Clinical experience with ipilimumab 3 mg/kg: real-world efficacy and safety data from an expanded access programme cohort.

PubWeight™: 1.59‹?› | Rank: Top 4%

🔗 View Article (PMC 4030525)

Published in J Transl Med on May 07, 2014

Authors

Paolo A Ascierto1, Ester Simeone, Vanna Chiarion Sileni, Jacopo Pigozzo, Michele Maio, Maresa Altomonte, Michele Del Vecchio, Lorenza Di Guardo, Paolo Marchetti, Ruggero Ridolfi, Francesco Cognetti, Alessandro Testori, Maria Grazia Bernengo, Michele Guida, Riccardo Marconcini, Mario Mandalà, Carolina Cimminiello, Gaetana Rinaldi, Massimo Aglietta, Paola Queirolo

Author Affiliations

1: Istituto Nazionale Tumori Fondazione 'G, Pascale', Napoli, Italy. paolo.ascierto@gmail.com.

Articles citing this

Genomic Classification of Cutaneous Melanoma. Cell (2015) 3.91

Immune-Related Adverse Events, Need for Systemic Immunosuppression, and Effects on Survival and Time to Treatment Failure in Patients With Melanoma Treated With Ipilimumab at Memorial Sloan Kettering Cancer Center. J Clin Oncol (2015) 2.60

What have we learned from cancer immunotherapy in the last 3 years? J Transl Med (2014) 1.52

Nivolumab in melanoma: latest evidence and clinical potential. Ther Adv Med Oncol (2015) 1.09

Baseline neutrophil-to-lymphocyte ratio is associated with outcome of ipilimumab-treated metastatic melanoma patients. Br J Cancer (2015) 1.03

BRAF-mutant melanoma: treatment approaches, resistance mechanisms, and diagnostic strategies. Onco Targets Ther (2015) 0.99

Targeting immune checkpoints in unresectable metastatic cutaneous melanoma: a systematic review and meta-analysis of anti-CTLA-4 and anti-PD-1 agents trials. Cancer Med (2016) 0.84

Assessing a novel immuno-oncology-based combination therapy: Ipilimumab plus electrochemotherapy. Oncoimmunology (2015) 0.82

Ipilimumab in the real world: the UK expanded access programme experience in previously treated advanced melanoma patients. Melanoma Res (2015) 0.81

Phase I Clinical Trial of Ipilimumab in Pediatric Patients with Advanced Solid Tumors. Clin Cancer Res (2015) 0.80

The role of immunotherapy in solid tumors: report from the Campania Society of Oncology Immunotherapy (SCITO) meeting, Naples 2014. J Transl Med (2014) 0.79

The efficacy and safety of nivolumab in the treatment of advanced melanoma: a meta-analysis of clinical trials. Onco Targets Ther (2016) 0.78

Long-term survival as a treatment benchmark in melanoma: latest results and clinical implications. Ther Adv Med Oncol (2015) 0.78

Open-label, multicenter, single-arm phase II DeCOG-study of ipilimumab in pretreated patients with different subtypes of metastatic melanoma. J Transl Med (2015) 0.78

Analysis of BRAF and NRAS Mutation Status in Advanced Melanoma Patients Treated with Anti-CTLA-4 Antibodies: Association with Overall Survival? PLoS One (2015) 0.78

Targeted therapies in melanoma. Surg Oncol Clin N Am (2015) 0.76

Association of CTLA-4 Gene Variants with Response to Therapy and Long-term Survival in Metastatic Melanoma Patients Treated with Ipilimumab: An Italian Melanoma Intergroup Study. Front Immunol (2017) 0.75

Ipilimumab Real-World Efficacy and Safety in Korean Melanoma Patients from the Korean Named-Patient Program Cohort. Cancer Res Treat (2016) 0.75

Long-term drug costs per life-month gained associated with first-line treatments for unresectable or metastatic melanoma. Exp Hematol Oncol (2016) 0.75

Ipilimumab (Anti-Ctla-4 Mab) in the treatment of metastatic melanoma: Effectiveness and toxicity management. Hum Vaccin Immunother (2016) 0.75

Early analysis of surrogate endpoints for metastatic melanoma in immune checkpoint inhibitor trials. Medicine (Baltimore) (2016) 0.75

Health Care Resource Utilization and Associated Costs Among Metastatic Cutaneous Melanoma Patients Treated with Ipilimumab (INTUITION Study). Oncologist (2017) 0.75

Perspectives in immunotherapy: meeting report from the "Immunotherapy Bridge", Napoli, November 30th 2016. J Transl Med (2017) 0.75

Multicenter, real-life experience with checkpoint inhibitors and targeted therapy agents in advanced melanoma patients in Switzerland. Melanoma Res (2017) 0.75

