Vaccination of patients with advanced non-small cell lung cancer with an optimized cryptic hTERT peptide (Vx-001)

7642 Background: To evaluate the immunological and clinical efficacy of the optimized peptide TERT572Y (Vx-001) presented by HLA-A*0201 in patients with advanced non-small cell lung cancer (NSCLC). Methods: Twenty-two patients with residual (n=8) or progressive (n=14) advanced NSCLC following chemotherapy and/or radiotherapy received two subcutaneous injections of the optimized TERT572Y peptide followed by four injections of the native TERT572 peptide given every 3 weeks. Peptide-specific immune responses were monitored by Elispot assay and/or TERT572Y pentamer staining. Clinical outcome was compared with that of 22 case-matched historical control patients. Results: Thirteen (59%) out of 22 patients completed the vaccination program. Toxicity consisted primarily of local skin reactions. TERT572-specific CD8+ cells were detected in 16 (76.2%) out of 21 patients after the 2nd vaccination and 10 (90.9%) out of 11 patients after the 6th vaccination. Stable disease occurred in 8 (36.4%) patients with a median duration of 11.2 months. Patients with an early immunological response (n=16) had a significantly longer time to disease progression and overall survival than non-responders (n=5) (log-rank tests p=0.046 and p=0.012, respectively). The estimated median overall survival was 30.0 (range, 2.8–40.0) and 4.1 (range, 2.4–10.9) months for immunological responders and non-responders, respectively. Moreover, median overall survival was 30.6 months (95% CI:10.9–48.9) and 6.1 months (95% CI:4.4–7.8) for the vaccinated and case-matched historical control patients, respectively (p=0.074). Conclusions: TERT572Y peptide vaccine is well tolerated and effective in eliciting a specific T-cell immunity which seems to be associated with prolonged patients’ survival. No significant financial relationships to disclose.

Download Full-text

Docetaxel compared with vinorelbine in elderly patients with advanced non-small cell lung cancer (NSCLC): A randomized phase II Hellenic Oncology Research Group trial

Journal of Clinical Oncology ◽

10.1200/jco.2007.25.18_suppl.7615 ◽

2007 ◽

Vol 25 (18_suppl) ◽

pp. 7615-7615 ◽

Cited By ~ 3

Author(s):

A. Karampeazis ◽

L. Vamvakas ◽

A. Agelidou ◽

V. Chandrinos ◽

X. Tsiafaki ◽

...

Keyword(s):

Lung Cancer ◽

Overall Survival ◽

Elderly Patients ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Statistical Difference ◽

Median Overall Survival ◽

Performance Status ◽

Small Cell ◽

Small Cell Lung

7615 Background: To compare docetaxel versus vinorelbine as front-line treatment of elderly patients with advanced non-small-cell lung cancer (NSCLC). Methods: Chemotherapy-naive patients >65 years, with stage histologically or cytologically documented IIIB/IV NSCLC and performance status (PS) 0–3 were randomly assigned to receive docetaxel 38 mg/m2 (days 1 and 8) or vinorelbine 25 mg/m2 (days 1 and 8) every 21 days. Treatment was continued for a maximum of six cycles and was interrupted in case of disease progression or unacceptable toxicity. Results: A total of 112 patients with median age of 76 years (range, 66–87) were enrolled onto the study. PS 2–3 had 39 (35%) patients. The two treatment groups were well balanced. There was no statistical difference between the 2 arms in median overall survival (6.27 months vs 3.97 months; p=0.129), in median time to progression (2.2 months vs 2 months; p=0.863.) and in overall response rate (5.3% vs 11.3%; p=0.247). Docetaxel conferred a statistically significant survival benefit compared to vinorelbine only in patients with PS 0–1 (11.4 months vs 4.3 months; p=0.009). Among patients treated with docetaxel there was a significant difference in median overall survival for patients with PS 0–1 compared with patients with PS 2–3 (11.4 months vs 2.5 months; p=0.004) while there was no statistical difference in the vinorelbine arm (4.3 months vs 2.8 months; p=0.970).The most common grade 3 and 4 toxicity was neutropenia (3.4% for docetaxel; 27.8% for vinorelbine; p=0.0001). Other toxicities were mild, well tolerated and similar for both groups with the exception of asthenia grade 2 (8.6% for docetaxel; 24.1% for vinorelbine; p=0.026). Conclusions: Docetaxel improves survival compared with vinorelbine in elderly patients with advanced non-small-cell lung cancer and good performance status without increasing toxicity. No significant financial relationships to disclose.

Download Full-text

Hybrid scheme with carboplatin and etoposide intravenous (iv) and oral in patients with small cell lung cancer: Should we treat in a different way based on the age?

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e17515 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e17515-e17515

Author(s):

Andrea Ruiz-Valdepeñas ◽

Magda Palka ◽

Patricia Ibeas ◽

Bernard Gaston Doger de Speville ◽

Elena Almagro ◽

...

