Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer: Results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial

Andrea Ardizzoni, Marcello Tiseo, Luca Boni, Andrew D. Vincent, Rodolfo Passalacqua, Sebastiano Buti, Domenico Amoroso, Andrea Camerini, Roberto Labianca, Giovenzio Genestreti, Corrado Boni, Libero Ciuffreda, Francesco Di Costanzo, Filippo De Marinis, Lucio Crinò, Antonio Santo, Antonio Pazzola, Fausto Barbieri, Nicoletta Zilembo, Ida ColantonioCarmelo Tibaldi, Rodolfo Mattioli, Mara A. Cafferata, Roberta Camisa, Egbert F. Smit

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Abstract

Purpose: To compare efficacy of pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC, in progression during or after first-line platinum-based chemotherapy, were randomly assigned to receive pemetrexed (arm A) or pemetrexed plus carboplatin (arm B). Primary end point was progression-free survival (PFS). A preplanned pooled analysis of the results of this study with those of the NVALT7 study was carried out to assess the impact of carboplatin added to pemetrexed in terms of overall survival (OS). Results: From July 2007 to October 2009, 239 patients (arm A, n = 120; arm B, n = 119) were enrolled. Median PFS was 3.6 months for arm A versus 3.5 months for arm B (hazard ratio [HR], 1.05; 95% CI, 0.81 to 1.36; P = .706). No statistically significant differences in response rate, OS, or toxicity were observed. A total of 479 patients were included in the pooled analysis. OS was not improved by the addition of carboplatin to pemetrexed (HR, 90; 95% CI, 0.74 to 1.10; P = .316; P heterogeneity = .495). In the subgroup analyses, the addition of carboplatin to pemetrexed in patients with squamous tumors led to a statistically significant improvement in OS from 5.4 to 9 months (adjusted HR, 0.58; 95% CI, 0.37 to 0.91; P interaction test = .039). Conclusion: Second-line treatment of advanced NSCLC with pemetrexed plus carboplatin does not improve survival outcomes as compared with single-agent pemetrexed. The benefit observed with carboplatin addition in squamous tumors may warrant further investigation.

Original languageEnglish
Pages (from-to)4501-4507
Number of pages7
JournalJournal of Clinical Oncology
Volume30
Issue number36
DOIs
Publication statusPublished - Dec 20 2012

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Pemetrexed
Carboplatin
Non-Small Cell Lung Carcinoma
Drug Therapy
Survival
Disease-Free Survival
Platinum
Neoplasms

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer : Results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial. / Ardizzoni, Andrea; Tiseo, Marcello; Boni, Luca; Vincent, Andrew D.; Passalacqua, Rodolfo; Buti, Sebastiano; Amoroso, Domenico; Camerini, Andrea; Labianca, Roberto; Genestreti, Giovenzio; Boni, Corrado; Ciuffreda, Libero; Di Costanzo, Francesco; De Marinis, Filippo; Crinò, Lucio; Santo, Antonio; Pazzola, Antonio; Barbieri, Fausto; Zilembo, Nicoletta; Colantonio, Ida; Tibaldi, Carmelo; Mattioli, Rodolfo; Cafferata, Mara A.; Camisa, Roberta; Smit, Egbert F.

In: Journal of Clinical Oncology, Vol. 30, No. 36, 20.12.2012, p. 4501-4507.

Research output: Contribution to journalArticle

Ardizzoni, A, Tiseo, M, Boni, L, Vincent, AD, Passalacqua, R, Buti, S, Amoroso, D, Camerini, A, Labianca, R, Genestreti, G, Boni, C, Ciuffreda, L, Di Costanzo, F, De Marinis, F, Crinò, L, Santo, A, Pazzola, A, Barbieri, F, Zilembo, N, Colantonio, I, Tibaldi, C, Mattioli, R, Cafferata, MA, Camisa, R & Smit, EF 2012, 'Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer: Results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial', Journal of Clinical Oncology, vol. 30, no. 36, pp. 4501-4507. https://doi.org/10.1200/JCO.2012.43.6758
Ardizzoni, Andrea ; Tiseo, Marcello ; Boni, Luca ; Vincent, Andrew D. ; Passalacqua, Rodolfo ; Buti, Sebastiano ; Amoroso, Domenico ; Camerini, Andrea ; Labianca, Roberto ; Genestreti, Giovenzio ; Boni, Corrado ; Ciuffreda, Libero ; Di Costanzo, Francesco ; De Marinis, Filippo ; Crinò, Lucio ; Santo, Antonio ; Pazzola, Antonio ; Barbieri, Fausto ; Zilembo, Nicoletta ; Colantonio, Ida ; Tibaldi, Carmelo ; Mattioli, Rodolfo ; Cafferata, Mara A. ; Camisa, Roberta ; Smit, Egbert F. / Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer : Results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial. In: Journal of Clinical Oncology. 2012 ; Vol. 30, No. 36. pp. 4501-4507.
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abstract = "Purpose: To compare efficacy of pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC, in progression during or after first-line platinum-based chemotherapy, were randomly assigned to receive pemetrexed (arm A) or pemetrexed plus carboplatin (arm B). Primary end point was progression-free survival (PFS). A preplanned pooled analysis of the results of this study with those of the NVALT7 study was carried out to assess the impact of carboplatin added to pemetrexed in terms of overall survival (OS). Results: From July 2007 to October 2009, 239 patients (arm A, n = 120; arm B, n = 119) were enrolled. Median PFS was 3.6 months for arm A versus 3.5 months for arm B (hazard ratio [HR], 1.05; 95{\%} CI, 0.81 to 1.36; P = .706). No statistically significant differences in response rate, OS, or toxicity were observed. A total of 479 patients were included in the pooled analysis. OS was not improved by the addition of carboplatin to pemetrexed (HR, 90; 95{\%} CI, 0.74 to 1.10; P = .316; P heterogeneity = .495). In the subgroup analyses, the addition of carboplatin to pemetrexed in patients with squamous tumors led to a statistically significant improvement in OS from 5.4 to 9 months (adjusted HR, 0.58; 95{\%} CI, 0.37 to 0.91; P interaction test = .039). Conclusion: Second-line treatment of advanced NSCLC with pemetrexed plus carboplatin does not improve survival outcomes as compared with single-agent pemetrexed. The benefit observed with carboplatin addition in squamous tumors may warrant further investigation.",
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T1 - Pemetrexed versus pemetrexed and carboplatin as second-line chemotherapy in advanced non-small-cell lung cancer

