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  • 1
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    Patients with Rare Cancers in the Drug Rediscovery Protocol (DRUP) Benefit from Genomics-Guided Treatment
    American Association for Cancer Research (AACR) ; 2022
    In:  Clinical Cancer Research Vol. 28, No. 7 ( 2022-04-01), p. 1402-1411
    Details
    In: Clinical Cancer Research, American Association for Cancer Research (AACR), Vol. 28, No. 7 ( 2022-04-01), p. 1402-1411
    Abstract: Patients with rare cancers (incidence less than 6 cases per 100,000 persons per year) commonly have less treatment opportunities and are understudied at the level of genomic targets. We hypothesized that patients with rare cancer benefit from approved anticancer drugs outside their label similar to common cancers. Experimental Design: In the Drug Rediscovery Protocol (DRUP), patients with therapy-refractory metastatic cancers harboring an actionable molecular profile are matched to FDA/European Medicines Agency–approved targeted therapy or immunotherapy. Patients are enrolled in parallel cohorts based on the histologic tumor type, molecular profile and study drug. Primary endpoint is clinical benefit (complete response, partial response, stable disease ≥ 16 weeks). Results: Of 1,145 submitted cases, 500 patients, including 164 patients with rare cancers, started one of the 25 available drugs and were evaluable for treatment outcome. The overall clinical benefit rate was 33% in both the rare cancer and nonrare cancer subgroup. Inactivating alterations of CDKN2A and activating BRAF aberrations were overrepresented in patients with rare cancer compared with nonrare cancers, resulting in more matches to CDK4/6 inhibitors (14% vs. 4%; P ≤ 0.001) or BRAF inhibitors (9% vs. 1%; P ≤ 0.001). Patients with rare cancer treated with small-molecule inhibitors targeting BRAF experienced higher rates of clinical benefit (75%) than the nonrare cancer subgroup. Conclusions: Comprehensive molecular testing in patients with rare cancers may identify treatment opportunities and clinical benefit similar to patients with common cancers. Our findings highlight the importance of access to broad molecular diagnostics to ensure equal treatment opportunities for all patients with cancer.
    Type of Medium: Online Resource
    ISSN: 1078-0432 , 1557-3265
    URL: Article
    DOI: 10.1158/1078-0432.CCR-21-3752
    RVK:
    XA 36791
    Language: English
    Publisher: American Association for Cancer Research (AACR)
    Publication Date: 2022
    detail.hit.zdb_id: 1225457-5
    detail.hit.zdb_id: 2036787-9
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  • 2
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    Efficacy and predictors of response of nivolumab in treatment-refractory MSI solid tumors: Results of a tumor-agnostic DRUP cohort.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 2590-2590
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 2590-2590
    Abstract: 2590 Background: Microsatellite unstable (MSI) tumors represent 4% of all cancer diagnoses and are known to be sensitive to immune checkpoint inhibitors (ICI). Despite the progress made, a significant proportion of patients with MSI tumors does not respond, highlighting the urgent need to identify additional predictive biomarkers. In this study, we evaluated the efficacy of the PD-1 inhibitor nivolumab across pre-treated solid MSI tumors and performed extensive biomarker analysis to better characterize ICI-effectiveness in this setting. Methods: Adult patients with MSI tumors who exhausted all standard of care treatment options were eligible for inclusion and were enrolled in the Drug Rediscovery Protocol (DRUP), a clinical trial that treats cancer patients with approved targeted- and immunotherapies outside their registered indication, based on their tumor molecular profile (NCT0295234). Patients were treated with nivolumab (four cycles of 240 mg every 2 weeks, followed by 480 mg every 4 weeks) until disease progression or unmanageable toxicity. Primary endpoint was clinical benefit (CB, objective response (OR) or stable disease ≥ 16 weeks). Whole genome sequencing and RNA sequencing were performed on pre-treatment biopsies to reveal potential predictors of response or resistance to anti-PD1. Results: 130 evaluable patients were enrolled with in total 16 different tumor types. CB was observed in 62% (95% CI 46 – 54) ( N = 80) with an OR in 45% (95% CI 53 – 70) ( N = 58). After a median follow-up of 14.5 months (95% CI 13 – 19), median progression free survival was 18 months (95% CI 9 – not reached) and median overall survival was not reached. HLA class I status and mutational burden were not significantly associated with CB. However, in depth biomarker analyses identified that mutational burden was