TY - JOUR
T1 - A triplet chemotherapy with cisplatin, docetaxel and gemcitabine in patients with advanced non-small-cell lung cancer
T2 - A phase I/II study
AU - Tabata, Masahiro
AU - Kozuki, Toshiyuki
AU - Ueoka, Hiroshi
AU - Kiura, Katsuyuki
AU - Harita, Shingo
AU - Tada, Atsuhiko
AU - Shibayama, Takuo
AU - Takigawa, Nagio
AU - Yonei, Toshiro
AU - Gemba, Kenichi
AU - Segawa, Yoshihiko
AU - Kishino, Daizo
AU - Tada, Shinya
AU - Hiraki, Shunkichi
AU - Tanimoto, Mitsune
PY - 2007/6
Y1 - 2007/6
N2 - Purpose: We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m2 and 30 mg/m2, respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m2 was conducted and primary objective in the phase II portion was response rate. Results: The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m2 because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C max and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities. These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.
AB - Purpose: We conducted a phase I/II study of triplet chemotherapy consisting of cisplatin (CDDP), docetaxel (DCT) and gemcitabine (GEM) in patients with advanced non-small-cell lung cancer (NSCLC). Methods: Fifty-three untreated patients with stage IIIB or IV NSCLC were enrolled. All drugs were given on days 1 and 8. The doses of CDDP and DCT were fixed at 40 mg/m2 and 30 mg/m2, respectively. In the phase I portion, a dose escalation study of GEM with starting dose of 400 mg/m2 was conducted and primary objective in the phase II portion was response rate. Results: The maximally tolerated dose (MTD) and recommended dose (RD) of GEM were determined as 800 mg/m2 because grade 3 non-hematological toxicity (liver damage, diarrhea, and fatigue) developed in three of nine patients evaluated at that dose level. In pharmacokinetic analysis, C max and AUC of dFdC and dFdU were increased along with the dose escalation of GEM. However, no relationship between pharmacokinetic parameters and toxicity or response was observed. Objective response rate was 34% and median survival time was 11.7 months. Though major toxicity was myelosuppression, there were no life-threatening toxicities. These results indicate that this triplet chemotherapy is feasible and effective in patients with advanced NSCLC.
KW - Cisplatin
KW - Docetaxel
KW - Gemcitabine
KW - Non-small-cell lung cancer
KW - Phase I/II study
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U2 - 10.1007/s00280-006-0346-y
DO - 10.1007/s00280-006-0346-y
M3 - Article
C2 - 17009034
AN - SCOPUS:34247324280
SN - 0344-5704
VL - 60
SP - 53
EP - 59
JO - Cancer Chemotherapy and Pharmacology
JF - Cancer Chemotherapy and Pharmacology
IS - 1
ER -
