A phase I trial of concurrent chemoradiotherapy with non-split administration of docetaxel and cisplatin for dry stage III non-small-cell lung cancer
Cancer Chemotherapy and Pharmacology, 05/14/2012  Clinical Article

Hida N et al. – Concurrent chemoradiotherapy (cCRT) with non–split docetaxel (D) plus cisplatin (P) was a tolerable and effective regimen, and recommended dose (RD) was 50/80mg/m² every 4weeks.

• Patients (aged ≤70years) 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; 60mg/m² at Levels 1–3, 80mg/m² at Level 4) and D (day 1; 30mg/m² at Level 1, 40mg/m² at Level 2, 50mg/m² at Levels 3–4) were administered every 4weeks for 2–4 courses.

• 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 [80mg/m²], D [60mg/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/P80mg/m² in this cCRT.
• The objective response rate was 89 %, and the median survival time was 23.6months.