Randomized phase II trial of docetaxel/irinotecan and gemcitabine/irinotecan with or without celecoxib in the second-line treatment of non-small-cell lung cancer.

PURPOSE: Trials combining irinotecan/docetaxel and irinotecan/gemcitabine in second-line treatment of non-small-cell lung cancer (NSCLC) have yielded promising results. Preliminary data suggested that the selective cyclooxygenase -2 inhibitor celecoxib (CBX) might enhance efficacy of chemotherapeutic regimens. This multicenter, phase II, randomized trial investigated efficacy and safety of irinotecan and docetaxel and irinotecan and gemcitabine, with or without CBX, in second-line treatment of NSCLC. PATIENTS AND METHODS: Patients 18 years or older were randomly assigned to receive irinotecan 60 mg/m2 and docetaxel 35 mg/m2, or irinotecan 100 mg/m2 and gemcitabine 1,000 mg/m2, with or without CBX 400 mg twice daily, for four cycles. Primary efficacy end points were median and 1-year survival probabilities. Patient-reported symptoms were assessed by the Lung Cancer Symptoms Scale (LCSS). RESULTS: A total of 133 patients were assessable for efficacy and safety. Median survival time was 6.31 months for patients treated with CBX and 8.99 months for those treated with chemotherapy alone. One-year survival rates were 24% and 36% respectively. The overall toxicity rates and LCSS scores were similar between patients treated or not treated with CBX. Four deaths were considered possibly treatment related. CONCLUSION: Survival results for the second-line regimens in this study were similar to results reported for single-agent therapy in this setting. CBX did not appear to enhance efficacy or improve patient-reported symptoms. The addition of high-dose CBX to second-line chemotherapy in NSCLC cannot be recommended.

Carboplatin and docetaxel in advanced non-small-cell lung cancer: results of a multicenter phase II study.

BACKGROUND: To evaluate the efficacy of carboplatin and docetaxel combination in patients with advanced non-small-cell lung cancer. METHODS: In a phase II study, patients with inoperable stage IIIB or stage IV non-small-cell lung cancer (ECOG performance status of 0 or 1) were treated with the combination of carboplatin AUC 5 mg/ml.min and docetaxel 80 mg/m2 administered once every 3 weeks. RESULTS: A total of 45 patients were accrued to the study. The median age was 62 years and adenocarcinoma was the most common histology. Patients received a median of four cycles of chemotherapy. The objective response rate was 29% with a median survival of 11.9 months among evaluable patients. The 1-year survival rate was 47%. Febrile neutropenia (17%) was the most common hematological toxicity associated with the regimen whereas grade 3 fatigue (4%) was the major nonhematological toxicity. CONCLUSIONS: The combination of carboplatin plus docetaxel is well tolerated and is effective for the treatment of patients with previously untreated advanced or metastatic non-small-cell lung cancer.

New approaches to symptom improvements in lung cancer patients.

The efficacy of chemotherapy in treating lung cancer continues to be assessed by the impact treatment has on disease progression and survival. Where differences between treatments are marginal and survival times cannot be realistically extended, symptom relief and improving health-related quality of life (QoL) become treatment priorities. Clinical trials in lung cancer often now include an assessment of symptom relief and QoL, and have confirmed the benefit of chemotherapy compared with best supportive care. Collection of symptom relief and QoL data is based on subjective reporting by patients, which can be influenced by extraneous and confounding factors. To ensure reproducibility and interpretability, standardized, validated instruments with known psychometric properties and culturally adapted language are required to capture QoL data from lung cancer patients in clinical trials. A number of available questionnaires, developed and validated for use in oncology studies, are reviewed in this paper. A selection of published lung cancer studies that have used these instruments are described and their outcomes summarized. These studies show that symptom assessment can be integrated in study protocols successfully, but there is a recognized need for improved and consistent measurement in future studies.