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Clinical activity of cirmtuzumab, an anti-ROR1 antibody, in combination with ibrutinib: Interim results of a phase Ib/II study in mantle cell lymphoma (MCL) or chronic lymphocytic leukemia (CLL).

Lee, Hun Ju; Choi, Michael Y.; Siddiqi, Tanya; Wierda, William G.; Claudia Barrientos, Jacqueline; Lamanna, Nicole; Goldenberg, Alec; Isufi, Iris; Tuscano, Joseph M.; Subbiah, Suki; Weihe, Elizabeth Kristine; Ianopulos, Xen; Breitmeyer, James Bradley; Hsu, Frank J.; Wang, Michael; Jamieson, Catriona Hm; Kipps, Thomas J.
ISSN: 0732-183x
CID: 4848442

Cirmtuzumab, an Anti-ROR1 Antibody, in Combination with Ibrutinib: Clinical Activity in Mantle Cell Lymphoma (MCL) or Chronic Lymphocytic Leukemia (CLL) from a Phase 1/2 Study

Lee, Hun Ju; Choi, Michael Y.; Siddiqi, Tanya; Wierda, William G.; Barrientos, Jacqueline C.; Lamanna, Nicole; Goldenberg, Alec; Isufi, Iris; Tuscano, Joseph; Subbiah, Suki; Koff, Jean L.; Leslie, Lori A.; Chung, Gina G.; Weihe, Elizabeth K.; Ianopulos, Xen; Breitmeyer, James B.; Hsu, Frank J.; Wang, Michael; Jamieson, Catriona; Kipps, Thomas J.
ISSN: 0006-4971
CID: 4848462

Cirmtuzumab, a ROR1 Targeted Mab, Reverses Cancer Stemness, and Its Combination with Ibrutinib Is Safe and Effective: Planned Analysis of the Cirll Phase 1/2 Trial for CLL and MCL

Choi, Michael Y.; Ghia, Emanuela M.; Siddiqi, Tanya; Wierda, William G.; Lee, Hun Ju; Barrientos, Jacqueline C.; Lamanna, Nicole; Goldenberg, Alec; Tzachanis, Dimitrios; Reid, Erin G.; Weihe, Elizabeth K.; Rassenti, Laura Z.; Isufi, Iris; Bieler, Stewart; Ianopulos, Xen; Breitmeyer, James B.; Jamieson, Catriona; Kipps, Thomas J.
ISSN: 0006-4971
CID: 4848452

Sorafenib use for recurrent hepatocellular cancer after resection or transplantation: Observations from a US regional analysis of the GIDEON registry

Martin, Robert C G 2nd; Bruenderman, Elizabeth; Cohn, Allen; Piperdi, Bilal; Miksad, Rebecca; Geschwind, Jean-Francois; Goldenberg, Alec; Sanyal, Arun; Zigmont, Ellen; Babajanyan, Svetlana; Foreman, Pamela; Mantry, Parvez; McGuire, Brendan; Gholam, Pierre
Treatment of unresectable recurrent hepatocellular carcinoma (HCC) in patients who recur after resection or orthotopic liver transplantation (OLT) remains a clinical challenge. One option is sorafenib, although little is known about its safety and tolerance in this unique patient population; therefore, we analyzed patients who underwent prior surgical resection and/or OLT and were treated with sorafenib in US cohort of GIDEON registry. In US, 645 patients were enrolled; 553 for intent to treat and 563 for safety. Data were analyzed in the safety population of 479 patients no surgery and 56 for resection or OLT. Forty-one patients underwent resection prior to the initiation of sorafenib, 15 patients had previously received an OLT, and 6 patients had both resection and OLT. Initial low starting doses (400 mg/day) were observed for more patients with prior OLT (71%) than prior resection (36%), resection and OLT (50%), concomitant OLT (25%), and no surgery (36%). Most AEs occurred in the first 4 weeks of treatment. Drug-related AEs were higher in patients with prior resection (87%), prior OLT (100%), or both (100%) than in patients with concomitant OLT (63%) or no surgery (70%). However, incidence of AEs resulting in permanent discontinuation were similar in all groups (19-38%).
PMID: 28318501
ISSN: 1879-1883
CID: 2508152

