A Randomized Controlled Trial Comparing Two Different Schedules for Cisplatin Treatment in Patients with Locoregionally Advanced Nasopharyngeal Cancer.

PURPOSE: Previous studies suggest that a cumulative cisplatin dose of 200 mg/m2 might be adequate in the intensity-modulated radiation therapy (IMRT) era for locoregionally advanced nasopharyngeal carcinoma (LANPC). However, two cycles of once-every-3-weeks cisplatin at 100 mg/m2 has never been prospectively compared with standard once-a-week cisplatin regimen. PATIENTS AND METHODS: This trial was conducted at three hospitals from 2011 to 2016. Patients who met the eligibility criteria were recruited (ChiCTR-TRC-12001979) and randomly assigned (1:1) via a computer-generated sequence to receive once-every-3-weeks cisplatin at 100 mg/m2 for two cycles or once-a-week cisplatin at 40 mg/m2 for six cycles concurrently with IMRT. Primary endpoint was failure-free survival and between-group absolute difference of 10% as the noninferiority margin. RESULTS: A total of 510 patients were enrolled. Median follow-up time was 58.3 months with 85.4% of 3-year failure-free survival in the once-every-3-weeks group and 85.6% in the once-a-week group. An absolute difference of -0.2% (95% confidence interval, -6.3 to 5.9; P noninferiority = 0.0016). Acute toxicities of grade 3 or higher occurred in 55.8% in the once-every-3-weeks group and 66.3% in the once-a-week group (P = 0.015). The most common acute toxicities were hematologic abnormalities, including leukopenia (16% vs. 27%; P = 0.0022) and thrombocytopenia (1% vs. 5%; P = 0.015). The late grade 3-4 auditory loss rate was significantly lower in the once-every-3-weeks group than the once-a-week group (6% vs. 13%; P = 0.0039). CONCLUSIONS: Once-every-3-weeks cisplatin as concurrent chemoradiotherapy is noninferior to once-a-week cisplatin in the treatment efficacy in the LANPC. Although both regimens are well tolerated, severe acute toxicities and late-onset auditory loss are higher in the once-a-week group.

[Investigation of pathogenic bacteria for pulmonary infections and their drug resistance in neurological intensive care unit].

OBJECTIVE: To investigate the pathogenic bacterial spectrum responsible for pulmonary infections and their drug resistance in patients admitted to neurological care unit. METHODS: Sputum specimens were obtained from patients who developed pulmonary infections in neurological intensive care unit between January, 2001 and June, 2002 for bacterial culture and isolation. K-B paper disc method was employed for determination of the drug sensitivity of the bacterial isolates. RESULTS: In the 207 strains obtained from the patients, the majority (68.51%) were Gram-negative and 30.91/ Gram-positive bacteria, with fungi detected in one case (0.48%). The major pathogenic bacteria for pulmonary infection were, in the order of frequency, Staphylococcus aureus(14.49%), Pseudomonas aeruginosa (14.49%), Klebsiella pneumoniae (8.7%), Enterobacter cloacae (6.76%), and Enterobacter aerogenes (6.28%). Drug sensitivity tests showed increased drug resistance of the bacteria, but Staphylococcus aureus still remained sensitive to vancomycin and most of the Gram-negative bacillus sensitive to imipenem. CONCLUSION: The major pathogenic bacteria causing pulmonary infections in neurological intensive care unit are Staphylococcus aureus and Pseudomonas aeruginosa, and their drug resistance is obviously increased, suggesting the necessity of strengthening bacterial surveillance and more adequate clinical use of antibiotics.