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  • American Society of Clinical Oncology (ASCO)  (9)
  • 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
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  • 2
    Online Resource
    Online Resource
    Randomized phase II trial of cisplatin and radiotherapy with or without erlotinib in patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN).
    American Society of Clinical Oncology (ASCO) ; 2012
    In:  Journal of Clinical Oncology Vol. 30, No. 15_suppl ( 2012-05-20), p. 5503-5503
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 30, No. 15_suppl ( 2012-05-20), p. 5503-5503
    Abstract: 5503 Background: The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced SCCHN. Cetuximab-radiotherapy is superior to radiotherapy alone in this population, validating EGFR as a target. Erlotinib, a small molecule inhibitor of EGFR, has activity in recurrent/metastatic disease. Adding EGFR inhibition to standard cisplatin-radiotherapy may improve efficacy. Methods: Patients with locally advanced SCCHN were randomized to receive cisplatin 100mg/m 2 on days 1,22 and 43 combined with 70Gy of radiotherapy (arm A) or the same chemoradiotherapy combined with erlotinib 150mg/day, starting one week prior to radiotherapy and continued to its completion (arm B). Randomizing 204 patients had 80% power to compare a 60% complete response rate (CRR) to a 40% null rate. Available tumors were tested for p16, ERCC1 and EGFR FISH. Results: Between June 2006 and October 2011, 204 patients were randomized. Results presented are based on intention to treat. There were more females on arm A however no other differences in patient characteristics, including p16 positivity. Patients on arm B had more rash and gastrointestinal adverse events, but treatment arms did not differ for rates of other grade III/IV toxicities or serious adverse events (SAEs). Arm A had a CRR of 61% and arm B had a CRR of 68% (p=0.3). With a median follow-up of 23 months, there were only 29 events in the overall survival analysis and 46 in the progression-free survival (PFS) analysis. The 2 and 3 year PFS were 71% and 63% for arm A and 78% and 73% for arm B (p=0.61). Conclusions: The addition of erlotinib did not increase the rate of SAEs but failed to significantly increase CRR. As seen in other recent trials, our results in both arms are superior to historical comparisons. Updated PFS data will be presented. Supported by a grant from the investigator-initiated trial program of Genentech/OSI.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2012.30.15_suppl.5503
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2012
    detail.hit.zdb_id: 2005181-5
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  • 3
    Online Resource
    Online Resource
    Gastrostomy, tracheostomy, opioid, and health care utilization among patients with recurrent/metastatic head and neck cancer receiving immunotherapy.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 28_suppl ( 2022-10-01), p. 296-296
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 28_suppl ( 2022-10-01), p. 296-296
    Abstract: 296 Background: Immune checkpoint inhibitors (ICI) are approved for recurrent and/or metastatic squamous head and neck cancers (R/M HNSCC). Landmark trials have shown stable or improved patient (pt) reported quality of life outcomes. It is unclear how these translate into gastrostomy (G) and tracheostomy (T) dependence, opioid use, or ER/unplanned hospitalizations (UH) in an unselected population. We sought to explore these in our large single institution cohort. Methods: We reviewed R/M HNSCC pts receiving ICI at a tertiary referral NCI designated cancer center. Outcomes were assessed between the first dose of ICI and 100 days after the last dose of ICI. Overall survival (OS) was estimated via Kaplan-Meier estimation. Differences between groups were assessed via log-rank testing procedure and adjusted for age, tumor characteristics, and smoking status. Results: Between 1/2012 and 12/2019, we treated 152 pts with ICI, mostly male (n = 142, 82%), partnered/married (n = 103, 68%), with median age 64 years (range 23 – 90). The most common primary sites were oropharynx (n = 55, 36%) and oral cavity (n = 33, 22%). 