GECOP-MMC: phase IV randomized clinical trial to evaluate the efficacy of hyperthermic intraperitoneal chemotherapy (HIPEC) with mytomicin-C after complete surgical cytoreduction in patients with colon cancer peritoneal metastases.

BACKGROUND: The French PRODIGE 7 trial, published on January 2021, has raised doubts about the specific survival benefit provided by HIPEC with oxaliplatin 460 mg/m2 (30 minutes) for the treatment of peritoneal metastases from colorectal cancer. However, several methodological flaws have been identified in PRODIGE 7, specially the HIPEC protocol or the choice of overall survival as the main endpoint, so its results have not been assumed as definitive, emphasizing the need for further research on HIPEC. It seems that the HIPEC protocol with high-dose mytomicin-C (35 mg/m2) is the preferred regime to evaluate in future clinical studies. METHODS: GECOP-MMC is a prospective, open-label, randomized, multicenter phase IV clinical trial that aims to evaluate the effectiveness of HIPEC with high-dose mytomicin-C in preventing the development of peritoneal recurrence in patients with limited peritoneal metastasis from colon cancer (not rectal), after complete surgical cytoreduction. This study will be performed in 31 Spanish HIPEC centres, starting in March 2022. Additional international recruiting centres are under consideration. Two hundred sixteen patients with PCI ≤ 20, in which complete cytoreduction (CCS 0) has been obtained, will be randomized intraoperatively to arm 1 (with HIPEC) or arm 2 (without HIPEC). We will stratified randomization by surgical PCI (1-10; 11-15; 16-20). Patients in both arms will be treated with personalized systemic chemotherapy. Primary endpoint is peritoneal recurrence-free survival at 3 years. An ancillary study will evaluate the correlation between surgical and pathological PCI, comparing their respective prognostic values. DISCUSSION: HIPEC with high-dose mytomicin-C, in patients with limited (PCI ≤ 20) and completely resected (CCS 0) peritoneal metastases, is assumed to reduce the expected risk of peritoneal recurrence from 50 to 30% at 3 years. TRIAL REGISTRATION: EudraCT number: 2019-004679-37; Clinicaltrials.gov: NCT05250648 (registration date 02/22/2022, ).

[Primary endometriosis of the abdominal wall: an entity to be included in the differential diagnosis of abdominal wall masses]. / Endometriosis primaria de pared abdominal, una enfermedad que debe ser considerada en el diagnóstico diferencial de las tumoraciones de la pared abdominal.

Endometriosis consists of the presence of extrauterine endometrial tissue. It is usually localized in the pelvis, although it can also be found in other sites. Cutaneous localization is unusual and the most frequent form appears on scars from obstetric or gynecological interventions. It can, however, develop spontaneously, especially in umbilical or inguinal areas and can be confused with irreducible hernias or granulomas. We present the cases of three patients with spontaneous endometriotic nodules of the abdominal wall. The lesions were located in the umbilical region in two patients and in the suprapubic area in one. In two patients clinical suspicion led to preoperative diagnosis, although diagnosis is usually established after histopathological analysis of the surgical specimen.

Endometriosis primaria de pared abdominal, una enfermedad que debe ser considerada en el diagnóstico diferencial de las tumoraciones de la pared abdominal / Primary endometriosis of the abdominal wall: an entity to be included in the differential diagnosis of abdominal wall masses

Se denomina endometriosis a la presencia de tejido endometrial extrauterino. Su localización habitual es intrapélvica, aunque puede localizarse en otros lugares. La localización cutánea es rara y la forma más frecuente aparece sobre cicatrices de intervenciones ginecológicas u obstétricas, aunque puede aparecer de forma espontánea, sobre todo en la zona umbilical o inguinal, y puede confundirse con hernias no reductibles o granulomas. Presentamos los casos de 3 pacientes con nódulos endometriósicos espontáneos en las pared abdominal, dos en localización umbilical y otro suprapúbico, en dos de los cuales se pudo establecer el diagnóstico preoperatoriamente ante la sospecha clínica, aunque lo habitual es que el diagnóstico se establezca tras el estudio anatomopatológico de la pieza de resección (AU)

Endometriosis consists of the presence of extrauterine endometrial tissue. It is usually localized in the pelvis, although it can also be found in other sites. Cutaneous localization is unusual and the most frequent form appears on scars from obstetric or gynecological interventions. It can, however, develop spontaneously, especially in umbilical or inguinal areas and can be confused with irreducible hernias or granulomas. We present the cases of three patients with spontaneous endometriotic nodules of the abdominal wall. The lesions were located in the umbilical region in two patients and in the suprapubic area in one. In two patients clinical suspicion led to preoperative diagnosis, although diagnosis is usually established after histopathological analysis of the surgical specimen (AU)