Association of weight change following smoking cessation with the risk of tuberculosis development: A nationwide population-based cohort study.

BACKGROUND: Smoking or weight loss is a risk of tuberculosis (TB) development. However, the impact of weight change after smoking cessation on the occurrence of TB remains elusive. We aimed to determine the relationship between weight change after smoking cessation and the risk of TB development. METHODS: We conducted a population-based cohort study using the national database in Republic of Korea. Of the 10,490,491 subjects who underwent health check-up in 2009, we enrolled 9,953,124 subjects without a previous TB history and followed them until 2017. We divided all study participants into the following three groups: never, former, and current smokers. The primary endpoint was newly developed TB. RESULTS: Among 9,953,124 subjects analyzed, 5,922,845 (59.5%) were never smokers, 1,428,209 (14.4%) were former smokers, and 2,602,080 (26.1%) were current smokers. The risk of TB development was significantly higher in current smokers than in never smokers (adjusted hazard ratio (aHR) 1.158; 95% confidence interval [CI] 1.131-1.186). Among current smokers, individuals who stopped smoking and maintained weight after baseline evaluation had a significantly lower risk of TB development compared with those who continued to smoke (aHR 0.771; 95% CI 0.741-0.892). However, even after smoking cessation, individuals who lost weight were at a significantly higher risk of TB development compared with those who continued to smoke (aHR 1.327; 95% CI 1.119-1.715). CONCLUSIONS: Our findings suggest that smoking is a risk factor for TB and weight maintenance (neither gaining or losing) after quitting smoking might reduce the risk of TB development.

Impaired Lung Function and Lung Cancer Incidence: A Nationwide Population-Based Cohort Study.

BACKGROUND: It is unclear whether the presence of minimal lung function impairment is an independent risk factor for the development of lung cancer in general populations. METHODS: We conducted a population-based cohort study using nationally representative data from the Korean National Health and Nutrition Examination Survey and the Korean National Health Insurance Service. RESULTS: Of 20,553 participants, 169 were diagnosed with lung cancer during follow-up (median, 6.5 years). Participants with obstructive lung function impairment had increased risk of lung cancer (aHR: 2.51; 95% CI: 1.729-3.629) compared with those with normal lung function. The lower was the quartile or decile of forced expiratory volume in one second (FEV1) or the FEV1/forced vital capacity (FVC) ratio, the significantly higher was the incidence rate of lung cancer (p for trend < 0.0001). With FEV1 values in the lowest quartile (Q4), the incidence of lung cancer was significantly increased regardless of FVC (FEV1 Q4 and FVC values in the higher three quartiles Q1-3: aHR 1.754; 95% CI 1.084-2.847, FEV1 Q4 and FVC Q4: aHR 1.889; 95% CI 1.331-2.681). CONCLUSION: Our findings suggest that minimal lung function impairment, as expressed by lower FEV1 or FEV1/FVC value, may be associated with increased risk of lung cancer.

Long-term outcomes and prognostic factors in patients with mild hemoptysis.

OBJECTIVE: The aim of this retrospective study was to observe the long-term outcomes of conservative treatment and bronchial artery embolization (BAE) in patients with mild hemoptysis and to analyze the risk factors associated with hemoptysis recurrence. METHODS: Patients with mild hemoptysis from January 2005 to January 2016 were enrolled in this study. The patients' medical records, including smoking history, etiologic diseases, bronchoscopic findings, mortality, BAE information, and follow-up data of recurrent hemoptysis, were reviewed and analyzed. RESULTS: A total of 288 patients with mild hemoptysis were included in this study. Of them, 71 patients (24.7%) underwent BAE and 217 patients (75.3%) were treated conservatively. The clinical success rate of BAE was 98.6%, with a low minor complication rate of 5.6%. Bronchoscopy before treatments was performed in 237 patients (82.3%). Fifty-five patients (19.1%) experienced recurrent hemoptysis during a median follow-up period of 2.4years (interquartile range: 1.0-4.4years). Patients who showed active bleeding or blood clots on bronchoscopy had a significantly lower recurrence-free survival rate than patients with no bronchoscopic evidence of bleeding or blood clots (p=0.012). The risk factors affecting recurrence were heavy smoking (p=0.002, hazard ratio [HR]: 3.57), aspergillosis (p=0.035, HR: 6.01), and bronchoscopic findings of active bleeding (p=0.016, HR: 3.29) or blood clots (p=0.012, HR: 2.77). CONCLUSIONS: The recurrence rate of hemoptysis was not negligible in patients with mild hemoptysis. BAE can be considered in patients with a high risk of recurrence.

