A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer

Alain J. Geulibter, Teresa Gamucci, Camillo F. Pollera, Francesco Di Costanzo, Carmen Nuzzo, Angela Gabriele, Carlo Signorelli, Silvia Gasperoni, Virginia Ferraresi, Diana Giannarelli, Francesco Cognetti, Massimo Zeuli

Research output: Contribution to journalArticle

11 Citations (Scopus)

Abstract

Objective: This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer. Research design and methods: Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120mg/m2 on Day 1 of each 3-week cycle). Results: Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%Cl: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% Cl: 15.1-not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%). Conclusions: The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naive metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.

Original languageEnglish
Pages (from-to)2117-2123
Number of pages7
JournalCurrent Medical Research and Opinion
Volume23
Issue number9
DOIs
Publication statusPublished - Sep 2007

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oxaliplatin
Colorectal Neoplasms
Drug Therapy
Intention to Treat Analysis
Survival
Vomiting
Diarrhea
Research Design
gefitinib
Capecitabine
Safety

Keywords

  • Colorectal cancer
  • EGFR
  • First line
  • Targeted therapy

ASJC Scopus subject areas

  • Medicine(all)

Cite this

A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer. / Geulibter, Alain J.; Gamucci, Teresa; Pollera, Camillo F.; Di Costanzo, Francesco; Nuzzo, Carmen; Gabriele, Angela; Signorelli, Carlo; Gasperoni, Silvia; Ferraresi, Virginia; Giannarelli, Diana; Cognetti, Francesco; Zeuli, Massimo.

In: Current Medical Research and Opinion, Vol. 23, No. 9, 09.2007, p. 2117-2123.

Research output: Contribution to journalArticle

Geulibter, Alain J. ; Gamucci, Teresa ; Pollera, Camillo F. ; Di Costanzo, Francesco ; Nuzzo, Carmen ; Gabriele, Angela ; Signorelli, Carlo ; Gasperoni, Silvia ; Ferraresi, Virginia ; Giannarelli, Diana ; Cognetti, Francesco ; Zeuli, Massimo. / A phase II trial of gefitinib in combination with capecitabine and oxaliplatin as first-line chemotherapy in patients with advanced colorectal cancer. In: Current Medical Research and Opinion. 2007 ; Vol. 23, No. 9. pp. 2117-2123.
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abstract = "Objective: This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer. Research design and methods: Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120mg/m2 on Day 1 of each 3-week cycle). Results: Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6{\%}) patients experienced a complete response (CR), 14 (40{\%}) a partial response (PR) and 11 (31.4{\%}) had stable disease (SD). The disease control rate (CR + PR + SD) was 80{\%}, the median time to progression was 7.3 months (95{\%}Cl: 4.76-9.2) and the estimated median overall survival was 21.9 months (95{\%} Cl: 15.1-not reached). The most common grade 3 to 4 toxicities included diarrhoea (31{\%}) and vomiting (5.7{\%}). Conclusions: The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naive metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.",
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AU - Geulibter, Alain J.

AU - Gamucci, Teresa

AU - Pollera, Camillo F.

AU - Di Costanzo, Francesco

AU - Nuzzo, Carmen

AU - Gabriele, Angela

AU - Signorelli, Carlo

AU - Gasperoni, Silvia

AU - Ferraresi, Virginia

AU - Giannarelli, Diana

AU - Cognetti, Francesco

AU - Zeuli, Massimo

PY - 2007/9

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N2 - Objective: This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer. Research design and methods: Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120mg/m2 on Day 1 of each 3-week cycle). Results: Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%Cl: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% Cl: 15.1-not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%). Conclusions: The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naive metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.

AB - Objective: This study was designed as a multicentre phase II trial to assess the efficacy and safety of gefitinib in association with capecitabine and oxaliplatin in patients with untreated metastatic colorectal cancer. Research design and methods: Patients with metastatic colorectal cancer that had received no prior chemotherapy for advanced disease were treated with oral gefitinib (250 mg daily) plus oral capecitabine (1000mg/m2 twice a day on Days 1-14) and intravenous oxaliplatin (120mg/m2 on Day 1 of each 3-week cycle). Results: Thirty-five patients were enrolled. In the intention-to-treat analysis, 3 (8.6%) patients experienced a complete response (CR), 14 (40%) a partial response (PR) and 11 (31.4%) had stable disease (SD). The disease control rate (CR + PR + SD) was 80%, the median time to progression was 7.3 months (95%Cl: 4.76-9.2) and the estimated median overall survival was 21.9 months (95% Cl: 15.1-not reached). The most common grade 3 to 4 toxicities included diarrhoea (31%) and vomiting (5.7%). Conclusions: The combination of capecitabine, oxaliplatin and gefitinib appears to have promising activity in chemotherapy-naive metastatic colorectal cancer. A higher disease control rate and an increase in median overall survival were seen compared with previous reports with capecitabine and oxaliplatin in similar patient populations. The tolerability profile appears to be predictable and similar to capecitabine/oxaliplatin regimens.

KW - Colorectal cancer

KW - EGFR

KW - First line

KW - Targeted therapy

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