[show abstract][hide abstract] ABSTRACT: Le cancer gastrique est un problème sanitaire mondial avec environ 930000 nouveaux cas et 700000 décès chaque année . Il reste le 2e cancer digestif en France, avec environ 7000 nouveaux cas et 6000 décès par an. Son pronostic reste médiocre avec une survie
relative globale à 10 ans de l’ordre de 20 % en raison d’un diagnostic tardif (notamment en Occident). Ainsi, aux États-Unis,
le cancer gastrique est localisé, localement avancé, métastatique et non classé au diagnostic dans 23 %, 32 %, 33 % et 12
% des cas, respectivement, avec des taux de survie à 5 ans de 62 %, 22 %, 3 % et 13 %, respectivement. à l’inverse, au Japon,
des programmes de dépistage de masse du cancer gastrique ont permis un diagnostic plus fréquemment fait à un stade précoce
avec un taux de survie à 5 ans de l’ordre de 60 % .
[show abstract][hide abstract] ABSTRACT: BACKGROUND: A dramatic increase in the incidence of the diffuse form of gastric adenocarcinomas and particularly signet ring cell carcinomas has been observed in Western countries. Evidence is accruing that signet ring cell carcinomas may have inherent chemo resistance leaving many clinicians unsure of the benefits of delaying surgery to pursue a neoadjuvant approach.Methods/design: PRODIGE-19-FFCD1103-ADCI002 is a prospective multicentre controlled randomised phase II/III trial comparing current standard of care of perioperative chemotherapy (2x3 cycles of Epirubicin, cisplatin, 5-fluorouracil) with a strategy of primary surgery followed by adjuvant chemotherapy (6 cycles of Epirubicin, cisplatin, 5-fluorouracil) in patients with a stage IB-III gastric signet ring cell tumour. The principal objective of the phase II study (84 patients) is to determine if the experimental arm (primary surgery followed by adjuvant chemotherapy) has sufficient interest in terms of percentage of living patients at 24 months to be evaluated in a phase III trial. If 7 or less patients in the experimental arm are alive at 24 months, phase III will not be initiated. The primary objective of phase III (230 additional patients) is to demonstrate superiority of the experimental arm in terms of overall survival. Secondary endpoints include overall survival at 36 months, disease free survival at 24 and 36 months, R0 resection rates, treatment tolerance, postoperative mortality and morbidity evaluated by Clavien-Dindo severity index, the prognostic impact of positive peritoneal cytology and the assessment of quality of life. An ancillary study will assess the emotional and cognitive impact of surgery and perioperative chemotherapy for both the patient and their partner. DISCUSSION: As inherent chemo resistance of signet ring cell tumours and delay in definitive surgery may favour tumour progression we hypothesise that a policy of primary surgery followed by adjuvant chemotherapy will improve overall survival compared to a standard perioperative chemotherapeutic strategy. This randomised phase II/III trial is the first dedicated to this histological subtype. Whilst the development of new biomarkers and targeted therapies are awaited, the results of this trial should further help in devising individualised protocols of patient care in a tumour group whose diversity increasingly demands assessment of alternative strategies.Trial registration: NCT01717924 (ClinicalTrials.gov).
BMC Cancer 06/2013; 13(1):281. · 3.33 Impact Factor
[show abstract][hide abstract] ABSTRACT: Cancers of the esophagus and stomach have a major impact on patients' nutritional status by virtue of these organs' inherent digestive functions. Many patients with these cancers will require surgical intervention, which imposes further metabolic demands and compounds preexisting nutritional disorders. Patients with esophagogastric cancer are likely to have lost weight by the time the diagnosis is made. This fact alone is of clinical importance, because it is well known that patients who have lost weight will have higher operative mortality and morbidity rates than patients who maintain their weight. Initial assessment of patients with esophagogastric cancer should include a routine evaluation of nutritional status. This will allow the identification of patients who are at risk of complications, particularly in the postoperative setting. These patients should be targeted for specific nutritional support.
Annals of Surgical Oncology 02/2012; 19(7):2128-34. · 4.12 Impact Factor
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