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skin cancer

Adjuvant Nivolumab vs Ipilimumab in Resected Stage III or IV Melanoma

The phase III Checkmate 238 trial has shown improved recurrence-free survival with adjuvant nivolumab (Opdivo) vs ipilimumab (Yervoy) in patients with resected advanced melanoma. The findings were reported by Weber and colleagues in The New England Journal of Medicine. Study Details In the...

skin cancer

Overall Survival With Nivolumab/Ipilimumab, or Nivolumab Alone, vs Ipilimumab in Advanced Melanoma

Overall survival outcomes in the phase III CheckMate 067 trial indicate improved survival with nivolumab (Opdivo)/ipilimumab (Yervoy) vs ipilimumab and with nivolumab vs ipilimumab in patients with previously untreated advanced melanoma. These findings were reported in The New England Journal of...

skin cancer

Immune-Related Toxicity and Time to Treatment Failure With Nivolumab Plus Ipilimumab in Advanced Melanoma

As reported in JAMA Oncology by Shoushtari et al, a single-center experience has shown a very high rate of clinically significant immune-related adverse events with nivolumab (Opdivo) plus ipilimumab (Yervoy) for advanced melanoma. Their findings suggest that the full course of four doses of...

skin cancer

Pembrolizumab vs Ipilimumab in Advanced Melanoma: Final Overall Survival Analysis of KEYNOTE-006

The final overall survival analysis of the phase III KEYNOTE-006 trial showed maintained superiority of pembrolizumab (Keytruda) vs ipilimumab (Yervoy) in advanced melanoma. The results were reported by Schachter et al in The Lancet. An interim analysis showed improved progression-free and overall...

skin cancer

Standard-Dose Pembrolizumab Plus Reduced-Dose Ipilimumab in Advanced Melanoma

In the phase IB KEYNOTE-029 study, standard-dose pembrolizumab (Keytruda) plus reduced-dose ipilimumab (Yervoy) produced high response rates in patients with advanced melanoma. These results were reported by Long et al in The Lancet Oncology. Study Details In the study, 153 patients with...

skin cancer

Nivolumab Treatment Beyond Disease Progression in Advanced Melanoma

In a retrospective analysis reported in JAMA Oncology, Long et al found that a substantial proportion of patients with advanced melanoma derived benefit from continued nivolumab (Opdivo) treatment after Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1–defined disease...

skin cancer

Overall Survival With Nivolumab vs Chemotherapy in Ipilimumab-Refractory Advanced Melanoma

As reported in the Journal of Clinical Oncology by Larkin et al, the phase III CheckMate 037 trial has shown no difference in overall survival with nivolumab (Opdivo) vs investigator’s choice of chemotherapy in ipilimumab (Yervoy)-refractory advanced melanoma. More chemotherapy patients never ...

skin cancer

Dabrafenib Plus Trametinib in BRAF V600–Mutant Melanoma Brain Metastases

A phase II trial has shown that the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinst) produces responses in brain metastases in patients with BRAF V600–mutant melanoma. These findings were reported by Davies et al in The Lancet Oncology. Study ...

skin cancer

Melanoma-Specific Survival With Completion Dissection vs Observation for Sentinel Node Metastasis

The phase III MSLT-II trial showed that completion dissection was not associated with improved melanoma-specific overall survival vs observation in patients with sentinel node metastasis, although a benefit was observed in regional disease control. The findings were reported in The New England...

skin cancer

Conditional Survival After Initial Diagnosis and Treatment of Stage III Melanoma

In an Australian study reported in the Journal of Clinical Oncology, Haydu et al found that conditional melanoma-specific survival was worse within the first 2 years of diagnosis of stage III disease for men, increasing age, and increasing American Joint Committee on Cancer (AJCC) stage. The...

skin cancer

Survival in Advanced Melanoma With Ipilimumab at 10 mg/kg vs 3 mg/kg

In a phase III trial reported by Ascierto et al in The Lancet Oncology, treatment with ipilimumab (Yervoy) at 10 mg/kg vs 3 mg/kg resulted in improved overall survival in patients with advanced unresectable or metastatic melanoma. As noted by the investigators, although options for first-line...

skin cancer

Belgian Study Combines BRAF and MEK Inhibition in Advanced BRAF 600–Mutant Melanoma

In a Belgian two-center phase II trial reported in The Lancet Oncology, Schreuer et al found that rechallenge with the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) showed activity in patients with BRAF V600–mutant melanoma whose disease had progressed on...

skin cancer

Binimetinib vs Dacarbazine: Which Was More Effective in NRAS-Mutant Melanoma?

