BackgroundThis study was designed to evaluate the efficacy and safety of XELOX plus bevacizumab in a Japanese metastatic colorectal cancer population that included elderly patients.MethodsThis was a multicenter, single-arm, open-label prospective study. The major inclusion criteria were previously untreated metastatic colorectal cancer, presence of measurable lesions, age ≥20 years; Eastern Cooperative Oncology Group performance status of 0–2, and adequate organ function. Patients received bevacizumab (7.5 mg/kg on day 1) and XELOX (130 mg/m2 oxaliplatin on day 1 plus 1,000 mg/m2 capecitabine b.i.d. on days 1–14) every 3 weeks. The primary endpoint was confirmed objective response rate.ResultsThe study included 47 patients (male/female 30/17; median age 69 years; age range 38–81 years with 10 patients ≥75 years; PS 0/1/2, 40/5/2) enrolled between May 2010 and March 2011. Responses were assessed in 46 eligible patients. The objective response rate was 52.2 % (95 % confidence interval [CI] 37.0–67.1). The median progression-free survival and overall survival were 10.0 months (95 % CI 7.8–12.3) and 34.6 months (95 % CI 19.9–not estimable), respectively. Frequently encountered grade 3 and 4 adverse events in this study were aspartate aminotransferase elevation (23.4 %), alanine aminotransferase elevation (21.3 %), anorexia (12.8 %), neutropenia (10.6 %), fatigue (8.5 %) and anemia (6.4 %). Grade 3 or 4 peripheral neuropathy was not observed.ConclusionFirst-line treatment with XELOX plus bevacizumab showed a promising response rate and an acceptable tolerability profile in the clinical practice of Japanese metastatic colorectal cancer patients that included elderly patients.RegistryUMIN-CTR, ID number: UMIN000003915, URL:https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000004706&language=E
BackgroundIt is unclear whether S-1 plus cisplatin is effective for patients with recurrent gastric cancer after adjuvant S-1 chemotherapy.MethodsWe retrospectively evaluated the efficacy of S-1 plus cisplatin in patients whose gastric cancer recurred after adjuvant S-1 chemotherapy.ResultsIn the 52 patients evaluated, the median duration of adjuvant S-1 chemotherapy was 8.1 months, and the median recurrence-free interval (RFI) since the last administration of adjuvant S-1 was 6.4 months. Among the 36 patients with measurable lesions, 7 achieved a complete or partial response, and 13 were evaluated as having stable disease, for an overall response rate of 19.4% and a disease control rate of 55.6%. For all patients, the median progression-free survival (PFS) was 4.8 months, and the median overall survival (OS) was 12.2 months. Compared with patients with an RFI of <6 months (n = 25), patients with an RFI of ≥6 months (n = 27) had a significantly higher response rate (5.0 vs. 37.5%, respectively), longer PFS (2.3 vs. 6.2 months, respectively), and longer overall survival (7.3 vs. 16.6 months, respectively). According to a multivariate Cox model including performance status (PS) and reason for discontinuation of adjuvant S-1, an RFI of 6 months was still significantly associated with PFS and OS.ConclusionsS-1 plus cisplatin is effective for patients with gastric cancer that recurs after adjuvant S-1 chemotherapy, especially for those with an RFI of ≥6 months.
Reflux esophagitis (RE) and columnar-lined esophagus (CLE) are frequently observed after esophagectomy. The incidence of these conditions according to time and to the route of esophageal reconstruction after esophagectomy remains unknown. The aim of this study was to clarify any changes and differences of the incidence of RE and CLE in patients who underwent gastric tube reconstruction after esophagectomy. A hundred patients who underwent cervical esophagogastrostomy after resection of the thoracic esophagus were included in this study. We reviewed their endoscopic findings at 1 month, at 1 year and at 2 years after surgery, and compared the incidence rates of RE and CLE with the passage of time and among the three reconstruction routes; a subcutaneous route, a retrosternal route, and a posterior mediastinal route. The incidence rate of RE was 42%, 37% and 38%, at 1 month, 1 year and at 2 years after surgery, respectively. There was no significant difference in the incidence of RE according to the time after surgery. The incidence rate of severe RE (Grade C and D in the Los Angeles Classification) was 9% percent at 1 month after surgery, 18% at 1 year after surgery and 22% at 2 years after surgery, significantly increasing with passage of time. The incidence rate of CLE was 0% at 1 month after surgery, 14% at 1 year after surgery and 40% at 2 years after surgery, significantly increasing with passage of time. No difference was observed in the incidence of RE and that of CLE among the three routes of esophageal reconstruction. Severe RE and CLE increase with passage of time after cervical esophagogastrostomy. Therefore, careful endoscopic follow-up is necessary for such patients irrespective of the route of esophageal reconstruction.
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