scholarly journals PCN145 Treatment Patterns and Outcomes Among Patients With Unresectable Stage III or Stage IV Melanoma in Mexico

2012 ◽  
Vol 15 (4) ◽  
pp. A234
Author(s):  
A. Silva ◽  
M. Lázaro-León ◽  
R. de la peña ◽  
P. Frausto ◽  
J.J. Vargas-Valencia ◽  
...  
Keyword(s):  
Stage Iv ◽  
Treatment Patterns ◽  
Stage Iii ◽  
Unresectable Stage ◽  
Stage Iv Melanoma

A phase II single arm study of pazopanib and paclitaxel as first-line treatment for unresectable stage III and stage IV melanoma: Interim analysis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. 8524-8524 ◽  
Author(s):  
John P. Fruehauf ◽  
Beverly Alger ◽  
Basmina Parmakhtiar ◽  
James G. Jakowatz ◽  
Claudette Bettis ◽  
...  
Keyword(s):  
Phase Ii ◽  
Interim Analysis ◽  
Cell Cancer ◽  
Stage Iv ◽  
Stage Iii ◽  
First Line ◽  
Open Label ◽  
Unresectable Stage ◽  
Biomarker Analysis ◽  
Stage Iv Melanoma

8524 Background: Metastatic melanoma lacks effective therapy. Pazopanib is a small-molecule inhibitor of VEGFR-1,2,3, PDGFR-B and c-KIT that has antiangiogenic activity in renal cell cancer as well as inhibition of melanoma tumor xenografts. We designed a phase II single arm, open label clinical trial evaluating pazopanib in combination with metronomic paclitaxel as first line therapy for subjects with unresectable stage III and stage IV melanoma. Methods: This protocol utilizes a Simon 2-stage Minimax design, with a planned interim analysis to confirm >3 responders to move to the second stage. To date, 20 eligible patients have been enrolled with 17 evaluable for response. All subjects were treatment naïve and received paclitaxel at 80mg/m2 weekly for three weeks in a 4 week cycle and pazopanib at 800mg as a continuous daily oral dose. The primary endpoint is 6 month progression free survival. Exploratory endpoints include biomarker analysis that may be associated with treatment outcomes (serum VEGF, soluble VEGF R2, serum HIF, serum TSP1 and BRAF mutation status). An additional exploratory endpoint includes the in vitro activity of pazopanib and paclitaxel on patient biopsy material co-cultured with vascular endothelial cells. RECIST criteria were used to define treatment response. Results: For the 17 evaluable patients treated to date the following results were seen: 1 CR, 6 PR’s, 8 SD’s and 2 PD’s. The overall RR (CR+PR) was 40%. Total disease control rate was 80% (PR+SD). The most common AEs/lab abnormalities were nausea (71%), hypertension (57%), fatigue (57%) and vomiting (43%). Grade 3-4 AEs included hypertension (28%), transaminitis (21%) and neutropenia (14%). One patient discontinued for grade 4 transaminitis which subsequently resolved completely. Dose reductions were required for pazopanib in 5 patients and for paclitaxel in one patient. Conclusions: Planned interim analysis of this phase II study demonstrated that pazopanib in combination with paclitaxel was well tolerated and resulted in a 40% response rate, indicating that this combination is of further interest. Accrual will continue to reach a goal of 60 patients.

A phase I trial of ipilimumab plus bevacizumab in patients with unresectable stage III or stage IV melanoma.

