Phase II study of cisplatin combined to irinotecan administered alternatingly with docetaxel in advanced non-small cell lung cancer.

OBJECTIVE: To assess the activity and toxicity of cisplatin and irinotecan alternating with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). MATERIAL AND METHOD: Eligibility included chemo-naïve stage IIIB with malignant effusion and stage IV NSCLC patients with measurable disease and a good performance status. Twenty-four patients were enrolled into the present study. There were 19 males and 5 females with a median age of 58.5 years and the median performance status was 1. Ninety-six percent had stage IV disease. These patients received cisplatin at 80 mg/ m2 and irinotecan at 200 mg/m2 on day 1, followed by docetaxel at 75 mg/m2 on day 22, in 6-week cycle for a maximum of 3 cycles. RESULTS: Eight out of twenty-two evaluable patients obtained a partial response (36%). The median time to tumor progression was 6 months. The median survival time and 1-year survival rate were 10.4 months and 45% respectively. The most frequent severe toxicities were neutropenia, anemia, and diarrhea. Febrile neutropenia occurred in four patients (16%), and was the cause of treatment-related deaths in two (8%). Other nonhematologic toxicities were mild including nausea, vomiting, and skin rash. CONCLUSION: Alternating cisplatin and irinotecan with docetaxel, as used in the present study was feasible and demonstrated encouraging efficacy in patients with non-small cell lung cancer However, this approach appears to be more toxic, especially in myelosuppression, than in previous reports of the sequential use of the similar agents.

A phase II study of docetaxel and carboplatin in Thai patients with advanced non-small-cell lung cancer.

OBJECTIVE: This phase II study aimed to assess the effectiveness of the docetaxel plus carboplatin combination in chemotherapy-naive Thai patients with advanced non-small-cell lung cancer (NSCLC). MATERIAL AND METHOD: Forty patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1, stage IIIB/IV NSCLC were enrolled in a phase H study between August 2001 and April 2003. Docetaxel 75 mg/m2 and Carboplatin AUC = 6 were given every 3 weeks. Response to treatment and toxicity were graded using standard WHO criteria. The Thai Functional Living Index Cancer (T-FLIC) scale was used to assess the Quality of Life (QoL) of all treated patients. RESULTS: Forty patients (median age: 55 years, range, 39-68 years; PS:0-1) were enrolled: one had stage IIIB disease with effusion, while thirty-nine had stage IV disease. Five patients were non-evaluable due to death within the first cycle; two dying of febrile neutropenia and sepsis, two of pulmonary infection, and one of unknown etiology. Partial response (PR) was seen in 28.6% patients, stable disease (SD) in 25.7%, and progressive disease (PD) in 45.7%. The median survival time was 32 weeks and the 1-year survival rate was 30.7%. Body mass index (BMI) was the only factor associated with survival time (univariate analysis: p = 0.006; multivariate analysis: p = 0.004). Other factors (gender, age, histology, ECOG PS, and glomerular filtration rate) were not predict for survival. The major treatment-related toxicities were neutropenia (from 152 treatment cycles there were grade 4: 19.7%; grade 3: 23.7%), febrile neutropenia (from 152 treatment cycles there was 3.95%), and diarrhea (grades 3/4: 0.66%). The QoL scores improved significantly throughout the treatment period. CONCLUSION: The regimen of docetaxel and carboplatin is active in advanced NSCLC and may be considered for first-line therapy.

Reliability of the Thai-modified Function Living Index Cancer questionnaire version 2 (T-FLIC 2) for the evaluation of quality of life in non-small cell lung cancer patients.

Quality of life is an important measurement of medical outcome. The objective of the present study was to determine the reliability and validity of the Thai-Modified Function Living Index Cancer questionnaire version 2 (T-FLIC 2) in Non-Small Cell Lung Cancer (NSCLC) patients. The FLIC was developed into Thai version 2 and applied to a sample of 36 in-patients with NSCLC. Reliability was assessed by internal consistency using the Cronbach's alpha statistic, and validity was checked by construct validity using the factor analysis statistic. Cronbach's alpha coefficient, equal to 0.8710, showed good reliability. A factor analysis was conducted to examine construct validity. It revealed a 5-factor solution accounting for 58.075 percent of the variance. In conclusion, the T-FLIC 2 is a reliable and valid measurement of the quality of life in NSCLC patients and can be used in clinical trials, studies of outcome and research in oncology.

