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A phase III concurrent chemoradiotherapy trial with cisplatin and paclitaxel or docetaxel or gemcitabine in unresectable non-small cell lung cancer: KASLC 0401

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Abstract

Purpose

Concurrent chemoradiotherapy (CCRT) is recommended for the management of patients with unresectable non-small cell lung cancer (NSCLC). This prospective study aimed to compare the efficacy of concurrently delivered cisplatin doublets with paclitaxel, or docetaxel, or gemcitabine.

Methods

The main eligibility criteria consisted of previously untreated stage IIIB NSCLC. The subjects were randomized into three arms: paclitaxel 45 mg/m2/week (TP), docetaxel 20 mg/m2/week (DP), and gemcitabine 350 mg/m2/week (GP) in addition to cisplatin 20 mg/m2/week. Three-dimensional conformal radiotherapy was given once daily, weekly 5 fractions and the total prescription dose was 60–66 Gy. The primary endpoint was response rate, and the secondary endpoints were survival and toxicity.

Results

A total of 101 patients were recruited into this trial of whom 93 (TP: 33, DP: 29, GP: 31) patients were treated with CCRT from March 2005 to July 2007. Similar response rates were observed across arms: TP: 63.6 %, DP: 72.4 %, GP: 61.3 % (p = 0.679). There was no statistically significant difference of median survival (TP: 27.3, DP: 27.6, GP: 16.5 months, p = 0.771). In subgroup analysis, a survival benefit of consolidation chemotherapy was not seen, but leucopenia (63.2 %) and neutropenia (68.4 %) more than grade 3 were significantly high in DP arm. The grade ≥3 radiation esophagitis was more frequent in the GP arm (22.6 %, p = 0.163).

Conclusions

Among the three arms, no statistically significant difference in response rate, survival, and toxicity was observed. However, clinically significant radiation toxicity was more frequent in the GP arm.

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Acknowledgments

This study was conducted as the Korean Association for the Study of Lung Cancer 0401 and supported by a Grant (CRI09036-1) from Chonnam National University Hospital Research Institute of Clinical Medicine.

Conflict of interest

The authors indicated no potential conflicts of interest.

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Authors and Affiliations

  1. Lung and Esophageal Cancer Clinic, Chonnam National University Hwasun Hospital, 322 Seoyang-ro, Hwasun-eup, Jeonnam, 519-809, Republic of Korea

    In-Jae Oh, Kyu-Sik Kim, Young-Chul Kim, Mee-Sun Yoon & Sung-Ja Ahn

  2. Department of Internal Medicine, Chonnam National University, Gwangju, Republic of Korea

    In-Jae Oh, Kyu-Sik Kim, Young-Chul Kim, Hee-Jung Ban, Yong-Soo Kwon, Yu-Il Kim & Sung-Chul Lim

  3. Department of Radiation Oncology, Chonnam National University, Gwangju, Republic of Korea

    Woong-Ki Chung, Taek-Keun Nam, Joo-Young Song, Mee-Sun Yoon & Sung-Ja Ahn

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  1. In-Jae Oh
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  2. Kyu-Sik Kim
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Correspondence to Sung-Ja Ahn.

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Oh, IJ., Kim, KS., Kim, YC. et al. A phase III concurrent chemoradiotherapy trial with cisplatin and paclitaxel or docetaxel or gemcitabine in unresectable non-small cell lung cancer: KASLC 0401. Cancer Chemother Pharmacol 72, 1247–1254 (2013). https://doi.org/10.1007/s00280-013-2308-5

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  • DOI: https://doi.org/10.1007/s00280-013-2308-5

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