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  • 11
    Online Resource
    Online Resource
    How Melanoma Is Treated in Real Life
    American Medical Association (AMA) ; 2008
    In:  Archives of Dermatology Vol. 144, No. 5 ( 2008-05-01)
    Details
    In: Archives of Dermatology, American Medical Association (AMA), Vol. 144, No. 5 ( 2008-05-01)
    Type of Medium: Online Resource
    ISSN: 0003-987X
    URL: Article
    DOI: 10.1001/archderm.144.5.664
    RVK:
    XA 28900
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2008
    Location Call Number Limitation Availability
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  • 12
    Online Resource
    Online Resource
    Voodoo Medicine Still Going Strong: A Tale of Melanoma, Faith, and Failure
    American Medical Association (AMA) ; 2008
    In:  Archives of Dermatology Vol. 144, No. 1 ( 2008-01-01)
    Details
    In: Archives of Dermatology, American Medical Association (AMA), Vol. 144, No. 1 ( 2008-01-01)
    Type of Medium: Online Resource
    ISSN: 0003-987X
    URL: Article
    DOI: 10.1001/archdermatol.2007.21
    RVK:
    XA 28900
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2008
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  • 13
    Online Resource
    Online Resource
    Differential Diagnosis of Melanocytic Lesions and Molecular Biology
    American Medical Association (AMA) ; 2011
    In:  Archives of Dermatology Vol. 147, No. 2 ( 2011-02-01), p. 232-
    Details
    In: Archives of Dermatology, American Medical Association (AMA), Vol. 147, No. 2 ( 2011-02-01), p. 232-
    Type of Medium: Online Resource
    ISSN: 0003-987X
    URL: Article
    DOI: 10.1001/archdermatol.2010.438
    RVK:
    XA 28900
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2011
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  • 14
    Online Resource
    Online Resource
    Upstream MAPK pathway inhibition: MEK inhibitor followed by a BRAF inhibitor in advanced melanoma patients.
    American Society of Clinical Oncology (ASCO) ; 2013
    In:  Journal of Clinical Oncology Vol. 31, No. 15_suppl ( 2013-05-20), p. 9071-9071
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 31, No. 15_suppl ( 2013-05-20), p. 9071-9071
    Abstract: 9071 Background: The presence of activating BRAF mutations in about 60% of all metastatic melanomas (mM) has led to the development of inhibitors (i) targeting the RAF and MEK kinases. MEK is the downstream effector of BRAF. However, the blockage of the MAPK pathway is limited due to the development of resistance mechanisms. MEK resistance can confer cross-resistance to BRAF inhibition, whereas BRAF resistance is independent from the MAPK pathway. Hence, it seems reasonable to start a MAPK pathway inhibition by a BRAFi. An upstream inhibition beginning the treatment reversed with a MEKi followed by a BRAFi has not yet been clinically explored. Methods: Patients at the Dermatology Department of the University Hospital of Zurich with mM harboring a BRAF mutation formed the study cohort. Patients were divided into a group who was treated initially with a BRAFi (vemurafenib or LGX818) followed by a MEKi (AZD6244, trametinib, or MEK 162), and a group who first received a MEKi and was later treated with a BRAFi. Duration of disease control (DDC) was measured in time from the initiation of the treatment to discontinuation due to disease progression or toxicity. Results: A total of 16 patients (7 females, 9 males, age 30-73 years) with BRAF mutated mM were evaluated. The median DDC (mDDC) was similar in both groups. When patients were treated first with a BRAFi (n=7), the mDDC for BRAFi was 7.6 and for MEKi 1.7 months, respectively. In contrast, when the treatment sequence was inversed (n=9), the mDDC for MEKi was 3.9 and for BRAFi 4.7 months. We observed some benefit (partial response, stable disease) using chemotherapy after BRAFi/MEKi progression. Conclusions: This analysis indicates that the sequential MEK-RAF inhibition of the MAPK pathway is acceptable in BRAF mutant mM patients. The sum of the DDC of both groups (9.3 and 8.6 months) is comparable to the promising BRAFi/MEKi combination therapy (median PFS 9.4 months). Besides the sequenced administration analyzed here, an intermittent administration should be further studied.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/jco.2013.31.15_suppl.9071
    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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  • 15
    Online Resource
    Online Resource
