A Prospective Multicenter Phase II Study on the Feasibility and Efficacy of S-1 and Oxaliplatin Neoadjuvant Chemotherapy for Locally Advanced Rectal Cancer.

BACKGROUND: Neoadjuvant chemoradiotherapy and total mesorectal excision compose the standard of care for rectal cancer in multiple guidelines. However, neoadjuvant chemoradiotherapy has not exhibited clear survival benefits but rather has led to an increase in adverse events. Conversely, neoadjuvant chemotherapy is expected to prevent adverse events caused by radiation, yet this treatment is still controversial. OBJECTIVE: The purpose of this study was to evaluate the feasibility and efficacy of S-1 and oxaliplatin neoadjuvant chemotherapy together with total mesorectal excision for resectable locally advanced rectal cancer. DESIGN: The study was a prospective, single-arm phase II trial. SETTINGS: The study was conducted at multiple institutions. PATIENTS: Fifty-eight patients with resectable locally advanced rectal cancer were enrolled. INTERVENTION: Three cycles of S-1 and oxaliplatin were administered before surgery. S-1 was administered orally at 80 mg/m2 per day for 14 consecutive days, followed by a 7-day resting period. Oxaliplatin was given intravenously on the first day at a dose of 130 mg/m2 per day. The duration of 1 cycle was considered to be 21 days. Total mesorectal excision with bilateral lymph node dissection was carried out after neoadjuvant chemotherapy. MAIN OUTCOME MEASURES: The study was designed to detect the feasibility and efficacy of S-1 and oxaliplatin as neoadjuvant chemotherapy. RESULTS: The completion rate of 3 courses of S-1 and oxaliplatin as neoadjuvant chemotherapy was 94.8% (55/58). The reasons for discontinuation were thrombocytopenia (3.4%) and liver injury (1.7%). The most common severe (grade ≥3) adverse effect of neoadjuvant chemotherapy was thrombocytopenia (3.4%). There were no severe adverse clinical symptoms. Consequently, R0 resection was achieved in 51 (98.1%) of 52 patients. Pathologic complete response occurred in 10 patients (19.2%). LIMITATIONS: This was a single-arm, nonrandomized phase II study. CONCLUSIONS: The combination of S-1 and oxaliplatin neoadjuvant chemotherapy and total mesorectal excision is a feasible and promising treatment option for resectable locally advanced rectal cancer. See Video Abstract at http://links.lww.com/DCR/B555. UN ESTUDIO PROSPECTIVO MULTICNTRICO FASE II SOBRE LA FACTIBILIDAD Y EFICACIA DE LA QUIMIOTERAPIA NEOADYUVANTE SCON OXALIPLATINO PARA EL CNCER DE RECTO LOCALMENTE AVANZADO: ANTECEDENTES:La quimiorradioterapia neoadyuvante y la escisión mesorrectal total constituyen el estándar de atención para el cáncer de recto en varias guías. Sin embargo, la quimiorradioterapia neoadyuvante no ha mostrado beneficios claros en la sobrevida, pero si ha creado un aumento de eventos adversos. Por otro lado, se espera que la quimioterapia neoadyuvante prevenga los eventos adversos asociados a la radiación, aunque este tratamiento sigue siendo controvertido.OBJETIVO:Evaluar la factibilidad y eficacia de la quimioterapia neoadyuvante S-1 con oxaliplatino en conjunto con la escisión mesorrectal total para el cáncer de recto localmente avanzado resecable.DISEÑO:El estudio fue un ensayo prospectivo fase II de brazo único.AMBITO:Estudio realizado en múltiples instituciones.PACIENTES:Se incluyeron 58 pacientes con cáncer de recto localmente avanzado resecable.INTERVENCIÓN:Se administraron tres ciclos de S-1 con oxaliplatino antes de la cirugía. Se administró S-1 por vía oral a 80 mg / m2 / día durante 14 días consecutivos, seguido de un período de descanso de 7 días. El oxaliplatino se administró por vía intravenosa el primer día a una dosis de 130 mg / m2 / día. Se consideró la duración de un ciclo de 21 días. Posterior a la quimioterapia neoadyuvante se realizó la excisión total mesorrectal con disección ganglionar bilateral.PRINCIPALES VARIABLES EVALUDADAS:El estudio fue diseñado para conocer la factibilidad y eficacia de S-1 con oxaliplatino como quimioterapia neoadyuvante.RESULTADOS:La tasa de conclusión con tres ciclos de S-1 con oxaliplatino como quimioterapia neoadyuvante fue del 94,8% (55/58). Los motivos de interrupción fueron trombocitopenia (3,4%) y daño hepático (1,7%). El efecto adverso grave más común (grado ≥ 3) de la quimioterapia neoadyuvante fue la trombocitopenia (3,4%). No hubo síntomas clínicos adversos graves. Como resultado, la resección R0 se logró en 51 de 52 pacientes (98,1%). Una respuesta patológica completa se obtuvo en 10 pacientes (19,2%).LIMITACIONES:Fue un estudio de fase II no aleatorizado de un solo brazo.CONCLUSIONES:La combinación de S-1 con oxaliplatino como quimioterapia neoadyuvante y escisión mesorrectal total es factible y es una opción de tratamiento prometedora para el cáncer de recto localmente avanzado resecable. Consulte Video Resumen en http://links.lww.com/DCR/B555. (Traducción-Dr Juan Antonio Villanueva-Herrero).