50 (35%) had ≥2 lines of prior systemic therapy and 29 (19%) had an ECOG ≥2. The most common pt races were white (n = 114, 75%), Asian (n = 14, 9%), and Hispanic, any race (n = 6, 4%). 83 (55%) and 23 (15%) had history of smoking and heavy alcohol use respectively. Median duration of ICI therapy was 95 days (range 1-1720). Prior to ICI, 49 (32%) had G, 17 (11%) had T, and 15 (10%) had both. While on ICI, 6 (4%) had G placed, and 1 (1%) had a G removed; 1 (1%) had T placed, and 2 (1%) had T removed. 69 (45%) had ER visits and 57 (38%) had UH; 11 (7%) were directly related to ICI adverse effects. Prior to ICI, 104 (68%) were on opiates; requirements increased in 58 (41%) pts and decreased in 17 (12%) pts. Pre-existing G prior to ICI had worse OS on log-rank testing, but significance was lost when adjusted for variables. Pre-existing T prior to ICI (p = 0.001, HR 3.08, 95% Cl [1.56,6.08] ), and pts with increasing opiate requirements on ICI (p value = 0.0007, HR 2.13, 95% Cl [1.38,3.28]) had worse OS. Conclusions: In our cohort, ICI did not change G or T usage. Pre-existing T and increasing opiate use were also associated with worse survival. Our data supports augmentation of palliative care and advanced care planning in the R/M HNSCC population.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.28_suppl.296
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2022
    detail.hit.zdb_id: 2005181-5
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  • 4
    Online Resource
    Online Resource
    Timing of postoperative radiation therapy and survival in resected salivary gland cancers: Long-term results from a single institution.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. e18052-e18052
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. e18052-e18052
    Abstract: e18052 Background: Timely administration of postoperative radiation therapy (PORT) impacts oncologic outcomes in resected squamous cell carcinomas of the head and neck. Salivary gland cancers (SGCs) are uncommon, and timing of PORT has not been extensively explored. We aimed to determine if the interval between surgery and PORT impacts outcomes in SGCs. Methods: We retrospectively identified patients with SGCs who underwent curative intent surgical resection followed by adjuvant PORT at our tertiary referral center. Demographic, tumor, and treatment data were collected. Patients with non-oncologic resections and/or delay of 〉 6 months to radiation start were excluded. Locoregional control (LRC), relapse free survival (RFS), and overall survival (OS) were estimated using the Kaplan Meier method. A multivariate analysis explored the association between demographics, tumor characteristics, and PORT timing with oncologic outcomes using a stepwise Cox proportional hazards model. Results: Between 1/1/1997 and 12/31/2017 180 eligible patients were identified. Patient characteristics are described in Table. The median time to PORT start was 61 (range 8-121) days, 169 (93.9%) of patients received neutron beam PORT. With a median follow up of 8.2 years in surviving patients, the 5-year OS and LRC estimates were 73% and 67%, respectively. In a multivariate analysis, only nodal involvement, histologic grade, and age at diagnosis were associated with OS, while nodal involvement, tumor size, and age at time of diagnosis were associated with LCR and RFS. Time to PORT start or completion was not statistically associated with survival outcomes on multivariate analysis. Conclusions: SGC patients who underwent surgery in our tertiary institution received PORT within a median of 61 days after surgery. With long term follow up, PORT timing in this retrospective series was not associated with worse oncologic outcomes, and support timely administration of PORT with 3 months of surgical resection. Further work is necessary to assess generalizability of these results.[Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.e18052
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2021
    detail.hit.zdb_id: 2005181-5
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  • 5
    Online Resource
    Online Resource
    Cetuximab concurrent with postoperative radiation (Cet-XRT) in poor risk patients with resected squamous cell carcinomas of the head and neck (SCCHN).