    Five-year overall survival (OS) in COLUMBUS: A randomized phase 3 trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients (pts) with BRAF V600-mutant melanoma.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 9507-9507
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 9507-9507
    Abstract: 9507 Background: Combined BRAF/MEK inhibitor therapy has demonstrated benefits on progression-free survival (PFS) and OS and is standard of care for the treatment of advanced BRAF V600-mutant melanoma. Here we report a 5-year update from the COLUMBUS trial. Methods: In Part 1 of COLUMBUS, 577 pts with advanced/metastatic BRAF V600-mutant melanoma, untreated or progressed after first-line immunotherapy, were randomized 1:1:1 to encorafenib 450 mg QD + binimetinib 45 mg BID (COMBO450), encorafenib 300 mg QD (ENCO300), or vemurafenib 960 mg BID (VEM). An updated analysis including PFS, OS, objective response rate (ORR; by blinded independent central review), and safety was conducted after minimum follow-up of 65.2 months (mo). Data are as is; study is ongoing. Results: At data cut-off (Sep 15, 2020), there were 131 (68%), 117 (60%), and 145 (76%) deaths in the COMBO450, ENCO300, and VEM treatment arms, respectively. The median OS (95% CI) and 5-year OS rate (95% CI) with COMBO450 were 33.6 (24.4–39.2) mo and 34.7% (28.0–41.5), respectively (median follow-up: 70.4 mo). The 5-year OS rate (95% CI) in COMBO450 pts who had normal lactate dehydrogenase (LDH) levels at baseline was 45.1% (36.5–53.2). Median OS and 5-year OS rates for ENCO300 and VEM, as well as for pts with normal and high LDH levels and 〉 3 organs involved at baseline, are shown in the table. For COMBO450, ENCO300, and VEM, the 5-year PFS rate was 22.9%, 19.3%, and 10.2%; ORR (95% CI) was 64.1% (56.8–70.8), 51.5% (44.3–58.8), and 40.8% (33.8–48.2); and the median duration of response (DOR) was 18.6, 15.5, and 12.3 mo, respectively. Safety results were consistent with the known tolerability profile of COMBO450. Additional efficacy and updated safety analyses will be presented. Following study drug discontinuation, the most common subsequent treatment in all arms was checkpoint inhibitors. Conclusions: Updated OS and DOR results with COMBO450 demonstrate continued long-term benefits in pts with BRAF V600-mutant melanoma. Clinical trial information: NCT01909453. [Table: see text]
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.9507
    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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  • 16
    Online Resource
    Online Resource
    Percutaneous hepatic perfusion (PHP) with melphalan for patients with ocular melanoma liver metastases: Preliminary results of FOCUS (PHP-OCM-301/301A) phase III trial.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 9510-9510
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 9510-9510
    Abstract: 9510 Background: Ocular melanoma, the most common intraocular malignancy, frequently metastasizes to the liver but to date there is no established standard of care for hepatic-dominant ocular melanoma patients. The FOCUS trial began as a randomized, phase III trial (301) comparing PHP with best alternative care (BAC). The trial was subsequently amended (301A) to remove the BAC arm due to enrollment concerns. Methods: Eligible patients with hepatic-dominant ocular melanoma were randomized 1:1 to receive PHP or BAC (investigator’s choice of TACE, pembrolizumab, ipilimumab, or dacarbazine) on the 301 trial. All eligible patients received PHP on the 301A trial. PHP patients could receive up to 6 PHP treatments, repeated every 6-8 weeks with melphalan dosed at 3.0mg/kg ideal body weight (IBW). Patients with progressive disease (PD) were discontinued from study treatment and all patients are followed until death. Patientswere imaged every 12 (±2) weeks until PD. The primary endpoint, ORR (per RECIST 1.1) as assessed by Independent Review Committee, will be characterized by the point estimate and 95% CI for each group (PHP and BAC). Categorical efficacy variables will be presented as frequency counts and percentages and 95% CI. Time-to-event variables will be summarized using Kaplan-Meier methods (median and 95% CI). Results: 144 patients were enrolled overall; 102 were assigned to PHP (301: n=43; 301A: n=59) and 42 were assigned to BAC. 91 PHP patients received treatment (301: n=40; 301A: n=51) and 32 BAC patients received treatment. At the time of this analysis, 4 PHP patients were still ongoing on study treatment with a minimum follow-up of 24 weeks. 