Melanoma-inhibiting activity assay predicts survival in patients receiving a therapeutic cancer vaccine after complete resection of american joint committee on cancer stage III melanoma

2004 ◽  
Vol 11 (1) ◽  
pp. 85-93 ◽  
Author(s):  
Mark B. Faries ◽  
Rishab K. Gupta ◽  
Xing Ye ◽  
Eddy C. Hsueh ◽  
Donald L. Morton
Keyword(s):  
Cancer Vaccine ◽  
Complete Resection ◽  
Stage Iii ◽  
Cancer Stage ◽  
Inhibiting Activity ◽  
Activity Assay ◽  
Therapeutic Cancer Vaccine ◽  
American Joint Committee ◽  
Stage Iii Melanoma

scholarly journals Reply to Improving the survival of patients with American Joint Committee on Cancer stage III and IV melanoma

Cancer ◽  
2018 ◽  
Vol 124 (10) ◽  
pp. 2254-2255
Author(s):  
Sarah Sloot ◽  
Yian A. Chen ◽  
Xiuhua Zhao ◽  
Jamie L. Weber ◽  
Jacob J. Benedict ◽  
...  
Keyword(s):  
Stage Iii ◽  
Cancer Stage ◽  
American Joint Committee

scholarly journals Cumulative Incidence and Predictors of CNS Metastasis for Patients With American Joint Committee on Cancer 8th Edition Stage III Melanoma

2020 ◽  
Vol 38 (13) ◽  
pp. 1429-1441 ◽  
Author(s):  
Lauren E. Haydu ◽  
Serigne N. Lo ◽  
Jennifer L. McQuade ◽  
Rodabe N. Amaria ◽  
Jennifer Wargo ◽  
...  
Keyword(s):  
Primary Tumor ◽  
Cumulative Incidence ◽  
Mitotic Rate ◽  
Stage Iii ◽  
Time Points ◽  
Cns Metastasis ◽  
American Joint Committee ◽  
Stage Iii Melanoma ◽  
8Th Edition

PURPOSE Improved understanding of the incidence, risk factors, and timing of CNS metastasis is needed to inform surveillance strategies for patients with melanoma. PATIENTS AND METHODS Clinical data were extracted from the databases of 2 major melanoma centers in the United States and Australia for 1,918 patients with American Joint Committee on Cancer (AJCC) 8th edition stage III melanoma, diagnosed from 1998-2014, who had (negative) baseline CNS imaging within 4 months of diagnosis. The cumulative incidence of CNS metastasis was calculated in the presence of the competing risk of death, from stage III presentation and at benchmark time points 1, 2, and 5 years postdiagnosis. RESULTS At a median follow-up of 70.2 months, distant recurrence occurred in 711 patients (37.1%). The first site of distant metastasis was CNS only for 3.9% of patients, CNS and extracranial (EC) for 1.8%, and EC only for 31.4%. Overall, 16.7% of patients were diagnosed with CNS metastasis during follow-up. The cumulative incidence of CNS metastasis was 3.6% (95% CI, 2.9% to 4.6%) at 1 year, 9.6% (95% CI, 8.3% to 11.0%) at 2 years, and 15.8% (95% CI, 14.1% to 17.6%) at 5 years. The risk of CNS metastasis was significantly influenced by patient sex, age, AJCC stage, primary tumor site, and primary tumor mitotic rate in multivariable and conditional analyses. High primary tumor mitotic rate was significantly associated with increased risk of CNS metastasis at diagnosis and all subsequent time points examined. CONCLUSION Similar rates of CNS metastasis were observed in 2 large, geographically distinct cohorts of patients with stage III melanoma. The results highlight the importance of primary tumor mitotic rate. Furthermore, they provide a framework for developing evidence-based surveillance strategies and evaluating the impact of contemporary adjuvant therapies on the risk of CNS metastasis development.

Ipilimumab versus placebo after complete resection of stage III melanoma: Initial efficacy and safety results from the EORTC 18071 phase III trial.