[Ischemic Colitis after Closure of Temporary Ileostomy for Low Anterior Resection of Rectal Cancer in a Dialysis Patient-A Case Report].

Dialysis patients are at increased risk of ischemic colitis and are likely to develop irreversible ischemic colitis. We report a rare case of ischemic colitis after the closure of a temporary ileostomy for low anterior resection(LAR)of rectal cancer in a dialysis patient. A 77-year-old man undergoing maintenance dialysis was diagnosed as having colorectal cancer with a type 2 tumor at the anastomosis site of high anterior resection performed for sigmoid colon cancer 14 years ago. After undergoing excision which included the anastomosis site of the previous operation, LAR with anastomosis in the transverse colon and rectum and temporary ileostomy were performed. Seven months later, closure of the temporary ileostomy was performed, which resulted in ileus and septic shock. Computed tomography(CT)revealed inflammation in the colon on the oral side of the anastomosis, which was diagnosed as ischemic colitis. Ischemic colitis did not improve with conservative treatment, and fever reoccurred at each maintenance dialysis session. Therefore, ileostomy was performed again, but multiple organ failure due to disseminated intravascular coagulopathy(DIC)progressed and he died. It is considered that Hartmann's operation should be selected for dialysis patients with serious underlying diseases, and if ischemic colitis is observed after closure of the stoma temporary colostomy in such patients, the lesion site of ischemic colitis should be excised promptly and colostomy should be performed again.

[A Case of Strangulation Ileus with Hemorrhagic Shock Caused by an Internal Hernia of the Small Intestine].

PATIENT: An 81-year-old man. Past medical history: distal gastrectomy and Roux-en-Y reconstruction. CHIEF COMPLAINT: epigastric pain, nausea, and hematemesis. History of present illness: the man developed epigastric pain, nausea, and hematemesis the day before visiting our hospital. Upper gastrointestinal endoscopy revealed that the small intestinal mucosa was extensively congested, and a clinical condition due to the previous gastric surgery was suspected. Therefore, the man was admitted to our department. The patient was diagnosed with strangulation ileus by contrast-enhanced abdominal CT, and was referred for emergency surgery. At the time of entering the operating room 3 hours later, his abdomen was remarkably swollen. After anesthesia induction, his blood pressure dropped to 40-49 mmHg, and he was in a state of shock. Strangulation ileus was caused by an internal hernia of the small intestine through the gap between the mesenteric sutures of the Roux-en-Y reconstruction. The small intestinal wall was significantly discolored and remarkably expanded due to bleeding into the small intestine. We determined that mass resection of the small intestine posed high risk, and performed only reduction of the small intestinal hernia. Since strangulated ileus causing hemorrhagic shock is rare, we describe the case and review the literature on the topic.

[A case of complete remission(CR)persisting from UFT-E in an old patient with liver metastasis of gastric cancer].

A 82-year-old woman with gastric cancer underwent distal gastrectomy with level 2 lymph node dissection(M, Less, 2.2 x 2.0 cm, type 1, fH0, fP0, fM0, fT2, fN2(+), por 1, med, INF beta, ly2, v2, fPM(-), fDM(-), fStage IIIa). At first, adjuvant chemotherapy was not given because of her advanced age, but CEA increased to 43.2 ng/mL and a CT scan showed multiple liver metastasis. After we began oral chemotherapy with UFT-E 300 mg/day, the CEA level normalized and a CT scan revealed the liver metastasis had disappeared within about 9 months. There were no side effects for a course, and she has been free from any sign of recurrence. This was a very rare case in which single administration of UFT-E caused complete remission. Even an old patient should be treated aggressively because this treatment is relatively safe.

[A case of perforated gastric cancer in which complete response was confirmed with resection following TS-1/CDDP combined chemotherapy after omentopexy].

The present patient was a 50-year-old male with sudden upper abdominal pain. The patient exhibited pallor, and physical examination revealed a rigid abdomen. Abdominal x-ray revealed free air, and emergency laparotomy was performed to confirm upper gastrointestinal tract perforation. A perforated lesion of approximately 1 cm in diameter was found on the anterior wall at the gastric angle. The area surrounding the lesion was tumor-like, and the posterior wall was fused invasively with the pancreas. Malignancy was suspected; however, considering the patient's general status, greater omentum grafts were opted for. The patient was diagnosed with type III gastric cancer by gastroendoscopy post-operatively, and TS-1/CDDP therapy was started on the 28th day after surgery. After three courses of treatment, the tumor was found to have smoothened, wall consolidation was improved, and a second surgery was performed. During laparotomy, a nodule in the round ligament of liver was found and removed; however, there were no other medical findings that raised suspicion of peritoneal dissemination or liver metastasis. It was concluded that radical surgery was possible, and distal gastrectomy (D 2) was performed. Pathological examination revealed that signet ring cell carcinoma was present on only part of the mucous membrane. The lower and muscle layers of the serous membrane and the nodule in the round ligament of liver were replaced by fibrous tissue, indicating the disappearance of cancer cells. Two years and three months after surgery, the patient exhibited no signs of recurrence.