Continuous positive airway pressure versus high-flow nasal cannula oxygen therapy for acute hypoxemic respiratory failure: A randomized controlled trial.

BACKGROUND AND OBJECTIVE: The relative effectiveness of initial non-invasive respiratory strategies for acute respiratory failure using continuous positive airway pressure (CPAP) or high-flow nasal cannula (HFNC) is unclear. METHODS: We conducted a multicenter, open-label, parallel-group randomized controlled trial to compare the efficacy of CPAP and HFNC on reducing the risk of meeting the prespecified criteria for intubation and improving clinical outcomes of acute hypoxemic respiratory failure. The primary endpoint was the time taken to meet the prespecified criteria for intubation within 28 days. RESULTS: Eighty-five patients were randomly assigned to the CPAP or HFNC group. Eleven (28.9%) in the CPAP group and twenty (42.6%) in the HFNC group met the criteria for intubation within 28 days. Compared with HFNC, CPAP reduced the risk of meeting the intubation criteria (hazard ratio [HR], 0.327; 95% CI, 0.148-0.724; p = 0.006). There were no significant between-group differences in the intubation rates, in-hospital and 28-day mortality rates, ventilator-free days, duration of the need for respiratory support, or duration of hospitalization for respiratory illness. Pulmonary oxygenation was significantly better in the CPAP group, with significantly lower pH and higher partial pressure of carbon dioxide, but there were no differences in the respiratory rate between groups. CPAP and HFNC were associated with few possibly causal adverse events. CONCLUSION: CPAP is more effective than HFNC at reducing the risk of meeting the intubation criteria in patients with acute hypoxemic respiratory failure.

Home High-Flow Nasal Cannula Oxygen Therapy for Stable Hypercapnic COPD: A Randomized Clinical Trial.

Rationale: The long-term effects of using a high-flow nasal cannula for chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease remain unclear. Objectives: To assess whether long-term high-flow nasal cannula use reduces the number of exacerbations and improves other physiological parameters in patients with chronic hypercapnic respiratory failure caused by chronic obstructive pulmonary disease. Methods: We enrolled 104 participants (aged ⩾40 yr) with daytime hypercapnia (Global Initiative for Chronic Obstructive Lung Disease stages 2-4) receiving long-term oxygen therapy (⩾16 h/d for ⩾1 mo) and randomly assigned them to high-flow nasal cannula/long-term oxygen therapy and long-term oxygen therapy groups. The primary endpoint was the moderate or severe exacerbation rate. We compared changes from baseline in arterial blood gas values, peripheral oxygen saturation, pulmonary function, health-related quality-of-life scores, and the 6-minute-walk test. Measurements and Main Results: High-flow nasal cannula use significantly reduced the rate of moderate/severe exacerbations (unadjusted mean count 1.0 vs. 2.5, a ratio of the adjusted mean count between groups [95% confidence interval] of 2.85 [1.48-5.47]) and prolonged the duration without moderate or severe exacerbations. The median time to first moderate or severe exacerbation in the long-term oxygen therapy group was 25 (14.1-47.4) weeks; this was not reached in the high-flow nasal cannula/long-term oxygen therapy group. High-flow nasal cannula use significantly improved health-related quality of life scores, peripheral oxygen saturation, and specific pulmonary function parameters. No safety concerns were identified. Conclusions: A high-flow nasal cannula is a reasonable therapeutic option for patients with stable hypercapnic chronic obstructive pulmonary disease and a history of exacerbations. Clinical trial registered with www.umin/ac.jp (UMIN000028581) and www.clinicaltrials.gov (NCT03282019).

Nationwide survey of refractory asthma with bronchiectasis by inflammatory subtypes.

