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.

Thai female non-smoker with recurrent lung adenocarcinoma who has dramatic and prolonged response to gefitinib for over one year.

A 53-year old non-smoking Thai female was diagnosed with metastatic non-small cell lung cancer to bone. The initial biopsy from the bone lesion showed metastatic adenocarcinoma. She achieved partial response after treatments with radiation therapy to the bones, followed by 6 cycles of combination chemotherapy. About 4 months later, recurrence of the pulmonary and osseous disease was apparent. She has ECOG performance status of 3. Gefitinib 250 mg/day was administered until disease progression for about 14 months. After 6 weeks on this therapy, she had dramatic improvement of all symptoms including her performance status and had nearly complete resolution of all pulmonary lesions. Tolerability was good, with only mild fatigue. The overall survival was 28 months. This illustrates that gefitinib could produce significant clinical benefits in selected Thai patients even with poor performance status. This result is consistent with previous reports that the clinical characteristics of female, non-smoker and adenocarcinoma histology seem to predict response to gefitinib.

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.