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"Melanoma"
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Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma
In a randomized trial involving more than 900 patients undergoing resection of advanced melanoma, adjuvant nivolumab was associated with a higher rate of 12-month recurrence-free survival than ipilimumab (70.5% vs. 60.8%) and with fewer adverse events.
Journal Article
The neuroscientist who lost her mind : my tale of madness and recovery
As a deadly cancer spread inside her brain, neuroscientist Barbara Lipska was plunged into madness--only to miraculously survive with her memories intact. In the tradition of \"My Stroke of Insight\" and \"Brain on Fire,\" this memoir recounts her ordeal and explains its unforgettable lessons about the brain and mind.
Book
Adjuvant Dabrafenib plus Trametinib in Stage III BRAF-Mutated Melanoma
In patients with surgically resected melanoma, those with
BRAF
mutations who received 1 year of oral adjuvant therapy with dabrafenib and trametinib had a 53% lower risk of 3-year recurrence than those who received placebo.
Journal Article
Five-Year Outcomes with Dabrafenib plus Trametinib in Metastatic Melanoma
In long-term follow-up of more than 500 patients with melanoma containing a
BRAF
V600E or V600K mutation, a combination of dabrafenib plus trametinib was associated with progression-free survival in 19% of the patients and overall survival in 34% at 5 years. A complete response to dabrafenib plus trametinib was the strongest predictor of long-term survival.
Journal Article
Neoadjuvant immune checkpoint blockade in high-risk resectable melanoma
Preclinical studies suggest that treatment with neoadjuvant immune checkpoint blockade is associated with enhanced survival and antigen-specific T cell responses compared with adjuvant treatment
1
; however, optimal regimens have not been defined. Here we report results from a randomized phase 2 study of neoadjuvant nivolumab versus combined ipilimumab with nivolumab in 23 patients with high-risk resectable melanoma (
NCT02519322
). RECIST overall response rates (ORR), pathologic complete response rates (pCR), treatment-related adverse events (trAEs) and immune correlates of response were assessed. Treatment with combined ipilimumab and nivolumab yielded high response rates (RECIST ORR 73%, pCR 45%) but substantial toxicity (73% grade 3 trAEs), whereas treatment with nivolumab monotherapy yielded modest responses (ORR 25%, pCR 25%) and low toxicity (8% grade 3 trAEs). Immune correlates of response were identified, demonstrating higher lymphoid infiltrates in responders to both therapies and a more clonal and diverse T cell infiltrate in responders to nivolumab monotherapy. These results describe the feasibility of neoadjuvant immune checkpoint blockade in melanoma and emphasize the need for additional studies to optimize treatment regimens and to validate putative biomarkers.
Neoadjuvant combination treatment with nivolumab and ipilimumab in patients with high-risk melanoma results in higher response rates than nivolumab monotherapy and warrants future optimization of dosing regimens to preserve efficacy while limiting toxicity.
Journal Article
Completion Dissection or Observation for Sentinel-Node Metastasis in Melanoma
Patients with melanoma and positive sentinel nodes were randomly assigned to completion lymph-node dissection or observation. Melanoma-specific survival did not differ significantly between the groups.
Sentinel-lymph-node biopsy is a standard procedure in the care of appropriately selected patients with melanoma. The first Multicenter Selective Lymphadenectomy Trial (MSLT-I) confirmed the value of early nodal evaluation and treatment.
1
–
3
This prospective, international, randomized trial showed that the pathologic status of the sentinel node or nodes was the most important prognostic factor and that patients who underwent sentinel-node biopsy had fewer recurrences of melanoma than patients who underwent wide excision and nodal observation. Among patients with intermediate-thickness melanomas (defined as 1.2 to 3.5 mm) and nodal metastases, early surgical treatment, guided by sentinel-node biopsy, was associated with increased . . .
Journal Article
Neoadjuvant anti-PD-1 alone or in combination with anti-TIGIT or an oncolytic virus in resectable stage IIIB–D melanoma: a phase 1/2 trial
Neoadjuvant immunotherapies have shown antitumor activity in melanoma. Substudy 02C of the global, rolling-arm, phase 1/2, adaptive-design KEYMAKER-U02 trial is evaluating neoadjuvant pembrolizumab (anti-PD-1) alone or in combination, followed by adjuvant pembrolizumab, for stage IIIB–D melanoma. Here we report results from the first three arms: pembrolizumab plus vibostolimab (anti-TIGIT), pembrolizumab plus gebasaxturev (coxsackievirus A21) and pembrolizumab monotherapy. Pathologic complete responses occurred in 10 of 26 patients (38%) with pembrolizumab plus vibostolimab, 7 of 25 (28%) with pembrolizumab plus gebasaxturev and 6 of 15 (40%) with pembrolizumab monotherapy. Major pathologic responses occurred in 13 (50%), 10 (40%) and 7 (47%) patients, respectively. Safety was manageable. Treatment-related adverse events occurred in 24 of 26 patients (92%) with pembrolizumab plus vibostolimab, 21 of 25 (84%) with pembrolizumab plus gebasaxturev and 12 of 15 (80%) with pembrolizumab monotherapy; grade 3 or 4 treatment-related adverse events occurred in 2 (8%), 7 (28%) and 1 (7%) patient in each arm, respectively. No deaths due to adverse events occurred. Exploratory objective responses per RECIST v1.1 were observed in 13 (50%), 8 (32%) and 4 (27%) patients, in each arm, respectively. In a post hoc analysis, scores for tumor mutational burden and an 18-gene T cell-inflamed gene expression profile were generally higher in patients with major pathologic response. Longer follow-up will provide insight into the incremental benefit of combining neoadjuvant pembrolizumab with other therapies in stage IIIB–D melanoma. ClinicalTrials.gov registration:
NCT04303169
.
In an ongoing adaptive-design trial exploring different combinations of neoadjuvant immunotherapies including the anti-PD-1 agent pembrolizumab, the anti-TIGIT agent vibostolimab and the oncolytic virus gebasaxturev, neoadjuvant pembrolizumab-based regimens elicited encouraging clinical responses in patients with resectable melanoma.
Journal Article
Correction: PCC0208025 (BMS202), a small molecule inhibitor of PD-L1, produces an antitumor effect in B16-F10 melanoma-bearing mice
[This corrects the article DOI: 10.1371/journal.pone.0228339.].
Journal Article
Nivolumab in Previously Untreated Melanoma without BRAF Mutation
In this trial, the anti–programmed death 1 antibody nivolumab was associated with a significantly higher response rate and longer survival than standard dacarbazine chemotherapy in previously untreated patients with metastatic melanoma without a
BRAF
mutation.
The global incidence of melanoma continues to rise, and the mortality associated with unresectable or metastatic melanoma remains high.
1
Globally, 132,000 new cases of melanoma are diagnosed and an estimated 48,000 persons die from advanced melanoma each year.
2
,
3
Ipilimumab has been shown to improve the rate of survival at 2 years, as compared with a vaccine control, among previously treated patients with metastatic melanoma as well as among previously untreated patients who also received dacarbazine.
4
,
5
BRAF and MEK inhibitors are approved agents that, as monotherapy, have been associated with a survival advantage as compared with chemotherapy, with a . . .
Journal Article