Lung cancer in Maharaj Nakorn Chiang Mai Hospital: comparison of the clinical manifestations between the young and old age groups.

OBJECTIVES: To examine and compare the clinical manifestations of lung cancer between the age groups of 40 years or less and over 40 years at Maharaj Nakorn Chiang Mai Hospital from January 2002 - December 2003. MATERIAL AND METHOD: Six hundred and nineteen patients with confirmed pathological cell type lung cancer were newly registered. RESULTS: The mean age was 60.1 years and male to female ratio 1.79:1. Their smoking history was presented in 72% of patients, with cough being the most common symptom followed by weight loss, dyspnea, chest pain, and hemoptysis with a median duration of 2 months. Mass or nodule was the most common radiographic finding, and adenocarcinoma was the most common pathological cell type. Most of the patients (82.4%) presented in the advanced stage. There were 19 patients (3.1%) aged equal to 40 years or less. In this group, chest pain and adenocarcinoma were presented more significantly, while a smoking history was found to be less significant in females. The duration of symptoms in this group tended to be shorter (1.3 months), but not statistically significant. More than 80% of both patient groups presented in the advanced stage. CONCLUSION: Lung cancer in the young is uncommon, but most clinical manifestations are not different from older patients. The less significant smoking history, especially in females, tendency of shorter duration of symptoms, and more frequent adenocarcinoma in the younger patients may have some factors that are associated and should be studied further.

Study of cisplatin-vinblastine plus amifostine in patients with locally advanced or metastatic non-small cell lung cancer.

OBJECTIVE: To determine whether pretreatment with amifostine would reduce the toxicity of cisplatin with no reduction in antitumor efficacy in patients with advanced non-small lung cancer PATIENTS AND METHOD: Patients with locally advanced or metastatic non-small cell lung cancer, aged less than 75 years, with an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 were enrolled in the study. Amifostine was administered at a dose of 740 mg/m2 before chemotherapy. Then cisplatin at 100 mg/m2 was administered on day 1 and vinblastine 5 mg/m2 given on days 1, 8 and 15 in a 28 day cycle. RESULTS: Forty one patients were enrolled Baseline characteristics included; a median age of 58 years (range, 28-72); 23 males and 18 females; performance status of 0 (1 patient), 1 (38 patients) and 2 (2 patients); stage IIIa (1 patient), stage IIIb (10 patients) and stage IV (30 patients). The predominant histology was adenocarcinoma (60.97%). A median of 4 cycles (range, 1-6) were administered Thirty six cases out of forty one patients were assessable for response. The response rate was 38%. All those responding gave partial response. The median survival time was 33 weeks. One and two years survival were 23.9% and 9% respectively. Grade 3/4 toxicity was primarily hematologic. Grade 3/4 leukopenia occurred in 12.4%. Grade 3/4 thrombocytopenia occurred in 1.2%. Anemia grade 3/4 occurred in 7.5%. The observed grade 3/4 nonhematological toxicities were hypertension, hypocalcemia, nausea and vomiting and sensory neuropathy. Other toxicities were grade 2 or below. CONCLUSION: This study demonstrated that amifostine has the potential to be a broad spectrum cytoprotectant of normal tissues from toxicity caused by chemotherapy and no effect on therapeutic outcome in lung cancer patients.

Treatment of advanced non-small cell lung cancer with vinorelbine in elderly Thai patients.

