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  • Online Resource  (5)
  • Baik, Christina S  (5)
  • Santana-Davila, Rafael  (5)
  • English  (5)
  • 1
    Online Resource
    Online Resource
    End-of-life health care utilization (EOLHCU) in patients with recurrent, metastatic head and neck squamous cell carcinoma (RMHNSCC) treated with immune checkpoint inhibitors (IO).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. e18516-e18516
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. e18516-e18516
    Abstract: e18516 Background: Demographic and EOLHCU trends are undefined in the growing population of IO-treated RMHNSCC; we sought to study these in a single institution retrospective study. Methods: We identified 228 RMHNSCC pts who received ≥1 IO dose between 01/2013 and 12/2018; of these, 74 were deceased with accessible EOLHCU data such as advanced care plan documentation (ACPD) or evidence of systemic therapy or ER/hospital/ICU admission within 30 days of death (DOD). Demographic, tumor and treatment data were obtained. Overall survival (OS) was estimated using the Kaplan Meier method; multivariable analysis was performed using a Cox proportional hazards model. In an exploratory analysis, EOLHCU was compared to a cohort of 379 deceased thoracic malignancy (TM) pts using a chi-square test. This project was approved by our institutional IRB. Results: Median pt age was 62 (25 – 90). Most were male (56, 75%), white (60, 81%), current/former smokers (46, 62%); 34 (46%) smoked ≥10 pack years. Common primary sites included the oral cavity (28, 37.8%) and oropharynx (24, 32.4%). ECOG PS at IO initiation was 0 in 15 pts (20%,) 1 in 37 (50%), 2 in 20 (27%), 3 in 1 (1%), and unknown in 1 (1%). Of the 42 (57%) treated off-trial, 18 (42%) had an ECOG ≥ 2. 71 (95%) had prior curative intent therapy. 42 (57%) had distant metastases. Compared to TM, IO-treated RMHNSCC pts were more likely to have ACPD (66% vs. 45% p 〈 0.01), an ED visit (42.3% vs 19.5%, p 〈 0.01) and/or a hospital admission (42.3% vs 17%, p 〈 0.01) within 30 DOD. There was no difference in ICU admissions within 30 DOD (9.9% vs. 8.2%, p = 0.81), ICU deaths (7% vs. 4%, p = 0.4), or systemic therapy within 7 (4.2% vs. 2.4%, p = 0.63), 14 (8.5% vs. 6.6%, p = 0.76) or 30 (25% vs 19%, p = 0.31) DOD. Among IO-treated RMHNSCC pts, multivariable analysis revealed inferior OS with worse PS (ECOG 2-3 vs. 0: HR = 7.76, p = 0.00002, 95% CI = 3.07 - 19.64; ECOG 1 vs. 0: HR = 2.97, p = 0.008, CI = 1.33 - 6.62). OS also decreased with smoking status (current/former vs. never: HR 2.18, p = 0.007, CI = 1.24-3.84). No association was observed between ECOG PS, age or smoking status at IO initiation and any EOLHCU metric. Conclusions: At our center, a significant proportion of deceased, IO-treated RMHNSCC pts had an ECOG PS ≥ 2 and an inferior OS compared to ECOG 0/1. Exploratory comparison with a non-RMHNSCC TM cohort suggests high rates of EOLHCU within 30 DOD despite ACPD, representing an opportunity for supportive care augmentation. Whether EOLHCU differs among IO vs non-IO treated RMHNSCC is unknown and merits further study.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.e18516
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 2
    Online Resource
    Online Resource
    Peripheral blood T-cell receptor repertoire profiling of advanced non-small cell lung cancer patients receiving PD-1/PD-L1 treatment.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. e21004-e21004
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. e21004-e21004
    Abstract: e21004 Background: Whether peripheral blood T cell receptor (TCR) repertoire profiling can serve as a biomarker to predict clinical benefit from anti-PD-1/PD-L1 checkpoint immunotherapy is not well understood. Moreover, it is not known which methods for TCR repertoire analysis are most clinically meaningful. To address this, we have performed TCR repertoire analysis of patients with advanced/metastatic non-small cell lung cancer (NSCLC) receiving PD-1/PD-L1 treatment. Methods: We analyzed 29 patients receiving PD-1/PD-L1 monotherapy or combination therapy in any line of treatment, excluding patients with EGFR mutations or Alk alterations. Genomic DNA was extracted from peripheral blood examples, and CDR3 regions of the rearranged TCR beta genes were amplified and sequenced using the immunoSEQ platform (Adaptive Biotechnologies, Seattle, WA). Libraries were sequenced using Illumina HiSeq 2500. TCR clonality, diversity, evenness, and the percentage of high-frequency clones ( 〉 0.1% of the repertoire) were calculated at pre-treatment and post-treatment (1 – 3 months) timepoints. Morisita’s overlap index was calculated for 25 paired pre- and post-treatment samples. Metrics were compared in patients with and without durable clinical response at 6 months using the Mann-Whitney test. Results: There were no statistically significant differences in TCR repertoire clonality, diversity, evenness, or high-frequency clones between patients with and without durable clinical benefit, either at pre-treatment or post-treatment time points (p 〉 0.05). Conclusions: TCR repertoire metrics including clonality, diversity, evenness, percentage of high-frequency clones, and Morisita’s overlap index do not predict immunotherapy responses in this cohort of advanced/metastatic NSCLC patients receiving PD-1/PD-L1 monotherapy or combination therapy. Limitations of this study include sample size and heterogeneity of the patient cohort. This highlights the need for advanced TCR repertoire metrics, for example, considering shared TCR specificities and clonal identity. In ongoing work, we are defining TCR specificity groups and TCR clones in NSCLC as biomarkers of immunotherapy responsiveness.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.e21004
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 3
    Online Resource
    Online Resource
    Prognostic role of mid-treatment PET/CT and plasma cytokines in patients undergoing chemoradiation for locally advanced non-small cell lung cancer (LA-NSCLC).
