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  1. Article ; Online: T-Cell Lymphoma From CAR T-Cell Therapy-A New Safety Notice.

    Prasad, Vinay

    JAMA

    2024  Volume 331, Issue 5, Page(s) 389–390

    MeSH term(s) Humans ; Immunotherapy, Adoptive/adverse effects ; Lymphoma, T-Cell/etiology ; Receptors, Antigen, T-Cell/therapeutic use ; Receptors, Chimeric Antigen/therapeutic use
    Chemical Substances Receptors, Antigen, T-Cell ; Receptors, Chimeric Antigen
    Language English
    Publishing date 2024-01-11
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2023.27885
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  2. Article ; Online: CAR T cells in multiple myeloma: lessons learned.

    Prasad, Vinay

    Nature reviews. Clinical oncology

    2024  

    Language English
    Publishing date 2024-05-07
    Publishing country England
    Document type Journal Article
    ZDB-ID 2491410-1
    ISSN 1759-4782 ; 1759-4774
    ISSN (online) 1759-4782
    ISSN 1759-4774
    DOI 10.1038/s41571-024-00898-8
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  3. Article: Neoadjuvant followed by adjuvant pembrolizumab in melanoma: time biases in the data analysis of the SWOG S1801 trial.

    Olivier, Timothée / Prasad, Vinay

    Translational oncology

    2024  Volume 45, Page(s) 101959

    Abstract: The SWOG S1801 trial investigated the role of pembrolizumab, an anti-PD1 immune checkpoint inhibitor, in the perioperative setting of stage III or IV melanoma. This phase 2 trial compared two groups: one receiving pembrolizumab both before and after ... ...

    Abstract The SWOG S1801 trial investigated the role of pembrolizumab, an anti-PD1 immune checkpoint inhibitor, in the perioperative setting of stage III or IV melanoma. This phase 2 trial compared two groups: one receiving pembrolizumab both before and after surgery (neoadjuvant-adjuvant), and another receiving it only post-surgery (adjuvant-only), with event-free survival (EFS) as the primary endpoint. Neoadjuvant strategies, involving pre-surgical drug administration, potentially offer rapid tumor control and a unique opportunity to assess tumor response. However, they may expose to toxicity and delay or preclude surgery. The study met its primary endpoint, with a 72 % EFS rate in the neoadjuvant-adjuvant group, and 49 % in the adjuvant group. Here, we question the results' applicability with three potential limitations. Key concerns include an arbitrary rule in event assignment, possibly affecting the event distribution over time. Second, different rates of early censoring between groups introduce the possibility of informative censoring, which could have led to an artefactual benefit in EFS. Lastly, phase 2 trial results, by definition, carry risk of fluke results, and should be confirmed in phase 3 trial before wide adoption. Collectively, these factors must be integrated into a careful interpretation of the SWOG S1801 trial outcomes. More robust data are needed to fully appraise strengths and limitations of neoadjuvant pembrolizumab in melanoma treatment.
    Language English
    Publishing date 2024-04-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2443840-6
    ISSN 1936-5233
    ISSN 1936-5233
    DOI 10.1016/j.tranon.2024.101959
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  4. Article ; Online: Reliable, cheap, fast and few: What is the best study for assessing medical practices? Randomized controlled trials or synthetic control arms?

    Prasad, Vinay

    European journal of clinical investigation

    2021  Volume 51, Issue 8, Page(s) e13580

    MeSH term(s) Historically Controlled Study/economics ; Humans ; Observational Studies as Topic/economics ; Randomized Controlled Trials as Topic/economics
    Language English
    Publishing date 2021-06-19
    Publishing country England
    Document type Journal Article
    ZDB-ID 186196-7
    ISSN 1365-2362 ; 0014-2972 ; 0960-135X
    ISSN (online) 1365-2362
    ISSN 0014-2972 ; 0960-135X
    DOI 10.1111/eci.13580
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  5. Article ; Online: COVID-19 vaccines: history of the pandemic's great scientific success and flawed policy implementation.

    Prasad, Vinay / Haslam, Alyson

    Monash bioethics review

    2024  

    Abstract: The COVID-19 vaccine has been a miraculous, life-saving advance, offering staggering efficacy in adults, and was developed with astonishing speed. The time from sequencing the virus to authorizing the first COVID-19 vaccine was so brisk even the ... ...

    Abstract The COVID-19 vaccine has been a miraculous, life-saving advance, offering staggering efficacy in adults, and was developed with astonishing speed. The time from sequencing the virus to authorizing the first COVID-19 vaccine was so brisk even the optimists appear close-minded. Yet, simultaneously, United States' COVID-19 vaccination roll-out and related policies have contained missed opportunities, errors, run counter to evidence-based medicine, and revealed limitations in the judgment of public policymakers. Misplaced utilization, contradictory messaging, and poor deployment in those who would benefit most-the elderly and high-risk-alongside unrealistic messaging, exaggeration, and coercion in those who benefit least-young, healthy Americans-is at the heart. It is important to consider the history of COVID-19 vaccines to identify where we succeeded and where we failed, and the effects that these errors may have more broadly on vaccination hesitancy and routine childhood immunization programs in the decades to come.
    Language English
    Publishing date 2024-03-09
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2510076-2
    ISSN 1836-6716 ; 1321-2753
    ISSN (online) 1836-6716
    ISSN 1321-2753
    DOI 10.1007/s40592-024-00189-z
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  6. Article ; Online: Sotorasib in KRAS