Randomized phase II study comparing weekly docetaxel-cisplatin vs. gemcitabine-cisplatin in elderly or poor performance status patients with advanced non-small cell lung cancer.

BACKGROUND: Docetaxel/cisplatin (DP) and gemcitabine/cisplatin (GP) are standard treatment regimens for advanced non-small cell lung cancer (NSCLC). In spite of potent efficacy, the conventional 1-day DP is regarded as having more toxicity as compared with GP. There is increasing interest in a biweekly split administration of DP to reduce its toxicity. Hypothesis was that first-line biweekly DP is as safe as GP in the elderly or poor performance status (PS) patients. METHODS: Chemotherapy-naïve patients with advanced NSCLC (IIIB/IV) who were elderly (65<) or PS (ECOG 2) were randomized to DP or GP arm by balancing for ECOG (0-1 vs. 2) and stage (IIIB vs. IV). DP comprised docetaxel (35 mg/m2)/cisplatin (30 mg/m2) iv on days 1 and 8, every 3 weeks. GP comprised gemcitabine (1000 mg/m2)/cisplatin (30 mg/m2) iv on days 1 and 8, every 3 weeks. Chemotherapy lasted up to 4-6 cycles or until progression. Primary endpoint was safety (proportion of grade 3/4 toxicities). Planned sample size was 49 patients in each arm. RESULTS: From November 2009 to August 2012, a total of 99 patients were randomized (DP 50/GP 49) from nine institutions. Adenocarcinoma and squamous cell carcinoma were observed in 62% and 33% of patients, respectively. Toxicity profiles were comparable for both arms and the differences were not statistically significant except for anemia and leucocytopenia. Any grade of anemia (86 vs. 98%) and of leucocytopenia (18 vs. 43%) was more common in the GP arm with statistical significance. Oral mucositis tended to be predominant in the DP arm. Patients in the DP arm (51%) suffered grade 3 or higher toxicities as did 47% in the GP arm (47%). The most common grade 3 or higher toxicities were as follows: In the DP arm, neutropenia (8%), leucopenia (8%), anemia (4%), pneumonia with normal ANC (4%) and febrile neutropenia (2%) were observed. In the GP arm, anemia (15%), neutropenia (15%), pneumonia with normal ANC (4%), thrombocytopenia (4%) and leucopenia (2%) were observed. The best overall response rates (CR + PR) for the DP and GP arms were 20.0 and 21% with no CR, respectively, and disease control rates (CR + PR + SD) were 70.0 and 76%, respectively. Median progression-free survival and median overall survival were 3.7 and 14.9 months in the DP arm and 5.6 and 20.8 months in the GP arm, respectively. CONCLUSION: This study showed that DP is similar to GP in terms of efficacy and toxicity in treatment of elderly or poor performance patients. Both regimens showed similar grade 3/4 toxicities with different profiles.

Identification of EGFR Mutations by Immunohistochemistry with EGFR Mutation-Specific Antibodies in Biopsy and Resection Specimens from Pulmonary Adenocarcinoma.

