Phase II study of adjuvant chemotherapy with pemetrexed and cisplatin with a short hydration method for completely resected nonsquamous non-small cell lung cancer.

BACKGROUND: Cisplatin (CDDP) and vinorelbine as an adjuvant chemotherapy improve the overall survival of patients with completely resected non-small cell lung cancer (NSCLC). However, the treatment completion rate is low due to severe adverse events (AEs). Pemetrexed (PEM) has been used in advanced NSCLC due to its high safety and efficacy. Additionally, the safety of a short hydration method for CDDP administration has been previously reported. Here, we investigated the feasibility of CDDP plus PEM with a short hydration method as adjuvant chemotherapy. METHODS: A total of 21 completely resected nonsquamous NSCLC patients with pathological stage IIA to IIIA disease were enrolled into the study. Adjuvant chemotherapy consisted of four cycles of CDDP (75 mg/m2 ) plus PEM (500 mg/m2 ) every three weeks with a short hydration method. The primary endpoint was the treatment completion rate, and the secondary endpoints included toxicity, the two-year relapse-free survival (RFS) rate, and the outpatient treatment rate. RESULTS: A total of 21 patients (median age: 66 years; 12 males) were enrolled in two centers. All cases were adenocarcinoma with PS0 (71.4%) or PS1 (28.6%). A total of 81.0% of the patients received four cycles of therapy as scheduled and the primary endpoint was met. The rate of outpatient chemotherapy completion after the second cycle was 90.5%. The grade 3 or higher toxicities were anorexia (n = 2) and pulmonary thromboembolism (n = 1). No grade 3/4 hematological toxicities or creatinine level elevations were observed. The two-year RFS rate was 57.3%. CONCLUSIONS: CDDP and PEM with a short hydration is well tolerated in the outpatient setting with limited toxicity. KEY POINTS: SIGNIFICANT FINDINGS OF THE STUDY: CDDP plus PEM adjuvant therapy with a short hydration method is well tolerated in the outpatient setting with limited toxicity. WHAT THIS STUDY ADDS: CDDP plus PEM with a short hydration method has the potential to be one of the options of adjuvant therapy in the future.

Phase 2 study of S-1 and carboplatin plus bevacizumab followed by maintenance S-1 and bevacizumab for chemotherapy-naive patients with advanced nonsquamous non-small cell lung cancer.

BACKGROUND: A previous phase 3 trial demonstrated noninferiority in terms of overall survival for combined S-1 (an oral fluoropyrimidine) and carboplatin compared with combined paclitaxel and carboplatin as first-line treatment for advanced non-small cell lung cancer (NSCLC). In the current study, the authors evaluated the efficacy and safety of combined S-1, carboplatin, and bevacizumab followed by maintenance with S-1 and bevacizumab in chemotherapy-naive patients with advanced nonsquamous NSCLC. METHODS: Patients received carboplatin (area under the concentration-time curve, 5 mg mL(-1) per minute) and bevacizumab (15 mg/kg) on day 1 plus oral S-1 (80 mg/m2 per day) on days 1 through 14 every 21 days for up to 6 cycles. For patients without disease progression, S-1 and bevacizumab were continued until disease progression or unacceptable toxicity developed. RESULTS: Forty-eight patients were enrolled in the phase 2 study; of these, 35 patients (72.9%) completed at least 4 cycles. Most toxicities of grade ≥3 were hematologic, and no increase in relative incidence associated with maintenance with S-1 and bevacizumab was observed. The objective response rate was 54.2% (95% confidence interval, 39.2%-68.6%), and the median progression-free survival was 6.8 months (95% confidence interval, 4.3-8.2 months). CONCLUSIONS: The regimen of combined S-1, carboplatin, and bevacizumab followed by maintenance with S-1 and bevacizumab was active and feasible as first-line treatment for advanced nonsquamous NSCLC.

An open-label, prospective clinical study to evaluate the efficacy of prophylactic antibiotics after diagnostic bronchoscopy.