RATIONALE: Bronchiectasis and bronchiolitis are differential diagnoses of asthma; moreover, they are factors associated with worse asthma control. OBJECTIVE: We determined clinical courses of bronchiectasis/bronchiolitis-complicated asthma by inflammatory subtypes as well as factors affecting them. METHODS: We conducted a survey of refractory asthma with non-cystic fibrosis bronchiectasis/bronchiolitis in Japan. Cases were classified into three groups, based on the latest fractional exhaled NO (FeNO) level (32 ppb for the threshold) and blood eosinophil counts (320/µL for the threshold): high (type 2-high) or low (type 2-low) FeNO and eosinophil and high FeNO or eosinophil (type 2-intermediate). Clinical courses in groups and factors affecting them were analysed. RESULTS: In total, 216 cases from 81 facilities were reported, and 142 were stratified: 34, 40 and 68 into the type 2-high, -intermediate and -low groups, respectively. The frequency of bronchopneumonia and exacerbations requiring antibiotics and gram-negative bacteria detection rates were highest in the type 2-low group. Eighty-seven cases had paired latest and oldest available data of FeNO and eosinophil counts; they were analysed for inflammatory transition patterns. Among former type 2-high and -intermediate groups, 32% had recently transitioned to the -low group, to which relatively low FeNO in the past and oral corticosteroid use contributed. Lastly, in cases treated with moderate to high doses of inhaled corticosteroids, the frequencies of exacerbations requiring antibiotics were found to be higher in cases with more severe airway lesions and lower FeNO. CONCLUSIONS: Bronchiectasis/bronchiolitis-complicated refractory asthma is heterogeneous. In patients with sputum symptoms and low FeNO, airway colonisation of pathogenic bacteria and infectious episodes are common; thus, corticosteroids should be carefully used.

[THE MINIMUM NUMBER OF SPUTUM SMEAR SAMPLES NEEDED FOR THE DIAGNOSIS OF TUBERCULOSIS].

[Objective] To determine whether three sputum examinations with fluorescent staining are necessary to diag- nose tuberculosis (TB) in our hospital. [Patients] From April 2005 to December 2012, 379 TB patients were admitted and received anti-TB therapy in our hospital. [Methods] A retrospective study was conducted to assess the positivity rates of sputum smears based on three exami- nations. The positivity rate of first sputum smear and the cumulative smear-positive rates in the second and third were determined. Then, we also determined difference of positivity rates in sputum properties, sampling procedures and cavity formation. [Results] Of the 379 patients who met the screening criteria, 300 tested positive based on the first sputum smear (79.2%). The positivity rate of the first sputum smears was higher in the purulent sputum group than in the mucous sputum group (91.2% vs. 72.3%). Cavity formation, and sputum extraction procedures were not related to the positivity rate of the first sputum smears. In the mucous sputum group, the cumulative smear-positive rate in the second test significantly rose, but did not rise in the third test. [Conclusions] Three sputum smear examinations were necessary in patients who submitted mucous sputum samples. It is important to get purulent sputum.

[[CASE OF TUBERCULOSIS COMPLICATIONS DURING PREGNANCY LEADING TO AN INFECTION OUTBREAK].]

A 31-year-old woman developed a constant cough during the 8th week of pregnancy and was diagnosed with bronchial asthma. She was prescribed prednisolone and inhaled corticosteroids. At 28 weeks of pregnancy, she showed worsening weight loss, fever, night sweats, hoarseness, and coughs. At 31 weeks of pregnancy, a scatter shadow and cavitary lesions were detected on the chest radiograph. Acid- fast bacilli smear test and tuberculosis (TB) polymerase chain reaction tests yielded positive results (G-8), and she was diagnosed with TB. Contact tracing and screening indicated 3 patients with TB onset and 18 patients with latent TB infec- tion attributed to the initial patient, who infected a total of 36 people. In the present case, physicians were reluctant to order a chest radiograph for fear of harming the fetus and did not order sputum or interferon gamma release (IGRA) assay tests either. The diagnosis was delayed by 152 days, which was considered as a factor that caused the outbreak. The diag- nosis of TB in a pregnant patient may be very challenging because symptoms may initially be ascribed to the pregnan- cy, and delayed diagnosis and treatment of military TB can lead to the death of the mother and fetus. Consequently, to ensure early diagnosis and treatment, chest radiography and sputum and IGRA tests are recommended for pregnant women who have TB symptoms or are at high risk for TB.

[AN OUTBREAK OF PULMONARY TUBERCULOSIS DUE TO DEFINITE EXOGENOUS REINFECTION AMONG ELDERLY INDIVIDUALS IN WELFARE FACILITIES].

