Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial

Christine Rotonda; Amélie Anota; Mariette Mercier; Bérangère Bastien; Gisèle Lacoste; Jean-Marc Limacher; Elisabeth Quoix; Franck Bonnetain

doi:10.1371/journal.pone.0132568

Impact of TG4010 Vaccine on Health-Related Quality of Life in Advanced Non-Small-Cell Lung Cancer: Results of a Phase IIB Clinical Trial

PLoS One. 2015 Jul 24;10(7):e0132568. doi: 10.1371/journal.pone.0132568. eCollection 2015.

Authors

Christine Rotonda¹, Amélie Anota², Mariette Mercier³, Bérangère Bastien⁴, Gisèle Lacoste⁴, Jean-Marc Limacher⁴, Elisabeth Quoix⁵, Franck Bonnetain²

Affiliations

¹ National Quality of Life in Oncology Platform, Nancy, France; INSERM, CIC-EC CIE6, Nancy, France; CHU Nancy, Clinical Epidemiology and Evaluation Department, Nancy, France.
² National Quality of Life in Oncology Platform, Nancy, France; Université de Franche-Comté, EA 3181, Besançon, France; CHU Besançon, Methodological and quality of life unit in oncology, Besançon, France.
³ National Quality of Life in Oncology Platform, Nancy, France; Université de Franche-Comté, EA 3181, Besançon, France.
⁴ Transgene SA, Illkirch, France.
⁵ Hôpitaux Universitaires de Strasbourg, Strasbourg, France.

Abstract

Background: This study describes the effect of TG4010 vaccine on Health related Quality of Life (HRQOL) in patients with stage IIIb and IV non-small-cell lung cancer (NSCLC).

Methods: 148 patients with advanced NSCLC expressing MUC1 were randomly assigned to receive TG4010 plus chemotherapy or chemotherapy alone. HRQOL was assessed with the Functional Assessment of Cancer Therapy-Lung (FACT-L) at baseline and every 6 weeks until disease progression. Time until definitive deterioration (TUDD) of the four well-being dimensions of the FACT-L physical (PWB), functional (FWB), emotional (EWB) and social well-being (SWB) and the Lung Cancer Subscale (LCS) domains were analyzed for a 5-point minimal clinically important difference.

Results: No difference of TUDD of HRQOL has been found between treatment arms. No prognostic factors have been found to have a significant impact on the TUDD of PWB, SWB and LCS domains. The gender, the performance status and the smoking habits seemed to be associated with a shorter TUDD of EWB domain. The smokers and the former smokers seemed to present a shorter TUDD of FWB domain.

Conclusion: This study suggests that adding therapeutic vaccination with TG4010 to standard chemotherapy in patients with advanced NSCLC is associated with a similar evolution in HRQOL compared to chemotherapy alone.

Publication types

Clinical Trial, Phase II
Comparative Study
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Aged
Cancer Vaccines / administration & dosage*
Cancer Vaccines / therapeutic use
Carcinoma, Non-Small-Cell Lung / drug therapy*
Carcinoma, Non-Small-Cell Lung / metabolism
Carcinoma, Non-Small-Cell Lung / pathology
Cisplatin / therapeutic use*
Deoxycytidine / analogs & derivatives*
Deoxycytidine / therapeutic use
Female
Gemcitabine
Humans
Lung Neoplasms / drug therapy*
Lung Neoplasms / metabolism
Lung Neoplasms / pathology
Male
Membrane Glycoproteins / administration & dosage*
Membrane Glycoproteins / therapeutic use
Middle Aged
Mucin-1 / metabolism
Quality of Life / psychology
Treatment Outcome

Substances

Cancer Vaccines
MUC1 protein, human
Membrane Glycoproteins
Mucin-1
TG4010
Deoxycytidine
Cisplatin
Gemcitabine

Grants and funding

This study was supported by Transgene SAS and by ADNA, a French government-funded programme for personalised medicine. GL, BB and JML are full time employees of Transgene SA. Transgene SA provided support in the form of salaries for authors GL, BB and JML, and as the sponsor of the study was involved in the study design, data collection and analysis, decision to publish, or review of the manuscript. The specific roles of these authors are articulated in the ‘author contributions’ section.