Phase I study of docetaxel plus S-1 combination chemotherapy for recurrent non-small cell lung cancer

Fujitaka,Kazunori; Hattori,Noboru; Senoo,Tadashi; Iwamoto,Hiroshi; Ohshimo,Shinichiro; Kanehara,Masashi; Ishikawa,Nobuhisa; Haruta,Yoshinori; Murai,Hiroshi; Kohno,Nobuoki

doi:10.3892/ol.2010.218

January-February 2011 Volume 2 Issue 1

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January-February 2011 Volume 2 Issue 1

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Article

Phase I study of docetaxel plus S-1 combination chemotherapy for recurrent non-small cell lung cancer

Authors:
- Kazunori Fujitaka
- Noboru Hattori
- Tadashi Senoo
- Hiroshi Iwamoto
- Shinichiro Ohshimo
- Masashi Kanehara
- Nobuhisa Ishikawa
- Yoshinori Haruta
- Hiroshi Murai
- Nobuoki Kohno
View Affiliations / Copyright

Affiliations: Department of Molecular and Internal Medicine, Graduate School of Biomedical Science, Hiroshima University, Hiroshima 734-8551, Japan
Pages: 167-170
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Published online on: November 23, 2010

https://doi.org/10.3892/ol.2010.218
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Abstract

S-1 is a novel oral fluorouracil prodrug that plays a role in non-small cell lung cancer (NSCLC). Docetaxel (DTX) is one of the standard agents for relapsed NSCLC. We performed a phase I study of DTX plus S-1 combination therapy as second-line treatment for NSCLC to determine the maximum tolerated dose (MTD) and recommended dose (RD). Patients with recurrent NSCLC, aged 20-74 years with an Eastern Cooperative Oncology Group performance status of 0-1 and measurable lesions, were enrolled. The treatment consisted of four dose levels. The patients received DTX (40-60 mg/m2 intravenously on day 1) and S-1 (65-80 mg/m2 orally, daily on days 1-14) for each 21-day cycle. Three to six patients were treated at each dose level with the two drugs, with MTD defined as the dose level at which dose-limiting toxicity (DLT) occurred in 33% of the patients. A total of 17 patients were enrolled. At dose level 4 (DTX, 60 mg/m2; S-1, 80 mg/m2) 3 of 5 patients experienced DLT and this level was regarded as the MTD. Therefore, dose level 3 (DTX, 60 mg/m2; S-1, 65 mg/m2) was selected as the RD for subsequent studies. The DLTs were neutropenia (grade 4) and mucositis (grade 3). The response rate was 5.9% (1 of 17 patients achieved a partial response) and 14 of 17 patients achieved stable disease. This combination regimen showed a tolerable and manageable profile in recurrent NSCLC and therefore warrants further evaluation.

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Journals

International Journal of Molecular Medicine

International Journal of Oncology

Molecular Medicine Reports

Oncology Reports

Experimental and Therapeutic Medicine

Oncology Letters

Biomedical Reports

Molecular and Clinical Oncology

World Academy of Sciences Journal

International Journal of Functional Nutrition

International Journal of Epigenetics

Medicine International

Phase I study of docetaxel plus S-1 combination chemotherapy for recurrent non-small cell lung cancer

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