PURPOSE: We report an outbreak of 64 cases of tuberculosis (TB) that spread in a welfare facility for elderly individuals. OBJECTIVE AND METHODS: First, 64 TB patients who had contact with the source patient were screened at our hospital. We examined the time course up to the discovery of symptoms and analyzed the results for variable numbers of tandem repeats (VNTR) and the drug susceptibility tests. Second, we performed chest computed tomography to examine lesions due to a previous TB infection. RESULT: The source patient had recurrent aspiration pneumonia. The delay in doctor consultation was considered day 0, and the delay of diagnosis was 267 days. On examining the contacts, we found that 29 patients had TB while 35 had a latent TB infection. Results of the VNTR and the drug susceptibility tests showed that all the patients who developed TB had the same pattern as that of the source patient. Chest computed tomography showed lesions due to a previous TB infection in 8 patients. CONCLUSION: Based on the results of the VNTR and drug susceptibility tests, we concluded that the outbreak was due to an exogenous infection from the same source. All 8 patients who showed lesions due to a previous TB infection were aged > 81 years, and TB in these patients was found to be due to exogenous re-infection.

Phase II trial of S-1 as third-line or further chemotherapy in patients with advanced non-small-cell lung cancer.

OBJECTIVES: This study was conducted to evaluate the efficacy and safety of S-1 in patients with advanced non-small-cell lung cancer (NSCLC), receiving two or more prior chemotherapy regimens. METHODS: S-1 was administered orally for 14 consecutive days, followed by a 7-day rest period. This treatment course was repeated until disease progression or intolerable toxicity occurred. RESULTS: From 2010 to 2012, 45 patients were enrolled in this study. Of the 45 patients, 4 patients [8.9 %, 95 % confidence interval (CI) 0.6-17.2 %] exhibited a partial response and 24 patients (53.3 %) exhibited stable disease. The disease control rate was 62.2 % (95 % CI 48.1-76.4 %). Median progression-free survival was 71 days, and median survival time was 205 days. Four patients had grade 3 hematological toxicities, but toxicities of grade 4 were not observed in this study. CONCLUSION: Although S-1 monotherapy as third-line treatment or beyond was well tolerated, the response rate for this regimen did not demonstrate sufficient activity for patients with advanced NSCLC.

[A case of alveolar hemorrhage 35 years after propylthiouracil treatment].

A 69-year-old woman had received oral treatment of propylthiouracil (PTU) under a diagnosis of hyperthyroidism for 35 years. In the first 10 days of January 2009, she noticed the development of a cough. In February of the same year, she consulted a clinic with bloody sputum. Chest X-ray films revealed diffuse infiltration in both lungs, and she came to our hospital for further examination. An alveolar hemorrhage was identified by bronchial alveolar lavage testing. Because the cough was relieved by stopping PTU administration and there has been no relapse during 2-year follow-up, this case was diagnosed as PTU-induced diffuse alveolar hemorrhage. Her myeloperoxidase (MPO) -anti-neutrophil cytoplasmic antibody (ANCA) level was 55 EU, suggesting ANCA-associated angitis. However, as a drug lymphocyte stimulation test to PTU was also positive and her MPO-ANCA level was not elevated, the onset mechanism of this case was unclear.

Hochuekkito Combined with Pulmonary Rehabilitation in Apathetic Patients with Chronic Obstructive Pulmonary Disease: A Randomized Controlled Pilot Trial.

The main treatment goals for chronic obstructive pulmonary disease (COPD) are the reduction of its symptoms and future risks. The addition of the traditional herbal medicine Hochuekkito (TJ-41) treatment to pulmonary rehabilitation (PR) has been reported to improve dyspnea and health-related quality of life (HRQOL) in patients with COPD. However, the reason for this improvement is not sufficiently understood. The purpose of the present study was to investigate whether the addition of TJ-41 treatment to PR improves symptoms of apathy, dyspnea, and HRQOL and increases physical activity among apathetic patients with COPD. Apathetic patients with COPD were randomly assigned to receive low-intensity exercise with (TJ-41 group) or without (control group) TJ-41 treatment for 12 weeks. A total of 29.9% of COPD patients had apathetic symptoms without severe depression. After the 12-week treatment, Apathy Scale, Patient Health Questionnaire-9, visual analog scale for dyspnea, and COPD assessment test energy scores decreased significantly in the TJ-41 group (p < 0.05), but not in the control group. Additionally, the total number of steps taken was significantly higher in the TJ-41 group than in the control group. TJ-41 combined with PR may benefit apathetic patients with COPD with respect to apathy, dyspnea, HRQOL, and physical activity, but larger randomized placebo-controlled trials are required to validate the findings because of the small sample size and lack of placebo controls in this study.

[Clinical analysis of non-tuberculous mycobacteriosis cases complicated with pulmonary aspergillosis].

