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 language | English |
|---|---|
| Pages (from-to) | 279-286 |
| Number of pages | 8 |
| Journal | Oncology (Switzerland) |
| Volume | 93 |
| Issue number | 5 |
| DOIs | |
| Publication status | Published - Oct 1 2017 |
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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 journal › Article
}
TY - JOUR
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
PY - 2017/10/1
Y1 - 2017/10/1
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.
KW - Capecitabine
KW - Combination chemotherapy
KW - FDG-PET/CT
KW - Gastric cancer
KW - Irinotecan
KW - Neoadjuvant chemotherapy
KW - Oxaliplatin
KW - Pathological response
KW - Phase II study
UR - http://www.scopus.com/inward/record.url?scp=85028994086&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85028994086&partnerID=8YFLogxK
U2 - 10.1159/000479154
DO - 10.1159/000479154
M3 - Article
VL - 93
SP - 279
EP - 286
JO - Oncology
JF - Oncology
SN - 0030-2414
IS - 5
ER -