2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 8511-8511 ◽  
Author(s):  
F. S. Hodi ◽  
P. A. Friedlander ◽  
M. B. Atkins ◽  
D. F. McDermott ◽  
D. P. Lawrence ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Trial ◽  
Stage Iv ◽  
Stage Iii ◽  
Unresectable Stage ◽  
Stage Iv Melanoma

scholarly journals The cost of unresectable stage III or stage IV melanoma in Italy

2012 ◽  
Vol 31 (1) ◽  
Author(s):  
Michele Maio ◽  
Paolo Ascierto ◽  
Alessandro Testori ◽  
Ruggero Ridolfi ◽  
Emilio Bajetta ◽  
...  
Keyword(s):  
Stage Iv ◽  
Stage Iii ◽  
Unresectable Stage ◽  
The Cost ◽  
Stage Iv Melanoma

scholarly journals High GDF-15 Serum Levels Independently Correlate with Poorer Overall Survival of Patients with Tumor-Free Stage III and Unresectable Stage IV Melanoma

2016 ◽  
Vol 136 (12) ◽  
pp. 2444-2452 ◽  
Author(s):  
Benjamin Weide ◽  
Tina Schäfer ◽  
Alexander Martens ◽  
Anastasia Kuzkina ◽  
Laura Uder ◽  
...  
Keyword(s):  
Overall Survival ◽  
Stage Iv ◽  
Serum Levels ◽  
Stage Iii ◽  
Unresectable Stage ◽  
Stage Iv Melanoma

scholarly journals 300 Final analysis of a prospective, randomized, double-blind, placebo-controlled phase IIb trial of tumor lysate, particle-loaded, dendritic cell vaccine in stage III/IV melanoma: 36-month analysis

2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A327-A327
Author(s):  
Lexy Adams ◽  
Robert Chick ◽  
Guy Clifton ◽  
Timothy Vreeland ◽  
Patrick McCarthy ◽  
...  
Keyword(s):  
Disease Free Survival ◽  
Stage Iv ◽  
Standard Of Care ◽  
Stage Iii ◽  
Tumor Lysate ◽  
Double Blind ◽  
Free Survival ◽  
Resected Stage ◽  
Disease Free ◽  
Stage Iv Melanoma

BackgroundThe tumor lysate, particle-loaded, dendritic cell (TLPLDC) vaccine is created ex vivo by loading autologous dendritic cells (DC) with yeast cell wall particles (YCWP) containing autologous tumor lysate, thus delivering tumor antigens to the DC cytoplasm via phagocytosis. TLPLDC then activates a robust T cell response against the unique antigens for each patient. The primary analysis of the prospective, randomized, multi-center, double-blind, placebo-controlled phase IIb trial in patients with resected stage III/IV melanoma showed TLPLDC improved 24-month disease-free survival (DFS) in the per-treatment (PT) analysis (patients completing the 6-month primary vaccine series). Here, we examine the secondary endpoint of 36-month DFS and overall survival (OS).MethodsPatients with resected stage III/IV melanoma were randomized 2:1 to TLPLDC vaccine or placebo (autologous DC loaded with empty YCWP). Treatments were given at 0, 1, 2, 6, 12 and 18 months. The protocol was amended to include patients receiving concurrent checkpoint inhibitors (CPIs) to follow changes in standard of care. The co-primary endpoints were 24-month DFS by intention-to-treat (IT) analysis and per-treatment (PT) analysis, with secondary endpoints including 36-month DFS and OS by ITT and PT analysis, pre-specified analysis by stage, and safety as measured by CTCAE v4.03.ResultsOverall, 103 patients received TLPLDC and 41 placebo. In PT analysis, 65 patients received TLPLDC and 32 placebo. Total adverse events (AEs), grade 3+ AEs, and serious AEs (SAEs) were similar in placebo vs TLPLDC groups, with one related SAE per treatment arm. By ITT analysis, 36-month OS was 76.2% for TLPLDC vs 70.3% for placebo (HR 0.72, p=0.437) and 36-month DFS was 35.6% vs 27.1% (HR 0.95, p=0.841). By PT analysis, 36-month DFS was improved with TLPLDC (57.5% vs 35.0%; HR 0.50, p=0.025, figure 1). This effect was even more dramatic in resected stage IV patients (36-month DFS: 60.9% vs 0%; HR 0.12, p=0.001, figure 2).ConclusionsThis phase IIb trial again demonstrates the safety of the TLPLDC vaccine, and an improved 36-month DFS in patients with resected stage III/IV melanoma who complete the primary vaccine series, particularly in the stage IV subgroup. Next, a phase III trial will evaluate the efficacy of TLPLDC vaccine as adjuvant treatment for resected stage IV melanoma, with patients randomized to receive standard of care PD-1 inhibitors + TLPLDC versus PD-1 inhibitors + placebo.Abstract 300 Figure 136-month disease free survival for patients receiving TLPLDC vs placebo by PT analysisAbstract 300 Figure 236-month disease free survival for subset of stage IV melanoma patients receiving TLPLDC vs placebo by PT analysisTrial RegistrationThis is a phase IIb clinical trial registered under NCT02301611Ethics ApprovalThis study was approved by Western IRB, protocol 20141932.