The aim of this study was to prospectively examine the effect of prophylactic antibiotic use on the development of respiratory infections and on the worsening of symptoms after diagnostic fiberoptic bronchoscopy procedures. This study was an open-label, multicenter, controlled, clinical trial. Patients were alternately assigned to a group given prophylactic antibiotics after bronchoscopy (prophylaxis(+) group) and a group not given antibiotic prophylaxis after bronchoscopy (prophylaxis(-) group), and they were followed-up for 1 week. 158 patients were assigned to the prophylaxis(-) group and 153 to the prophylaxis(+) group. Therapeutic antibiotic administration was needed in 3 patients (1.90%) in the prophylaxis(-) group and 5 patients (3.27%) in the prophylaxis(+) group (risk ratio 1.014, 95% confidence interval 0.978-1.052; p=0.446). Worsening of symptoms after bronchoscopy occurred in 57.6% of all patients by day 7, but no significant differences were observed between the 2 study groups. Prophylactic antibiotic use after bronchoscopy did not prevent the development of infectious events and worsening of symptoms, suggesting that prophylactic antibiotics might not be necessary for routine diagnostic bronchoscopic procedures.

Cervical carcinoma with full-thickness stromal invasion: efficacy of dynamic MR imaging in the assessment of parametrial involvement.

The purpose of this study was to investigate the efficacy of dynamic MR imaging in the assessment of parametrial involvement by cervical carcinoma with full-thickness stromal invasion on thin-section oblique axial T2-weighted images. Dynamic MR images of 24 patients with cervical carcinoma with full-thickness stromal invasion on thin-section oblique axial T2-weighted images were evaluated with pathologic correlation. Dynamic MR imaging was performed using a turboFLASH, 3D-FISP, or 2D-FLASH technique. The imaging planes of dynamic MR imaging were oblique axial planes of the uterine cervix. Dynamic MR imaging was performed twice, once for the early phase (40 to 60 sec after the administration of contrast media) and once for the late phase (5 min). Contrast enhancement of the tumor was divided into six types. Type I, cervical stroma with low signal intensity surrounding a tumor with high signal intensity, was seen in the early phase of dynamic MR imaging; type II-RR, the hyperintense rim was seen from the early phase to the late phase; type II-RO, the hyperintense rim was seen in the early phase only; type II-OR, the hyperintense rim was seen in the late phase only; type II-O, the hyperintense rim was not seen at all; and type III, tumor invasion with high signal intensities was seen beyond the cervical stroma in the early phase of dynamic MR imaging. The numbers for each type of cervical carcinoma on dynamic MR images were as follows: type I, four parametrial sites; type II-RR, 0; type II-RO, 0; type II-OR, 13; type II-O, 14; and type III, one. Three-dimensional diameters (transverse, craniocaudal, and anteroposterior) of the primary tumor were measured using dividers. All parametrial sites of type I and type II-OR showed no parametrial involvement. One parametrial site of type III and three parametrial sites of type II-O showed parametrial involvement, and 11 of type II-O showed no parametrial involvement. None of the patients showed type I-RR or type II-RO. When type I and type II-OR were categorized as criteria of no parametrial involvement and type III and transverse diameters of 3.5 cm or over classified as type II-O were categorized as criteria of parametrial involvement, the rate of diagnostic accuracy was 95.8%. Dynamic MR imaging is considered to be substantially useful in the assessment of parametrial involvement with cervical carcinoma with full-thickness stromal invasion by thin-section oblique axial T2-weighted images.

Cervical carcinoma with full-thickness stromal invasion: relationship between tumor size on T2-weighted images and parametrial involvement.

PURPOSE: The purpose of this work was to investigate the relationship between tumor size on T2-weighted images and parametrial involvement by cervical carcinoma with full-thickness stromal invasion and to evaluate whether the size of the tumor on T2-weighted images is a useful index of parametrial involvement. METHOD: T2-weighted images of 33 patients with cervical carcinoma showed full-thickness stromal invasion. Three-dimensional diameters (transverse, anteroposterior, and craniocaudal) of the primary tumor were measured on T2-weighted images. The area and volume of the tumor were also calculated. RESULTS: There were statistically significant differences between the patients with parametrial involvement and those without parametrial involvement for each tumor size. The criteria that showed the best accuracy for each tumor size were determined. CONCLUSION: The tumor size on T2-weighted images is considered to be a useful index for evaluating parametrial involvement by cervical carcinoma with full-thickness stromal invasion.