A phase II study of concurrent chemoradiation with weekly docetaxel, carboplatin, and radiation therapy followed by consolidation chemotherapy with docetaxel and carboplatin for locally advanced inoperable non-small cell lung cancer (NSCLC).
ABSTRACT The current standard of care for good performance status patients with locally advanced non-small cell lung carcinoma is concurrent chemoradiation, although a clearly superior regimen has not been identified. Docetaxel has been shown to possess good single-agent activity against non-small cell lung cancer (NSCLC) and radiosensitizing properties, both alone and synergistically with carboplatin. We undertook this phase II study to determine the safety and efficacy of weekly docetaxel-carboplatin and concurrent radiation therapy followed by docetaxel-carboplatin consolidation for the treatment of locally advanced NSCLC.
Sixty-seven patients having previously untreated stage IIIA or IIIB unresectable NSCLC were enrolled, with 61 patients evaluated for endpoints. Docetaxel 20 mg/m IV infusion over 30 minutes followed by carboplatin area under the curve = 2 over 30 minutes was administered weekly during concurrent thoracic radiotherapy. After 3 week rest, consolidation docetaxel 75 mg/m(2) IV infusion over 60 minutes and carboplatin area under the curve = 6 over 30 minutes was administered every 3 weeks for two cycles. Concurrent thoracic radiation consisted of 45 Gy (1.8 Gy fractions 5 d/wk for first 5 weeks) followed by 18 Gy boost (2.0 Gy fractions 5 d/wk for 2 weeks) for a total dose of 63 Gy.
One and 2 years overall survival rates were 45 and 20%, respectively. Progression free survival at 1 year was 27%. Median survival time was 12 months. Median time to progression was 8 months. The primary hematologic toxicity was leukopenia. The primary nonhematologic toxicity was esophagitis.
The administered regimen of weekly docetaxel-carboplatin and concurrent radiation therapy followed by docetaxel-carboplatin consolidation has acceptable toxicity profile. However, the overall survivals at 1 and 2 years are somewhat disappointing.
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ABSTRACT: The majority of patients with nonsmall cell lung cancer (NSCLC) present with locally advanced mediastinal disease. Radiation therapy is the backbone, and nowadays a combination with chemotherapy is considered standard treatment. In this review we present a short history of the developments in this field with an update of all new developments. We address the questions how to optimally combine chemotherapy, targeted agents and radiation therapy. The results from recently published papers dealing with combined chemoradiotherapy (CRT) and the data of two meta-analyses are reviewed. Some drugs are very suitable candidates for CRT such as cisplatin, pemetrexed and etoposide, whereas others should be avoided or used with caution (adriamycin, gemcitabine). Our evaluation indicates that there are quite a number of positive developments in the treatment of locally advanced NSCLC but there is still much to improve. Variables such as patient condition, tumor biology, dose of radiation therapy, method of application (intensity modulated radiation therapy, four-dimensional planning) and dose of chemotherapy all influence treatment outcome and should be taken into account in designing the best treatment. Well-defined studies should be undertaken balancing the possible positive effect of therapy and toxicity.Current opinion in oncology 03/2011; 23(2):140-9. DOI:10.1097/CCO.0b013e328341eed6 · 3.76 Impact Factor
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ABSTRACT: To assess the clinical applicability of a protocol evaluated in a previously reported phase II study of concurrent chemoradiotherapy followed by consolidation chemotherapy with bi-weekly docetaxel and carboplatin in patients with stage III, unresectable, non-small-cell lung cancer (NSCLC). Between January 2000 and March 2006, 116 previously untreated patients with histologically proven, stage III NSCLC were treated with concurrent chemoradiotherapy. Radiation therapy was administered in 2-Gy daily fractions to a total dose of 60 Gy in combination with docetaxel, 30 mg/m(2), and carboplatin at an area under the curve value of 3 every 2 weeks during and after radiation therapy. The median survival time for the entire group was 25.5 months. The actuarial 2-year and 5-year overall survival rates were 53% and 31%, respectively. The 3-year cause-specific survival rate was 60% in patients with stage IIIA disease, whereas it was 35% in patients with stage IIIB disease (p = 0.007). The actuarial 2-year and 5-year local control rates were 62% and 55%, respectively. Acute hematologic toxicities of Grade ≥3 severity were observed in 20.7% of patients, while radiation pneumonitis and esophagitis of Grade ≥3 severity were observed in 2.6% and 1.7% of patients, respectively. The feasibility of the protocol used in the previous phase II study was reconfirmed in this series, and excellent treatment results were achieved.International journal of radiation oncology, biology, physics 05/2011; 82(5):1791-6. DOI:10.1016/j.ijrobp.2011.03.007 · 4.18 Impact Factor