Clinical pathways implementation in a community-based oncology practice: Real-world outcomes in patients with non-small cell lung cancer segmented by disease stage at diagnosis.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18719-e18719
Author(s):  
Natalie R. Dickson ◽  
Karen Beauchamp ◽  
Toni S. Perry ◽  
Ashley Roush ◽  
Deborah Goldschmidt ◽  
...  
Keyword(s):  
Treatment Initiation ◽  
Clinical Pathways ◽  
Stage Iv ◽  
Treatment Patterns ◽  
Stage I ◽  
Stage Iii ◽  
Disease Stage ◽  
Stage At Diagnosis ◽  
Small Cell Lung ◽  
Stage Iv Disease

e18719 Background: Clinical pathways have been introduced as tools to optimize cancer care delivery, but evidence of their value in the real world is limited. This retrospective study was performed to assess treatment patterns and clinical outcomes in patients with non-small cell lung cancer (NSCLC) before and after pathway implementation at Tennessee Oncology (TO). Methods: Chart data were abstracted for patients (≥18 years) diagnosed with Stage I-IV NSCLC who initiated first-line (1L) systemic treatment at a TO clinic and had follow-up for ³6 months or until death. Patients were divided into two cohorts: pre-pathways (treatment initiation 2014–2015) and post-pathways (treatment initiation 2016–2018). Patient characteristics, treatment patterns, and outcomes were described and compared across cohorts. An exploratory study endpoint was the evaluation of outcomes based on disease stage at diagnosis. Results: Among 501 patients (251 pre-pathways and 250 post-pathways), most had advanced or metastatic NSCLC at diagnosis (Stage III: 40%; Stage IV: 42%). Chemotherapy comprised almost all 1L systemic therapy used pre-pathways (Stage I/II: 100%; Stage III: 96%; Stage IV: 83%). Post-pathways, chemotherapy remained the most common 1L therapy in patients with Stage I/II (89%) and Stage III (72%) disease, but among patients with Stage IV disease, use of chemotherapy decreased (47%) and immuno-oncology (IO) therapy alone or in combination became common (45%). Median duration of 1L therapy was longer post-pathways in patients with Stage III (2.1 months vs 1.4 months pre-pathways; P < 0.01) and Stage IV disease (3.3 months vs 2.3 months pre-pathways; P < 0.01) but did not differ among Stage I/II patients. Median progression-free survival was significantly longer post-pathways in patients with Stage IV disease (7.0 months vs 4.2 months pre-pathways; P < 0.05), but not in other disease-stage subgroups. Median overall survival increased non-significantly post-pathways for all disease stage subgroups (Stage I/II: 26 months vs 20 months pre-pathways; Stage III: 26 months vs 20 months; Stage IV: 10 months vs 9 months). For each disease stage, rates of severe adverse events were similar between cohorts. Conclusions: While outcomes for patients diagnosed with Stage III/IV NSCLC were generally improved following the implementation of clinical pathways, this change coincided with a dramatic shift in available treatment options. Improvements post-pathways were mainly observed in patients diagnosed with advanced disease. Thus, differences in outcomes between pre-pathways and post-pathways cohorts in our study are more likely attributable to other evolving practices in cancer care, particularly the availability of newer, more effective treatments such as IO therapy as part of standard practice, than implementation of the clinical pathways.

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