In the phase III NEMO trial reported in The Lancet Oncology, Dummer et al found that treatment with the MEK inhibitor binimetinib improved progression-free survival vs dacarbazine in patients with advanced NRAS-mutant melanoma. Study Details In the open-label trial, 402 patients from 118 sites in ...

skin cancer

Are Most Patients With Metastatic Melanoma Eligible for Immunotherapy Clinical Trials?

A Danish study reported in the European Journal of Cancer by Donia et al indicates that more than half of patients with metastatic melanoma do not satisfy requirements for enrollment in phase III trials of immune checkpoint inhibitors. Study Details The study involved 276 unselected cases...

skin cancer

Health-Related Quality of Life in Pivotal Trial of Adjuvant Ipilimumab in Stage III Melanoma

As reported in The Lancet Oncology by Coens et al, there was little difference between adjuvant ipilimumab (Yervoy) vs placebo in health-related quality of life in patients with high-risk stage III melanoma in the phase III EORTC 18071 trial supporting the 2014 approval of ipilimumab in this...

skin cancer

Intermittent Vismodegib Regimens in Patients With Multiple Basal Cell Carcinomas

In a phase II trial reported in The Lancet Oncology, Dréno et al found that two long-term intermittent vismodegib (Erivedge) dosing regimens provided a similar reduction in the number of clinically significant basal cell carcinomas among patients with multiple lesions. Study Details In the ...

skin cancer

Safety Profile of Nivolumab Monotherapy in Advanced Melanoma

As reported in the Journal of Clinical Oncology, Weber et al performed a pooled analysis of the safety profile of nivolumab (Opdivo) monotherapy in advanced melanoma, including a focus on potential immune-related (select) adverse events. The analysis pooled safety data from 576 patients receiving...

skin cancer

Factors Predictive of Outcomes With Dabrafenib/Trametinib in Metastatic BRAF-Mutant Melanoma

Long et al identified factors predictive of progression-free and overall survival with combined dabrafenib (Tafinlar) plus trametinib (Mekinist) in patients with BRAF V600E–mutant or BRAF V600K–mutant metastatic melanoma, according to a pooled individual data analysis reported in The...

skin cancer

Pooled Analysis of Outcome With Nivolumab Alone or With Ipilimumab in Advanced Mucosal or Cutaneous Melanoma

A pooled analysis of outcomes in patients receiving nivolumab (Opdivo) or nivolumab plus ipilimumab (Yervoy) for advanced mucosal or cutaneous melanoma in clinical trials was reported by D’Angelo et al in the Journal of Clinical Oncology. The pooled analysis involved 889 patients who...

skin cancer

Fulminant, Fatal Myocarditis Reported in Two Patients After Starting Combined Immune Checkpoint Blockade Treatment

In an article in The New England Journal of Medicine, Johnson et al reported the occurrence of fulminant, fatal immune-related myocarditis in two patients who received combined ipilimumab (Yervoy) and nivolumab (Opdivo) for metastatic melanoma. Patient Courses One patient was a 65-year-old woman...

skin cancer

Psychoeducational Intervention Reduces Fear of Melanoma Recurrence in Patients With High-Risk Melanoma

In an Australian trial reported in the Journal of Clinical Oncology, Dieng et al found that use of a psychoeducational intervention reduced the fear of cancer recurrence and stress among patients at high risk of developing a second primary melanoma. Study Details In the trial, 164 patients from 3 ...

skin cancer

Association of PD-L1 Expression and Response to Pembrolizumab in Advanced Melanoma

In an analysis from the phase IB KEYNOTE-001 trial, Daud et al found that the level of programmed cell death ligand 1 (PD-L1) expression was associated with outcomes of pembrolizumab (Keytruda) treatment in patients with advanced melanoma. These findings were reported in the Journal of Clinical...

skin cancer

Adjuvant Ipilimumab Prolongs Survival in High-Risk Stage III Melanoma, Phase III Study Reports

In the phase III European Organisation for Research and Treatment of Cancer (EORTC) trial 18071 reported at the recent European Society for Medical Oncology meeting and in The New England Journal of Medicine by Eggermont et al, adjuvant ipilimumab (Yervoy) was found to improve recurrence-free and...

skin cancer

‘Encouraging Survival Outcomes’ Reported With Combined Nivolumab and Ipilimumab in Advanced Melanoma

Hodi et al found “encouraging survival outcomes” with the addition of nivolumab to ipilimumab in patients with previously untreated unresectable stage III or IV melanoma, according to 2-year overall survival data in the phase II CheckMate 069 trial. These results were reported in The...

skin cancer

Durable Responses Reported With Avelumab in Chemotherapy-Refractory Metastatic Merkel Cell Carcinoma

In a phase II trial reported in The Lancet Oncology, Kaufman et al found that the anti–PD-L1 (programmed cell death ligand 1) monoclonal antibody avelumab produced durable responses in patients with stage IV Merkel cell carcinoma progressing after cytotoxic chemotherapy. Study Details In...