Characterizing expanded access and compassionate use programs for experimental drugs. BMC Res Notes (2017) 0.75

Checkpoint inhibitors in melanoma and early phase development in solid tumors: what's the future? J Transl Med (2017) 0.75

Articles cited by this

Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med (2010) 67.34

Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med (2011) 26.90

Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res (2009) 24.11

Improved survival with MEK inhibition in BRAF-mutated melanoma. N Engl J Med (2012) 11.72

Autoimmunity correlates with tumor regression in patients with metastatic melanoma treated with anti-cytotoxic T-lymphocyte antigen-4. J Clin Oncol (2005) 9.72

Prognostic and clinicopathologic associations of oncogenic BRAF in metastatic melanoma. J Clin Oncol (2011) 7.18

Prognostic factors related to clinical response in patients with metastatic melanoma treated by CTL-associated antigen-4 blockade. Clin Cancer Res (2007) 5.51

Management of immune-related adverse events and kinetics of response with ipilimumab. J Clin Oncol (2012) 5.23

CTLA-4 blockade with ipilimumab: long-term follow-up of 177 patients with metastatic melanoma. Clin Cancer Res (2012) 4.56

MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol (2013) 4.26

Development of ipilimumab: contribution to a new paradigm for cancer immunotherapy. Semin Oncol (2010) 2.51

Four-year survival rates for patients with metastatic melanoma who received ipilimumab in phase II clinical trials. Ann Oncol (2013) 2.34

Resistance to BRAF-targeted therapy in melanoma. Eur J Cancer (2013) 2.23

Development of ipilimumab: a novel immunotherapeutic approach for the treatment of advanced melanoma. Ann N Y Acad Sci (2013) 2.03

Targeting BRAF for patients with melanoma. Br J Cancer (2010) 1.56

Upcoming strategies for the treatment of metastatic melanoma. Arch Dermatol Res (2012) 1.22

Releasing the brake on the immune system: ipilimumab in melanoma and other tumors. Cancer Biother Radiopharm (2010) 1.22

Efficacy and safety of ipilimumab in patients with pre-treated, uveal melanoma. Ann Oncol (2013) 1.20

Assessment of association between BRAF-V600E mutation status in melanomas and clinical response to ipilimumab. Cancer Immunol Immunother (2012) 1.11

Efficacy and safety of ipilimumab 3mg/kg in patients with pretreated, metastatic, mucosal melanoma. Eur J Cancer (2013) 1.07

Articles by these authors

Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med (2011) 45.46

Ipilimumab plus dacarbazine for previously untreated metastatic melanoma. N Engl J Med (2011) 26.90

Guidelines for the evaluation of immune therapy activity in solid tumors: immune-related response criteria. Clin Cancer Res (2009) 24.11

Combined Nivolumab and Ipilimumab or Monotherapy in Untreated Melanoma. N Engl J Med (2015) 14.71

Nivolumab in previously untreated melanoma without BRAF mutation. N Engl J Med (2014) 10.38

Randomized phase II trial of the efficacy and safety of trastuzumab combined with docetaxel in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer administered as first-line treatment: the M77001 study group. J Clin Oncol (2005) 8.87

Postoperative irradiation with or without concomitant chemotherapy for locally advanced head and neck cancer. N Engl J Med (2004) 8.60

Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet (2012) 8.00

A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res (2009) 5.99

Combined vemurafenib and cobimetinib in BRAF-mutated melanoma. N Engl J Med (2014) 5.43

Phase III randomized clinical trial comparing tremelimumab with standard-of-care chemotherapy in patients with advanced melanoma. J Clin Oncol (2013) 5.36

Combined BRAF and MEK inhibition versus BRAF inhibition alone in melanoma. N Engl J Med (2014) 4.71

A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med (2007) 4.59

MEK162 for patients with advanced melanoma harbouring NRAS or Val600 BRAF mutations: a non-randomised, open-label phase 2 study. Lancet Oncol (2013) 4.26

Efficacy and safety of 12-weekly versus 4-weekly zoledronic acid for prolonged treatment of patients with bone metastases from breast cancer (ZOOM): a phase 3, open-label, randomised, non-inferiority trial. Lancet Oncol (2013) 3.67

Adjuvant therapy with pegylated interferon alfa-2b versus observation alone in resected stage III melanoma: final results of EORTC 18991, a randomised phase III trial. Lancet (2008) 3.62

A novel type of cellular senescence that can be enhanced in mouse models and human tumor xenografts to suppress prostate tumorigenesis. J Clin Invest (2010) 3.47

Tremelimumab for patients with chemotherapy-resistant advanced malignant mesothelioma: an open-label, single-arm, phase 2 trial. Lancet Oncol (2013) 3.28

