Concurrent chemoradiotherapy or endoscopic stenting for advanced squamous cell carcinoma of esophagus: a case-control study.

BACKGROUND: We evaluated the role of chemoradiotherapy (CRT) for patients with inoperable squamous esophageal cancer. METHODS: Patients with locally advanced or metastatic squamous esophageal carcinoma who received CRT were recruited. The CRT consists of continuous infusion of 5-fluorouracil at 200 mg/m(2)/day, and cisplatin at 60 mg/m(2) on days 1 and 22, with concurrent radiotherapy for a total of 50 to 60 Gy in 25 to 30 fractions over 6 weeks. Efficacy was assessed by endoscopy and computed tomographic scan before and 8 weeks after completion of the treatment program. Median survival and the need for palliative esophageal stenting were compared with another group of patients who received endoscopic stenting. RESULTS: From 1996 to 2003, a total of 36 consecutive patients (33 male, mean +/- SD age 63.2 +/- 9.5 years) with T4 disease (81%) with or without cervical nodal metastasis (50%) received CRT, while 36 patients treated with endoscopic stenting alone were recruited as controls. Both groups were comparable in demographics, pretreatment dysphagia score, comorbidities, and tumor characteristics. CRT was completed in 32 patients (89%). There was no treatment-related mortality. Tumor volume was greatly reduced after CRT in 19 patients. Four patients (11%) received salvage esophagectomy 9 to 42 months after CRT. Compared with the stenting group, CRT statistically significantly improved 5-year survival (15% vs. 0%, P = .01), median survival (10.8 months vs. 4.0 months, P < .005), and need for stenting (22% vs. 100%, P = .005). CONCLUSIONS: Palliative CRT can effectively improve the symptoms of dysphagia in patients with inoperable squamous esophageal carcinoma. It results in better survival compared with endoscopic stenting in these patients.

Multicenter prospective randomized trial comparing standard esophagectomy with chemoradiotherapy for treatment of squamous esophageal cancer: early results from the Chinese University Research Group for Esophageal Cancer (CURE).

We conducted a prospective randomized trial to compare the efficacy and survival outcome by chemoradiation with that by esophagectomy as a curative treatment. From July 2000 to December 2004, 80 patients with potentially resectable squamous cell carcinoma of the mid or lower thoracic esophagus were randomized to esophagectomy or chemoradiotherapy. A two- or three-stage esophagectomy with two-field dissection was performed. Patients treated with chemoradiotherapy received continuous 5-fluorouracil infusion (200 mg/m2/day) from day 1 to 42 and cisplatin (60 mg/m2) on days 1 and 22. The tumor and regional lymphatics were concomitantly irradiated to a total of 50-60 Gy. Tumor response was assessed by endoscopy, endoscopic ultrasonography, and computed tomography scan. Salvage esophagectomy was performed for incomplete response or recurrence. Forty-four patients received standard esophagectomy, whereas 36 were treated with chemoradiotherapy. Median follow-up was 16.9 months. The operative mortality was 6.8%. The incidence of postoperative complications was 38.6%. No difference in the early cumulative survival was found between the two groups (RR = 0.89; 95% confidence interval, 0.37-2.17; log-rank test P = 0.45). There was no difference in the disease-free survival. Patients treated with surgery had a slightly higher proportion of recurrence in the mediastinum, whereas those treated with chemoradiation sustained a higher proportion of recurrence in the cervical or abdominal regions. Standard esophagectomy or chemoradiotherapy offered similar early clinical outcome and survival for patients with squamous cell carcinoma of the esophagus. The challenge lies in the detection of residue disease after chemoradiotherapy.

Premedication with orally administered midazolam in adults undergoing diagnostic upper endoscopy: a double-blind placebo-controlled randomized trial.

BACKGROUND: A double-blind placebo-controlled randomized trial was conducted to investigate the safety and the efficacy of orally administered midazolam as premedication for patients undergoing elective EGD. METHODS: A total of 130 patients were randomized to receive either 7.5 mg of midazolam orally (n = 65) or a placebo (n = 65) as premedication. Outcomes measures included the anxiety score (visual analog scale) during EGD, overall tolerance, extent of amnesia, overall satisfaction, patient willingness to repeat the procedure, recovery time, and hemodynamic changes after medication. RESULTS: The median (interquartile range) anxiety score during the procedure in the midazolam group was significantly lower than that in the control group (2.0 [0-4.9] vs. 3.8 [2.1-7.95], p < 0.001). A significantly greater number of patients in the midazolam group graded overall tolerance as "excellent or good" (70.8% vs. 49.2%, p = 0.012) and reported a partial to complete amnesia response (52.3% vs. 32.3%, p = 0.02) when compared with the control group. Patients in the midazolam group were more willing to repeat the procedure if necessary (89.2% vs. 69.2%, p = 0.005). The median (interquartile range) recovery time was significantly longer in the midazolam group than in the control group (5 [5-15] minutes vs. 5 [5-10] minutes, p = 0.014). There were no statistically significant differences in satisfaction score and hemodynamic changes between groups. CONCLUSIONS: Premedication by oral administration of midazolam is a safe and an effective method of sedation that significantly reduces anxiety and improves overall tolerance for patients undergoing EGD.

Premedication with intravenous ketorolac trometamol (Toradol) in colonoscopy: a randomized controlled trial.

OBJECTIVE: We conducted a prospective double-blinded placebo-controlled randomized trial to investigate the effect of ketorolac trometamol (KT) administered intravenously as premedication in colonoscopy. METHODS: One hundred and forty patients undergoing colonoscopy were randomized to receive either 60 mg of KT (KT group (KTG), n=70) or placebo (normal saline group (NSG), n=70) intravenously as premedication 30 min prior to procedure. Patient-controlled sedation (PCS) was used as the mode of sedation. Outcome measures included patient self-assessed pain score in a 10-cm unscaled visual analog scale (VAS), endoscopist assessment of patient pain score in VAS, patient's willingness to repeat colonoscopy, administered and demanded doses of PCS, patient satisfaction score in VAS, and hemodynamic changes during and after the procedure. RESULTS: The mean patient self-assessed pain score (SD) during procedure was significantly lower in KTG than NSG: 5.08 (2.74) vs 6.62 (2.45); p=0.001. The mean endoscopist assessment of patient pain score (SD) was significantly lower in KTG than NSG as well: 3.99 (2.80) vs 5.28 (2.71); p=0.006. More patients in KTG were willing to repeat procedure as compared with NSG (80.0%vs 57.1%; p=0.004). No significant difference was found in the administered and demanded doses of PCS, mean satisfactory scores and hemodynamic changes in both groups. No serious complication related to intravenous (IV) KT was noted. CONCLUSIONS: Premedication with IV KT (Toradol) improves pain control during colonoscopy with no associated serious complications.