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  1. Article ; Online: Malignant Pleural Effusions in the Era of Immunotherapy and Antiangiogenic Therapy.

    Wong, Terrence / Fuld, Alexander D / Feller-Kopman, David J

    Seminars in respiratory and critical care medicine

    2023  Volume 44, Issue 4, Page(s) 447–453

    Abstract: Malignant pleural effusions (MPE) have historically been associated with a poor prognosis, and patients often require a series of invasive procedures and hospitalizations that significantly reduce quality of life at the terminus of life. However, ... ...

    Abstract Malignant pleural effusions (MPE) have historically been associated with a poor prognosis, and patients often require a series of invasive procedures and hospitalizations that significantly reduce quality of life at the terminus of life. However, advances in the management of MPE have coincided with the era of immunotherapies, and to a lesser extent, antiangiogenic therapies for the treatment of lung cancer. Landmark studies have shown these drugs to improve overall survival and progression-free survival in patients with lung cancer, but a paucity of phase III trial data exists for the impact of immune checkpoint inhibitors (ICI) on lung cancers associated with MPE. This review will focus on the leading studies investigating the impact of ICI and antiangiogenic therapies in patients with lung cancer and MPE. The diagnostic and prognostic values of vascular endothelial growth factor and endostatin expression levels in malignancy will also be discussed. These advancements are changing the paradigm of MPE management from palliation to treatment for the first time since 1767 when MPE was first reported. The future holds the promise of durable response and extended survival in patients with MPE.
    MeSH term(s) Humans ; Pleural Effusion, Malignant/drug therapy ; Pleural Effusion, Malignant/diagnosis ; Vascular Endothelial Growth Factor A ; Quality of Life ; Lung Neoplasms/drug therapy ; Immunotherapy
    Chemical Substances Vascular Endothelial Growth Factor A
    Language English
    Publishing date 2023-06-12
    Publishing country United States
    Document type Review ; Journal Article
    ZDB-ID 1183617-9
    ISSN 1098-9048 ; 1069-3424
    ISSN (online) 1098-9048
    ISSN 1069-3424
    DOI 10.1055/s-0043-1769092
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  2. Article: Malignant Pleural Effusions in the Era of Immunotherapy and Antiangiogenic Therapy

    Wong, Terrence / Fuld, Alexander D. / Feller-Kopman, David J.

    Seminars in Respiratory and Critical Care Medicine

    (Pleural Diseases)

    2023  Volume 44, Issue 04, Page(s) 447–453

    Abstract: Malignant pleural effusions (MPE) have historically been associated with a poor prognosis, and patients often require a series of invasive procedures and hospitalizations that significantly reduce quality of life at the terminus of life. However, ... ...

    Series title Pleural Diseases
    Abstract Malignant pleural effusions (MPE) have historically been associated with a poor prognosis, and patients often require a series of invasive procedures and hospitalizations that significantly reduce quality of life at the terminus of life. However, advances in the management of MPE have coincided with the era of immunotherapies, and to a lesser extent, antiangiogenic therapies for the treatment of lung cancer. Landmark studies have shown these drugs to improve overall survival and progression-free survival in patients with lung cancer, but a paucity of phase III trial data exists for the impact of immune checkpoint inhibitors (ICI) on lung cancers associated with MPE. This review will focus on the leading studies investigating the impact of ICI and antiangiogenic therapies in patients with lung cancer and MPE. The diagnostic and prognostic values of vascular endothelial growth factor and endostatin expression levels in malignancy will also be discussed. These advancements are changing the paradigm of MPE management from palliation to treatment for the first time since 1767 when MPE was first reported. The future holds the promise of durable response and extended survival in patients with MPE.
    Keywords malignant pleural effusion ; immunotherapy ; checkpoint inhibitor ; angiogenesis
    Language English
    Publishing date 2023-06-12
    Publisher Thieme Medical Publishers, Inc.
    Publishing place Stuttgart ; New York
    Document type Article
    ZDB-ID 1183617-9
    ISSN 1098-9048 ; 1069-3424
    ISSN (online) 1098-9048
    ISSN 1069-3424
    DOI 10.1055/s-0043-1769092
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  3. Article ; Online: Pemetrexed in advanced non-small-cell lung cancer.

    Fuld, Alexander D / Dragnev, Konstantin H / Rigas, James R

    Expert opinion on pharmacotherapy

    2010  Volume 11, Issue 8, Page(s) 1387–1402

    Abstract: Importance of the field: Current therapeutic options for advanced non-small-cell lung cancer (NSCLC) yield relatively modest improvements in survival leading to an ongoing search for new active treatment agents. In the past decade, pemetrexed has had an ...

