Docetaxel plus trans-tracheal injection of adenoviral-mediated p53 versus docetaxel alone in patients with previously treated non-small-cell lung cancer
Autor: | Zhao Sun, Y. Wang, Jianfeng Zhou, D Chen, Xiaohong Ning, Shuchang Chen, H Zhang |
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Rok vydání: | 2011 |
Předmět: |
Adult
Cancer Research Pathology medicine.medical_specialty Disease free survival Lung Neoplasms Antineoplastic Agents Docetaxel urologic and male genital diseases Disease-Free Survival Drug Administration Schedule Adenoviridae Injections Carcinoma Non-Small-Cell Lung medicine Carcinoma Humans In patient Lung cancer neoplasms Molecular Biology Aged business.industry organic chemicals Middle Aged respiratory system medicine.disease Combined Modality Therapy Trachea Cancer research Molecular Medicine Taxoids Tracheal injection Non small cell Tumor Suppressor Protein p53 Previously treated business therapeutics medicine.drug |
Zdroj: | Cancer Gene Therapy. 18:444-449 |
ISSN: | 1476-5500 0929-1903 |
Popis: | This phase II clinical trial compared the efficacy and safety of two types of treatment in patients with non-small-cell lung cancer (NSCLC) who had previously been treated with chemotherapy. Patients diagnosed with NSCLC (with either measurable or evaluable lesions) and had been treated with chemotherapy were eligible for this study. They were randomly assigned to two groups. The DOCp53 group received trans-tracheal Adp53 injection (1 × 10(12) vp dosage) on day 1 and day 8, as well as docetaxel at 75 mg m(-2) on day 2. The DOC group only received docetaxel at 75 mg m(-2) on day 1. Patients in each group received treatment for two cycles before reevaluation. Between February 2005 and December 2006, 40 patients were recruited for this study. In all, 19 of them were assigned to the DOCp53 group and 21 were assigned to the DOC group. After a mean follow-up of 12 months, the median survival time (MST) was 7.7 months (95% CI, 4.53 to 10.84) for patients in the DOCp53 group and 5.9 months (95% CI, 4.11 to 7.68) in the DOC group (P = 0.44, log-rank test). In the DOCp53 group, two patients with diffuse metastatic disease of lung had partial response (PR) in addition to eight with stable disease (SD). No PR and 13 SD were observed in the DOC group. Toxic reactions that could be attributed to the Adp53 vector were transient fever and limited hemoptysis. For patients with relapsed NSCLC, trans-tracheal injection of Adp53 in addition to docetaxel did not improve overall survival or efficacy. However, direct trans-tracheal injection of Adp53 proved to be a safe procedure, with tolerable levels of toxicity. |
Databáze: | OpenAIRE |
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