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01.12.2013 | Original Article

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

verfasst von: In-Jae Oh, Kyu-Sik Kim, Young-Chul Kim, Hee-Jung Ban, Yong-Soo Kwon, Yu-Il Kim, Sung-Chul Lim, Woong-Ki Chung, Taek-Keun Nam, Joo-Young Song, Mee-Sun Yoon, Sung-Ja Ahn

Erschienen in: Cancer Chemotherapy and Pharmacology | Ausgabe 6/2013

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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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Titel: A phase III concurrent chemoradiotherapy trial with cisplatin and paclitaxel or docetaxel or gemcitabine in unresectable non-small cell lung cancer: KASLC 0401
verfasst von: In-Jae Oh
Kyu-Sik Kim
Young-Chul Kim
Hee-Jung Ban
Yong-Soo Kwon
Yu-Il Kim
Sung-Chul Lim
Woong-Ki Chung
Taek-Keun Nam
Joo-Young Song
Mee-Sun Yoon
Sung-Ja Ahn
Publikationsdatum: 01.12.2013
Verlag: Springer Berlin Heidelberg
Erschienen in: Cancer Chemotherapy and Pharmacology / Ausgabe 6/2013
Print ISSN: 0344-5704
Elektronische ISSN: 1432-0843
DOI: https://doi.org/10.1007/s00280-013-2308-5

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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