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

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  1 , Amélie Anota  2 , Mariette Mercier  3 , Bérangère Bastien  4 , Gisèle Lacoste  4 , Jean-Marc Limacher  4 , Elisabeth Quoix  5 , Franck Bonnetain  2
Affiliations
Clinical Trial

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 et al. PLoS One. .

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.

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Conflict of interest statement

Competing Interests: This study was supported by Transgene SAS. This work is a contribution to ADNA (Advanced Diagnostics for New Therapeutic Approaches), a program dedicated to personalized medicine, coordinated by Institut Mérieux and supported by the French public agency Bpifrance. GL, BB and JML are full time employees of Transgene SA. There are no patents related to the quality of life data presented in the publication, however. TG4010 is a product in development, not marketed so far and protected by a family of patents. This does not alter the authors’ adherence to all the PLOS ONE policies on sharing data and materials.

Figures

Fig 1
Fig 1. CONSORT Flow chart showing patients randomised in each group and the number of patients answering FACT-L questionnaire at baseline and follow-up.
Patients still in the study time of the questionnaire completion.
Fig 2
Fig 2. Time to a five-point definitive deterioration in Health related Quality of Life score or death: (A) Physical Well-Being dimension (PWB); (B) Emotional Well-Being dimension (EWB); (C) Social Well-Being dimension (SWB); (D) Functional Well-Being dimension (FWB); (E) Lung Cancer Subscale (LCS).
Arm 1: combination therapy arm; Arm 2: control arm.
See this image and copyright information in PMC

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