79 PHP-treated patients and 29 BAC-treated patients were evaluable for response. ORR among PHP patients was 32.9% (26/79; 95% CI: 22.75-40.40%). ORR among BAC patients was 13.8% (4/29; 95% CI: 3.89-31.66%). The median PFS was 9.03 months (95% CI: 6.24-11.83) among PHP patients and was 3.06 months (95% CI: 2.69-5.65) among BAC patients; this difference was statistically significant ( p=0.0004). Among the 94 patients assessed for safety after treatment with PHP, 40.4% of patients experienced a serious treatment-emergent adverse event, the majority of which were hematological and resolved without sequelae. There were no treatment related deaths in the trial. Conclusions: In this analysis of preliminary data from the FOCUS trial, PHP demonstrates a statistically superior ORR and significantly prolonged PFS in comparison with BAC in the treatment of hepatic metastases from ocular melanoma. The data is encouraging as efficacious treatments for hepatic metastases from ocular melanoma are desperately needed. These early data show an improvement over the previous phase III study in terms of both efficacy (ORR and PFS) as well as toxicity using second generation filters. Clinical trial information: NCT02678572.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.9510
    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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  • 17
    Online Resource
    Online Resource
    IL-6 blockade for prophylaxis and management of immune-related adverse events (irAEs) with anti-PD-1 based immunotherapy.
    American Society of Clinical Oncology (ASCO) ; 2021
    In:  Journal of Clinical Oncology Vol. 39, No. 15_suppl ( 2021-05-20), p. 9553-9553
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 39, No. 15_suppl ( 2021-05-20), p. 9553-9553
    Abstract: 9553 Background: Immune checkpoint inhibitors (ICIs) have activity across many tumor types, but activation of the immune system may also lead to significant, often steroid-refractory irAEs. We sought to determine the activity of tocilizumab, an anti-IL6R monoclonal antibody (mAb), in treatment or prevention of auto-immune irAE in ICI-treated patients (pts). Methods: Institutional databases from 2 melanoma centers were reviewed for pts treated with ICIs and tocilizumab. Treatment and melanoma outcomes were prospectively assessed. Longitudinal assessment of c-reactive protein (CRP) and assessment of clinical improvement (defined as irAE resolution to grade ≤1 CTCAEv5) or prophylaxis (absence of flare, defined as ≥ grade 2) were utilized to evaluate the benefit of tocilizumab. Paired Wilcoxon rank test was used to compare CRP levels prior to ICI administration, at the onset of irAEs and after tocilizumab administration. Results: 22 pts were identified. 2 pts were treated prophylactically (pre-existing dermatomyositis [n = 1] and giant cell arteritis [GCA, n = 1] ) before the administration of PD1. 20 pts were treated for management of irAEs due to PD1 +/-CTLA4 (multiple concurrent irAEs [n = 3], steroid refractory irAES [hepatitis & pancreatitis, n = 2], steroid+anti-TNFα refractory colitis [n = 2] , steroid+other immunosuppressive-refractory hepatitis [n = 1], cytokine release syndrome-related AEs [n = 6] , musculoskeletal irAEs [n = 6]). 15 (68.2%) pts with irAEs required hospitalization and of those, 13 (86.7%) received tocilizumab whilst inpatient. Median time to irAE onset from ICI start was 48 days (range 8-786) and from irAE onset to tocilizumab administration 32 days (range 1-192). Median time to irAE resolution from tocilizumab administration was 7 days (range 1-799). Clinical improvement/benefit was demonstrated in 21/22 patients; one patient with ir-hepatitis did not respond. Median CRP prior to ICI administration was 32mg/L (range 0.3-99), at the onset of irAE 49.5mg/L (range 0.3-251, p = 0.055) and after the tocilizumab administration 18mg/L (range 0.3-18, p = 0.0015). Tocilizumab was well tolerated with self-limiting and transient toxicities in 17 (77.3%) patients. There were two grade 4 events; gastrointestinal tract perforation and Fournier gangrene, the latter unrelated to tocilizumab. Two (9%) patients died due to melanoma. From start of ICI, median progression-free survival (PFS) was 5.88 months and median overall survival (OS) was not reached. Conclusions: Tocilizumab was a well-tolerated and effective steroid-sparing treatment for both management of irAEs, as well as prevention of a flare of pre-existing auto-immune disorders during ICI administration. Prospective trials to evaluate its efficacy and impact on cancer outcomes compared with standard strategies are required.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2021.39.15_suppl.9553
