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Cancer Chemotherapy and Pharmacology
Published in: Cancer Chemotherapy and Pharmacology 6/2012

Open Access 01-06-2012 | Original Article

A phase I trial of concurrent chemoradiotherapy with non-split administration of docetaxel and cisplatin for dry stage III non-small-cell lung cancer (JCOG9901DI)

Authors: Naoya Hida, Hiroaki Okamoto, Yuuki Misumi, Akira Sato, Mari Ishii, Fumihiro Kashizaki, Tsuneo Shimokawa, Teppei Shimizu, Koshiro Watanabe

Published in: Cancer Chemotherapy and Pharmacology | Issue 6/2012

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Abstract

Purpose

This study aimed to establish the maximum tolerated dose of concurrent chemoradiotherapy (cCRT) with conventional administration of the docetaxel (D) plus cisplatin (P) (conv-DP) regimen.

Methods

Patients (aged ≤70 years) with unresectable dry stage III non-small-cell lung cancer (NSCLC) and having performance status 0 or 1 and adequate organ function were eligible. They received radiotherapy (60 Gy in 30 fractions) once daily starting on day 2. Concurrent P (day 1; 60 mg/m2 at Levels 1–3, 80 mg/m2 at Level 4) and D (day 1; 30 mg/m2 at Level 1, 40 mg/m2 at Level 2, 50 mg/m2 at Levels 3–4) were administered every 4 weeks for 2–4 courses.

Results

Eighteen patients were enrolled (stage IIIA/IIIB, 5/13 patients). Three cases of dose-limiting toxicity were observed in this study, although another 3 cases were added at Levels 2 and 3. Radiotherapy was completed in 15 patients. Seventeen patients received more than 2 courses of chemotherapy. Neither Grade 3/4 esophagitis nor severe hematological events were observed at Levels 1–4. However, dose escalation to Level 5 (P [80 mg/m2], D [60 mg/m2]) was stopped because the Level 5 dose was the recommended dose (RD) of chemotherapy alone for stage IIIB/IV NSCLC in Japan. Therefore, the RD was determined as D50/P80 mg/m2 in this cCRT. The objective response rate was 89 %, and the median survival time was 23.6 months.

Conclusions

cCRT with non-split DP was a tolerable and effective regimen, and RD was 50/80 mg/m2 every 4 weeks.
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Metadata
Title
A phase I trial of concurrent chemoradiotherapy with non-split administration of docetaxel and cisplatin for dry stage III non-small-cell lung cancer (JCOG9901DI)
Authors
Naoya Hida
Hiroaki Okamoto
Yuuki Misumi
Akira Sato
Mari Ishii
Fumihiro Kashizaki
Tsuneo Shimokawa
Teppei Shimizu
Koshiro Watanabe
Publication date
01-06-2012
Publisher
Springer-Verlag
Published in
Cancer Chemotherapy and Pharmacology / Issue 6/2012
Print ISSN: 0344-5704
Electronic ISSN: 1432-0843
DOI
https://doi.org/10.1007/s00280-012-1871-5

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