Supplementary Figure S1 from Sunitinib-Induced Myeloid Lineage Redistribution in Renal Cell Cancer Patients: CD1c+ Dendritic Cell Frequency Predicts Progression-Free Survival

Redistribution

10.1158/1078-0432.22439656

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Supplementary figure 1 from Anti–PD-1 Efficacy in Patients with Metastatic Urothelial Cancer Associates with Intratumoral Juxtaposition of T Helper-Type 1 and CD8+ T cells

Maud Rijnders Hayri E. Balcıoğlu Debbie Robbrecht Astrid A.M. Oostvogels Rebecca Wijers

Study design

Urothelial cancer

10.1158/1078-0432.22482048.v1

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Supplementary figure 7 from Anti–PD-1 Efficacy in Patients with Metastatic Urothelial Cancer Associates with Intratumoral Juxtaposition of T Helper-Type 1 and CD8+ T cells

Maud Rijnders Hayri E. Balcıoğlu Debbie Robbrecht Astrid A.M. Oostvogels Rebecca Wijers

CD20+ B-cells are present in immune cell niches in lesions of responders upon anti-PD1 treatment

Urothelial cancer

10.1158/1078-0432.22482027.v1

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Postapproval trials versus patient registries: comparability of advanced melanoma patients with brain metastases

Melanoma Research (2020)

Rawa K. Ismail Nienke O. Sikkes Michel W.J.M. Wouters Doranne L. Hilarius Anna M.G. Pasmooij

Postapproval trials and patient registries have their pros and cons in the generation of postapproval data. No direct comparison between clinical outcomes of these data sources currently exists for advanced melanoma patients. We aimed to investigate whether a patient registry can complement or even replace postapproval trials. Postapproval single-arm clinical trial data from the Medicines Evaluation Board and real-world data from the Dutch Melanoma Treatment Registry were used. The study population consisted of advanced melanoma patients with brain metastases treated with targeted therapies (BRAF- or BRAF-MEK inhibitors) in the first line. A Cox hazard regression model and a propensity score matching (PSM) model were used to compare the two patient populations. Compared to patients treated in postapproval trials (n = 467), real-world patients (n = 602) had significantly higher age, higher ECOG performance status, more often ≥3 organ involvement and more symptomatic brain metastases. Lactate dehydrogenase levels were similar between both groups. The unadjusted median overall survival (mOS) in postapproval clinical trial patients was 8.7 (95% CI, 8.1-10.4) months compared to 7.2 (95% CI, 6.5-7.7) months (P < 0.01) in real-world patients. With the Cox hazard regression model, survival was adjusted for prognostic factors, which led to a statistically insignificant difference in mOS for trial and real-world patients of 8.7 (95% CI, 7.9-10.4) months compared to 7.3 (95% CI, 6.3-7.9) months, respectively. The PSM model resulted in 310 matched patients with similar survival (P = 0.9). Clinical outcomes of both data sources were similar. Registries could be a complementary data source to postapproval clinical trials to establish information on clinical outcomes in specific subpopulations.

Real world data

10.1097/cmr.0000000000000707

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Supplementary figure 3 from Anti–PD-1 Efficacy in Patients with Metastatic Urothelial Cancer Associates with Intratumoral Juxtaposition of T Helper-Type 1 and CD8+ T cells

Maud Rijnders Hayri E. Balcıoğlu Debbie Robbrecht Astrid A.M. Oostvogels Rebecca Wijers

Clusters of peripheral blood CD4+ T-cell subsets in mUC patients with and without a tumor response to anti-PD1

Urothelial cancer

10.1158/1078-0432.22482042

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Supplementary table 1 from Anti–PD-1 Efficacy in Patients with Metastatic Urothelial Cancer Associates with Intratumoral Juxtaposition of T Helper-Type 1 and CD8+ T cells

Maud Rijnders Hayri E. Balcıoğlu Debbie Robbrecht Astrid A.M. Oostvogels Rebecca Wijers

Immune parameters in blood, plasma and tumor tissue from mUC patients with stable disease as best overall response to anti-PD1

Urothelial cancer

10.1158/1078-0432.22482015.v1

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Comprehensive characterization of circulating tumor cells and cell‐free DNA in patients with metastatic melanoma