    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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  • 18
    Online Resource
    Online Resource
    Contribution of MEK Inhibition to BRAF/MEK Inhibitor Combination Treatment of BRAF -Mutant Melanoma: Part 2 of the Randomized, Open-Label, Phase III COLUMBUS Trial
    American Society of Clinical Oncology (ASCO) ; 2023
    In:  Journal of Clinical Oncology Vol. 41, No. 29 ( 2023-10-10), p. 4621-4631
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 41, No. 29 ( 2023-10-10), p. 4621-4631
    Abstract: COMBO300 improved PFS, ORR, and tolerability compared with ENCO300, confirming the contribution of binimetinib to efficacy and safety.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.22.02322
    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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  • 19
    Online Resource
    Online Resource
    FOCUS phase 3 trial results: Percutaneous hepatic perfusion (PHP) with melphalan for patients with ocular melanoma liver metastases (PHP-OCM-301/301A).
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 9510-9510
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 9510-9510
    Abstract: 9510 Background: Ocular melanoma, the most common intraocular malignancy, frequently metastasizes to the liver but to date there is no established standard of care for hepatic-dominant ocular melanoma patients. The FOCUS trial began as a randomized, Ph 3 trial (301) comparing PHP with best alternative care (BAC). The trial was subsequently amended (301A) to halt the BAC arm due to enrollment concerns. Methods: Eligible patients with hepatic-dominant ocular melanoma were randomized 1:1 to receive PHP or BAC (investigator’s choice of TACE, pembrolizumab, ipilimumab, or dacarbazine) on the 301 trial. All eligible patients received PHP on the 301A trial. PHP patients could receive up to 6 PHP treatments, repeated every 6-8 weeks with melphalan dosed at 3.0mg/kg ideal body weight (IBW). Patients with progressive disease (PD) were discontinued from study treatment and all patients are followed until death. Patientswere imaged every 12 (±2) weeks until PD. The primary endpoint, ORR (per RECIST 1.1) as assessed by Independent Review Committee, was characterized by the point estimate and 95% CI for each group (PHP and BAC). Results: 144 patients were enrolled overall; 102 were assigned to PHP (301: n = 43; 301A: n = 59) and 42 were assigned to BAC. 91 PHP patients received treatment (301: n = 40; 301A: n = 51) and 32 BAC patients received treatment. ORR among PHP patients was 35.2% (32/91; 95% CI: 25.44-45.88%). ORR among BAC patients was 12.5% (4/32; 95% CI: 3.51-28.99%; p= 0.0154). The median DOR was 14 months for PHP patients and not calculable for BAC patients. The DCR among PHP patients was 73.6% (67/91; 95% CI: 63.35-82.31%) and among BAC patients was 37.5% (12/32; 95% CI: 21.10-56.31%; p= 0.0002). The median PFS was 9.03 months (95% CI: 6.34-11.56) among PHP patients and was 3.12 months (95% CI: 2.89-5.65) among BAC patients ( p= 0.0007). The median OS was 20.53 months (95% CI: 16.59-24.35) among PHP patients and was 14.06 months (95% CI: 9.99-19.78) among BAC patients. With the last treatment occurring in May 2021, the OS, DOR, and PFS data continues to mature as patients are still being followed for survival. Among the 94 patients assessed for safety after treatment with PHP, 42.6% of patients experienced a serious treatment-emergent adverse event, the majority of which were hematological, transient in nature, and resolved without sequelae. There were no treatment related deaths in the trial. Conclusions: In this analysis of data from the FOCUS trial, PHP demonstrates superior ORR, DOR, DCR, PFS, and OS in comparison with BAC in the treatment of hepatic metastases from ocular melanoma. This therapy offers a potential option for patients with this rare indication that is associated with a poor prognosis and few treatment options. Clinical trial information: NCT02678572.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.9510
    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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  • 20
    Online Resource
    Online Resource
    Efficacy and safety of "second adjuvant" therapy with BRAF/MEK inhibitors after resection of recurrent melanoma following adjuvant PD-1–based immunotherapy.