T2 - Results of the GOIRC 02-2006 randomized phase II study and pooled analysis with the NVALT7 trial

AU - Ardizzoni, Andrea

AU - Tiseo, Marcello

AU - Boni, Luca

AU - Vincent, Andrew D.

AU - Passalacqua, Rodolfo

AU - Buti, Sebastiano

AU - Amoroso, Domenico

AU - Camerini, Andrea

AU - Labianca, Roberto

AU - Genestreti, Giovenzio

AU - Boni, Corrado

AU - Ciuffreda, Libero

AU - Di Costanzo, Francesco

AU - De Marinis, Filippo

AU - Crinò, Lucio

AU - Santo, Antonio

AU - Pazzola, Antonio

AU - Barbieri, Fausto

AU - Zilembo, Nicoletta

AU - Colantonio, Ida

AU - Tibaldi, Carmelo

AU - Mattioli, Rodolfo

AU - Cafferata, Mara A.

AU - Camisa, Roberta

AU - Smit, Egbert F.

PY - 2012/12/20

Y1 - 2012/12/20

N2 - Purpose: To compare efficacy of pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC, in progression during or after first-line platinum-based chemotherapy, were randomly assigned to receive pemetrexed (arm A) or pemetrexed plus carboplatin (arm B). Primary end point was progression-free survival (PFS). A preplanned pooled analysis of the results of this study with those of the NVALT7 study was carried out to assess the impact of carboplatin added to pemetrexed in terms of overall survival (OS). Results: From July 2007 to October 2009, 239 patients (arm A, n = 120; arm B, n = 119) were enrolled. Median PFS was 3.6 months for arm A versus 3.5 months for arm B (hazard ratio [HR], 1.05; 95% CI, 0.81 to 1.36; P = .706). No statistically significant differences in response rate, OS, or toxicity were observed. A total of 479 patients were included in the pooled analysis. OS was not improved by the addition of carboplatin to pemetrexed (HR, 90; 95% CI, 0.74 to 1.10; P = .316; P heterogeneity = .495). In the subgroup analyses, the addition of carboplatin to pemetrexed in patients with squamous tumors led to a statistically significant improvement in OS from 5.4 to 9 months (adjusted HR, 0.58; 95% CI, 0.37 to 0.91; P interaction test = .039). Conclusion: Second-line treatment of advanced NSCLC with pemetrexed plus carboplatin does not improve survival outcomes as compared with single-agent pemetrexed. The benefit observed with carboplatin addition in squamous tumors may warrant further investigation.

AB - Purpose: To compare efficacy of pemetrexed versus pemetrexed plus carboplatin in pretreated patients with advanced non-small-cell lung cancer (NSCLC). Patients and Methods: Patients with advanced NSCLC, in progression during or after first-line platinum-based chemotherapy, were randomly assigned to receive pemetrexed (arm A) or pemetrexed plus carboplatin (arm B). Primary end point was progression-free survival (PFS). A preplanned pooled analysis of the results of this study with those of the NVALT7 study was carried out to assess the impact of carboplatin added to pemetrexed in terms of overall survival (OS). Results: From July 2007 to October 2009, 239 patients (arm A, n = 120; arm B, n = 119) were enrolled. Median PFS was 3.6 months for arm A versus 3.5 months for arm B (hazard ratio [HR], 1.05; 95% CI, 0.81 to 1.36; P = .706). No statistically significant differences in response rate, OS, or toxicity were observed. A total of 479 patients were included in the pooled analysis. OS was not improved by the addition of carboplatin to pemetrexed (HR, 90; 95% CI, 0.74 to 1.10; P = .316; P heterogeneity = .495). In the subgroup analyses, the addition of carboplatin to pemetrexed in patients with squamous tumors led to a statistically significant improvement in OS from 5.4 to 9 months (adjusted HR, 0.58; 95% CI, 0.37 to 0.91; P interaction test = .039). Conclusion: Second-line treatment of advanced NSCLC with pemetrexed plus carboplatin does not improve survival outcomes as compared with single-agent pemetrexed. The benefit observed with carboplatin addition in squamous tumors may warrant further investigation.

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