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Gemcitabine plus cisplatin chemotherapy with concurrent para-toluenesulfonamide local injection therapy for peripherally advanced nonsmall cell lung cancer larger than 3 cm in the greatest dimension.

Abstract：

:Para-toluenesulfonamide (PTS), active ingredient being PTS, is a new anticancer drug applied through local intratumoral injection. The aim of this phase II clinical trial was to investigate the response and toxicity of standard gemcitabine (GEM) plus cisplatin (CIS) chemotherapy with concurrent intratumoral injection of PTS in peripherally advanced nonsmall cell lung cancer. Patients received 1250 mg/m of GEM on day 1, 8, and 75 mg/m of CIS on day 1, every 21 days for four cycles. PTS was injected intratumorally through percutaneous injection under computed tomography guidance on days 5, 12, 15, and 18 of cycle 1, and repeated on days 5 and 12 of cycle 2 if a less than 50% necrotic area was achieved after the first cycle according to the computed tomography scan. Twelve (46.2%) patients had metastatic disease, whereas 14 (53.8%) patients had stage IIIB disease. All 26 patients were assessable for response. Overall response rate by intention-to-treat was 53.8% (95% confidence interval: 34.6-73.0%). Median progression-free survival and overall survival were 6.5 months (95% confidence interval: 3.8-10.2 months) and 14.5 months (10.0-18.0 months), respectively. One-year and 2-year survivals were 57.7 and 22.4%, respectively. The grade 3-4 hematologic adverse events were neutropenia in six patients (23.1%), anemia in three (11.5%), and thrombocytopenia in four patients (15.4%). Nonhematologic toxicities were generally mild and usually not dose-limiting. Although grade 1-2 emesis occurred in nine patients (34.6%), only one had grade 3 vomiting. Grade 1-2 cough, local pain, and peripheral neurotoxocity developed in 12 (46.2%), three (11.5%), and five (19.2%) patients, respectively. There were no treatment-related deaths. GEM/CIS chemotherapy with concurrent PTS local injection therapy is a well-tolerated modality with potential activity in previously untreated peripheral advanced nonsmall cell lung cancer patients.

journal_name

Anticancer Drugs

journal_title

Anti-cancer drugs

authors

He J,Ying W,Yang H,Xu X,Shao W,Guan Y,Jiang M,Wu Y,Zhong B,Wang D,Tucker S,Zhong N

doi

10.1097/CAD.0b013e32832fe48f

subject

Has Abstract

pub_date

2009-10-01 00:00:00

pages

838-44

issue

eissn

0959-4973

issn

1473-5741

journal_volume

pub_type

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Gemcitabine plus cisplatin chemotherapy with concurrent para-toluenesulfonamide local injection therapy for peripherally advanced nonsmall cell lung cancer larger than 3 cm in the greatest dimension.