skin cancer

Study Suggests Benefit of Adjuvant Radiation Therapy but Not Chemotherapy in Some Patients With Merkel Cell Carcinoma

In an analysis of National Cancer Data Base data reported in the Journal of the National Cancer Institute, Bhatia et al found that adjuvant radiotherapy was associated with a survival benefit in patients with stage I and II but not stage III Merkel cell carcinoma, with no benefit of adjuvant...

kidney cancer
lung cancer
skin cancer

Incidence of PD-1 Inhibitor–Related Pneumonitis in Advanced NSCLC, Renal Cell Carcinoma, and Melanoma

In a systematic review and meta-analysis reported in JAMA Oncology, Nishino et al identified the rates of PD-1 (programmed cell death protein 1) inhibitor–related pneumonitis in patients with advanced non–small cell lung cancer (NSCLC), renal cell carcinoma, and melanoma. Rates were...

skin cancer

Study Confirms Benefit of Cobimetinib Plus Vemurafenib in Advanced BRAF V600–Mutant Melanoma

As reported by Ascierto et al in The Lancet Oncology, longer-term follow-up in the pivotal phase III coBRIM trial confirmed the benefit of adding cobimetinib to vemurafenib (Zelboraf) in first-line treatment of BRAF V600–mutant unresectable stage IIIC or IV melanoma. Study Details In the...

skin cancer

Potential Link Between Pembrolizumab Use and Demyelinating Polyradiculoneuropathy Reported in Two Cases of Advanced Melanoma

In a letter to the editor in The New England Journal of Medicine, de Maleissye et al described two cases of severe demyelinating polyradiculoneuropathy that occurred after pembrolizumab (Keytruda) treatment for advanced melanoma. Case 1 A 45-year-old woman receiving pembrolizumab at 2 mg/kg every ...

skin cancer

Pathway Defects in Acquired Resistance to PD-1 Inhibition in Melanoma Identified

In a study reported in The New England Journal of Medicine, Zaretsky et al found that defects in interferon receptor signaling and antigen-presenting pathways were associated with acquired resistance to PD-1 (programmed cell death protein 1) inhibition in melanoma. Resistance Mutations Identified ...

skin cancer

Ipilimumab Combined With Antigen-Specific Cytotoxic T Lymphocytes May Be of Benefit in Metastatic Melanoma

In a study reported in the Journal of Clinical Oncology by Chapuis et al, concurrent use of cytotoxic T lymphocyte (CTL) antigen-4 (CTLA-4) blockade with ipilimumab (Yervoy) and adoptively transferred antigen-specific CTLs produced enduring responses in patients with stage IV melanoma. Study...

skin cancer

Sequential Nivolumab/Ipilimumab Appears More Active Than Reverse Sequence in Advanced Melanoma

In the phase II CheckMate 064 trial reported in The Lancet Oncology, Weber et al found that sequential nivolumab (Opdivo)/ipilimumab (Yervoy) was more active than the reverse sequence (ipilimumab/nivolumab) in patients with advanced melanoma. Study Details In the open-label study, 138 patients...

lung cancer
skin cancer

Pembrolizumab Active for Untreated/Progressive Brain Metastases in Melanoma or NSCLC

Goldberg et al found that pembrolizumab (Keytruda) was active in untreated or progressive brain metastases in melanoma and non–small cell lung cancer (NSCLC), according to a single-center phase II trial reported in The Lancet Oncology. Study Details The study included 36 patients at Yale...

skin cancer

Factors Associated With Response to Dabrafenib/Trametinib in BRAF Inhibitor–Refractory Metastatic Melanoma

Poor response to combined BRAF and MEK inhibition with dabrafenib (Tafinlar)/trametinib (Mekinist) in patients with BRAF inhibitor–refractory metastatic melanoma may be associated with failure to significantly inhibit the MAPK pathway, according to a single-center phase II study reported in...

skin cancer

Pembrolizumab Active in Virus-Positive and ‑Negative Advanced Merkel Cell Carcinoma

The PD-1 (programmed cell death protein 1) inhibitor pembrolizumab (Keytruda) was active in advanced Merkel cell carcinoma in both Merkel cell polyomavirus (MCP)-positive and -negative tumors, according to Nghiem et al, who reported their phase II study findings in The New England Journal of...

skin cancer

Higher EZH2 and Ki67 Expression May Be Associated With Aggressive Basal Cell Carcinoma

In a study reported in a research letter in JAMA Oncology, Rao et al found that high expression of EZH2 and Ki67 was associated with more-aggressive basal cell carcinoma.EZH2 is a histone methyltransferase of the polycomb repressive complex 2. EZH2 overexpression or gain of function mutations has...

skin cancer

Vitamin D Level Associated With Melanoma Outcome Independent of C-Reactive Protein Level