2014 ◽  
Vol 32 (15_suppl) ◽  
pp. LBA9008-LBA9008 ◽  
Author(s):  
Alexander M. Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Jean Jacques Grob ◽  
Reinhard Dummer ◽  
Jedd D. Wolchok ◽  
...  
Keyword(s):  
Complete Resection ◽  
Phase Iii ◽  
Stage Iii ◽  
Efficacy And Safety ◽  
Phase Iii Trial ◽  
Stage Iii Melanoma

Pembrolizumab versus placebo after complete resection of high-risk stage III melanoma: New recurrence-free survival results from the EORTC 1325-MG/Keynote 054 double-blinded phase III trial at three-year median follow-up.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10000-10000 ◽  
Author(s):  
Alexander M. Eggermont ◽  
Christian U. Blank ◽  
Mario Mandalà ◽  
Georgina V. Long ◽  
Victoria Atkinson ◽  
...  
Keyword(s):  
Lymph Node ◽  
High Risk ◽  
Complete Resection ◽  
Phase Iii ◽  
Stage Iii ◽  
Recurrence Free Survival ◽  
Stage Iiia ◽  
Free Survival ◽  
Stage Iii Melanoma

10000 Background: We conducted the phase 3 double-blind EORTC 1325/KEYNOTE-054 trial to evaluate pembrolizumab vs placebo in patients (pts) with resected high-risk stage III melanoma. Based on 351 recurrence-free survival (RFS) events and at a median follow-up of 1.25 years (yrs), pembrolizumab improved RFS (hazard ratio (HR) 0.57, P<0.0001) as compared to placebo (Eggermont, NEJM 2018). This led to the approval of pembrolizumab adjuvant treatment by EMA and FDA. Methods: Eligible pts included those ≥18 yrs of age with complete resection of cutaneous melanoma metastatic to lymph node(s), classified as AJCC-7 stage IIIA (at least one lymph node metastasis >1 mm), IIIB or IIIC (without in-transit metastasis). A total of 1019 pts were randomized (stratification by stage and region) to pembrolizumab at a flat dose of 200 mg (N=514) or placebo (N=505) every 3 weeks for a total of 18 doses (~1 year) or until disease recurrence or unacceptable toxicity. The 2 co-primary endpoints were RFS in the intention-to-treat overall population and in pts with PD-L1-positive tumors. Here, we report an updated RFS analysis based on a longer follow-up. Results: Overall, 15%/46%/39% of pts had stage IIIA/IIIB/IIIC. At 3.05-yr median follow-up, pembrolizumab (190 RFS events) compared with placebo (283 RFS events) prolonged RFS, in the overall population and in the PD-L1 positive tumor subgroup (see Table). RFS was consistently prolonged across subgroups, in particular according to AJCC-7 staging, BRAF-V600 E/K mutation status. Conclusions: Pembrolizumab, administered at 200 mg every 3 weeks for up to 1 year as adjuvant therapy, provided, at a 3-yr median follow-up, a sustained improvement in RFS, which was clinically meaningful, in resected high-risk stage III melanoma. This improvement was consistent across subgroups. In the overall population, the 3-yr cumulative incidence of distant metastasis being the first recurrence was 22.3% (pembrolizumab group) vs 37.3% (placebo group) (HR 0.55, 95% CI 0.44-0.69). Clinical trial information: NCT02362594. [Table: see text]

Evaluation of the prognostic significance of serum galectin-3 in American Joint Committee on Cancer stage III and stage IV melanoma patients

2009 ◽  
Vol 19 (5) ◽  
pp. 316-320 ◽  
Author(s):  
Pierre Vereecken ◽  
Ahmad Awada ◽  
Stefan Suciu ◽  
Gilberto Castro ◽  
Renato Morandini ◽  
...  
Keyword(s):  
Prognostic Significance ◽  
Stage Iv ◽  
Stage Iii ◽  
Cancer Stage ◽  
American Joint Committee ◽  
Galectin 3 ◽  
Melanoma Patients ◽  
Stage Iv Melanoma

Ipilimumab versus placebo after complete resection of stage III melanoma: Initial efficacy and safety results from the EORTC 18071 phase III trial.

2014 ◽  
Vol 32 (18_suppl) ◽  
pp. LBA9008-LBA9008 ◽  
Author(s):  
Alexander M. Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Jean Jacques Grob ◽  
Reinhard Dummer ◽  
Jedd D. Wolchok ◽  
...  
Keyword(s):  
Lymph Node ◽  
High Risk ◽  
Adjuvant Therapy ◽  
Complete Resection ◽  
Advanced Melanoma ◽  
Phase Iii ◽  
Stage Iii ◽  
Phase Iii Trial ◽  
Risk Of Recurrence ◽  
Stage Iii Melanoma