OBJECTIVES: To clarify the clinical features of nontuberculous mycobacteriosis (NTM) complicated with chronic pulmonary aspergillosis (CPA), we analyzed 257 cases diagnosed with newly developed NTM during the last 12 years in our hospital. RESULTS: Fifty-six per cent of the patients were females. Ten cases (3.9%) of them were complicated with CPA in their clinical course. Mean age at the diagnosis of CPA was 65.5 years, and 8 of 10 cases were males. The average period from the diagnosis of NTM to CPA was almost 7 years. Six NTM cases were classified as the cavitary type and 4 as the nodular-bronchiectasis type. At the time of the diagnosis of CPA, NTM bacilli were isolated in 5 cases, but in the other 5 bacilli were not detected. Radiologically it was found that in many cases the infiltrative shadow had increased and the cavity wall had thickened. Antifungal drug administration was effective in 67% of the cases. In particular, in cases with progressive infiltrative shadows, the antifungal drug was effective in 83% of patients. DISCUSSION: For the clinical management of NTM, careful attention to the complication of CPA is required.

[Pulmonary tuberculosis with atypical radiological findings in a patient with chronic obstructive pulmonary disease].

A 77-year-old-man who had been treated for chronic obstructive pulmonary disease (COPD) was referred to our hospital for further examination of a chest X-ray abnormality. The chest X-ray showed consolidation in the right upper and middle lung field. Chest computed tomography showed an airspace consolidation extending subpleurally and nonsegmentally without nodular lesions. The tentative diagnosis was cryptogenic organizing pneumonia. However, bronchoalveolar lavage fluid was positive for acid-fast bacilli on smear and also positive for tuberculosis PCR, leading to a diagnosis of tuberculous pneumonia. Tuberculous pneumonia in COPD patients can be non-segmental and mimic organizing pneumonia.

High long-term survival of bulk femoral head autograft for acetabular reconstruction in cementless THA for developmental hip dysplasia.

BACKGROUND: Deficient acetabula associated with acetabular dysplasia cause difficulty achieving adequate coverage of the acetabular component during THA. Autografting with the removed femoral head has been used for several decades to achieve better coverage, but the long-term benefits of this technique remain controversial, with some series reporting high rates of graft resorption and collapse. QUESTIONS/PURPOSES: We evaluated the fate of bulk femoral head autograft for acetabular reconstruction in cementless THA for developmental hip dysplasia. PATIENTS AND METHODS: We retrospectively reviewed 70 patients (83 hips) (68 women, two men) with a mean age of 57 years at index surgery. According to the classification of Crowe et al. for hip dysplasia, 10 hips were classified as Type I, 45 as Type II, 19 as Type III, and nine as Type IV. Minimum followup was 9 years (mean, 11 years; range, 9-14 years). RESULTS: We observed no collapsed grafts. In all patients we observed disappearance of the host-graft interface and appearance of radiodense bands in the grafts bridging host iliac bone and at the lateral edges of the acetabular sockets; remodeling with definite trabecular reorientation was seen in 90%. The 10-year survival rate without acetabular revision for any reason was 94%. The mean Merle d'Aubigné and Postel hip score improved from a mean of 9.1 preoperatively to 17.2 at last followup. CONCLUSIONS: Cementless THA combined with autologous femoral bone graft in patients with developmental dysplasia resulted in a high rate of survival. Structural bone grafting achieved a stable construct until osseointegration occurred. We believe the radiodense bands represent a radiographic sign of successful completion of repair of the deficient acetabulum. Congruous and stable contact of the cancellous portion of the graft to the host bed by impaction and use of improved porous cementless sockets may be associated with successful socket survival. LEVEL OF EVIDENCE: Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

[A case of multidrug-resistant tuberculosis who acquired additional resistance to ethambutol before the result of the initial drug sensitivity test was reported].

On December 6, 2008, a 52-year-old man presented to a clinic with chronic cough, sputum, and chest discomfort, which had lasted since mid-November. Since the chest radiograph showed a small cavity with small nodules and granular shadows, he was referred to another hospital. On TB-PCR, the gastric juice was positive. Therefore, on December 16, 2008, treatment for pulmonary tuberculosis was initiated with isoniazid, rifampicin, ethambutol, and pyrazinamide. However, on February 4, 2009, a drug susceptibility test revealed that the bacilli were resistant to isoniazid and rifampicin. Therefore, he was referred to our hospital. At that time, he had no symptoms and his sputum smear was negative. We performed a right upper lobectomy. The smear result of the surgical specimen was heavily positive (equivalent to Gaffky 6), and the drug susceptibility test showed resistance to ethambutol in addition to isoniazid and rifampicin. After surgery, we treated him with pyrazinamide, streptomycin, para-aminosalicylate, ethionamide, and levofloxacin. We report this case of multidrug-resistant tuberculosis without past treatment who acquired additional resistance to ethambutol during the first 2 months of chemotherapy. When treating multidrug-resistant tuberculosis, very careful consideration of susceptibility to other drugs is warranted.

