independent review vs PBO (HR = 0.57, P = 0.001) and was FDA approved. Most common grade ≥ 3 adverse events were neutropenia (29% BV vs 10% PBO) and peripheral sensory neuropathy (10% vs 1%). The aim of this study was to determine the NNT with BV to avoid 1 additional event, disease progression/death. METHODS The NNT with BV was calculated as the inverse of the absolute risk reduction (ARR); ARR was the PFS event rate per investigator (INV) assessment in the PBO arm minus the event rate in the BV arm of the AETHERA trial. The AETHERA trial recruited pts ≥ 18 yrs at risk of residual HL post-ASCT defined by ≥ 1 of: history of refractory HL; relapse/progression < 12 months after frontline therapy; extranodal involvement at time of pre-ASCT relapse. Pts were randomized to receive BV 1.8 mg/kg or PBO on day 1 of each 21-day cycle, for up to 16 cycles/disease progression. RESULTS 329 pts (median age 32 yrs [range 18-76]; 53% male) received BV (n = 165) or PBO (n = 164). Fewer PFS events per INV analysis were experienced by pts in the BV arm vs PBO arm. The NNT with BV to prevent a disease progression/death ranged from 4.08 (95% CI 2.94, 6.96) to 7.79 pts (95% CI 5.05, 16.4) over 48 months (Table). At 24 months (time majority of pts have progressed post-ASCT), the NNT to prevent a disease progression/death was 4.92 pts (95% CI 3.29, 10.39). CONCLUSIONS AETHERA data suggest that, at various time points, 1 in every 5-8 pts treated with BV consolidation therapy will benefit by avoiding disease progression/death. This further demonstrates BVs clinical benefit in the post-ASCT consolidation setting. CLINICAL TRIAL INFORMATION NCT01100502. [Table: see text].
Journal of Thoracic Oncology | 2017
Taofeek K. Owonikoko; Kristiaan Nackaerts; Tibor Csoszi; Gyula Ostoros; Christina S. Baik; Claudio Dansky Ullmann; Erin Zagadailov; Emily Sheldon-Waniga; Dirk Huebner; E. Jane Leonard; David R. Spigel