PURPOSE: Mutation-specific antibodies have recently been developed for identification of epidermal growth factor receptor (EGFR) mutations by immunohistochemistry (IHC). This study was designed to investigate whether the type of specimen (biopsy vs. resection) would make a difference in determining mutation status by IHC, and to evaluate whether biopsies are suitable for detection of mutant EGFR protein. MATERIALS AND METHODS: IHC was performed using mutation-specific antibodies for E746-A750 deletion (DEL) and L858R point mutation (L858R) in biopsies and tissue microarrays of resected tumors from 154 patients with pulmonary adenocarcinoma. Results were then compared with DNA sequencing data. RESULTS: Molecular-based assays detected EGFR mutations in 62 patients (40.3%), including 14 (9.1%) with DEL, and 31 (20.1%) with L858R. IHC with two mutation-specific antibodies showed a homogeneous staining pattern, and correctly identified EGFR mutation status in 89% (137/154). Overall (biopsy/resection) sensitivity, specificity, positive predictive value, and negative predictive value were 75.6% (78.3%/72.7%), 94.5% (90.9%/96.3%), 85% (78.3%/88.9%), and 90.4% (90.9%/89.7%), respectively. CONCLUSION: Our data showed that IHC using EGFR mutation-specific antibodies is useful for detection of EGFR mutations with high specificity and good sensitivity not only for resection specimens but also for biopsy materials. Therefore, IHC using EGFR mutation-specific antibodies may preclude a second biopsy procedure to obtain additional tissues for identification of EGFR mutations by molecular assays in biopsies from advanced cancer, particularly when tumor cells in the samples are limited.

Nebulized morphine for intractable cough in advanced cancer: two case reports.

BACKGROUND: Cough is a distressing symptom in advanced cancer. Opioids are used to relieve respiratory symptoms including dyspnea and cough. In addition to a central mechanism, opioids are thought to work peripherally via opioid receptors of the lung. Therefore, direct inhalation of morphine has been investigated in chronic lung disease or cancer. We report our experience of a nebulized form of morphine to control intractable cough in patients with advanced cancer. METHODS AND RESULTS: Case 1 is a 63-year-old female with terminal lung cancer complaining of a severe dry cough with dyspnea and sleeplessness. Case 2 is a 53-year-old female with thymic carcinoma with multiple lung metastases suffering from severe cough accompanying chest pain and dyspnea. With usual treatment, cough did not improve in these patients. We then administered a nebulized form of morphine: hydrochloro-morphine 5 mg mixed with 3 mL normal saline inhaled by mouth using a nebulizer. When the morphine dose was increased to 10 mg and 15 mg, the patients' cough was relieved to a symptom level of moderate and mild, respectively. Without experiencing any severe systemic side effects of opioids, the patients continued nebulized morphine until death or discharge. CONCLUSION: Nebulized morphine was effective in controlling intractable cough due to cancer and it was convenient and safe.

Clinicoradiologic evidence of pulmonary lymphatic spread in adult patients with tuberculosis.

OBJECTIVE: The purpose of this study is to evaluate the prevalence and clinicoradiologic characteristics of pulmonary tuberculosis with lymphatic involvement. MATERIALS AND METHODS: A total of 126 adults with active tuberculosis who underwent CT were enrolled. A retrospective investigation of CT images focused on the presence of perilymphatic micronodules, as well as other CT features of active tuberculosis. We selected two groups of patients with micronodules according to distribution (perilymphatic vs centrilobular). We compared clinical and CT findings between the two groups. RESULTS: Fifteen patients were excluded because of coexisting pulmonary disease. Among 111 patients, the prevalence of perilymphatic micronodules, galaxy or cluster signs, and interlobular septal thickening was 64 (58%), 18 (16%), and 30 (27%), respectively. Of 106 patients with micronodules, 37 and 40 were classified into the perilymphatic and centrilobular groups, respectively. Compared with the centrilobular group, the perilymphatic group had statistically significantly lower frequencies of positive acid-fast bacilli smears (32% vs 70%), consolidation (70% vs 98%), and cavitation (30% vs 60%). However, frequencies of interlobular septal thickening (41% vs 18%), galaxy or cluster signs (30% vs 0%), and pleural effusion (43% vs 20%) were statistically significantly higher in the perilymphatic group. CONCLUSION: CT findings representing pulmonary perilymphatic involvement are relatively common in adults with tuberculosis. These findings may represent lymphatic spread of tuberculosis and provide an explanation for the unusual CT features of pulmonary tuberculosis mimicking sarcoidosis and the low detection of Mycobacterium tuberculosis in patients with micronodules.

