A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study)

H. LeCaer; L. Greillier; R. Corre; H. Jullian; J. Crequit; L. Falchero; C. Dujon; H. Berard; A. Vergnenegre; C. Chouaid; A. Vergnenegre; B. Melloni; F. Barlesi; C. Gimenez; L. Greillier; H. LeCaer; J. R. Barriere; J. Crequit; J. B. Auliac; R. Poirier; J. Le Treut; H. Berard; P. Thomas; P. Muller; M. Grivaux; C. Locher; C. Chouaid; Baud; D. Paillotin; R. Corre; H. Lena; J. Y. Delhoume; C. Dujon; H. Jullian; J. Simonian; P. David; L. Falchero; I. Monnet; J. A. Silvani; R. Gervais

doi:10.1016/j.lungcan.2012.02.004

A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study)

H. LeCaer, L. Greillier, R. Corre, H. Jullian, J. Crequit, L. Falchero, C. Dujon, H. Berard, A. Vergnenegre, C. Chouaid, A. Vergnenegre, B. Melloni, F. Barlesi, C. Gimenez, L. Greillier, H. LeCaer, J. R. Barriere, J. Crequit, J. B. Auliac, R. PoirierJ. Le Treut, H. Berard, P. Thomas, P. Muller, M. Grivaux, C. Locher, C. Chouaid, Baud, D. Paillotin, R. Corre, H. Lena, J. Y. Delhoume, C. Dujon, H. Jullian, J. Simonian, P. David, L. Falchero, I. Monnet, J. A. Silvani, R. Gervais

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Résumé

Background: The aim of this randomized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine (G) followed by erlotinib at disease progression (arm A) versus erlotinib followed by G at progression (arm B) in vulnerable elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). Methods: Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA (socioeconomic, cognitive and emotional status, depression, nutritional status, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), time to first progression (TTP1) and safety were secondary endpoints. Results: Between May 2006 and January 2010, 21 centers enrolled 100 patients, of whom 94 were eligible. TTP2 was 4.3 and 3.5 months in arm A and arm B, respectively; TTP1 was 2.5 and 2.2 months; and the median OS time was 4.4 and 3.9 months. The respective one-year survival rates were 27.3% and 20%. There was no major unexpected toxicity. Conclusion: In vulnerable elderly patients with NSCLC not selected for EGFR expression, both strategies were feasible but had modest efficacy. Further studies are needed to identify elderly patients who should receive palliative care only.

langue originale	Anglais
Pages (de - à)	97-103
Nombre de pages	7
journal	Lung Cancer
Volume	77
Numéro de publication	1
Les DOIs	https://doi.org/10.1016/j.lungcan.2012.02.004
état	Publié - 1 juil. 2012
Modification externe	Oui

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10.1016/j.lungcan.2012.02.004

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LeCaer, H., Greillier, L., Corre, R., Jullian, H., Crequit, J., Falchero, L., Dujon, C., Berard, H., Vergnenegre, A., Chouaid, C., Vergnenegre, A., Melloni, B., Barlesi, F., Gimenez, C., Greillier, L., LeCaer, H., Barriere, J. R., Crequit, J., Auliac, J. B., ... Gervais, R. (2012). A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study). Lung Cancer, 77(1), 97-103. https://doi.org/10.1016/j.lungcan.2012.02.004

LeCaer, H. ; Greillier, L. ; Corre, R. et al. / A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study). Dans: Lung Cancer. 2012 ; Vol 77, Numéro 1. p. 97-103.

@article{431696456ab44b1da9702c12339d39f5,

title = "A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study)",

abstract = "Background: The aim of this randomized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine (G) followed by erlotinib at disease progression (arm A) versus erlotinib followed by G at progression (arm B) in vulnerable elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). Methods: Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA (socioeconomic, cognitive and emotional status, depression, nutritional status, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), time to first progression (TTP1) and safety were secondary endpoints. Results: Between May 2006 and January 2010, 21 centers enrolled 100 patients, of whom 94 were eligible. TTP2 was 4.3 and 3.5 months in arm A and arm B, respectively; TTP1 was 2.5 and 2.2 months; and the median OS time was 4.4 and 3.9 months. The respective one-year survival rates were 27.3% and 20%. There was no major unexpected toxicity. Conclusion: In vulnerable elderly patients with NSCLC not selected for EGFR expression, both strategies were feasible but had modest efficacy. Further studies are needed to identify elderly patients who should receive palliative care only.",

keywords = "Chemotherapy, Co-morbidities, Frail elderly, Lung cancer, Phase II trial",

author = "H. LeCaer and L. Greillier and R. Corre and H. Jullian and J. Crequit and L. Falchero and C. Dujon and H. Berard and A. Vergnenegre and C. Chouaid and A. Vergnenegre and B. Melloni and F. Barlesi and C. Gimenez and L. Greillier and H. LeCaer and Barriere, {J. R.} and J. Crequit and Auliac, {J. B.} and R. Poirier and {Le Treut}, J. and H. Berard and P. Thomas and P. Muller and M. Grivaux and C. Locher and C. Chouaid and Baud and D. Paillotin and R. Corre and H. Lena and Delhoume, {J. Y.} and C. Dujon and H. Jullian and J. Simonian and P. David and L. Falchero and I. Monnet and Silvani, {J. A.} and R. Gervais",

note = "Funding Information: Supported by an unrestricted educational grant from Roche, Lilly, Sanofi-Aventis and Chugai. ",

