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Title of Journal: Med Oncol

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Abbravation: Medical Oncology

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Springer US

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DOI

10.1007/978-1-4684-1950-4_8

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1559-131X

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Emphasis Type="Italic"Pseudomonas aeruginosa/Em

Authors: Jianhua Chang Yunpeng Liu Baohui Han Caicun Zhou Chunxue Bai Jin Li
Publish Date: 2015/03/24
Volume: 32, Issue: 5, Pages: 139-
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Abstract

Pseudomonas aeruginosa preparation PAP has shown activity in inhibiting the metastasis of cancer and can improve the immune function of cancer patients during chemotherapy This study aimed to investigate whether PAP can improves the efficacy of chemotherapy in patients with advanced nonsmallcell lung cancer NSCLC A total of 72 subjects with stage IIIB/IV NSCLC were randomized into PAP arm n = 36 or control arm n = 36 at a 11 ratio Subjects had vinorelbine and cisplatin combined with 05 ml PAP/placebo on d1 followed by 1 ml PAP/placebo injected subcutaneously three times a week The primary end point was the objective response rate ORR and secondary endpoints were time to progression TTP overall survival OS safety and quality of life QOL Sixtysix patients were included in intenttotreat analysis After two cycles of treatment there was a borderline statistically significant improvement in ORR of PAP arm 4688 vs 2353  P = 00532 and after four cycles of treatment the ORR in PAP arm was 3125 versus 1471  in control arm P = 01110 Median TTP and OS were 160 and 454 days in PAP arm 196 and 388 days in control arm P = 04609 and 06587 respectively The 1year survival rate in PAP and control arms was 5355 and 5015  respectively PAP did not result in increased toxicity and or had negative impact on QOL The results demonstrate the therapeutic potential of PAP for advanced NSCLC PAP can be used with chemotherapy to improve the response rate Longterm followup might help define whether the combination therapy can result in survival benefitThe study has been approved by the appropriate ethics committee and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments All persons gave their informed consent prior to their inclusion in the study Details that might disclose the identity of the subjects under study have been omitted

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