Factors predictive of the failure of medical treatment in patients with pleural infection.

BACKGROUND/AIMS: The clinical outcomes of some patients with pleural infection may be favorable with medical treatment alone, but in others, the disease progresses and requires additional surgical treatment. However, little is known about the factors affecting this difference. The aim of this study was to investigate the factors predictive of failure of medical treatment in patients with pleural infection. METHODS: A cohort of 127 consecutive patients who were admitted to the hospital with pleural infection was studied. Clinical manifestations and laboratory findings in patients in whom medical treatment succeeded or failed were reviewed. RESULTS: In univariate analysis, the significant factors associated with medical treatment outcome were age, smoking history, duration of chief complaint, serum albumin level, and pleural fluid glucose and lactate dehydrogenase levels (p < 0.05). Multivariate logistic regression analysis identified age and duration of chief complaint as independent predictive factors for failure of medical treatment, with odds ratios of 0.871 (p = 0.013) and 0.797 (p = 0.026), respectively. Receiver operating characteristic curve analysis determined cutoff values of 50.5 years for age and 4.5 days for duration of chief complaint. CONCLUSIONS: We demonstrated that a younger age < 50.5 years and shorter duration of chief complaint < 4.5 days were independent predictive factors for the failure of medical treatment in patients with pleural infection. This suggests their role as evaluative criteria in setting indications for the optimal treatment in patients with pleural infection. A larger, prospective study is required to confirm these findings.

A multicenter phase II study of belotecan, a new camptothecin analogue, in elderly patients with previously untreated, extensive-stage small cell lung cancer.

PURPOSE: Belotecan is a new camptothecin analogue and a potent topoisomerase I inhibitor. The aim of this phase II study was to investigate the efficacy and toxicity of belotecan in previously untreated elderly patients with small cell lung cancer (SCLC). METHODS: A total of 26 patients, aged ≥65 years, with previously untreated, extensive-stage SCLC were enrolled in the study. Belotecan was administered by daily intravenous infusion at 0.5 mg/m(2)/day for 5 consecutive days every 3 weeks. RESULTS: The overall response rate and disease control rate of chemotherapy on an intention-to-treat basis were 35 and 54 %, respectively. The median overall survival was 6.4 months, and the median time to progression was 2.8 months. The most common toxicity was hematologic. Grade 3 or 4 neutropenia occurred in 80.8 % of patients, and grade 3 or 4 thrombocytopenia in 15.3 %. Non-hematologic toxic effects of grade 3 or 4 were uncommon. CONCLUSION: Belotecan had modest efficacy and well-tolerated toxicity in previously untreated, elderly SCLC patients. Single belotecan could be a promising treatment option, considering its lower toxicity in elderly patients who are unsuitable candidates for platinum plus etoposide chemotherapy.

Expression of Transforming Growth Factor ß1 and E-Cadherin Proteins in Pulmonary Adenocarcinoma: Its Significance in Tumor Progression.

PURPOSE: This study was conducted in order to investigate the significance of transforming growth factor ß1 (TGFß1) and E-cadherin proteins in tumor progression of lung adenocarcinoma and to evaluate their differential expression in association with morphologic characteristics. MATERIALS AND METHODS: A total of 65 pulmonary adenocarcinomas were reclassified according to the new classification system proposed by the International Association for the Study of Lung Cancer, American Thoracic Society, and European Respiratory Society. Tumor samples from 20 adenocarcinomas in situ (AIS, formerly bronchioloalveolar carcinoma [BAC]), 9 minimally invasive adenocarcinomas (MIA, formerly BAC with ≤ 5 mm invasion), 17 lepidic predominant adenocarcinomas (LPA, formerly mixed adenocarcinoma showing nonmucinous BAC features with >5 mm invasion), and 19 invasive adenocarcinomas with no BAC features were analyzed by immunohistochemistry for expression of TGFß1 and E-cadherin proteins. RESULTS: TGFß1 expression was detected in 46% (21/46) of noninvasive elements and 87% (39/45) of invasive elements (p=0.001). E-Cadherin expression was less frequent in invasive components than in noninvasive components (38% vs. 65%, p=0.009). Negative correlation was identified between TGFß1 expression and E-cadherin expression in noninvasive elements (p=0.022). More importantly, significantly higher frequency of TGFß1 expression was observed in noninvasive components of LPA (14/17, 82%), compared with those of either AIS (5/20, 25%) or MIA (2/9, 22%) (p=0.008). CONCLUSION: Our data indicate involvement of both TGFß1 and E-cadherin proteins in tumor progression of pulmonary adenocarcinoma. It is noteworthy that TGFß1 up-regulation precedes alveolar destruction by invasion of tumor cells. TGFß1 may thus have the potential to improve lung adenocarcinoma diagnostics and therapeutics.