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 9040-9040
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 9040-9040
    Abstract: 9040 Background: Patients with unresectable LA-NSCLC are treated with concurrent chemoradiation (CRT) and consolidation immunotherapy with survival that range from months to years or even decades. Early predictive biomarkers have potential to identify patients who are unlikely to benefit from continuing standard of care therapy and require a change in management. We investigated biomarkers that are widely available (PET/CT scan and plasma cytokine levels) to develop early predictors (mid-CRT) of survival in a phase II clinical trial of chemoradiation for LA-NSCLC. Methods: 37 Patients with AJCC v7 stage IIB-IIIB NSCLC were prospectively enrolled on the FLARE-RT trial (NCT02773238) from 2016-9. All patients underwent chemoradiation; 18 also received adjuvant durvalumab. PET/CT exams were performed at week 3 of CRT and response status was pre-defined by published metrics. 21 patients consented to peripheral blood collection at baseline and week 3, and plasma levels of 43 common inflammatory cytokines were measured. Bootstrapping over 100 iterations of the least absolute shrinkage and selection operator (LASSO) was performed to reduce feature dimensionality and guard against false discoveries. Cox regression of selected cytokine levels and PET response status, as well as time-dependent receiver-operating characteristic (ROC) analysis, were evaluated for associations to overall survival (OS). Results: Median follow-up was 18 months with 1-year OS 81% and PFS 52%. Mid-CRT PET response (as determined by pre-defined metrics) was strongly associated with OS (HR 5.6 [1.4-22.0], p = 0.015) after adjusting for radiation target volume, with 1-yr OS 94% for responders vs. 68% for non-responders (p = 0.017). Plasma TNFα level was also prognostic for OS (HR 1.9 [1.1-3.5] , p = 0.030). TNFα retained significance for OS (HR 2.3 [1.2-4.6], p = 0.016) after adjusting for PET response. Bivariate mid-CRT PET response and TNFα generated a parsimonious model to predict OS (AUC = 0.85, 18-month horizon). Conclusions: Risk stratification for long-term survival after chemoradiation in patients with LA-NSCLC may be achievable based on mid-chemoradiation assessment of widely available biomarkers (PET imaging and plasma TNFα level). Combined functional imaging and peripheral blood biomarkers will be validated in a larger sample of our trial cohort, along with other independent patient populations. Clinical trial information: NCT02773238.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.9040
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2020
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 4
    Online Resource
    Online Resource
    Impact of ECOG performance status on recurrent/metastatic head and neck squamous cell carcinomas treated with anti-PD1 inhibitors.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e18004-e18004
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e18004-e18004
    Abstract: e18004 Background: Anti-PD1 checkpoint inhibitors (ICI) represent an established standard of care for patients with recurrent/metastatic head & neck squamous cell carcinoma (RMHNSCC). Landmark studies excluded patients with ECOG performance status (PS) ≥ 2; the benefit of ICI in this population is therefore unknown. Methods: We retrospectively reviewed RMHNSCC patients who received at least 1 dose of ICI at our institution. Demographic data and clinical outcomes were obtained; the latter included objective response to ICI (ORR), physician-documented CTCAE grade 2+ toxicity (irAE), and any unplanned hospitalization within 100-days of last ICI dose (UH). Associations between demographic data and clinical outcomes were explored using both uni- and multivariate analysis. Overall survival (OS) was estimated using a Cox proportional hazards model; ORR, irAE, and UH were evaluated with logistic regression. This project was approved by our institutional IRB. Results: We identified 152 RMHNSCC patients who were treated with ICI between 1/2013 and 1/2019. ECOG PS was 0 in 42 (27%), 1 in 75 (50%), 2 in 27 (18%), 3 in 2 (1%), and unknown in 6 (4%) patients. The median age was 61 (range: 25 - 90). 124 (82%) were male, 124 (82%) were white, and 69 (45%) were never-smokers. The most common primary sites were the oropharynx (n = 59, 40%), oral cavity (n = 39, 26%), nasopharynx (n = 11, 7%), and larynx (n = 10, 6%). 54 (36%) were p16+ oropharynx cancers. CPS score was available in 10 (6.6%). Single agent ICI was received by 118 (77%) patients. 