year = "2012",

month = jul,

day = "1",

doi = "10.1016/j.lungcan.2012.02.004",

language = "English",

volume = "77",

pages = "97--103",

journal = "Lung Cancer",

issn = "0169-5002",

number = "1",

}

LeCaer, H, Greillier, L, Corre, R, Jullian, H, Crequit, J, Falchero, L, Dujon, C, Berard, H, Vergnenegre, A, Chouaid, C, Vergnenegre, A, Melloni, B, Barlesi, F, Gimenez, C, Greillier, L, LeCaer, H, Barriere, JR, Crequit, J, Auliac, JB, Poirier, R, Le Treut, J, Berard, H, Thomas, P, Muller, P, Grivaux, M, Locher, C, Chouaid, C, Baud, Paillotin, D, Corre, R, Lena, H, Delhoume, JY, Dujon, C, Jullian, H, Simonian, J, David, P, Falchero, L, Monnet, I, Silvani, JA & Gervais, R 2012, 'A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study)', Lung Cancer, VOL. 77, Numéro 1, p. 97-103. https://doi.org/10.1016/j.lungcan.2012.02.004

A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study). / LeCaer, H.; Greillier, L.; Corre, R. et al.
Dans: Lung Cancer, Vol 77, Numéro 1, 01.07.2012, p. 97-103.

Résultats de recherche: Contribution à un journal › Article › Revue par des pairs

TY - JOUR

T1 - A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study)

AU - LeCaer, H.

AU - Greillier, L.

AU - Corre, R.

AU - Jullian, H.

AU - Crequit, J.

AU - Falchero, L.

AU - Dujon, C.

AU - Berard, H.

AU - Vergnenegre, A.

AU - Chouaid, C.

AU - Vergnenegre, A.

AU - Melloni, B.

AU - Barlesi, F.

AU - Gimenez, C.

AU - Greillier, L.

AU - LeCaer, H.

AU - Barriere, J. R.

AU - Crequit, J.

AU - Auliac, J. B.

AU - Poirier, R.

AU - Le Treut, J.

AU - Berard, H.

AU - Thomas, P.

AU - Muller, P.

AU - Grivaux, M.

AU - Locher, C.

AU - Chouaid, C.

AU - Baud,

AU - Paillotin, D.

AU - Corre, R.

AU - Lena, H.

AU - Delhoume, J. Y.

AU - Dujon, C.

AU - Jullian, H.

AU - Simonian, J.

AU - David, P.

AU - Falchero, L.

AU - Monnet, I.

AU - Silvani, J. A.

AU - Gervais, R.

N1 - Funding Information: Supported by an unrestricted educational grant from Roche, Lilly, Sanofi-Aventis and Chugai.

PY - 2012/7/1

Y1 - 2012/7/1

N2 - Background: The aim of this randomized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine (G) followed by erlotinib at disease progression (arm A) versus erlotinib followed by G at progression (arm B) in vulnerable elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). Methods: Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA (socioeconomic, cognitive and emotional status, depression, nutritional status, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), time to first progression (TTP1) and safety were secondary endpoints. Results: Between May 2006 and January 2010, 21 centers enrolled 100 patients, of whom 94 were eligible. TTP2 was 4.3 and 3.5 months in arm A and arm B, respectively; TTP1 was 2.5 and 2.2 months; and the median OS time was 4.4 and 3.9 months. The respective one-year survival rates were 27.3% and 20%. There was no major unexpected toxicity. Conclusion: In vulnerable elderly patients with NSCLC not selected for EGFR expression, both strategies were feasible but had modest efficacy. Further studies are needed to identify elderly patients who should receive palliative care only.

AB - Background: The aim of this randomized phase II trial was to evaluate the feasibility and activity of weekly gemcitabine (G) followed by erlotinib at disease progression (arm A) versus erlotinib followed by G at progression (arm B) in vulnerable elderly patients with advanced non small-cell lung cancer (NSCLC), selected on the basis of a comprehensive geriatric assessment (CGA). Methods: Vulnerable elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a CGA (socioeconomic, cognitive and emotional status, depression, nutritional status, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), time to first progression (TTP1) and safety were secondary endpoints. Results: Between May 2006 and January 2010, 21 centers enrolled 100 patients, of whom 94 were eligible. TTP2 was 4.3 and 3.5 months in arm A and arm B, respectively; TTP1 was 2.5 and 2.2 months; and the median OS time was 4.4 and 3.9 months. The respective one-year survival rates were 27.3% and 20%. There was no major unexpected toxicity. Conclusion: In vulnerable elderly patients with NSCLC not selected for EGFR expression, both strategies were feasible but had modest efficacy. Further studies are needed to identify elderly patients who should receive palliative care only.

KW - Chemotherapy

KW - Co-morbidities

KW - Frail elderly

KW - Lung cancer

KW - Phase II trial

UR - http://www.scopus.com/inward/record.url?scp=84861742943&partnerID=8YFLogxK

U2 - 10.1016/j.lungcan.2012.02.004

DO - 10.1016/j.lungcan.2012.02.004

M3 - Article

C2 - 22405570

AN - SCOPUS:84861742943

SN - 0169-5002

VL - 77

SP - 97

EP - 103

JO - Lung Cancer

JF - Lung Cancer

IS - 1

ER -

LeCaer H, Greillier L, Corre R, Jullian H, Crequit J, Falchero L et al. A multicenter phase II randomized trial of gemcitabine followed by erlotinib at progression, versus the reverse sequence, in vulnerable elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0505 study). Lung Cancer. 2012 juil. 1;77(1):97-103. doi: 10.1016/j.lungcan.2012.02.004