Pulmonary cryptococcosis mimicking primary lung cancer with multiple lung metastases.

Cryptococcosis is an invasive fungal infection, which is more common in immunocompromised patients. However, pulmonary cryptococcosis can occur in immunocompetent patients and should be considered on a differential diagnosis for nodular or mass-like lesions in chest radiograph. Recently, we experienced a patient with pulmonary cryptococcosis, successfully treated with oral fluconazole therapy. A 74-year-old female patient was referred for an evaluation of abnormal images, a large consolidative mass with multiple nodular consolidations and small nodules that mimics primary lung cancer with multiple lung to lung metastases. Computed tomography-guided lung biopsy confirmed the diagnosis of pulmonary cryptococcosis. The follow-up image taken after 4 months with oral fluconazole treatment showed marked improvement.

Clinical experience of rigid bronchoscopy in single center.

BACKGROUND: The aim of this study was to analyze clinical situations requiring rigid bronchoscopy and evaluate usefulness of rigid bronchoscopic intervention in benign or malignant airway disorders. METHODS: We retrospectively reviewed 29 patients who underwent rigid bronchoscopy from November 2007 to February 2011 at St. Paul's Hospital, The Catholic University of Korea School of Medicine. RESULTS: Of the 29 patients, the most frequent underlying etiology was benign stenosis of trachea (n=20). Of those 20 patients, 16 had post-intubation tracheal stenosis (PITS), 2 had tracheal stenosis due to inhalation burn (IBTS) and other 2 had obstructive fibrinous tracheal pseudomembrane (OFTP). Other etiologies were airway malignancy (n=6), endobronchial stenosis due to tuberculosis (n=2), and foreign body (n=1). For treatment, silicone stent insertion was done in 16 cases of PITS and IBTS and mechanical removal was performed in 2 cases of OFTP. In 6 cases of malignant airway obstruction mechanical debulking was performed and silicone stents were inserted additionally in 2 cases. Balloon dilatation and electrocautery were used in 2 cases of endobronchial stenosis due to tuberculosis. In all cases of stent, airway obstructive symptom improved immediately. Granulation tissue formation was the most common complication. CONCLUSION: Tracheal stenosis was most common indication and silicone stenting was most common procedure of rigid bronchoscopy in our center. Rigid bronchoscopic procedures, at least tracheal silicone stenting, should be included in pulmonary medicine fellowship programs because it is a very effective and indispensable method to relieve critical airway obstruction which needs training to learn.

Molecular characterization of a tandem-repeat galectin-9 (RuGlec9) from Korean rose bitterling (Rhodeus uyekii).

