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

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.

Methods

  • 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.

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 [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.

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