    American Society of Clinical Oncology (ASCO) ; 2022
    In:  Journal of Clinical Oncology Vol. 40, No. 16_suppl ( 2022-06-01), p. 9575-9575
    Details
    In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 40, No. 16_suppl ( 2022-06-01), p. 9575-9575
    Abstract: 9575 Background: Both anti-PD-1 antibodies and BRAK/MEK inhibitors (BRAF/MEKi) reduce the risk of recurrence for patients with resected stage III melanoma. For patients with V600 BRAF-mutated melanoma who recur with resectable disease on or after adjuvant, many may be suitable for ‘second adjuvant' treatment after surgery. We sought to examine the efficacy and safety of ‘second adjuvant’ BRAF/MEKi in patients who recurred despite adjuvant PD-1 based immunotherapy. Methods: Patients with V600 BRAF-mutated melanoma treated with adjuvant PD-1 based immunotherapy for resected stage III/IV disease who recurred, underwent resection of recurrence and were then treated with adjuvant BRAF/MEKi were identified retrospectively from 13 centres. Demographics, disease characteristics, treatment details, and outcome data were examined. Results: 55 patients were included; median age at commencement of PD-1 was 53y, most were V600E (91%) and had IIIB (42%) or IIIC (44%) melanoma. PD-1 based adjuvant therapy included nivolumab (71%), nivolumab plus ipilimumab (14%), pembrolizumab (13%) and pembrolizumab plus mRNA-4157 vaccine (2%). Patients had initial recurrence after mean 8.4 months (95% CI 7.4-10.6), mainly while on treatment (65%), in regional nodes (42%), in-transit metastases (ITMs; 38%), both regional nodes and ITMs (7%) and distant metastases (13%). Surgical management included CLND (36%), selected nodal resection (11%), ITM resection (33%) and resection of distant metastasis (13%). A minority had adjuvant radiotherapy (17%). Stage at start of second adjuvant BRAF/MEKi included IIIB (29%), IIIC (53%) IIID (4%) and IV (15%). Patients received dabrafenib and trametinib (95%, N = 52) and encorafenib and binimetinib (5%, N = 3). After a median follow up of 21.4 months (19.7-25.4), 17 (31%) patients have recurred again. Mean duration of treatment was 9 months (95% CI 7.4-10.6); 20% ceased for toxicity, 7% for recurrence and 35% were on treatment at last follow up. The most common toxicity was pyrexia (43%) and 21% patients experienced a severe (G3-4) adverse event. Median RFS was 33.4 months (14.3.7-NR) and median DMFS was not reached. At 12 months, 72% (59-88) of patients were recurrence free and 90% (81-100) were free of distant recurrence. For those whose disease recurred again, most recurred after cessation of second adjuvant BRAF/MEKi (13/17, 76%). 7 (41%) recurred locally and 8 (47%) recurred with new metastatic disease but none had brain metastases. Conclusions: This is the first study examining outcomes of patients receiving second adjuvant targeted therapy for melanoma, after failure of adjuvant PD-1 based immunotherapy. While RFS appears shorter compared to first line trials, second adjuvant treatment with BRAF/MEKi appears safe and active in preventing further recurrence. Further data on sequencing adjuvant therapies are needed.
    Type of Medium: Online Resource
    ISSN: 0732-183X , 1527-7755
    URL: Article
    DOI: 10.1200/JCO.2022.40.16_suppl.9575
    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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