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Intrapleural therapy for malignant pleural effusions. A randomized comparison of bleomycin and tetracycline.

Abstract：

:Between December 1985 and August 1988, there were 115 patients at 13 centers who were entered on a randomized comparison of tetracycline and bleomycin for treatment of malignant pleural effusions. Fifteen patients were not treated, primarily due to rapid progression of systemic cancer. Fifteen patients entered on a high-dose regimen of bleomycin (120 units) were excluded from this analysis (following early closure of that arm), leaving 85 patients randomized to low-dose bleomycin (60 units; 44 patients) or tetracycline (1 g; 41 patients). Patients were required to have a cytologically positive pleural effusion, good performance status (0, 1, or 2), lung reexpansion following tube thoracostomy with drainage rates of 100 ml/24 or less, no prior intrapleural therapy, no prior systemic bleomycin therapy, no chest irradiation, and no recent (four weeks) change in systemic therapy. A total of 11 patients (five with bleomycin and six with tetracycline) were not evaluable due to technical problems with tube drainage (one), loss to follow-up (two), sudden death due to pulmonary embolus (one), and rapid progression of systemic disease (seven). There were no clinically significant differences in demographic factors, primary site, performance status, or presence of metastases other than pleural effusion. Overall survival did not differ between the two groups. Median time to recurrence or progression of the effusion was 32 days for tetracycline-treated patients and at least 46 days for bleomycin-treated patients (p = 0.037). The recurrence rate within 30 days of instillation was 36 percent (10/28) with bleomycin and 67 percent (18/27) with tetracycline (p = 0.023) (not all patients were restudied in the first 30 days). By 90 days the corresponding recurrence rates were 30 percent (11/37) for bleomycin and 53 percent (19/36) for tetracycline (p = 0.047). Toxicity was similar between groups.

journal_name

Chest

journal_title

Chest

authors

Ruckdeschel JC,Moores D,Lee JY,Einhorn LH,Mandelbaum I,Koeller J,Weiss GR,Losada M,Keller JH

doi

10.1378/chest.100.6.1528

subject

Has Abstract

pub_date

1991-12-01 00:00:00

pages

1528-35

issue

eissn

0012-3692

issn

1931-3543

pii

S0012-3692(16)52787-1

journal_volume

100

pub_type

临床试验,杂志文章,多中心研究,随机对照试验

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Intrapleural therapy for malignant pleural effusions. A randomized comparison of bleomycin and tetracycline.