    Abstract Importance of the field: Current therapeutic options for advanced non-small-cell lung cancer (NSCLC) yield relatively modest improvements in survival leading to an ongoing search for new active treatment agents. In the past decade, pemetrexed has had an increasingly established role in the treatment of advanced NSCLC in both first- and second-line settings.
    Areas covered in this review: Currently available published data on mechanism of action, pharmacokinetics, safety and efficacy of pemetrexed in the treatment of advanced NSCLC are described. Peer-reviewed publications on the development of pemetrexed and its clinical use in NSCLC were reviewed (1995 - 2009).
    What the reader will gain: Pemetrexed is a multitargeted antifolate cytotoxic agent. Key Phase II and Phase III trials are described that have shown pemetrexed's efficacy in both the first- and second-line treatment of advanced NSCLC. The efficacy of pemetrexed seems to vary between squamous and nonsquamous histologies. Possible reasons for this are explored. Additionally, the potential role of pemetrexed in maintenance therapy is discussed.
    Take home message: Pemetrexed is an effective treatment for advanced NSCLC, with an overall favorable toxicity profile. There is growing evidence that, in patients treated with pemetrexed, nonsquamous tumors have improved outcomes compared to squamous cell tumors. Pemetrexed may also have a role in maintenance therapy for NSCLC.
    MeSH term(s) Antimetabolites, Antineoplastic/pharmacokinetics ; Antimetabolites, Antineoplastic/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/metabolism ; Carcinoma, Non-Small-Cell Lung/mortality ; Carcinoma, Non-Small-Cell Lung/pathology ; Carcinoma, Squamous Cell/drug therapy ; Carcinoma, Squamous Cell/metabolism ; Carcinoma, Squamous Cell/mortality ; Carcinoma, Squamous Cell/pathology ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Glutamates/pharmacokinetics ; Glutamates/therapeutic use ; Guanine/analogs & derivatives ; Guanine/pharmacokinetics ; Guanine/therapeutic use ; Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/metabolism ; Lung Neoplasms/mortality ; Lung Neoplasms/pathology ; Pemetrexed ; Survival Rate ; Treatment Outcome
    Chemical Substances Antimetabolites, Antineoplastic ; Glutamates ; Pemetrexed (04Q9AIZ7NO) ; Guanine (5Z93L87A1R)
    Language English
    Publishing date 2010-06
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2001535-5
    ISSN 1744-7666 ; 1465-6566
    ISSN (online) 1744-7666
    ISSN 1465-6566
    DOI 10.1517/14656566.2010.482560
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  4. Article ; Online: Tumor-stage mycosis fungoides in palmoplantar localization with large-cell transformation and partial CD30 expression shows complete response to brentuximab vedotin.

    Pham, Anh Khoa / Carter, Joi B / Ratcliffe, Nora R / Fuld, Alexander D / Lansigan, Frederick / Burnside, Nancy J / Guill, Marshall A / Zug, Kathryn A / Jarvis, Lesley A / LeBlanc, Robert E

    Journal of cutaneous pathology

    2018  Volume 45, Issue 6, Page(s) 458–462

    Abstract: Mycosis fungoides in palmoplantar localization (MFPP) is a rare variant of MF that is confined to the hands and feet. Patients commonly receive treatment over many years for suspected palmoplantar dermatitis before the diagnosis is made. Most MFPP ... ...