predictive of CB in HLA-wildtype patients (52%) but not in HLA class I mutants (48%). Strikingly, in contrast to the paradigm that neoantigen-specific adaptive immunity is primarily involved in clearing MSI tumors, transcriptomics indicated that, compared to non-CB, CB was characterized by significantly higher expression of key modulators in innate immunity, including non-classical HLA transcripts (P = 4.2x10 -3 ), NKGD2 ligands MICA/MICB (P = 6.4x10 -3 ), killer immunoglobulin-like receptors ( P = 0.047) and butyrophilins ( P = 0.024). Conclusions: Nivolumab proved highly effective in pre-treated, advanced solid MSI tumors. Genomic analysis revealed that neoantigen burden only determined ICI-effectiveness in patients with wildtype HLA class I. Furthermore, transcriptomics revealed a central role of innate immunity in ICI-effectiveness in MSI tumors, which aligns with the fact that these tumors frequently lose HLA class I antigen presentation. Together, these results inform novel biomarker strategies to further refine precision medicine in this patient population. Clinical trial information: NCT0295234 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.2590
    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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  • 3
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    Update and external validation of a multivariable prediction model for tube feeding dependency for at least four weeks during chemoradiotherapy for head and neck cancer.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 6040-6040
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 6040-6040
    Abstract: 6040 Background: Patients who receive chemoradiation or bioradiation (CRT/BRT) for locally advanced head and neck squamous cell carcinoma (LAHNSCC) often experience high toxicity rates, which may interfere with oral intake, leading to (temporary) tube feeding (TF) dependency. International guidelines recommend gastrostomy insertion when the expected use of TF exceeds four weeks. In this study we aimed to update and externally validate a prediction model to identify patients in need for TF for at least four weeks, meeting the international criteria for prophylactic gastrostomy insertion. Methods: This retrospective multicenter cohort study was performed in four tertiary referral head and neck cancer centers in the Netherlands. The prediction model was developed using data from the University Medical Center Utrecht and the Netherlands Cancer Institute. The model was externally validated in patients from the Maastricht University Medical Center and Radboud University Medical Center. The primary endpoint was TF, initiated during or within 30 days after completion of CRT/BRT, and administered for at least four weeks. Potential predictors were retrieved from patient medical records and radiotherapy dose-volume parameters were calculated. Results: The developmental and validation cohort included 409 and 334 patients respectively. Multivariable analysis showed significant predictive value (p 〈 0.05) for adjusted diet at start of CRT/BRT, percentage weight change prior to treatment initiation, WHO performance status, tumor-site, nodal stage, mean radiation dose to the contralateral parotid gland, and mean radiation dose to the oral cavity. The area under the receiver operating characteristics curve for the updated model was 0.73 and after external validation 0.64. Positive and negative predictive value at 90% cut off were 80.0% and 48.2% respectively. Conclusions: This externally validated prediction model to estimate TF-dependency for at least four weeks in LAHNSCC patients performs well. This model, which will be presented, can be used in clinical practice to guide personalized decision making on prophylactic gastrostomy insertion.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.6040
    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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  • 4
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    177 Lu-PSMA radioligand therapy for patients with recurrent/metastatic (R/M) salivary gland cancer (SGC): A phase II pilot study.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 6099-6099
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 6099-6099