Keyword(s):

Lung Cancer ◽

Overall Survival ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Median Overall Survival ◽

Small Cell ◽

Small Cell Lung ◽

Hybrid Scheme ◽

Limited Stage ◽

One Year

e17515 Background: The increase in longevity due to a better quality of life in old people makes possible the chemotherapy treatment in the most of patients with Small Cell Lung Cancer. The aim of this research is to evaluate if there are differences in overall survival according to the age (comparing older and younger than 65 years old), in patients treated with the same scheme of chemotherapy. Methods: Patients diagnosed with small cell lung cancer between years 2003 and 2010 and treated in our hospital by the scheme carboplatin 300mg/m2 IV on day 1, with etoposid 100mg/m2 per day (iv on day 1 and oral days two to five), were retrospective reviewed to evaluate the overall survival by group of age (older and younger than 65 years old). Results: 96 patients diagnosed of small cell lung cancer were treated in our hospital between 2003 and 2010 with the aforementioned scheme of chemotherapy. 70 of them were on extended stage, and 26 had limited stage; 54 were until 65 years old (56.25%) and 42 were older (43.75%). In extended disease, the elder than 65 presented an overall survival rate one year after the diagnosis of 38.3% (SE 9.3%) and at 18 months 10.2% (SE 6.3%), with a median overall survival of 10 months (Range 1 to 22 months). The younger than sixty five had an overall survival at 12 months of 23.8% (SE 6.6%), and at 18 moths of 5.4 (3.7%), non significant (p:0.437). Their median overall survival was 8.23 months, with a range of <1month to 24 months. In the group with limited stage, the sample older than 65 had a probability of overall survival 1 year after the diagnosis of 46,2% (Standard error (SE), 13.8%), and 23.1% (SE 11.7%) at 18 months, versus a 48.6% (SE 14,8%) at 12 months and 19.4% (SE 12.2%) in younger (p:0.708). The median overall survival in elder than 65 with Limited stage was 11.5 months (6 to 81 months), and for the younger 15 months (range 4 to 25 months). Conclusions: The hybrid scheme carboplatin 300mg/m2 IV on day 1, with etoposid 100mg/m2 per day (iv on day 1 and oral days 2 to 5), provides an acceptable overall survival, without significant differences comparing older and younger than 65 years old, both in limited and extended stage.

Download Full-text

Vaccination of Patients With Advanced Non–Small-Cell Lung Cancer With an Optimized Cryptic Human Telomerase Reverse Transcriptase Peptide

Journal of Clinical Oncology ◽

10.1200/jco.2006.10.3465 ◽

2007 ◽

Vol 25 (19) ◽

pp. 2727-2734 ◽

Cited By ~ 70

Author(s):

Irini Bolonaki ◽

Athanassios Kotsakis ◽

Elsa Papadimitraki ◽

Despoina Aggouraki ◽

George Konsolakis ◽

...

Keyword(s):

Lung Cancer ◽

Reverse Transcriptase ◽

Small Cell Lung Cancer ◽

Cell Lung Cancer ◽

Immunological Response ◽

Small Cell ◽

Telomerase Reverse Transcriptase ◽

Small Cell Lung ◽

Skin Reactions ◽

Local Skin

PurposeTo evaluate the immunological and clinical response as well as the safety of the optimized peptide telomerase reverse transcriptase p572Y (TERT572Y) presented by HLA-A*0201 in patients with advanced non–small-cell lung cancer (NSCLC).Patients and MethodsTwenty-two patients with advanced NSCLC and residual (n = 8) or progressive disease (PD; n = 14) following chemotherapy and/or radiotherapy received two subcutaneous injections of the optimized TERT572Ypeptide followed by four injections of the native TERT572peptide administered every 3 weeks. Peptide-specific immune responses were monitored by enzyme-linked immunosorbent spot assay and/or TERT572Ypentamer staining.ResultsTwelve (54.5%) of 22 patients completed the vaccination program. Toxicity consisted primarily of local skin reactions. TERT572-specific CD8+cells were detected in 16 (76.2%) of 21 patients after the second vaccination, and 10 (90.9%) of 11 patients after the sixth vaccination. Stable disease (SD) occurred in eight (36.4%) of 22 vaccinated patients, with three (13.6%) having had PD before entering the study. The median duration of SD was 11.2 months. After a median follow-up of 10.0 months, patients with early developed immunological response (n = 16) had a significantly longer time to progression and overall survival (OS) than nonresponders (n = 5; log-rank tests P = .046 and P = .012, respectively). The estimated median OS was 30.0 months (range, 2.8 to 40.0 months) and 4.1 months (range, 2.4 to 10.9 months) for responders and nonresponders, respectively.ConclusionTERT572Ypeptide vaccine is well tolerated and effective in eliciting a specific T cell immunity. Immunological response is associated with prolonged survival. These results are encouraging and warrant further evaluation in a randomized study.

Download Full-text