    Abstract Mycosis fungoides in palmoplantar localization (MFPP) is a rare variant of MF that is confined to the hands and feet. Patients commonly receive treatment over many years for suspected palmoplantar dermatitis before the diagnosis is made. Most MFPP patients remain at patch or plaque stage, and often respond to treatment with radiotherapy. Herein, we describe a 77-year-old man who suffered 6 years of hand and foot dermatitis that failed multiple treatments, most notably TNF-α inhibitors and mycophenolate mofetil. He eventually developed a tumor on the hand, which was biopsied to reveal a dense dermal infiltrate of large lymphocytes (CD3+/CD4-/CD8-/TCR-BetaF1+/partial CD30+). A subsequent biopsy of an eczematous patch from his hand revealed an epidermotropic and syringotropic infiltrate comprised of smaller lymphocytes with a concordant immunophenotype and matching clonal peak with TCR gene rearrangement. He was diagnosed with MFPP and started on radiotherapy with a modest response; therefore, a decision was made to start brentuximab vedotin, which resulted in a complete response. MFPP is an exceedingly rare variant of MF that can show large-cell transformation and progress in stage. We highlight a possible association between disease progression and immunosuppressants and the potential role for treatment with brentuximab.
    MeSH term(s) Aged ; Biomarkers, Tumor/analysis ; CD30 Ligand/analysis ; CD30 Ligand/biosynthesis ; Cell Transformation, Neoplastic/pathology ; Foot ; Hand ; Humans ; Immunoconjugates/therapeutic use ; Male ; Mycosis Fungoides/drug therapy ; Mycosis Fungoides/pathology ; Skin Neoplasms/drug therapy ; Skin Neoplasms/pathology
    Chemical Substances Biomarkers, Tumor ; CD30 Ligand ; Immunoconjugates ; TNFSF8 protein, human ; brentuximab vedotin (7XL5ISS668)
    Language English
    Publishing date 2018-04-06
    Publishing country United States
    Document type Case Reports
    ZDB-ID 187078-6
    ISSN 1600-0560 ; 0303-6987
    ISSN (online) 1600-0560
    ISSN 0303-6987
    DOI 10.1111/cup.13140
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  5. Article ; Online: Berzosertib Plus Topotecan vs Topotecan Alone in Patients With Relapsed Small Cell Lung Cancer: A Randomized Clinical Trial.

    Takahashi, Nobuyuki / Hao, Zhonglin / Villaruz, Liza C / Zhang, Jun / Ruiz, Jimmy / Petty, W Jeffrey / Mamdani, Hirva / Riess, Jonathan W / Nieva, Jorge / Pachecho, Jose M / Fuld, Alexander D / Shum, Elaine / Chauhan, Aman / Nichols, Samantha / Shimellis, Hirity / McGlone, Jessie / Sciuto, Linda / Pinkiert, Danielle / Graham, Chante /
    Shelat, Meenakshi / Kattappuram, Robbie / Abel, Melissa / Schroeder, Brett / Upadhyay, Deep / Krishnamurthy, Manan / Sharma, Ajit Kumar / Kumar, Rajesh / Malin, Justin / Schultz, Christopher W / Goyal, Shubhank / Redon, Christophe E / Pommier, Yves / Aladjem, Mirit I / Gore, Steven D / Steinberg, Seth M / Vilimas, Rasa / Desai, Parth / Thomas, Anish

    JAMA oncology

    2023  Volume 9, Issue 12, Page(s) 1669–1677

    Abstract: Importance: Patients with relapsed small cell lung cancer (SCLC), a high replication stress tumor, have poor prognoses and few therapeutic options. A phase 2 study showed antitumor activity with the addition of the ataxia telangiectasia and Rad3-related ...

    Abstract Importance: Patients with relapsed small cell lung cancer (SCLC), a high replication stress tumor, have poor prognoses and few therapeutic options. A phase 2 study showed antitumor activity with the addition of the ataxia telangiectasia and Rad3-related kinase inhibitor berzosertib to topotecan.
    Objective: To investigate whether the addition of berzosertib to topotecan improves clinical outcomes for patients with relapsed SCLC.
    Design, setting, and participants: Between December 1, 2019, and December 31, 2022, this open-label phase 2 randomized clinical trial recruited 60 patients with SCLC and relapse after 1 or more prior therapies from 16 US cancer centers. Patients previously treated with topotecan were not eligible.
    Interventions: Eligible patients were randomly assigned to receive topotecan alone (group 1), 1.25 mg/m2 intravenously on days 1 through 5, or with berzosertib (group 2), 210 mg/m2 intravenously on days 2 and 5, in 21-day cycles. Randomization was stratified by tumor sensitivity to first-line platinum-based chemotherapy.
    Main outcomes and measures: The primary end point was progression-free survival (PFS) in the intention-to-treat population. Secondary end points included overall survival (OS) in the overall population and among patients with platinum-sensitive or platinum-resistant tumors. The PFS and OS for each treatment group were estimated using the Kaplan-Meier method. The log-rank test was used to compare PFS and OS between the 2 groups, and Cox proportional hazards models were used to estimate the treatment hazard ratios (HRs) and the corresponding 2-sided 95% CI.
    Results: Of 60 patients (median [range] age, 59 [34-79] years; 33 [55%] male) included in this study, 20 were randomly assigned to receive topotecan alone and 40 to receive a combination of topotecan with berzosertib. After a median (IQR) follow-up of 21.3 (18.1-28.3) months, there was no difference in PFS between the 2 groups (median, 3.0 [95% CI, 1.2-5.1] months for group 1 vs 3.9 [95% CI, 2.8-4.6] months for group 2; HR, 0.80 [95% CI, 0.46-1.41]; P = .44). Overall survival was significantly longer with the combination therapy (5.4 [95% CI, 3.2-6.8] months vs 8.9 [95% CI, 4.8-11.4] months; HR, 0.53 [95% CI, 0.29-0.96], P = .03). Adverse event profiles were similar between the 2 groups (eg, grade 3 or 4 thrombocytopenia, 11 of 20 [55%] vs 20 of 40 [50%], and any grade nausea, 9 of 20 [45%] vs 14 of 40 [35%]).
    Conclusions and relevance: In this randomized clinical trial, treatment with berzosertib plus topotecan did not improve PFS compared with topotecan therapy alone among patients with relapsed SCLC. However, the combination treatment significantly improved OS.
    Trial registration: ClinicalTrials.gov Identifier: NCT03896503.
    MeSH term(s) Humans ; Male ; Middle Aged ; Female ; Small Cell Lung Carcinoma/pathology ; Topotecan/adverse effects ; Lung Neoplasms/pathology ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Recurrence
    Chemical Substances Topotecan (7M7YKX2N15) ; berzosertib (L423PRV3V3)
    Language English
    Publishing date 2023-10-12
    Publishing country United States
    Document type Randomized Controlled Trial ; Clinical Trial, Phase II ; Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2023.4025
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  6. Article ; Online: A phase I trial and in vitro studies combining ABT-751 with carboplatin in previously treated non-small cell lung cancer patients.