In a study reported in the Journal of Clinical Oncology, Fang et al found that lower vitamin D levels were associated with poorer outcome in patients with melanoma independent of C-reactive protein (CRP) levels. Study Details The study involved data from 1,042 prospectively observed patients with ...

skin cancer

Assessment of Survival Impact of Atypical Responses With Pembrolizumab Treatment in Advanced Melanoma

As reported by Hodi et al in the Journal of Clinical Oncology, use of conventional Response Evaluation Criteria in Solid Tumors (RECIST) to assess response may have underestimated the benefit of treatment with the programmed cell death protein 1 (PD-1) inhibitor pembrolizumab (Keytruda) in the...

skin cancer

Improved Melanoma-Specific Survival Reported With Wider Excision Margin in High-Risk Primary Melanoma

Wider excision margins in high-risk primary cutaneous melanoma were associated with improved melanoma-specific survival, according to long-term follow-up in a UK-led trial reported by Hayes et al in The Lancet Oncology. No significant improvement in overall survival was observed. The initial report ...

skin cancer

Nivolumab Plus Ipilimumab in Unresectable or Metastatic Melanoma Regardless of BRAF Mutation Status

On January 23, 2016, the indication for nivolumab (Opdivo) plus ipilimumab (Yervoy) in unresectable or metastatic melanoma was expanded through accelerated approval to include patients regardless of BRAF V600 mutation status.1 The combination was previously approved for treatment of patients with ...

skin cancer

Increased Incidence of in Situ and Invasive Melanoma in Denmark

In a study reported in JAMA Dermatology,1 Neel Maria Helvind, MD, of the University Hospital Rigshospitalet, Copenhagen, Denmark, and colleagues analyzed the increases in melanoma incidence seen in Denmark between 1985 and 2012. Over that time, the incidence of malignant melanoma doubled to rates...

skin cancer

Dabrafenib for Unresectable or Metastatic Melanoma with BRAF V600E Mutation 

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.  Indication On May 29, 2013, dabrafenib (Tafinlar) was approved...

skin cancer

Cytokine-Induced Killer Cells Effective Against Autologous Metastatic Melanoma Including Cells With Stemness Features 

In a study reported in Clinical Cancer Research, Gammaitoni and colleagues investigated the tumor-killing activity of cytokine-induced killer cells against autologous metastatic melanoma and putative cancer stem cells. The investigators developed a preclinical autologous model using same...

skin cancer

Trametinib and Dabrafenib in Combination for Unresectable or Metastatic Melanoma With BRAF V600E or V600K Mutations

On January 9, 2014, the combination of trametinib (Mekinist) and dabrafenib (Tafinlar) was granted accelerated approval for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by a U.S. Food and Drug Administration (FDA)-approved...

skin cancer

FBXW7 as Tumor Suppressor and NOTCH1 Inhibition as Potential Strategy in Melanoma

In a study reported in the Journal of the National Cancer Institute, Aydin and colleagues found that mutation in and inactivation of FBXW7 and accumulation of NOTCH1, a substrate of FBXW7, were associated with melanoma tumorigenesis. FBXW7 was found to be mutated in 8% of 103 melanoma patients,...

skin cancer

First Approval of PD-1 Inhibitor: Pembrolizumab in Unresectable or Metastatic Melanoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On September 4, 2014, pembrolizumab (Keytruda) was granted...

skin cancer

Two Phase III Trials Show Benefit With BRAF/MEK Inhibitor Combination vs BRAF Inhibitor Alone in Advanced Melanoma

Two phase III trials have shown that the strategy of adding MEK inhibitor therapy to BRAF inhibitor therapy significantly improves progression-free survival in previously untreated patients with advanced BRAF-mutant melanoma.1,2 Overall survival benefit is also suggested by interim analysis in both ...

skin cancer

Phase II Study Shows Improved Survival With Addition of Sargramostim to Ipilimumab in Metastatic Melanoma

Use of the granulocyte-macrophage colony-stimulating factor (GM-CSF) sargramostim (Leukine) together with the cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4) inhibitor ipilimumab (Yervoy) prolonged overall survival but not progression-free survival in patients with metastatic melanoma,...

skin cancer

Nivolumab Improves Outcomes vs Dacarbazine in Previously Untreated Advanced Melanoma Without a BRAF Mutation

In a phase III trial reported in The New England Journal of Medicine, Robert and colleagues found that the programmed cell death protein-1 (PD-1) immune-checkpoint–inhibitor antibody nivolumab (Opdivo) significantly increased overall survival, progression-free survival, and objective response rate...

skin cancer

Anti–PD-1 Antibody Nivolumab in Previously Treated Unresectable or Metastatic Melanoma

In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs.   On December 22, 2014, the anti–PD-1 (programmed cell death...

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