    Abstract: 6099 Background: New treatments are warranted due to limited systemic treatment options for SGC patients (pts). Gallium [68Ga]Ga prostate-specific membrane antigen (PSMA) PET imaging results in SGC pts have demonstrated PSMA expression of SGC and thus indicated that PSMA radionuclide therapy may be a useful option, especially in the case of adenoid cystic carcinoma (AdCC) and salivary duct carcinoma (SDC) subtypes. Therefore, this study (EudraCT number 2019-003857-27) evaluated the safety and efficacy of PSMA-targeted radionuclide therapy in AdCC and SDC pts. Methods: This was a single-center, single-arm, phase II pilot study. R/M AdCC (n = 10) and SDC (n = 5) pts with sufficient PSMA tracer uptake on [ 68 Ga]Ga-PSMA PET imaging, i.e., ≥1 lesion ≥1.5cm with PSMA expression above mean liver level, were treated with 2-4 cycles of 7.4 GBq [ 177 Lu]Lu-PSMA-I & T, with an interval of 6±1 weeks. Baseline imaging was repeated for evaluation 4 weeks after cycle 2; in case of progressive disease (PD) per RECIST 1.1 the treatment was discontinued; otherwise, pts received the full treatment (4 cycles). All pts received whole body post-therapeutic imaging after 1, 24, 48, 72 h and 7d after each cycle. The primary endpoint was safety. Secondary endpoints include the objective response rate, progression-free survival (PFS), and overall survival (OS). Results: Between 6-2020 and 2-2023, 15 AdCC pts and 10 SDC pts were screened for eligibility. Five AdCC pts and 8 SDC pts were screen failures due to insufficient PSMA expression in 11 pts (AdCC n = 4; SDC n = 7) or due to brain metastases in 2 pts (AdCC n = 1; SDC n = 1). Ten AdCC and 2 SDC pts received at least one cycle of 7.4 GBq [ 177 Lu]Lu-PSMA-I & T. The most observed adverse events (grade 1-2) included: nausea (75%), dry mouth (75%), fatigue (67%), and anemia (58%). Two pts (17%) developed grade 3 toxicity; lymphocytopenia (n = 1) and hyponatremia (n = 1). No grade 4-5 toxicities were observed. Two pts (AdCC n = 1; SDC n = 1) received only 1 treatment cycle due to early PD. The interim-treatment evaluation resulted in the discontinuation of treatment after 2 cycles in an additional 3 AdCC and the second SDC pts due to PD. Six AdCC pts received the full treatment (4 cycles); no responses were observed; 3 pts (75%) showed stable disease of more than 3 months after treatment completion (5, 15 and 21 months); 3 pts showed PD at 3 months after treatment completion. Median PFS in 10 AdCC pts was 6.7 months (95%CI: 0.0-15.1); OS was not reached after a median follow-up of 11.9 months. Conclusions: [ 177 Lu]Lu-PSMA-I & T treatment in SGC pts is well-tolerated. The efficacy in AdCC was limited; only stable disease was achieved in 3 out of 10 pts. In most screened SDC pts, PSMA expression was insufficient to undergo [ 177 Lu]Lu-PSMA-I & T treatment; the 2 SDC pts included showed early PD. Dosimetry analyses will be performed to calculate the delivered radiation doses to organs at risk as well as tumor lesions. Clinical trial information: EUCTR2019-003857-27.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.6099
    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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  • 5
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    Retrospective analysis of genetically matched therapies in salivary gland cancer entities using a real-world database in a tertiary salivary gland cancer expertise center.
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 16_suppl ( 2023-06-01), p. 6098-6098
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 16_suppl ( 2023-06-01), p. 6098-6098
    Abstract: 6098 Background: Salivary gland cancer (SGC) is a rare cancer and includes twenty-two different entities. In the Radboudumc SGC expertise center, a real-word database was set up to uniformly collect data of SGC subtypes. More than 500 SGC patients have been enrolled and collection of data for 261 patients is currently completed. Here, we describe the retrospective analysis of genetic aberrations found in different SGC entities and the treatment of selected recurrent/metastatic (R/M) patients with genetically matched therapies (GMT). Methods: All SGC patients in the SGC registry of Radboudumc between 2017 and 2022 whose tumors underwent next generation sequencing (NGS) and/or gene fusion analysis within standard of care or clinical trial were included in this analysis. Both primary tumor specimen and metastatic tissue have been used for molecular analyses. GMT was given in basket trials or on basis of compassionate use for clinically relevant genetic aberrations that are considered actionable nowadays. Results: NGS and/or gene fusion analysis data was available for 162 out of 261 patients, and most frequently in salivary duct carcinoma (SDC) patients (82/162). The number of patients with genetic aberrations differed between SGC entities. In 112 patients at least one genetic aberration and/or gene fusion was detected regardless of whether the target was druggable. Ninety-three patients out of 112 patients had R/M disease. Both a gene fusion and one or more mutations were found in six patients (adenoid cystic carcinoma [AdCC], n = 3; SDC, n = 2; and secretary carcinoma [SC] , n = 1;). Depending on the SGC subtype, in 14.3 – 100% of the R/M cases with genetic aberrations and/or gene fusions a GMT was started (SDC, 