Aprepitant is a new neurokinin‐1 (NK1) receptor antagonist developed as a treatment for chemotherapy‐induced nausea and vomiting (CINV). To evaluate the efficacy and safety of aprepitant used in ...combination with standard therapy (granisetron and dexamethasone), we conducted a multicenter, phase II, placebo‐controlled, double‐blind, randomized study in Japanese cancer patients who received cancer chemotherapy including cisplatin (≥70 mg/m2). Aprepitant was administered for 5 days. A total of 453 patients were enrolled. In the three study groups, (i) standard therapy, (ii) aprepitant 40/25 mg (40 mg on day 1 and 25 mg on days 2–5) and (iii) aprepitant 125/80 mg (125 mg on day 1 and 80 mg on days 2–5), the percentage of patients with complete response (no emesis and no rescue therapy) was 50.3% (75/149 subjects), 66.4% (95/143 subjects) and 70.5% (103/146 subjects), respectively. This shows that efficacy was significantly higher in the aprepitant 40/25 mg and 125/80 mg groups than in the standard therapy group (χ2 test closed testing procedure: P = 0.0053 and P = 0.0004, respectively) and highest in the aprepitant 125/80 mg group. The delayed phase efficacy (days 2–5) was similar to the overall phase efficacy (days 1–5), indicating that aprepitant is effective in the delayed phase when standard therapy is not very effective. In terms of safety, aprepitant was generally well tolerated in Japanese cancer patients. (ClinicalTrials.gov number, NCT00212602.) (Cancer Sci 2010; 101: 2455–2461)
Background
Nedaplatin and nab-paclitaxel are each efficacious in the treatment of squamous cell lung cancer.
Patients and methods
Eligibility criteria were: no prior chemotherapy, advanced squamous ...cell lung cancer; performance status 0–1, age > 20 years but < 75 years, and adequate hematologic, hepatic and renal function. Patients received escalating doses of nab-paclitaxel under a fixed dose of nedaplatin (100 mg/m
2
, day 1) every 3 weeks in phase I. The initial nab-paclitaxel dose was 100 mg/m
2
on days 1 and 8 (level 1), and the next dose was 100 mg/m
2
on days 1, 8, and 15 (level 2). In phase II, patients received the recommended doses. The primary endpoint was tumor response rate.
Results
In phase I, three patients at level 1 experienced no dose-limiting toxicities (DLTs) and two patients at level 2 experienced DLTs. Level 1 was thus determined as the recommended dose. Twenty-three patients were enrolled in phase II. The 3 patients in level 1 and 23 patients in phase II were included together for analyses. Three of these 26 patients were excluded from response analysis due to pneumonia and patient refusal. Response rate was 91.3% (95% confidence interval, 72.0–98.9%). Toxicities observed during all cycles were tolerable.
Conclusions
The recommended dose for this combination was nedaplatin at 100 mg/m
2
on day 1 and nab-paclitaxel at 100 mg/m
2
on days 1 and 8 every 3 weeks. The combination of nedaplatin and nab-paclitaxel appears safe and efficacious in patients with untreated advanced squamous cell lung cancer.
Many problems exist in regard to the treatment of lung cancer patients with idiopathic pulmonary fibrosis (IPF), but few reported studies have investigated the long-term prognosis after pulmonary ...resection in such patients. The purpose of the present study was to determine the postoperative survival of patients with pathologic stage IA non-small cell lung cancer (NSCLC) and IPF.
We retrospectively reviewed 350 patients with pathologic stage IA NSCLC who underwent pulmonary resections at our institution between September 1994 and December 2007. We analyzed and compared 28 of these patients, who had simultaneous lung cancer and IPF, with the remaining 322 lung cancer patients without IPF.
The 5-year survival rates were 54.2% in pathologic stage IA lung cancer patients with IPF and 88.3% in those without IPF (p < 0.0001). Univariate analyses showed that age, sex, Brinkman Index, limited resection, operation time, adenocarcinoma, and IPF were significant prognostic factors for survival (p < 0.10). By multivariate analysis, however, only IPF was a significant prognostic factor for survival (p = 0.007). Propensity score-matching analysis confirmed that only IPF was significant prognostic factor (p = 0.043).
The 5-year survival rate of patients with pathologic stage IA NSCLC and IPF is 54.2%. IPF has independent, adverse effects on survival of pathologic stage IA NSCLC patients treated with pulmonary resection.
Background
Sublobar resection for lung cancer is associated with a higher risk of recurrence than that of lobectomy; we evaluated the factors considered to be predictors of recurrence.
Methods
By ...analyzing multicenter prospective studies of sublobar resection for patients with c-stage I non-small lung cancer who were unable to undergo lobectomy (KLSG-0801), we investigated the relationship between (1) tumor location (TL) and margin distance from the stump (MD), (2) the MD/tumor size (TS) ratio and prognosis, (3) and the margin cytology (MC) and prognosis.
Results
The correlation between TS and MD was statistically significant in cases of easily resectable regions defined by Lewis’ classification (
n
= 18). However, there was no correlation in difficult-to-resect regions (
n
= 14). Among cases of recurrence, the MD/TS ratio was less than 1. The 3-year survival rate was 100% for patients with MD/TS > 1 (
n
= 12), 59.7% for patients with MD/TS ≤ 1 (
n
= 20) (
p
= 0.06), 88.1% in cases of negative MC (
n
= 18), and 20% in cases of positive MC (
n
= 5) (
p
= 0.001).