Towards the introduction of the 'Immunoscore' in the classification of malignant tumours. J Pathol (2014) 3.21

High levels of exosomes expressing CD63 and caveolin-1 in plasma of melanoma patients. PLoS One (2009) 3.10

Randomized study of adjuvant chemotherapy for completely resected stage I, II, or IIIA non-small-cell Lung cancer. J Natl Cancer Inst (2003) 2.95

Cancer classification using the Immunoscore: a worldwide task force. J Transl Med (2012) 2.88

Mitf regulation of Dia1 controls melanoma proliferation and invasiveness. Genes Dev (2006) 2.87

A prospective phase II trial exploring the association between tumor microenvironment biomarkers and clinical activity of ipilimumab in advanced melanoma. J Transl Med (2011) 2.86

Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study. Lancet Oncol (2009) 2.80

Prognosis in patients with sentinel node-positive melanoma is accurately defined by the combined Rotterdam tumor load and Dewar topography criteria. J Clin Oncol (2011) 2.62

Vaccination of metastatic melanoma patients with autologous tumor-derived heat shock protein gp96-peptide complexes: clinical and immunologic findings. J Clin Oncol (2002) 2.57

Melanoma cells inhibit natural killer cell function by modulating the expression of activating receptors and cytolytic activity. Cancer Res (2012) 2.54

Adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma: a phase III randomized controlled trial of health-related quality of life and symptoms by the European Organisation for Research and Treatment of Cancer Melanoma Group. J Clin Oncol (2009) 2.50

Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol (2009) 2.48

Recommendations from the iSBTc-SITC/FDA/NCI Workshop on Immunotherapy Biomarkers. Clin Cancer Res (2011) 2.44

Long-term results of the randomized phase III trial EORTC 18991 of adjuvant therapy with pegylated interferon alfa-2b versus observation in resected stage III melanoma. J Clin Oncol (2012) 2.42

Defining the critical hurdles in cancer immunotherapy. J Transl Med (2011) 2.32

Expression of CXCR4 predicts poor prognosis in patients with malignant melanoma. Clin Cancer Res (2005) 2.28

Phase II trial (BREAK-2) of the BRAF inhibitor dabrafenib (GSK2118436) in patients with metastatic melanoma. J Clin Oncol (2013) 2.13

Ipilimumab efficacy and safety in patients with advanced melanoma: a retrospective analysis of HLA subtype from four trials. Cancer Immun (2010) 2.07

Antiangiogenic potential of the Mammalian target of rapamycin inhibitor temsirolimus. Cancer Res (2006) 2.07

Ipilimumab and fotemustine in patients with advanced melanoma (NIBIT-M1): an open-label, single-arm phase 2 trial. Lancet Oncol (2012) 2.03

Clinical experiences with anti-CD137 and anti-PD1 therapeutic antibodies. Semin Oncol (2010) 2.00

The role of BRAF V600 mutation in melanoma. J Transl Med (2012) 2.00

Results of esophagectomy for esophageal cancer in elderly patients: age has little influence on outcome and survival. J Thorac Cardiovasc Surg (2007) 1.99

Cisplatin, dacarbazine with or without subcutaneous interleukin-2, and interferon alpha-2b in advanced melanoma outpatients: results from an Italian multicenter phase III randomized clinical trial. J Clin Oncol (2002) 1.98

Functional T cells targeting NY-ESO-1 or Melan-A are predictive for survival of patients with distant melanoma metastasis. J Clin Oncol (2012) 1.97

C-reactive protein: a biomarker of survival in patients with metastatic renal cell carcinoma treated with subcutaneous interleukin-2 based immunotherapy. J Urol (2005) 1.93

Adjuvant chemotherapy in completely resected gastric cancer: a randomized phase III trial conducted by GOIRC. J Natl Cancer Inst (2008) 1.92

Cytokine-induced killer (CIK) cells as feasible and effective adoptive immunotherapy for the treatment of solid tumors. Expert Opin Biol Ther (2012) 1.91

Pegylated arginine deiminase treatment of patients with metastatic melanoma: results from phase I and II studies. J Clin Oncol (2005) 1.88

Clinical end points and response criteria in mycosis fungoides and Sézary syndrome: a consensus statement of the International Society for Cutaneous Lymphomas, the United States Cutaneous Lymphoma Consortium, and the Cutaneous Lymphoma Task Force of the European Organisation for Research and Treatment of Cancer. J Clin Oncol (2011) 1.85

Expansion of mesenchymal stem cells isolated from pediatric and adult donor bone marrow. J Cell Biochem (2006) 1.85

Randomized phase III trial of neoadjuvant chemotherapy in head and neck cancer: 10-year follow-up. J Natl Cancer Inst (2004) 1.80