Molecular Oncology (2024)

Manouk K. Bos Jaco Kraan Martijn P.A. Starmans Jean C. A. Helmijr Noortje Verschoor

Advances in therapeutic approaches for melanoma urge the need for biomarkers that can identify patients at risk for recurrence and to guide treatment. The potential use of liquid biopsies in identifying biomarkers is increasingly being recognized. Here, we present a head‐to‐head comparison of several techniques to analyze circulating tumor cells (CTCs) and cell‐free DNA (cfDNA) in 20 patients with metastatic melanoma. In this study, we investigated whether diagnostic leukapheresis (DLA) combined with multimarker flow cytometry (FCM) increased the detection of CTCs in blood compared to the CellSearch platform. Additionally, we characterized cfDNA at the level of somatic mutations, extent of aneuploidy and genome‐wide DNA methylation. Both CTCs and cfDNA measures were compared to tumor markers and extracranial tumor burden on radiological imaging. Compared to the CellSearch method applied on peripheral blood, DLA combined with FCM increased the proportion of patients with detectable CTCs from 35% to 70% ( P = 0.06). However, the median percentage of cells that could be recovered by the DLA procedure was 29%. Alternatively, cfDNA mutation and methylation analysis detected tumor load in the majority of patients (90% and 93% of samples successfully analyzed, respectively). The aneuploidy score was positive in 35% of all patients. From all tumor measurements in blood, lactate dehydrogenase (LDH) levels were significantly correlated to variant allele frequency ( P = 0.004). Furthermore, the presence of CTCs in DLA was associated with tumor burden ( P < 0.001), whereas the presence of CTCs in peripheral blood was associated with number of lesions on radiological imaging ( P < 0.001). In conclusion, DLA tended to increase the proportion of patients with detectable CTCs but was also associated with low recovery. Both cfDNA and CTCs were correlated with clinical parameters such as LDH levels and extracranial tumor burden.

Circulating tumor cell

Liquid biopsy

Cell-free fetal DNA

10.1002/1878-0261.13650

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Long-term survival of patients with advanced melanoma treated with BRAF-MEK inhibitors

Melanoma Research (2022)

Rawa K. Ismail Karijn P.M. Suijkerbuijk Anthonius de Boer Maaike van Dartel Doranne L. Hilarius

Recent results of patients with advanced melanoma treated with first-line BRAF-MEK inhibitors in clinical trials showed 5-year survival in one-third of patients with a median overall survival (OS) of more than 2 years. This study aimed to investigate these patients' real-world survival and identify the characteristics of long-term survivors. The study population consisted of patients with advanced cutaneous melanoma with a BRAF-V600 mutated tumor who were treated with first-line BRAF-MEK inhibitors between 2013 and 2017. Long-term survival was defined as a minimum OS of 2 years from start therapy. The median progression-free survival (mPFS) and median OS (mOS) of real-world patients ( n = 435) were respectively 8.0 (95% CI, 6.8-9.4) and 11.7 (95% CI, 10.3-13.5) months. Two-year survival was reached by 28% of the patients, 22% reached 3-year survival and 19% reached 4-year survival. Real-world patients often had brain metastases (41%), stage IV M1c disease (87%), ECOG PS ≥2 (21%), ≥3 organ sites (62%) and elevated LDH of ≥250 U/I (49%). Trial-eligible real-world patients had an mOS of 17.9 months. Patients surviving more than 2 years ( n = 116) more often had an ECOG PS ≤1 (83%), normal LDH (60%), no brain metastases (60%), no liver metastases (63%) and <3 organ sites (60%). Long-term survival of real-world patients treated with first-line BRAF-MEK inhibitors is significantly lower than that of trial patients, which is probably explained by poorer baseline characteristics of patients treated in daily practice. Long-term survivors generally had more favorable characteristics with regard to age, LDH level and metastatic sites, compared to patients not reaching long-term survival.

10.1097/cmr.0000000000000832

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Real-world outcomes of ipilimumab plus nivolumab for advanced melanoma in the Netherlands

Annals of Oncology (2019)

Michiel C.T. van Zeijl Michel W.J.M. Wouters Alfons J.M. van den Eertwegh L. C. de Wreede Maureen J.B. Aarts

10.1093/annonc/mdz255.041

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