Conclusion
Cases with positive MC had a significantly worse prognosis than those with negative MC. It may be difficult to secure an MD greater than the TS in a difficult-to-resect region according to Lewis’ classification.
We report a rare case wherein a mediastinal left basal pulmonary artery was detected during surgery. Intraoperative findings revealed mediastinal left lingular and basal segments of the pulmonary ...artery (A
4+5
+ A
8−10
) just dorsal to the superior pulmonary vein. The mediastinal left basal pulmonary artery is classified by its branching type, (1) complete type—wherein the entire that all basal pulmonary artery flow lies between the superior pulmonary vein and the left upper bronchus, as in like this case, (2) incomplete type—wherein that a part of the left basal pulmonary artery segment is on the flow mediastinal side. It is important to understand this rare aberration for undergoing safe surgery.
Liquid biopsy has been adapted as a diagnostic test for EGFR mutations in patients with advanced or metastatic non-small cell lung cancer (NSCLC). Loop-mediated isothermal amplification (LAMP) has ...been widely used for the rapid detection of pathogens through DNA amplification. This study investigated the efficacy of an EGFR-LAMP assay using plasma samples of patients with resected NSCLC tumors. The EGFR status was investigated using both LAMP and next-generation sequencing (NGS) assays in cases that met the following criteria: (1) pulmonary adenocarcinoma with EGFR mutation detected by the Therascreen EGFR PCR Kit and (2) preoperative plasma samples contained enough DNA for the LAMP and NGS experiments. Among 51 specimens from patients with EGFR-mutated tumors or metastatic lymph nodes, the LAMP assay detected 1 EGFR mutation that was also detected in the NGS assay. However, a plasma sample that demonstrated EGFR wild type in the LAMP assay showed an EGFR mutant status in NGS. The detection rates (1.9% in LAMP and 3.9% in NGS) were very low in both assays, demonstrating a similar performance in detecting EGFR mutations in NSCLC tumors; therefore, it could be a more suitable test for the advanced stage, not the early stage. Notably, the LAMP assay was more time-saving, cost-effective, and straightforward. However, further investigation is required to develop a more sensitive assay.
Background
Local therapy for stage I non-small cell lung cancer (NSCLC) is divided into surgical and radiation treatment, and given to patients unable to tolerate a lobectomy. A prospective phase II ...study of cases that received stereotactic body radio therapy (SBRT) (JCOG0403) revealed an overall 3-year survival rate (3-YSR) of 76.0 %, 3-year relapse free survival rate (3-YRFS) of 69.0 %, and rate of morbidity of grade 3 or greater of 9 %. However, few prospective multicenter studies have reported regarding surgery for high-risk stage I NSCLC patients.
Methods
We investigated this issue in the setting of a prospective multicenter observational study. Thirty-two high-risk NSCLC patients (30 males, 2 females; median age 74 years, 61–85 years) were analyzed.
Results
Two (6.3 %) showed morbidity of grade 3 or greater, though there were no postoperative deaths. The margin local control rate was 97.0 % (surgical margin recurrence, 1) and local recurrence control rate was 75.0 % (ipsilateral thorax recurrence, 8), while the 3-YSR and 3-YRFS was 79.0 and 75.9 %, respectively.
Conclusion
A sublobar pulmonary resection for patients unable to tolerate a lobectomy with stage I NSCLC was shown to be safe and provided results comparable with those of SBRT.
The histologic characteristics of air space enlargement with fibrosis (AEF) are compared with usual interstitial pneumonia (UIP), nonspecific interstitial pneumonia (NSIP) and centrilobular emphysema ...(CLE) to determine similarities and differences. Lung specimens from 39 patients were studied; 9 with AEF, 13 with UIP and 5 with CLE identified in lobectomy specimens for cancer and 12 NSIP cases identified on surgical lung biopsies. We determined the characteristics of cystic structures (i.e. abnormal airspace), degree of inflammation and severity of pneumocyte injury semi‐quantitatively. In AEF, the wall thickness of the cystic lesions (0.8 mm) was thinner than in UIP (2.1 mm) and thicker than in CLE (0.07 mm). The degree of inflammation and granulation tissue were milder in AEF than in UIP and NSIP and CLE showed milder inflammatory cells than AEF. As for pneumocyte injury, AEF had fewer erosions (0.1/case) and fewer ubiquitin‐positive pneumocytes than UIP (4.8 cells/slide) and NSIP (9.8 cells/slide). Our data suggested that the histological characteristics of AEF differed significantly from UIP, NSIP and CLE.
Background Empyema due to Candida species is a rare entity, and the significance of isolation of Candida species from the pleural effusion is not fully understood. Objective To elucidate the clinical ...features of Candida empyema. Methods We retrospectively reviewed the cases of 128 patients with culture-positive empyema. Results These 128 patients included 7 whose cause of empyema was esophago- or gastropleural fistula. Empyema was due to Candida species in 5 of the 7 patients. Primary diseases of these 5 patients were spontaneous esophageal rupture in 3 patients, esophageal rupture due to lung cancer invasion in 1 patient, and gastric ulcer perforation in 1 patient. None of these 5 patients had esophageal candidiasis. Among the 121 other patients with empyema not due to esophago- or gastropleural fistula, no patient had empyema due to Candida. Conclusion We believe that the empyema in these 5 patients was caused by normal commensal Candida species entering the pleural cavity when the fistula between the gastrointestinal tract and pleural cavity was formed. Isolation of Candida species can be an important clue for suspecting gastrointestinal tract perforation as a cause of empyema.
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