    Ma, Tian / Fuld, Alexander D / Rigas, James R / Hagey, Anne E / Gordon, Gary B / Dmitrovsky, Ethan / Dragnev, Konstantin H

    Chemotherapy

    2012  Volume 58, Issue 4, Page(s) 321–329

    Abstract: Background: ABT-751 is a novel antimitotic agent that exerted cytotoxic effects in preclinical studies. Carboplatin has efficacy in treating advanced non-small cell lung cancer (NSCLC) in combination with other drugs.: Methods: Lung cancer cell lines ...

    Abstract Background: ABT-751 is a novel antimitotic agent that exerted cytotoxic effects in preclinical studies. Carboplatin has efficacy in treating advanced non-small cell lung cancer (NSCLC) in combination with other drugs.
    Methods: Lung cancer cell lines were treated with ABT-751 and/or carboplatin to investigate their impact on cell growth. A phase I study with an expansion cohort was conducted in previously treated NSCLC patients. The primary objective was the maximum tolerated dose (MTD); secondary objectives were objective response rates, median survival, time to tumor progression, dose-limiting toxicities (DLTs), and pharmacodynamic evaluation of buccal swabs.
    Results: Combining ABT-751 with carboplatin significantly reduced growth and induced apoptosis of lung cancer cell lines. Twenty advanced NSCLC patients were enrolled. MTD was ABT-751 125 mg orally twice daily for 7 days with carboplatin AUC 6. DLTs included fatigue, ileus, neutropenia and pneumonitis. Two patients had confirmed partial responses. Median overall survival was 11.7 months (95% CI 5.9-27.0). Time to tumor progression was 2.8 months (95% CI 2.0-2.7). Four of 6 patients showed decreased cyclin D1 protein in posttreatment versus pretreatment buccal swabs.
    Conclusion: Combining ABT-751 with carboplatin suppressed growth of lung cancer cell lines and had modest clinical antitumor activity in advanced NSCLC previously treated predominantly with carboplatin. Further studies of this combination are not recommended while investigations of biomarkers in different patient populations, alternative schedules and combinations may be pursued.
    MeSH term(s) Administration, Oral ; Aged ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacology ; Antineoplastic Agents/therapeutic use ; Apoptosis/drug effects ; Area Under Curve ; Carboplatin/adverse effects ; Carboplatin/pharmacology ; Carboplatin/therapeutic use ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/metabolism ; Carcinoma, Non-Small-Cell Lung/mortality ; Cell Line, Tumor ; Cyclin D1/metabolism ; Drug Therapy, Combination ; Fatigue/etiology ; Female ; Humans ; Ileus/etiology ; Lung Neoplasms/drug therapy ; Lung Neoplasms/metabolism ; Lung Neoplasms/mortality ; Male ; Middle Aged ; Neutropenia/etiology ; Pneumonia/etiology ; Sulfonamides/adverse effects ; Sulfonamides/pharmacology ; Sulfonamides/therapeutic use ; Survival Rate
    Chemical Substances ABT751 ; Antineoplastic Agents ; Sulfonamides ; Cyclin D1 (136601-57-5) ; Carboplatin (BG3F62OND5)
    Language English
    Publishing date 2012-11-12
    Publishing country Switzerland
    Document type Clinical Trial, Phase I ; Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ZDB-ID 6708-8
    ISSN 1421-9794 ; 0009-3157
    ISSN (online) 1421-9794
    ISSN 0009-3157
    DOI 10.1159/000343165
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  7. Article: A Phase I Trial and in vitro Studies Combining ABT-751 with Carboplatin in Previously Treated Non-Small Cell Lung Cancer Patients

    Ma, Tian / Fuld, Alexander D. / Rigas, James R. / Hagey, Anne E. / Gordon, Gary B. / Dmitrovsky, Ethan / Dragnev, Konstantin H.