14/60; AdCC, 3/21; SC, 2/2; mucoepidermoid carcinoma, 2/4). The most given GMT among patients were monoclonal antibodies and tyrosine kinase inhibitors (TKI), respectively in nine and eleven patients, moreover immunotherapy was started in one patient. For example, eight SDC patients were treated with ERBB2 targeting agents (4/8 mutations; 4/8 copy number variants in ERBB2), showing a complete response in three patients. Additionally, one partial response and two stable diseases were observed, two patients were lost of follow-up. Two SC patients treated with a TKI based on the presence of the ETV6- NTRK gene fusion showed radiologically a partial response. Conclusions: In 69% of the SGC patients at least one genetic aberration and/or gene fusion was found, and in 23% of the R/M cases GMT was administered. Response differs between entities and GMT; a complete response was achieved after initiation of GMT in several patients. These data justify the use of NGS and gene fusion analysis in all salivary gland cancer entities, notably in subtypes lacking standard systemic therapies as this could offer other therapeutic options.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2023.41.16_suppl.6098
    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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  • 6
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    Health-related quality of life of patients treated with chemoradiotherapy plus or minus prophylactic antibiotics to reduce the number of pneumonias for locally advanced head and neck cancer, the PANTAP study
    Elsevier BV ; 2019
    In:  Oral Oncology Vol. 96 ( 2019-09), p. 105-112
    Details
    In: Oral Oncology, Elsevier BV, Vol. 96 ( 2019-09), p. 105-112
    Type of Medium: Online Resource
    ISSN: 1368-8375
    URL: Article
    DOI: 10.1016/j.oraloncology.2019.07.014
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2019
    detail.hit.zdb_id: 2011971-9
    detail.hit.zdb_id: 2202218-1
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  • 7
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    Development and external validation of a prediction model for tube feeding dependency for at least four weeks during chemoradiotherapy for head and neck cancer
    Elsevier BV ; 2022
    In:  Clinical Nutrition Vol. 41, No. 1 ( 2022-01), p. 177-185
    Details
    In: Clinical Nutrition, Elsevier BV, Vol. 41, No. 1 ( 2022-01), p. 177-185
    Type of Medium: Online Resource
    ISSN: 0261-5614
    URL: Article
    DOI: 10.1016/j.clnu.2021.11.019
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2022
    detail.hit.zdb_id: 2009052-3
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  • 8
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    Decalcification of Breast Cancer Bone Metastases With EDTA Does Not Affect ER, PR, and HER2 Results
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  American Journal of Surgical Pathology Vol. 43, No. 10 ( 2019-10), p. 1355-1360
    Details
    In: American Journal of Surgical Pathology, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. 10 ( 2019-10), p. 1355-1360
    Abstract: In metastatic breast cancer (MBC), expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2) guides treatment selection. In case of bone-only metastatic disease, ER, PR, and HER2 status assessment may be hampered by decalcification. We aimed to determine the optimal decalcification method, and to study discordance of receptor expression between paired primary breast tumors and optimally decalcified bone metastases. First, decalcification was simulated using acetic acid, hydrochloric/formic acid, and EDTA on 12 primary breast carcinomas. ER, PR, and HER2 immunohistochemistry (IHC) and HER2 in situ hybridization (ISH) were assessed, before and after the 3 decalcification methods. EDTA was considered the optimal method, as it did not affect IHC and as ISH failed in only 1/16 cases. Hydrochloric/formic acid altered ER and PR results, and, with acetic acid and hydrochloric/formic acid, ISH failed in, respectively, 94% and 100%. Second, ER, PR, and HER2 IHC was performed in paired primary tumors and EDTA-decalcified bone metastases obtained from patients with first presentation of MBC. Clinically relevant discordance was defined as changed receptor status with treatment implications. Paired samples of 77 patients, participating in the IMPACT-MBC trial, were evaluable. Hormonal receptor expression change was clinically relevant in 6 patients (7.9%) and HER2 expression change in 1 patient (1.3%). This study shows that EDTA decalcification minimally affects receptor expression results. The incidence of clinically relevant discordance between the primary tumor and bone metastases is low. These findings support that bone biopsies can reliably be used to assess receptor status.