Targeting cancer vasculature via endoglin/CD105: a novel antibody-based diagnostic and therapeutic strategy in solid tumours. Cardiovasc Res (2009) 1.78

A systematic approach to biomarker discovery; preamble to "the iSBTc-FDA taskforce on immunotherapy biomarkers". J Transl Med (2008) 1.77

Long-term follow-up of a comparison of nonmyeloablative allografting with autografting for newly diagnosed myeloma. Blood (2011) 1.76

Dendritic cell sarcoma: an analytic overview of the literature and presentation of original five cases. Crit Rev Oncol Hematol (2007) 1.75

Autologous nonmyeloablative hematopoietic stem cell transplantation in patients with severe anti-TNF refractory Crohn disease: long-term follow-up. Blood (2010) 1.74

The emerging toxicity profiles of anti-CTLA-4 antibodies across clinical indications. Semin Oncol (2010) 1.73

Prognostic factors in primary cutaneous B-cell lymphoma: the Italian Study Group for Cutaneous Lymphomas. J Clin Oncol (2006) 1.70

EANM-EORTC general recommendations for sentinel node diagnostics in melanoma. Eur J Nucl Med Mol Imaging (2009) 1.68

Selection of immunostimulant AS15 for active immunization with MAGE-A3 protein: results of a randomized phase II study of the European Organisation for Research and Treatment of Cancer Melanoma Group in Metastatic Melanoma. J Clin Oncol (2013) 1.67

Use of strong opioids in advanced cancer pain: a randomized trial. J Pain Symptom Manage (2004) 1.67

microRNA-214 contributes to melanoma tumour progression through suppression of TFAP2C. EMBO J (2011) 1.66

Gemcitabine versus bacille Calmette-Guérin after initial bacille Calmette-Guérin failure in non-muscle-invasive bladder cancer: a multicenter prospective randomized trial. Cancer (2010) 1.66

Outcome of patients with HER2-positive advanced breast cancer progressing during trastuzumab-based therapy. Oncologist (2006) 1.65

Monitoring response to primary chemotherapy in breast cancer using dynamic contrast-enhanced magnetic resonance imaging. Breast Cancer Res Treat (2004) 1.62

Post-surgery adjuvant therapy with intermediate doses of interferon alfa 2b versus observation in patients with stage IIb/III melanoma (EORTC 18952): randomised controlled trial. Lancet (2005) 1.60

Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy. J Clin Oncol (2007) 1.60

Factorial phase III randomised trial of rofecoxib and prolonged constant infusion of gemcitabine in advanced non-small-cell lung cancer: the GEmcitabine-COxib in NSCLC (GECO) study. Lancet Oncol (2007) 1.60

Sequencing of BRAF inhibitors and ipilimumab in patients with metastatic melanoma: a possible algorithm for clinical use. J Transl Med (2012) 1.60

Gemcitabine-based combinations for inoperable pancreatic cancer: have we made real progress? A meta-analysis of 20 phase 3 trials. Cancer (2007) 1.58

The biology of cancer testis antigens: putative function, regulation and therapeutic potential. Mol Oncol (2011) 1.57

Update on erythrodermic cutaneous T-cell lymphoma: report of the International Society for Cutaneous Lymphomas. J Am Acad Dermatol (2002) 1.54

The impact of lymphoscintigraphy technique on the outcome of sentinel node biopsy in 1,313 patients with cutaneous melanoma: an Italian Multicentric Study (SOLISM-IMI). J Nucl Med (2006) 1.53

Chordoma: clinical characteristics, management and prognosis of a case series of 25 patients. BMC Cancer (2010) 1.52

Endoglin (CD105): a powerful therapeutic target on tumor-associated angiogenetic blood vessels. Oncogene (2003) 1.49

Interval between neoadjuvant chemoradiotherapy and surgery for squamous cell carcinoma of the thoracic esophagus: does delayed surgery have an impact on outcome? Ann Surg (2010) 1.48

Hiccup in patients with advanced cancer successfully treated with gabapentin: report of three cases. N Z Med J (2003) 1.47

Benefit of taxanes as adjuvant chemotherapy for early breast cancer: pooled analysis of 15,500 patients. Cancer (2006) 1.47

Translocation-related sarcomas. Semin Oncol (2009) 1.45

Clinical and immunologic responses in melanoma patients vaccinated with MAGE-A3-genetically modified lymphocytes. Int J Cancer (2012) 1.45

Does granulocyte colony-stimulating factor worsen anemia in early breast cancer patients treated with epirubicin and cyclophosphamide? J Clin Oncol (2006) 1.45

Clinical genetic testing for familial melanoma in Italy: a cooperative study. J Am Acad Dermatol (2009) 1.45