66 (44%) had a documented irAE and 54 (36%) had an UH. A multivariate model for OS containing PS, smoking status and HPV status showed a strong association between inferior OS and ECOG 2/3 compared to 0/1 (p 〈 0.001; HR = 3.30, CI = 2.01-5.41), as well as former (vs. never) smoking status (p 〈 0.001; HR = 2.17, CI = 1.41-3.35). Current smoking (p = 0.25) did not reach statistical significance. On univariate analysis, poor PS was associated with inferior ORR (p = 0.03; OR = 0.25, CI = 0.06-0.77) and increased UH (p = 0.04; OR = 2.43, CI = 1.05—5.71). There was no significant association between irAE and any patient characteristic. Conclusions: We observed inferior overall survival among ICI-treated RMHNSCC patients with ECOG 2/3 in our single-institution, retrospective series. Our findings help frame discussion of therapeutic options in this poor-risk population. Further study must be done to determine which interventions are of greatest benefit for RMHNSCC patients with declining performance status.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e18004
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
  • 5
    Online Resource
    Online Resource
    Dual PD1 and CTLA4 immune checkpoint blockade and hypofractionated radiation in patients with salivary gland cancers.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 6011-6011
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 6011-6011
    Abstract: 6011 Background: No systemic therapy standard of care exists for recurrent/metastatic malignancies of the salivary glands (SGC) and immune checkpoint inhibitors (ICIs) have low response rates. Preclinical data in solid tumors suggest syngergistic antitumor effects of ICIs with hypofractionated radiation (XRT). This study explored the safety and activity of nivolumab (N) and ipilimumab (I)with palliative XRT. Methods: This phase I/II open label single arm trial enrolled patients (pts) with incurable SGCs (WHO 2017) with evidence of progression, ECOG 0-1, no prior antiPD1 or CTLA4 directed therapy, RECIST 1.1 measurable disease excluding the XRT site. Pts received N 3mg/kg IV Q 2 weeks x 12 doses followed by 480 mg IV Q4 weeks x 8 doses and I 1 mg/kg IV Q6 weeks x 4 doses. XRT was given to a total dose of 24Gy in 3 fractions every other day over 1 week (wk) and initiated 2 wks after the first dose of N and I. Research blood collection was obtained prior to wks 1, 8 and 16. The primary endpoint was safety and tolerability using CTCAE v. 4, secondary endpoints were objective response rates (ORR) by RECIST 1.1 criteria in non-radiated sites of measurable disease, overall survival (OS) and progression free survival (PFS). The study was approved by the FHCC IRB and registered on clinicaltrials.gov (NCT03749460). Results: Between 4/2019 and 5/2022, 20 pts were enrolled, the median age was 58 (range 27-77) years, 10 (50%) were male, 12 (60%) had ECOG 0, and 7 (35%) were Asian. Most common histologies were adenoid cystic 9 (45%) and salivary duct 4 (20%), 15 (75%) had no prior systemic therapy. Ten (50%) had both local and distant disease, 14 (70%) had commercial NGS testing, all had TMB 〈 10mut/Mb, MSI-stable tumors. All patients completed XRT with the most common XRT site being the lung 13(65%) and bone 7(35%). The median number of N doses received was 12 (range 3-20) and I doses 4 (range 1-4). Enrollment was halted until first 6 pts were assessed for dose limiting toxicities during initial 12 wks of treatment, none were observed. Among all pts enrolled, 5 (20%) Grade 3 AEs were observed: adrenal insufficiency, hypokalemia , lung infection, hypotension, and mania. No grade 4/5 toxicities were observed. One pt was not evaluable for RECIST 1.1 due to rapid disease progression: partial responses were observed in 4 (20%: 2 pts with salivary duct, 1 acinic cell and 1 adenoid cystic) with a median duration of 15.5 months (mos) (range 6-16 mos), stable disease in 6 (30%) all lasting 6 mos or greater, and progressive disease in 9 (45%). With a median follow-up of 16 mos, median OS was 25 mos (95% CI: [1.56, 2.59]) and median PFS was 7.2 mos (95% CI: [0.21, 1.56] ). Exploratory correlative peripheral blood analysis is ongoing and will be reported. Conclusions: Nivolumab/ipilimumab and palliative XRT results in low rates of severe toxicities, modest ORR but durable ORR/SD. Further work is necessary to explore predictors for response. Clinical trial information: NCT03749460 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.6011
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2023
    detail.hit.zdb_id: 2005181-5
    Location Call Number Limitation Availability
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    Online Resource
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