Obesity conveys poor outcome in patients with hepatocellular carcinoma treated by transarterial chemoembolization

Wu, S E; Charles, H W; Park, J S; Goldenberg, A S; Deipolyi, A R
PURPOSE: The purpose of this retrospective study was to evaluate the impact of obesity on radiologic outcomes in patients with hepatocellular carcinoma (HCC) treated by transarterial chemoembolization (TACE). MATERIALS AND METHODS: A total of 100 TACE procedures performed in 57 patients (42 men, 15 women) with a mean age of 62 years+/-8.4 (SD) (range: 39-83 years) were retrospectively reviewed. The 1-2-month follow-up computed tomography or magnetic resonance imaging examinations was assessed for new or residual disease and radiologic response using mRECIST criteria. Patients were categorized into two groups according to body mass index (BMI). Patients with BMI<25kg/m2 were further referred as to low BMI patients and those with BMI>/=25kg/m2 as high BMI patients. Outcomes were compared between the two groups. RESULTS: Low and high BMI patients were similar in regard to age, gender, HCC etiology and stage, and pre-procedure disease burden. TACE for high BMI, compared to low BMI, patients resulted in lower complete response (39% vs. 66%) and higher progressive disease (21% vs. 5%) rates (P=0.04), and higher rates of residual disease (63% vs. 39%, P=0.02) and new lesions in untreated liver (39% vs. 18%, P=0.04) on 1-2-month follow-up imaging. CONCLUSIONS: High BMI is associated with significantly more residual disease, new lesions, and progressive disease in patients with HCC treated by TACE.
PMID: 27372418
ISSN: 2211-5684
CID: 2388212

A phase II/III multicenter, open-label, 3-arm study of gilteritinib, gilteritinib plus azacitidine, or azacitidine alone in the treatment of newly diagnosed FLT3 mutation-positive acute myeloid leukemia (AML) patients ineligible for intensive induction chemotherapy. [Meeting Abstract]

Cortes, Jorge E.; Altman, Jessica; Ritchie, Ellen K.; Larson, Richard A.; Claxton, David; Minden, Mark D.; Goldenberg, Alec; Naoe, Tomoki; Yoon, Sung-Soo; Rousselot, Philippe H.; Mueller-Tidow, Carsten; Bernal del Castillo, Teresa; Havelange, Violaine; Ciceri, Fabio; Knopinska-Posluszny, Wanda; Liu, Shufang; Shrivastava, Archita; James, Angela Joubert; Rich, Elizabeth Shima; Bahceci, Erkut
ISSN: 0732-183x
CID: 4848432

Use of Transarterial Chemoembolization (TACE) and Sorafenib in Patients with Unresectable Hepatocellular Carcinoma: US Regional Analysis of the GIDEON Registry

Geschwind, Jean-Francois H; Gholam, Pierre M; Goldenberg, Alec; Mantry, Parvez; Martin, Robert C G; Piperdi, Bilal; Zigmont, Ellen; Imperial, Joanne; Babajanyan, Svetlana; Foreman, Pamela K; Cohn, Allen
BACKGROUND: Global Investigation of Therapeutic Decisions in Hepatocellular Carcinoma and of Treatment with Sorafenib (GIDEON) is a worldwide, prospective, non-interventional study to evaluate the safety of sorafenib in a variety of patient subsets. METHODS: Eligible patients had unresectable hepatocellular carcinoma for whom the decision had been made to treat with sorafenib. Treatment strategies were instituted at the physician's discretion. Patient and disease characteristics, treatment practices, incidences of adverse events (AEs), and overall survival were collected. RESULTS: In the United States, 563 patients were evaluable for safety. Subgroup analysis was performed for patients who underwent transarterial chemoembolization (TACE) prior to the initiation of sorafenib (group A, n=158), after the initiation of sorafenib only (group B, n=29), both (group C, n=38), or did not undergo TACE (n=318). Patient demographics were similar across the groups. In group A, 29% had Child-Pugh score B or C at diagnosis, and 19% had Barcelona Clinic Liver Cancer tumor stage C or D. In group B, 48% had Child-Pugh score B or C at study entry, and 31% had BCLC stage C or D. The majority of patients in all groups initially received full-dose sorafenib. Incidences of grade >/=3 drug-related AEs were 30%, 17%, and 16% in groups A, B, and C, respectively, and 22% in patients who did not undergo TACE. No new safety signals emerged. CONCLUSIONS: The results from GIDEON reaffirm that sorafenib can be safely used in the context of TACE.
PMID: 26989658
ISSN: 2235-1795
CID: 2051182

