Intrapleural paclitaxel for malig... [Cancer Chemother Pharmacol. 2012] - PubMed - NCBI
Intrapleural paclitaxel for malignant pleural effusion from ovarian
and breast cancer: a phase II study with pharmacokinetic analysis.
Abstract
INTRODUCTION:
Malignant
pleural effusion (MPE) is a frequent complication in many types of
tumors diminishing the patient's ability to perform activities. Despite
various studies on
talc treatment, some doubts about its safety and
effectiveness remain, so the search for a more ideal intrapleural agent
continues. We analyzed the effectiveness and safety of
intrapleural
paclitaxel in ovarian and breast cancer patients.
CONCLUSION:
Intrapleural
paclitaxel is a safe and effective palliative treatment for MPE from
breast and ovarian cancers and may be integrated with systemic
chemotherapy.
PATIENTS AND METHODS:
The
primary endpoint was overall response rate (ORR); secondary objectives
included time to progression (TTP), overall survival (OS) and safety of
intrapleural paclitaxel. Pharmacokinetics of the drug was also analyzed.
After drainage of pleural effusion and lung re-expansion, paclitaxel
120 mg/m(2) diluted in normal saline was infused through a preinserted
catheter which was immediately closed and reopened 24 h later. Blood and
pleural fluid samples were collected 1, 4 and 24 h after the end of
paclitaxel instillation. When MPE was less than 200 ml/24 h the catheter
was removed. Chest radiographs were performed at the beginning of
intrapleural paclitaxel, at 1 and 2 months later or with clinical
deterioration.
RESULTS:
We enrolled
18 patients with
recurrent MPE:
11 with ovarian cancer and 7 with breast cancer. ORR was
77.8% at 1 month and 88.8%. at 2 months. Median TTP was 5.5 months (CI
95% 0.9-10.1) and median OS was 8.9 months (CI 95% 0.1-17.6). Patients
achieving a complete response obtained a statistically significant
longer survival than did patients with partial response or progressive
disease. Chest pain, fever, and dyspnea were the most frequent side
effects. Intrapleural paclitaxel concentrations were very high (mean ±
SD = 478 ± 187 mg/l) and declined slowly (mean 24 h reduction ~30%).
Detectable but low taxol plasma levels were found in most patients (mean
± SD = 0.045 ± 0.073 mg/l).
CONCLUSION:
Intrapleural
paclitaxel is a safe and effective palliative treatment for MPE from
breast and ovarian cancers and may be integrated with systemic
chemotherapy.
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