Bacterial tracheobronchitis. A rare cause of adult airway stenosis.

Bacterial tracheobronchitis is a rare cause of airway stenosis in adults. This report describes a 73-year-old woman with a recent history of polysialadenitis, who presented with severe airway obstruction due to infection and stenosis of tracheal and bronchial tissue. Tissue culture of the bronchial mucosa showed growth of methicillin resistant Staphylococcus epidermidis (MRSE). Sputum culture showed growth of MRSE, Pseudomonas aeruginosa, Enterobacter cloacae and Enterococcus faecalis; the same organisms were cultured from the salivary glands. Tracheostomy and antibiotic therapy were effective in controlling the disease.

[A case of miliary tuberculosis and esophageal perforation secondary to tuberculous mediastinal lymphadenitis].

An 80-year-old woman was admitted to a local hospital following transient disturbance of consciousness after a fall. High intermittent fever developed after hospitalization and she was diagnosed as having mediastinal abscess with esophageal perforation. She underwent mediastinal drainage and surgical repair of the esophagus. Acid-fast bacilli were detected in her sputum. Chest CT scanning showed a diffuse granular shadow. Then she was diagnosed as having miliary tuberculosis and treated with combination of INH, RFP, EB, and PZA. However, five days after treatment was initiated, fever and skin eruption appeared and treatment has to be stopped after one month. Then she was referred to our hospital. We gradually increased the dosages of INH and RFP, which resulted in pyrexia. Therefore, we changed EB to SM. Fever subsided and we were able to administer the full dose of drugs from the beginning of January 2007. Thereafter, the patient improved gradually. However, she died in February 2007. At autopsy, we identified tuberculous mediastinal lymphadenitis, inflammatory granuloma under the esophageal mucosa and miliary tuberculosis. We report this case as a rare case of miliary tuberculosis and esophageal perforation secondary to tuberculous mediastinal lymphadenitis.

[A case of axillary lymph node tuberculosis with paradoxical worsening in breast lesion].

A 80-year-old woman was admitted to our hospital because of left axillary swelling. Needle biopsy specimen showed negative results on a smear for acid-fast bacilli and PCR. The histological findings showed epithelioid cell granuloma with caseous necrosis. QFT TB-2G showed positivity of 1.9 IU/ml in ESAT-6. We diagnosed tuberculous lymphadenopathy and administered antituberculous drugs. After 3 weeks of treatment, in spite of the regression of lymphadenopathy, mammary swelling had progressed. We performed a biopsy of the mammary lesion, but did not detect any abnormal findings. As the mammary lesion had regressed by the continued treatment of antituberculous drugs, we thought the mammary swelling was paradoxical worsening.

[Successful treatment of non-small cell lung cancer by gefitinib in an elderly patient with poor performance status].

A 91-year-old woman was admitted to our hospital with dyspnea. A chest radiograph and chest CT films revealed a large amount of pleural effusion in the right side pleural cavity. After serial thoracentesis, chest CT films showed a mass shadow in the right S(6). Adenocarcinoma cells were found in the pleural effusion, leading to a diagnosis of non-small cell lung cancer (stage IIIB). After administration of gefitinib, the mass shadow and pleural effusion reduced and her performance status improved. Gefitinib may be a well-tolerated therapeutic strategy in elderly and poor performance status patients with advanced non-small cell lung cancer.

Domiciliary High-Flow Nasal Cannula Oxygen Therapy for Patients with Stable Hypercapnic Chronic Obstructive Pulmonary Disease. A Multicenter Randomized Crossover Trial.