Chronic Thalidomide and Chemoembolization for Hepatocellular Carcinoma

Wu, Jennifer; Ng, Jennifer; Christos, Paul J; Goldenberg, Alec S; Sparano, Joseph; Sung, Max W; Hochster, Howard S; Muggia, Franco M
Author Summary BACKGROUND: Transcatheter arterial chemoembolization (TACE) has been used to curtail tumor vasculature and delay tumor progression in hepatocellular carcinoma (HCC). We conducted a phase I trial to evaluate the efficacy and toxicity of thalidomide when combined with TACE in patients with advanced HCC. METHODS: Between June 2000 and November 2003, 56 patients with unresectable HCC and amenable to TACE were enrolled. The starting dose of thalidomide was 200 mg/day and was escalated every 2 weeks as tolerated to a maximum dose of 1,000 mg/day. Dose reductions and discontinuation were determined by toxicity. TACE was performed 4 weeks after initiation of thalidomide therapy and repeated as necessary. RESULTS: Overall, 47 and 55 patients were evaluable for response and toxicity, respectively; the median dose of thalidomide given was 200 mg/day. Three patients (6.38%) patients achieved complete responses, whereas 10 (21.3%) had partial responses, for an overall response rate of 27.7%, and 27 (57.5%) had stable disease. Median progression-free survival was 7 months (95% confidence interval [CI]: 5-10 months), and median OS was 21 months (95% CI: 16-28 months) (Fig. 1). Fatigue and lethargy (49.1%), constipation (47.3%), and nausea (43.6%) were common. Grade 3-4 toxicities consisted mostly of increased aspartate aminotransferase (43.6%) and elevated alanine aminotransferase (38.2%) (Table 1). CONCLUSION: Thalidomide and TACE were commonly associated with nonhematologic side effects, with fatigue and constipation being prominent. With a lack of clear therapeutic benefit, this combination is unlikely to be pursued for HCC.
PMID: 25361625
ISSN: 1083-7159
CID: 1323132

Use of staging and scoring systems in hepatocellular carcinoma (HCC): Lessons from US regional analysis of the GIDEON registry [Meeting Abstract]

Miksad, Rebecca A.; Cohn, Allen Lee; El-Khoueiry, Anthony B.; Geschwind, Jean-Francois; Gholam, Pierre Michel; Goldenberg, Alec; Mantry, Parvez; Martin, Robert C. G.; McGuire, Brendan; Piperdi, Bilal; Sanyal, Arun J.; Imperial, Joanne; Venook, Alan Paul
ISSN: 0732-183x
CID: 980832

Potential factors influencing initial sorafenib dose selection in hepatocellular carcinoma (HCC): U. S. regional analysis of GIDEON [Meeting Abstract]

Piperdi, Bilal; Cohn, Allen Lee; El-Khoueiry, Anthony B.; Geschwind, Jean-Francois; Gholam, Pierre Michel; Mantry, Parvez; Martin, Robert C. G.; McGuire, Brendan; Miksad, Rebecca A.; Sanyal, Arun J.; Venook, Alan Paul; Babajanyan, Svetlana; Goldenberg, Alec
ISSN: 0732-183x
CID: 980822