    American Society of Clinical Oncology (ASCO) ; 2015
    In:  Journal of Clinical Oncology Vol. 33, No. 15_suppl ( 2015-05-20), p. e17037-e17037
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 33, No. 15_suppl ( 2015-05-20), p. e17037-e17037
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2015.33.15_suppl.e17037
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2015
    detail.hit.zdb_id: 2005181-5
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  • 6
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    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
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  • 7
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    Cisplatin and Radiotherapy With or Without Erlotinib in Locally Advanced Squamous Cell Carcinoma of the Head and Neck: A Randomized Phase II Trial
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 11 ( 2013-04-10), p. 1415-1421
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 11 ( 2013-04-10), p. 1415-1421
    Abstract: The combination of cisplatin and radiotherapy is a standard treatment for patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Cetuximab-radiotherapy is superior to radiotherapy alone in this population, validating epidermal growth factor receptor (EGFR) as a target. Erlotinib is a small-molecule inhibitor of EGFR. Adding EGFR inhibition to standard cisplatin-radiotherapy may improve efficacy. Patients and Methods Patients with locally advanced SCCHN were randomly assigned to receive cisplatin 100 mg/m 2 on days 1, 22, and 43 combined with 70 Gy of radiotherapy (arm A) or the same chemoradiotherapy with erlotinib 150 mg per day, starting 1 week before radiotherapy and continued to its completion (arm B). The primary end point was complete response rate (CRR), evaluated by central review. The secondary end point was progression-free survival (PFS). Available tumors were tested for p16 and EGFR by fluorescent in situ hybridization. Results Between December 2006 and October 2011, 204 patients were randomly assigned. Arms were well balanced for all patient characteristics including p16, with the exception of more women on arm A. Patients on arm B had more rash, but treatment arms did not differ regarding rates of other grade 3 or 4 toxicities. Arm A had a CRR of 40% and arm B had a CRR of 52% (P = .08) when evaluated by central review. With a median follow-up time of 26 months and 54 progression events, there was no difference in PFS (hazard ratio, 0.9; P = .71). Conclusion Erlotinib did not increase the toxicity of cisplatin and radiotherapy in patients with locally advanced HNSCC but failed to significantly increase CRR or PFS.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2012.46.3299
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2013
    detail.hit.zdb_id: 2005181-5
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  • 8
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    A phase I clinical trial of AZD1775 in combination with neoadjuvant weekly cisplatin and docetaxel in borderline resectable head and neck squamous cell carcinoma (HNSCC).
    American Society of Clinical Oncology (ASCO) ; 2017
    In:  Journal of Clinical Oncology Vol. 35, No. 15_suppl ( 2017-05-20), p. 6034-6034
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 35, No. 15_suppl ( 2017-05-20), p. 6034-6034
    Abstract: 6034 Background: The WEE1 tyrosine kinase regulates G2/M transition and maintains genomic stability. In TP53-deficient tumors (via mutation or HPV inactivation), inhibiting WEE1 with AZD1775 can lead to unrestrained mitosis and cell death. We conducted a Phase I clinical trial of AZD1775 in combination with chemotherapy to define the toxicity profile, establish the maximal tolerated dose (MTD) and assess preliminary efficacy in borderline resectable HNSCC. Methods: Stage III/IVB HNSCC deemed borderline resectable by a multidisciplinary team were enrolled in a phase 1, 3 + 3 design to evaluate escalating doses of AZD1775 starting at 125 mg PO BID x 2.5 days alone as lead-in and in combination with cisplatin (25mg/m2) and docetaxel (35 mg/m2) for three additional weeks. Tumors were sequenced with UWOncoPlex (262 cancer genes); HPV status assessed via p16 IHC; toxicities graded with CTCAE v. 4.04; responses measured via RECIST 1.1 and through pathologic assessment when available. Trial is open but primary endpoints were met. Results: Eleven patients were screened; 10 enrolled and were evaluable for toxicities. The most common Grade ≥ 2 toxicities were diarrhea (4), fatigue (4), neutropenia (3) and nausea (3). The drug-limiting toxicity was Grade 3 diarrhea (2). The MTD was established at 150mg PO BID x 2.5 days, alone and in combination with neoadjuvant cisplatin and docetaxel. Two patients were HPV+/TP53wt, 1 was HPV+/ TP53 mut; 6 were TP53mut/HPV-; 1 was TP53 wt/HPV-. Seven out 10 patients had a response. Two patients dropped out after the first week with AZD1775, one due to an allergic reaction to docetaxel and another due to non-compliance. Eight completed neoadjuvant therapy and 7 of those converted to surgery: 2 had pathologic CRs (both HPV+/TP53wt); 4 had PR (all TP53 mutants); 1 (TP53wt/HPV-) had a PR by RECIST, but SD by pathology and 1 had PD. Conclusions: AZD1775 is safe and tolerable in combination with neoadjuvant cisplatin and docetaxel. Results show this combination to have promising anti-tumor efficacy in borderline resectable HNSCC with TP53 deficiency, and merits further investigation with the established MTD as the recommended Phase II dose. Clinical trial information: NCT02508246.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2017.35.15_suppl.6034
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2017
    detail.hit.zdb_id: 2005181-5
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  • 9
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    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
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