Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer

Pathological Response as Primary Endpoint and FDG-PET Predictions

Rosa Berenato, Federica Morano, Filippo Pietrantonio, Christian Cotsoglou, Marta Caporale, Gabriele Infante, Alessandro Pellegrinelli, Alessandra Alessi, Carlo Battiston, Jorgelina Coppa, Barbara Padovano, Alessia Mennitto, Monica Niger, Giovanni Fucà, Silvia Lazzati, Giorgio Greco, Gabriele Delconte, Filippo De Braud, Vincenzo Mazzaferro, Maria Di Bartolomeo

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Objectives: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Methods: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al. [Cancer 2003;98:1521-1530]. The potential role of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) as a predictive biomarker of pathological tumor response was assessed in a subgroup of 19 evaluable patients. Results: Between January 2011 and October 2015, a total of 40 patients were enrolled. After the preoperative phase, 36 out of 40 patients (90%) were considered eligible for surgery: 12 patients (30%) achieved a pathological response. The most frequent grade 3/4 adverse events were diarrhea (27%), nausea (25%), and fatigue (17%). Grade 3 neutropenia occurred in 7.5% of patients. A lower standard uptake value at baseline FDG-PET/CT was associated with pathological response. Conclusion: COI combination is active with a manageable toxicity profile in patients with resectable GC or GEJ cancer. FDG-PET/CT imaging as a surrogate biomarker of pathological response in this setting appears fascinating but should be further investigated.

Original languageEnglish
Pages (from-to)279-286
Number of pages8
JournalOncology (Switzerland)
Volume93
Issue number5
DOIs
Publication statusPublished - Oct 1 2017

Fingerprint

oxaliplatin
irinotecan
Esophagogastric Junction
Stomach
Neoplasms
Stomach Neoplasms
Tumor Biomarkers
Capecitabine
Neutropenia
Lymph Node Excision
Nausea
Fatigue

Keywords

  • Capecitabine
  • Combination chemotherapy
  • FDG-PET/CT
  • Gastric cancer
  • Irinotecan
  • Neoadjuvant chemotherapy
  • Oxaliplatin
  • Pathological response
  • Phase II study

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer : Pathological Response as Primary Endpoint and FDG-PET Predictions. / Berenato, Rosa; Morano, Federica; Pietrantonio, Filippo; Cotsoglou, Christian; Caporale, Marta; Infante, Gabriele; Pellegrinelli, Alessandro; Alessi, Alessandra; Battiston, Carlo; Coppa, Jorgelina; Padovano, Barbara; Mennitto, Alessia; Niger, Monica; Fucà, Giovanni; Lazzati, Silvia; Greco, Giorgio; Delconte, Gabriele; De Braud, Filippo; Mazzaferro, Vincenzo; Di Bartolomeo, Maria.

In: Oncology (Switzerland), Vol. 93, No. 5, 01.10.2017, p. 279-286.

Research output: Contribution to journalArticle

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abstract = "Objectives: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Methods: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al. [Cancer 2003;98:1521-1530]. The potential role of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) as a predictive biomarker of pathological tumor response was assessed in a subgroup of 19 evaluable patients. Results: Between January 2011 and October 2015, a total of 40 patients were enrolled. After the preoperative phase, 36 out of 40 patients (90{\%}) were considered eligible for surgery: 12 patients (30{\%}) achieved a pathological response. The most frequent grade 3/4 adverse events were diarrhea (27{\%}), nausea (25{\%}), and fatigue (17{\%}). Grade 3 neutropenia occurred in 7.5{\%} of patients. A lower standard uptake value at baseline FDG-PET/CT was associated with pathological response. Conclusion: COI combination is active with a manageable toxicity profile in patients with resectable GC or GEJ cancer. FDG-PET/CT imaging as a surrogate biomarker of pathological response in this setting appears fascinating but should be further investigated.",
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T1 - Preoperative Capecitabine, Oxaliplatin, and Irinotecan in Resectable Gastric or Gastroesophageal Junction Cancer

T2 - Pathological Response as Primary Endpoint and FDG-PET Predictions

AU - Berenato, Rosa

AU - Morano, Federica

AU - Pietrantonio, Filippo

AU - Cotsoglou, Christian

AU - Caporale, Marta

AU - Infante, Gabriele

AU - Pellegrinelli, Alessandro

AU - Alessi, Alessandra

AU - Battiston, Carlo

AU - Coppa, Jorgelina

AU - Padovano, Barbara

AU - Mennitto, Alessia

AU - Niger, Monica

AU - Fucà, Giovanni

AU - Lazzati, Silvia

AU - Greco, Giorgio

AU - Delconte, Gabriele

AU - De Braud, Filippo

AU - Mazzaferro, Vincenzo

AU - Di Bartolomeo, Maria

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N2 - Objectives: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Methods: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al. [Cancer 2003;98:1521-1530]. The potential role of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) as a predictive biomarker of pathological tumor response was assessed in a subgroup of 19 evaluable patients. Results: Between January 2011 and October 2015, a total of 40 patients were enrolled. After the preoperative phase, 36 out of 40 patients (90%) were considered eligible for surgery: 12 patients (30%) achieved a pathological response. The most frequent grade 3/4 adverse events were diarrhea (27%), nausea (25%), and fatigue (17%). Grade 3 neutropenia occurred in 7.5% of patients. A lower standard uptake value at baseline FDG-PET/CT was associated with pathological response. Conclusion: COI combination is active with a manageable toxicity profile in patients with resectable GC or GEJ cancer. FDG-PET/CT imaging as a surrogate biomarker of pathological response in this setting appears fascinating but should be further investigated.

AB - Objectives: This phase II trial was aimed at assessing the safety and activity of capecitabine, oxaliplatin, and irinotecan (COI regimen) as a preoperative treatment for resectable gastric cancer (GC) or gastroesophageal junction (GEJ) cancer. Methods: Patients affected by T3-T4/N0-N+/M0 GC/GEJ cancer were treated with the COI regimen for 4 cycles followed by restaging and gastroresection with D2 lymphadenectomy. Four postoperative cycles were scheduled. The primary endpoint was pathological response rate according to Becker et al. [Cancer 2003;98:1521-1530]. The potential role of fluorodeoxyglucose positron emission tomography/computed tomography (FDG-PET/CT) as a predictive biomarker of pathological tumor response was assessed in a subgroup of 19 evaluable patients. Results: Between January 2011 and October 2015, a total of 40 patients were enrolled. After the preoperative phase, 36 out of 40 patients (90%) were considered eligible for surgery: 12 patients (30%) achieved a pathological response. The most frequent grade 3/4 adverse events were diarrhea (27%), nausea (25%), and fatigue (17%). Grade 3 neutropenia occurred in 7.5% of patients. A lower standard uptake value at baseline FDG-PET/CT was associated with pathological response. Conclusion: COI combination is active with a manageable toxicity profile in patients with resectable GC or GEJ cancer. FDG-PET/CT imaging as a surrogate biomarker of pathological response in this setting appears fascinating but should be further investigated.

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KW - Neoadjuvant chemotherapy

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KW - Phase II study

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