LBA9008 Background: Ipilimumab (Ipi), a fully human monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 to augment antitumor immune responses, is an approved treatment for advanced melanoma. Here, we report the results of a phase III trial designed to evaluate Ipi as an adjuvant therapy for resected stage III melanoma at high risk of recurrence. Methods: In this randomized, double-blind trial, eligible patients (pts) included those ≥18 yrs of age who underwent complete resection of stage III cutaneous melanoma (excluding lymph node metastasis ≤1 mm or in-transit metastasis). 951 pts were randomized (stratified by stage and region) 1:1 to receive Ipi 10 mg/kg (n=475) or placebo (Pbo, n=476) every 3 wks for 4 doses, then every 3 mos for up to 3 yrs until completion, disease recurrence, or unacceptable toxicity. The primary endpoint was recurrence-free survival (RFS), analyzed on the intent-to-treat population. 512 RFS events (recurrence or death) were needed to provide 90% power to detect an Ipi vs Pbo hazard ratio (HR) of 0.75 (2-sided α=5%). Results: Overall, 20%/44%/36% of pts had stage IIIA/IIIB/IIIC, 42% ulcerated primary, and 58% macroscopic lymph node involvement. At a median follow-up of 2.7 yrs, Ipi significantly improved RFS vs Pbo. RFS benefit was consistent across subgroups (e.g., stage IIIB or IIIC, ulcerated primary). Most common grade 3/4 immune-related adverse events (irAEs) in the Ipi and Pbo arms were gastrointestinal (15.9% vs 0.8%), hepatic (10.6% vs 0.2%), and endocrine (8.5% vs 0%). Most irAEs were managed and resolved using established algorithms. Of 471 pts who started Ipi, 245 (52%) discontinued treatment due to AEs [182 (38.6%) within 12 weeks]; 5 (1.1%) died due to drug-related AEs. Conclusions: In this phase III trial, Ipi as adjuvant therapy provided a clinically and statistically significant improvement in RFS vs Pbo for pts with stage III melanoma at high risk of recurrence. AE profile was generally consistent with that observed in advanced melanoma, although with a higher incidence of endocrinopathies. Clinical trial information: NCT00636168. EudraCT Number: 2007-001974-10. [Table: see text]

Prolonged Survival After Complete Resection of Disseminated Melanoma and Active Immunotherapy With a Therapeutic Cancer Vaccine

2002 ◽  
Vol 20 (23) ◽  
pp. 4549-4554 ◽  
Author(s):  
Eddy C. Hsueh ◽  
Richard Essner ◽  
Leland J. Foshag ◽  
David W. Ollila ◽  
Guy Gammon ◽  
...  
Keyword(s):  
Cancer Vaccine ◽  
Specific Effect ◽  
Complete Resection ◽  
Vaccine Therapy ◽  
Prolonged Survival ◽  
Delayed Type Hypersensitivity ◽  
Active Immunotherapy ◽  
Matched Pair ◽  
Therapeutic Cancer Vaccine ◽  
Adjuvant Vaccine

PURPOSE: The curative effect of surgery in certain patients with metastatic melanoma suggests the presence of endogenous antitumor responses. Because melanoma is immunogenic, we investigated whether a therapeutic cancer vaccine called Canvaxin (CancerVax Corporation, Carlsbad, CA) could enhance antitumor immune responses and thereby prolong survival.PATIENTS AND METHODS: Of 263 patients who underwent complete resection of American Joint Committee on Cancer stage IV melanoma, 150 received postoperative adjuvant vaccine therapy and 113 did not. The overall survival (OS) for the two groups was compared by Cox regression. Further survival analysis was performed by matched-pair analysis according to three prognostic variables: sex, metastatic site, and number of tumor-involved organ sites.RESULTS: Five-year OS rates were 39% for vaccine and 19% for nonvaccine patients. On multivariate analysis, vaccine therapy was the most significant prognostic variable in this cohort (P = .0001). Analysis of 107 matched pairs of vaccine and nonvaccine patients revealed a significant OS advantage for vaccine therapy (P = .0009): 5-year OS was 39% for vaccine patients versus 20% for nonvaccine patients. There was a significant delayed-type hypersensitivity (DTH) response to adjuvant vaccine therapy (P = .0001), and OS was significantly correlated with DTH to vaccine (P = .0001) but not with DTH to purified protein derivative (PPD), a control antigen.CONCLUSION: Prolonged survival was observed in patients who received postoperative active immunotherapy with Canvaxin therapeutic cancer vaccine. The correlation of survival with vaccine-DTH responses but not PPD-DTH indicates a treatment-specific effect. These findings suggest that adjuvant active specific immunotherapy should be considered after cytoreductive surgery for advanced melanoma.

Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): a randomised, double-blind, phase 3 trial

2015 ◽  
Vol 16 (5) ◽  
pp. 522-530 ◽  
Author(s):  
Alexander M M Eggermont ◽  
Vanna Chiarion-Sileni ◽  
Jean-Jacques Grob ◽  
Reinhard Dummer ◽  
Jedd D Wolchok ◽  
...  
Keyword(s):  
High Risk ◽  
Complete Resection ◽  
Stage Iii ◽  
Phase 3 ◽  
Double Blind ◽  
Stage Iii Melanoma
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