    Chemotherapy

    2012  Volume 58, Issue 4, Page(s) 321–329

    Abstract: Background: ABT-751 is a novel antimitotic agent that exerted cytotoxic effects in preclinical studies. Carboplatin has efficacy in treating advanced non-small cell lung cancer (NSCLC) in combination with other drugs. Methods: Lung cancer cell lines were ...

    Institution Departments of Pharmacology and Toxicology and Medicine, and Norris Cotton Cancer Center, Dartmouth Medical School, Hanover, N.H Dartmouth-Hitchcock Medical Center, Lebanon, N.H., and Abbott Laboratories, Abbott Park, Ill., USA
    Abstract Background: ABT-751 is a novel antimitotic agent that exerted cytotoxic effects in preclinical studies. Carboplatin has efficacy in treating advanced non-small cell lung cancer (NSCLC) in combination with other drugs. Methods: Lung cancer cell lines were treated with ABT-751 and/or carboplatin to investigate their impact on cell growth. A phase I study with an expansion cohort was conducted in previously treated NSCLC patients. The primary objective was the maximum tolerated dose (MTD); secondary objectives were objective response rates, median survival, time to tumor progression, dose-limiting toxicities (DLTs), and pharmacodynamic evaluation of buccal swabs. Results: Combining ABT-751 with carboplatin significantly reduced growth and induced apoptosis of lung cancer cell lines. Twenty advanced NSCLC patients were enrolled. MTD was ABT-751 125 mg orally twice daily for 7 days with carboplatin AUC 6. DLTs included fatigue, ileus, neutropenia and pneumonitis. Two patients had confirmed partial responses. Median overall survival was 11.7 months (95% CI 5.9–27.0). Time to tumor progression was 2.8 months (95% CI 2.0–2.7). Four of 6 patients showed decreased cyclin D1 protein in posttreatment versus pretreatment buccal swabs. Conclusion: Combining ABT-751 with carboplatin suppressed growth of lung cancer cell lines and had modest clinical antitumor activity in advanced NSCLC previously treated predominantly with carboplatin. Further studies of this combination are not recommended while investigations of biomarkers in different patient populations, alternative schedules and combinations may be pursued.
    Keywords Phase I clinical trial ; Non-small cell lung cancer ; ABT-751 ; Carboplatin
    Language English
    Publishing date 2012-11-12
    Publisher S. Karger AG
    Publishing place Basel, Switzerland
    Document type Article
    Note Clinical Study
    ZDB-ID 6708-8
    ISSN 1421-9794 ; 0009-3157
    ISSN (online) 1421-9794
    ISSN 0009-3157
    DOI 10.1159/000343165
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  8. Article ; Online: Primary melanoma of the spinal cord: a case report, molecular footprint, and review of the literature.

    Fuld, Alexander D / Speck, Maren E / Harris, Brent T / Simmons, Nathan E / Corless, Christopher L / Tsongalis, Gregory J / Pastel, David A / Hartford, Alan C / Ernstoff, Marc S

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2011  Volume 29, Issue 17, Page(s) e499–502

    MeSH term(s) GTP-Binding Protein alpha Subunits/genetics ; GTP-Binding Protein alpha Subunits, Gq-G11 ; Humans ; Magnetic Resonance Imaging ; Male ; Melanoma/diagnosis ; Melanoma/genetics ; Melanoma/pathology ; Melanoma/surgery ; Middle Aged ; Mutation ; Spinal Cord Neoplasms/diagnosis ; Spinal Cord Neoplasms/genetics ; Spinal Cord Neoplasms/pathology ; Spinal Cord Neoplasms/surgery
    Chemical Substances GNAQ protein, human ; GTP-Binding Protein alpha Subunits ; GTP-Binding Protein alpha Subunits, Gq-G11 (EC 3.6.5.1)
    Language English
    Publishing date 2011-06-10
    Publishing country United States
    Document type Case Reports ; Journal Article ; Review
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.2010.34.0695
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