The present study evaluated the efficacy and toxicity of vinorelbine as single chemotherapy for elderly Thai patients with advanced non-small cell lung cancer (NSCLC). Twenty-eight patients with no prior chemotherapy and ECOG performance status of 0-2 were enrolled in the study. There were 20 males and 8 females with a median age of 72 years, and the median ECOG performance status was 1. Eight cases were stage IIIB and 20 cases were stage IV. Fourteen cases were adenocarcinoma, 13 were squamous cell and one was large cell NSCLC. These patients received vinorelbine 25 mg/m2 on day 1 and 8. This treatment produced partial response in 5 of 25 evaluable patients (20%). Median survival time was 40 weeks. Hematologic toxicity caused 9% grade 3 anemia, 1.5% grade 4 neutropenia and 0.5% grade 4 neutropenia. Conclusion: Chemotherapy is a valuable treatment option for elderly patients with advanced NSCLC. Single agent vinorelbine is able to induce an overall response with a low toxicity level in elderly Thai patients with advanced NSCLC.

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

The purpose of this study was to evaluate the efficacy and safety of docetaxel as second-line chemotherapy for advanced non-small cell lung cancer (NSCLC). Thirty-four patients with advanced NSCLC received docetaxel 75 mg/m2 (1-h intravenous infusion) every 3 weeks, with corticosteroid premedication. Of 28 evaluable cases, 18 were adenocarcinoma, 3 squamous cell, 3 large cell and 4 undifferentiated carcinoma. There were 16 male and 12 female patients with a median age of 55 (37-73) years and their median Karnofsky performance status was 70 per cent (60-90%). Five cases (19.2%) had liver metastases, 3 (11.5%) brain metastases, 6 (23%) bone metastases, and 17 (65.3%) metastatic nodules in the lung. Seventeen cases (50%) had received cisplatin-based and 12 (12/34, 35.3%) paclitaxel plus carboplatin prior to entering the present study. Besides chemotherapy, seven cases had received prior thoracic irradiation and two whole brain irradiation. Two cases had prior surgery for malignant pleural effusion and one had thoracotomy for the resection of the primary tumor. The time from the last dose of chemotherapy to the start of this study was less than 6 months in 20 cases, 6-12 months in 9, 12-24 months in 3 and more than 24 months in 2 cases. One patient with initial small cell lung cancer had developed NSCLC before entering this study. Three out of 28 cases achieved partial response (10.7%) and 13 out of 28 achieved stable disease (46.5%). The median survival time was 23.8 weeks. Neutropenia, grade 3 and 4 occurred in 38.8 per cent of all cycles. Skin rashes, diarrhea, asthenia, alopecia, neuropathy and edema were common non-hematologic toxicities. Docetaxel should be considered as second line chemotherapy in advanced NSCLC when primary chemotherapy including cisplatin and/or paclitaxel had failed.

Paclitaxel and carboplatin plus megestrol acetate in the treatment of advanced non-small cell lung cancer.

The present study evaluated the efficacy and toxicity of paclitaxel and carboplatin with megestrol acetate for patients with stage IIIb and IV non-small cell lung cancer (NSCLC). Forty patients with no prior chemotherapy and Karnofsky performance status of > or = 60 were enrolled in the study. There were 18 males and 22 females with a median age of 57.5 years, and the median performance status was 70 per cent. Eleven cases were stage IIIb and 29 cases were stage IV. Twenty-five cases were adenoCA, 12 were squamous cell, 2 were large cell and one was undifferentiated NSCLC. These patients received paclitaxel 135 mg/m2 by intravenous infusion over 24 hours before carboplatin was given at AUC=6 by 2 hours infusion. Megestrol acetate 160 mg/day was given to all patients from day 2 to 14. This treatment produced partial remission in 12 of 39 evaluable patients (30.76%). Toxicity caused mild nausea, vomiting, myalgia, neuropathy, 20.95 per cent grade 3 neutropenia and 4.15 per cent grade 4 neutropenia. Grade 3 thrombocytopenia was 5.4 per cent, without grade 4. There were no statistically significant changes in weight, serum albumin, and quality of life throughout the cycle 1-6. Conclusion: The addition of megestrol acetate to chemotherapy benefitted these patients by minimizing constitute symptoms throughout the treatment period especially in the quality of life, weight loss and stabilized serum albumin.