    Olivier, Timothée / Prasad, Vinay

    Lancet (London, England)

    2024  Volume 403, Issue 10422, Page(s) 145

    MeSH term(s) Humans ; Lung Neoplasms/drug therapy ; Lung Neoplasms/genetics ; Proto-Oncogene Proteins p21(ras) ; Piperazines ; Pyridines ; Mutation ; Pyrimidines
    Chemical Substances sotorasib (2B2VM6UC8G) ; Proto-Oncogene Proteins p21(ras) (EC 3.6.5.2) ; Piperazines ; Pyridines ; KRAS protein, human ; Pyrimidines
    Language English
    Publishing date 2024-01-11
    Publishing country England
    Document type Letter
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(23)02035-4
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  7. Article ; Online: Equal censoring but still informative: When the reasons for censoring differ between treatment arms.

    Olivier, Timothée / Prasad, Vinay

    European journal of cancer (Oxford, England : 1990)

    2024  Volume 201, Page(s) 113942

    Abstract: In randomized controlled trials, informative censoring has been described as a potential bias, mainly affecting time-to-event composite endpoints, like progression-free survival (PFS). It is usually suspected in the presence of unequal attrition rates ... ...

    Abstract In randomized controlled trials, informative censoring has been described as a potential bias, mainly affecting time-to-event composite endpoints, like progression-free survival (PFS). It is usually suspected in the presence of unequal attrition rates between arms. Early censoring occurs for different reasons: patients may withdraw from a trial because of toxicity, or because of disappointment with their allocation arm. If censoring is more frequent in one arm due to increased toxicity, this removes the frailest individuals and introduces a bias favoring this arm. Conversely, patients who withdraw because of disappointment of their allocation arm may be more affluent and healthy patients, who will seek treatment options outside the protocol. In trials with one treatment arm presenting higher toxicity rates, and the other arm potentially leading to patient disappointment, censoring can occur for different reasons in each arm however with the same rates. We modeled this hypothesis in a randomized controlled trial where modifying only 15% of censored patients' fate in each arm at early time-points made the PFS gain fade. Equal censoring but for different reasons is a hitherto unexplored form of informative censoring with potentially large implications across the cancer clinical trials landscape.
    MeSH term(s) Humans ; Survival Analysis ; Neoplasms/drug therapy ; Randomized Controlled Trials as Topic
    Language English
    Publishing date 2024-02-17
    Publishing country England
    Document type Journal Article
    ZDB-ID 82061-1
    ISSN 1879-0852 ; 0277-5379 ; 0959-8049 ; 0964-1947
    ISSN (online) 1879-0852
    ISSN 0277-5379 ; 0959-8049 ; 0964-1947
    DOI 10.1016/j.ejca.2024.113942
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  8. Article ; Online: Dual Checkpoint Inhibition in Melanoma With ≥1% PD-L1-Time to Reassess the Evidence.

    Donia, Marco / Prasad, Vinay

    JAMA oncology

    2024  

    Language English
    Publishing date 2024-05-16
    Publishing country United States
    Document type Journal Article
    ISSN 2374-2445
    ISSN (online) 2374-2445
    DOI 10.1001/jamaoncol.2024.1117
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  9. Article ; Online: Our best weapons against cancer are not magic bullets.

    Prasad, Vinay

    Nature

    2020  Volume 577, Issue 7791, Page(s) 451

    MeSH term(s) Humans ; Neoplasms/prevention & control ; Neoplasms/therapy
    Language English
    Publishing date 2020-01-21
    Publishing country England
    Document type News ; Comment
    ZDB-ID 120714-3
    ISSN 1476-4687 ; 0028-0836
    ISSN (online) 1476-4687
    ISSN 0028-0836
    DOI 10.1038/d41586-020-00116-2
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  10. Article ; Online: Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer.

    Prasad, Vinay

    The New England journal of medicine

    2020  Volume 382, Issue 9, Page(s) 876

    MeSH term(s) Benzimidazoles ; Carbamates ; Cetuximab ; Colorectal Neoplasms ; Humans ; Proto-Oncogene Proteins B-raf ; Sulfonamides
    Chemical Substances Benzimidazoles ; Carbamates ; Sulfonamides ; binimetinib (181R97MR71) ; encorafenib (8L7891MRB6) ; BRAF protein, human (EC 2.7.11.1) ; Proto-Oncogene Proteins B-raf (EC 2.7.11.1) ; Cetuximab (PQX0D8J21J)
    Language English
    Publishing date 2020-03-03
    Publishing country United States
    Document type Letter ; Comment
    ZDB-ID 207154-x
    ISSN 1533-4406 ; 0028-4793
    ISSN (online) 1533-4406
    ISSN 0028-4793
    DOI 10.1056/NEJMc1915676
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