Galectin-9 is a b-galactoside-binding lectin that regulates many cellular functions, ranging from cell adhesion to pathogen recognition. We isolated and characterized the cDNA of tandem-repeat galectin-9 (RuGlec9) from the Korean rose bitterling (Rhodeus uyekii), an endemic Korean fish belonging to the Acheilognathinae subfamily of the Cyprinidae family. RuGlec9 cDNA is 1486 bp long and encodes a polypeptide of 323 amino acids containing two carbohydrate-recognition domains connected by a linker peptide. The deduced amino acid sequence of RuGlec9 shows 45-84% amino acid sequence identity to other galectin-9 sequences, including those from mammals and fish. RuGlec9 appeared in a large cluster with other galectin-9 sequences from fish and is more closely related to galectin-9 from Danio rerio than to those of other fish and mammals. RuGlec9 mRNA was expressed highly in the testis, spleen, intestine, stomach, and liver, and moderately in the brain, kidney, ovary, and gills of normal Korean rose bitterling. RuGlec9 mRNA expression in the spleen was increased by lipopolysaccharide. These results suggest that RuGlec9 plays a role in innate immunity in Korean rose bitterling.

Endoscopic cryotherapy of lung and bronchial tumors: a systematic review.

BACKGROUND/AIMS: We made a systematic review and evaluation of endoscopic cryotherapy of endobronchial tumors, investigating safety and efficacy. METHODS: Qualified studies regarding endoscopic cryotherapy of lung tumors were systemically evaluated using available databases according to predefined criteria. RESULTS: In total, 16 publications were included in the final assessment. A narrative synthesis was performed because a formal meta-analysis was not viable due to the lack of controlled studies and study heterogeneity. Overall success rates for significant recanalization of the obstruction were approximately 80%, although they varied, depending on disease status in the patient population. Complications from the procedure developed in 0-11.1% of cases, most of which were minor and controlled by conservative management. Although limited data were available on comprehensive functional assessment, some studies showed that respiratory symptoms, pulmonary function tests, and performance status were significantly improved. CONCLUSIONS: Endoscopic cryotherapy was found to be a safe and useful procedure in the management of endobronchial tumors although its efficacy and appropriate indications have yet to be determined in well-designed controlled studies.

A multicenter phase II study of belotecan, a new camptothecin analogue, as a second-line therapy in patients with small cell lung cancer.

Belotecan (Camtobell, CKD602) is a new camptothecin derivative antitumor agent that belongs to the topoisomerase inhibitors. The aim of this phase II study was to evaluate the efficacy and safety of single agent belotecan as a second-line therapy in patients with small cell lung cancer (SCLC). Patients who were previously treated for SCLC were entered into the study. Belotecan was given by daily intravenous infusion for five consecutive days, every three weeks. Twenty-five patients were enrolled in this study. On an intention-to-treat basis, belotecan induced an overall response rate of 24%, a median overall survival of 9.9 months, a median time to progression of 2.2 months, and a 1-year survival rate of 38.3%. Grade 3/4 neutropenia developed in 88.0% of patients and grade 3/4 thrombocytopenia in 40.0%. Nonhematologic toxicity of grade 3 or 4 was low. The results suggest that belotecan is relatively active and well tolerated as a second-line agent in patients with SCLC.

Immunohistochemical analysis of non-small cell lung cancer: correlation with clinical parameters and prognosis.

Non-small cell lung cancers (NSCLC) vary in their biologic behavior. Recurrence and tumor-related mortality may be attributable to molecular abnormalities in primary tumors. This study evaluated such immunophenotypes with regard to cell cycle regulation and proliferation, apoptosis, and angiogenesis, to determine their significance for patient outcome. Core biopsies from 219 patients with NSCLC were assembled on tissue microarrays, and the expressions of p16, p21, p27, cyclin B1, cyclin E, Ki-67, caspase-3, survivin, bcl-2, VEGF, and endostatin were evaluated by immunohistochemistry. Despite previously described prognostic relevance of some of the investigated molecules, many of those markers were not directly associated with recurrence or survival. However, there was a trend for p16 immunoreactivity to be associated with a good prognosis (57% vs. 42% in 5-yr survival) (p=0.071). bcl-2 expression was strongly correlated with a better outcome (65% vs. 45% in 5-yr survival) (p=0.029), and the hazard of death for bcl-2 positive patients was 0.42 times of that for bcl-2 negative patients (p=0.047). A multivariate analysis with Cox proportional hazards model confirmed that the lymph node status (p=0.043) and stage (p=0.003) were other independent prognostic factors. Our results suggest that p16 and bcl-2 provide prognostic information independent of the TNM stage in NSCLC.