    Type of Medium: Online Resource
    ISSN: 0147-5185
    URL: Article
    DOI: 10.1097/PAS.0000000000001321
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
    detail.hit.zdb_id: 2029143-7
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  • 9
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    A phase II study on the efficacy and toxicity of cabozantinib in recurrent/metastatic salivary gland cancer patients.
    American Society of Clinical Oncology (ASCO) ; 2020
    In:  Journal of Clinical Oncology Vol. 38, No. 15_suppl ( 2020-05-20), p. 6529-6529
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 38, No. 15_suppl ( 2020-05-20), p. 6529-6529
    Abstract: 6529 A phase II study on the efficacy and toxicity of cabozantinib in recurrent/metastatic salivary gland cancer patients. Background: Because c-MET and VEGFR are often overexpressed in salivary gland cancer (SGC), this study evaluated the efficacy and safety of cabozantinib in recurrent/metastatic (R/M) SGC pts. Methods: A single center, single arm, phase II study was conducted. Immunohistochemical c-MET positive (H-score ≥10) R/M SGC pts were included in 3 cohorts: adenoid cystic carcinoma (ACC), salivary duct carcinoma (SDC), and other SGCs. Objective growth or complaints due to the disease were required before inclusion in the ACC and other SGC cohort. No prior systemic treatments were required. Pts started 60 mg cabozantinib tablets OD. Primary endpoint was the objective response rate (ORR). A Simon two-stage design was used. In case of ≥1 objective response in the first 9 pts/cohort, 8 additional pts would be included in the cohort. Results: In total 25 pts were included from Sep. 2018 until premature closure due to severe toxicity in Nov. 2019. Median age was 56 years (range 49-72), prior treatments included: primary tumor resection ( n=19), radiotherapy ≥50Gy ( n=24), systemic therapy ( n=10; adjuvant in 2 pts, palliative in 8 pts). Six pts had grade 3 ( n=4), grade 4 ( n=1), or grade 5 ( n=1) wound/fistula complications, occurring at a median of 7.2 mths on cabozantinib (range 2.1-12.8). This resulted in a severe wound complication rate of 32% in 19 pts on treatment for ≥2 mths. Remarkably, 4 out of 6 pts developed this complication in the area exposed to high-dose Rx; 2/4 had a pre-existing fistula in this area. Median interval between Rx and start of cabozantinib was 71.3 mths (range 10.6-94.7). Other grade ≥3 adverse events in 〉 1 pt were: hypertension (5 pts), diarrhoea (2 pts) and dehydration (2 pts). Current median follow-up is 6.8 mths. The ORR was 6% (1/17 pts) in the ACC cohort, 20% (1/5 pts) in the SDC cohort, and 0% (0/3 pts) in other SGC pts; median PFS is 12.6 mths (95% CI 6.8 – 18.4 mths), 9.0 mths (insufficient events for 95% CI), and 6.9 mths (95% CI 0 – 15.2 mths), respectively. Median OS is not reached in any cohort. Conclusions: This phase II study on cabozantinib in R/M SGC pts demonstrated severe wound and fistula complications in 32% of pts on treatment for ≥2 mths, mostly (4/6 pts) within the radiotherapy field. Because of this toxicity the study was closed prematurely. Furthermore, cabozantinib showed minimal clinical activity in SGC pts. Research funding: Ipsen Pharmaceuticals Clinical trial information: NCT03729297 .
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2020.38.15_suppl.6529
    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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  • 10
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    Osteosarcoma of the head and neck (OHN): A multicenter case series of 79 adult patients in the Netherlands.
    American Society of Clinical Oncology (ASCO) ; 2014
    In:  Journal of Clinical Oncology Vol. 32, No. 15_suppl ( 2014-05-20), p. 10542-10542
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 32, No. 15_suppl ( 2014-05-20), p. 10542-10542
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2014.32.15_suppl.10542
    RVK:
    XA 52760
    RVK:
    XA 10000
    Language: English
    Publisher: American Society of Clinical Oncology (ASCO)
    Publication Date: 2014
    detail.hit.zdb_id: 2005181-5
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