Efficacy and safety of trastuzumab in combination with oxaliplatin and fluorouracil-based chemotherapy for patients with HER2-positive metastatic gastric and gastro-oesophageal junction adenocarcinoma patients: a retrospective study.
BACKGROUND
Trastuzumab with 5-fluorouracil (5-FU) and cisplatin offers prolonged survival in patients with HER2-overexpressing advanced gastric cancer (AGC) and advanced gastro-oesophageal junction cancer (AGOJ). Oxaliplatin in combination with intravenous 5-FU plus leucovorin (LV; modified [m]FOLFOX6) or capecitabine (XELOX) improves tolerability compared with 5-FU/cisplatin regimen. There are few data available on the efficacy and safety of trastuzumab-oxaliplatin-based chemotherapy in previously untreated HER2-positive AGC and AGOJ patients.


METHODS
Clinical data were retrospectively analysed in patients receiving trastuzumab plus mFOLFOX6 or XELOX as first-line therapy between July 2009 and December 2012. Eligible patients had histologically proven AGC or AGOJ, HER2 overexpression, and no prior chemotherapy for metastatic disease.


RESULTS
Thirty-four patients met the eligibility criteria. Median age was 63 years, 79% of patients had ECOG PS score of 0-1, and all had metastatic disease. Median duration of treatment was 7.5 months. Overall response rate was 41% (95% CI: 25-56). Median progression-free survival and overall survival were 9.0 months (95% CI: 5.6-12) and 17.3 months (95% CI: 13.5-32.3), respectively. Tolerability was acceptable. The most frequent grade 3-4 toxicities were neutropenia (8.8%) and neuropathy (17.6%).


CONCLUSIONS
mFOLFOX6-trastuzumab combination is an efficient regimen with an acceptable safety profile for AGC and AGOJ patients. These results warrant further prospective study.
Hôpital Saint-Antoine, 75012 Paris, France.
Émilie
É
Soularue
Hôpital Saint-Antoine, 75012 Paris, France.
Romain
R
Cohen
Hôpital Henri-Mondor, 94000 Créteil, France.
Christophe
C
Tournigand
Hôpital européen George-Pompidou, 75015 Paris, France.
Aziz
A
Zaanan
Institut mutualiste Montsouris, 75014 Paris, France.
Christophe
C
Louvet
Hôpital de la Pitié-Salpêtrière, 75013 Paris, France.
Jean-Baptiste
JB
Bachet
Hôpital Beaujon, 92110 Clichy, France.
Olivia
O
Hentic
Institut régional du cancer Montpellier - Val-d'Aurelle, 34000 Montpellier, France.
Emmanuelle
E
Samalin
Institut hospitalier franco-britannique, 92300 Levallois-Perret, France; GERCOR-IRC (Groupe coopérateur multidisciplinaire en oncologie-Innovative Research Consortium), 151, rue du Faubourg-Saint-Antoine, 75011 Paris, France.
Benoist
B
Chibaudel
Institut hospitalier franco-britannique, 92300 Levallois-Perret, France.
Aimery
A
de Gramont
Hôpital Saint-Antoine, 75012 Paris, France. Electronic address: thierry.andre@sat.aphp.fr.
Thierry
T
André
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004938:Esophageal Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D004943:Esophagogastric Junction; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D002955:Leucovorin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000009:adverse effects; D010071:Oxaloacetates; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000737:chemistry / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D000068878:Trastuzumab
D061067:Antibodies, Monoclonal, Humanized; D000069287:Capecitabine; D003841:Deoxycytidine; D005472:Fluorouracil; D002955:Leucovorin; D009944:Organoplatinum Compounds; D010071:Oxaloacetates; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human
Cancer gastrique; Oxaliplatin; Oxaliplatine; Stomach neoplasms; Trastuzumab