Primary polymorphous low-grade adenocarcinoma of lung treated by sleeve bronchial resection: a case report.

We report a surgical case of primary polymorphous low-grade adenocarcinoma (PLGA) of the minor salivary gland-type of the lung. A PLGA originating from the right upper lobar bronchial inlet was successfully treated by sleeve right upper lobectomy. PLGAs are thought to be indolent tumors that are preferentially localized to the palate, and they affect the minor salivary glands almost exclusively. Until now, two cases of distant metastases to the lung have been reported in the English literature. To the best of our knowledge, only one case of PLGA of minor salivary gland-type of the lung without evidence of a previous oropharyngeal primary tumor has been reported in the English literature. But the case was not a single lesion; it was bilateral tumors accompanied by tumors of the cervical lymph nodes. We report here the first case of a single primary PLGA of the minor salivary gland-type of the lung, which was successfully treated by sleeve bronchial resection of right upper lobe.

Sequential responses of adenocarcinoma of the lung to erlotinib after gefitinib in never smoker Korean woman.

A patient with adenocarcinoma of the lung was treated sequentially using two kinds of EGFR tyrosine kinase inhibitors, gefitinib and erlotinib. The patient was a 73-year-old female who received gefitinib as a second line treatment, which resulted in a partial response with response duration of 6 months. After progression of the disease, the patient received erlotinib, which resulted in partial response again with response duration of 11.5 months. This observation suggests that treatment with erlotinib may be effective in patients who develop progressive disease after a primary treatment with gefitinib following an initial response.

The efficacy and safety of Padexol (paclitaxel) and cisplatin for treating advanced non-small cell lung cancer.

PURPOSE: The authors conducted a multicenter study to evaluate the efficacy and safety of combination chemotherapy with Padexol and cisplatin for treating patients with advanced non-small cell lung cancer (NSCLC). MATERIALS AND METHODS: From November 2003 to April 2005, 42 chemo-naive patients with advanced NSCLC were enrolled into this study from 4 hospitals. The treatment consisted of Padexol 175 mg/m(2) as a 3-hr infusion, and this was followed by cisplatin 75 mg/m(2) administered as an intravenous infusion with standard premedication. The treatment was repeated every 3 weeks. RESULTS: Among the 42 patients (pts), 33 pts were evaluable for response. On the per protocol analysis, 1 patient (pt) (3.0%) achieved complete response (CR), 17 pts (51.5%) achieved partial response (PR), 6 pts (18.2%) achieved stable disease (SD), and 9 pts (27.3%) progressed; therefore, the overall response rate was 54.6% (95% CI: 37.6 approximately 71.5%). On the intention-to-treat analysis, 1 pt (2.4%) achieved CR, 18 pts (42.9%) achieved PR, 11 pts (26.2%) achieved SD, and 9 pts (21.4%) progressed; therefore, the overall response rate was 45.2% (95% CI: 30.2 approximately 60.3%). The response, as evaluated by the investigators, was independently reviewed by 2 external radiologists and it was as follows; 13 PR (43.3%), 14 SD (46.7%) and 3 progressive disease (10%). The median duration of response was 5.9 months. The median follow-up duration was 10.3 months (range: 1.3 to 22.1 months). The median time to progression was 5.8 months (95% CI: 4.7 to 7.4 months). The median survival time on the intention-to-treat analysis was 10.5 months (95% CI: 8.1 to 18.8 months). The most common grade 3 or 4 hematologic toxicities were neutropenia (26/180 cycles, 14.4%), anemia (7/180 cycles, 3.9%) and febrile neutropenia (2/180 cycles, 1.1%). The most frequent grade 3 or 4 non-hematologic toxicities were nausea (14/42 patients, 14.3%), anorexia (3/42 patients, 7.1%) and myalgia (3/42 patients, 7.1%). CONCLUSION: The authors observed that Padexol was as good as the other paclitaxel (Taxol or Genexol) formulations when combined with cisplatin for treating patients with advanced NSCLC.