RATIONALE: A growing evidence base suggests a benefit of using high-flow nasal cannula oxygen therapy in the acute setting. However, the clinical benefit of domiciliary use of high-flow nasal cannula oxygen therapy in patients with chronic hypercapnic respiratory failure due to chronic obstructive pulmonary disease remains unclear. OBJECTIVES: To evaluate the efficacy and safety of high-flow nasal cannula oxygen therapy use in patients with stable chronic obstructive pulmonary disease. METHODS: We conducted a multicenter, randomized crossover trial comparing high-flow nasal cannula oxygen therapy plus long-term oxygen therapy with long-term oxygen therapy only in 32 adults with stable hypercapnic chronic obstructive pulmonary disease. Participants were randomized to receive either 6 weeks of high-flow nasal cannula oxygen therapy/long-term oxygen therapy using the myAIRVO 2 device followed by another 6 weeks of long-term oxygen therapy only or long-term oxygen therapy only followed by high-flow nasal cannula oxygen therapy/long-term oxygen therapy. The primary outcome was the change in quality of life as assessed by St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease. A linear mixed-effects model was used to account for treatment effect, time effect, allocation effect, and participant effect. RESULTS: Of 32 study participants, 29 completed the study. At the end of 12 weeks, high-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment improved the mean total St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease score compared with long-term oxygen therapy only (7.8 points; 95% confidence interval, 3.7 to 11.9; P < 0.01). Similarly, high-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment improved the arterial partial pressure of carbon dioxide (adjusted treatment effect, -4.1 mm Hg; 95% confidence interval, -6.5 to -1.7 mm Hg), pH (adjusted treatment effect, +0.02; 95% confidence interval, 0.01 to 0.02), and median nocturnal transcutaneous carbon dioxide pressure (adjusted treatment effect, -5.1 mm Hg; 95% confidence interval, -8.4 to -1.8 mm Hg). High-flow nasal cannula oxygen therapy/long-term oxygen therapy treatment did not improve the arterial partial pressure of oxygen, dyspnea, spirometry, lung volume, 6-minute walk test, or physical activity. The most frequent high-flow nasal cannula oxygen therapy-related adverse event encountered was nocturnal sweating (n = 6 [20.7%]). Four severe adverse events occurred (two in each group) and were deemed unrelated to the intervention. CONCLUSIONS: Six weeks of treatment with high-flow nasal cannula oxygen therapy improved health-related quality of life and reduced hypercapnia in patients with stable hypercapnic chronic obstructive pulmonary disease. Clinical trial registered with www.clinicaltrials.gov (NCT02545855) and www.umin/ac.jp (UMIN000017639).

[Chronic necrotizing pulmonary aspergillosis in the surgically treated lung].

A 76-year-old man was admitted because of bloody sputum persisting for 3 months. Right upper lobectomy had been performed for non-small cell lung cancer (well-differentiated adenocarcinoma, pT1NOMO) 6 years prior, and the patient had uncontrolled diabetes. Chest computed tomography on admission showed a 1-cm nodule (fungus ball) in a cavitary lesion and consolidation with an air bronchogram were present in the right lung. Aspergillus flavus was detected in the patient's sputum, and laboratory tests were positive for Aspergillus antigen and antibody. Chronic necrotizing pulmonary aspergillosis (CNPA) was diagnosed in the surgically treated lung.

Docetaxel and cisplatin as second-line chemotherapy for advanced non-small cell lung cancer.

AIMS AND BACKGROUND: Docetaxel and cisplatin are both active against non-small cell lung cancer (NSCLC). This pilot study evaluated the efficacy and toxicity of docetaxel and cisplatin as second-line chemotherapy for patients with advanced NSCLC. PATIENTS AND METHODS: Eleven patients with advanced NSCLC who had no response to platinum-based treatment or had recurrence after a partial response were enrolled (2 stage III B, 9 stage IV; 8 men, 3 women). Median age was 58 years (range, 40 to 74 years). Seven patients had an Eastern Cooperative Oncology Group performance status of 0, and four had a performance status of 1. Four weeks or more after the end of previous therapy, all 11 patients received docetaxel 60 mg/m2 and cisplatin 80 mg/m2 on day 1 every four weeks. RESULTS: Two patients (18.2%) achieved a partial response,five (45.4%) patients had stable disease, and four (36.4%) patients showed progressive disease after initiation of second-line therapy. Median survival was 277 days. Median time to disease progression was 101 days, and the one-year survival rate was 36.4%. Hematological toxicities were moderate. Grade 3 and 4 leukocytopenia and neutropenia were observed in five (45.4%) patients. Grade 3 anemia occurred in one (9 .1%) patient. No severe non-hematological toxicities were observed except grade 3 nausea in two (18.2%) patients. CONCLUSIONS: The regimen of docetaxel and cisplatin has reasonable efficacy with moderate toxicity as second-line chemotherapy for patients with previously treated, advanced NSCLC.