TY - JOUR
T1 - A randomised phase II trial of preoperative chemotherapy of cisplatin-docetaxel or docetaxel alone for clinical stage IB/II non-small-cell lung cancer
T2 - Results of a Japan Clinical Oncology Group trial (JCOG 0204)
AU - Kunitoh, H.
AU - Kato, H.
AU - Tsuboi, M.
AU - Asamura, H.
AU - Tada, H.
AU - Nagai, K.
AU - Mitsudomi, T.
AU - Koike, T.
AU - Nakagawa, K.
AU - Ichinose, Y.
AU - Okada, M.
AU - Shibata, T.
AU - Saijo, N.
N1 - Funding Information:
We thank Ms Mieko Imai for the data management, and Mr Takashi Asakawa and Dr Naoki Ishizuka for the statistical analyses. This study was supported by the Grant-in-Aid for Cancer Research (114S-2, 14S-4, 17S-2, 17S-5) and Health Sciences Research Grant from the Ministry of Health, Labour and Welfare of Japan. Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, 5–8 June 2004, New Orleans, LA, and at the 11th World Conference on Lung Cancer, 3–6 July 2005, Barcelona, Spain. Registered in http://www.clinical trials.gov. ClinicalTrials.gov number, NCT00132639.
Copyright:
Copyright 2010 Elsevier B.V., All rights reserved.
PY - 2008/9/16
Y1 - 2008/9/16
N2 - Preoperative chemotherapy is a promising strategy in patients with early-stage resectable non-small-cell lung cancer (NSCLC); optimal chemotherapy remains unclear. Clinical (c-) stage IB/II NSCLC patients were randomised to receive either two cycles of docetaxel (D)-cisplatin (P) combination chemotherapy (D 60 mg m-2 and P 80 mg m-2 on day 1) every 3-4 weeks or three cycles of D monotherapy (70 mg m-2) every 3weeks. Thoracotomy was performed 4-5 weeks (DP) or 3-4 weeks (D) after chemotherapy. The primary end point was 1-year disease-free survival (DFS). From October 2002 to November 2003, 80 patients were randomised. Chemotherapy toxicities were mainly haematologic and well tolerated. There were two early postoperative deaths with DP (one intraoperative bleeding and one empyema). Pathologic complete response was observed in two DP patients. Docetaxel-cisplatin was superior to D in terms of response rate (45 vs 15%) and complete resection rate (95 vs 87%). Both DFS and overall survival were better in DP. Disease-free survival at 1, 2 and 4 years were 78, 65 and 57% with DP, and were 62, 44 and 36% with D, respectively. Preoperative DP was associated with encouraging resection rate and DFS data, and phase III trials for c-stage IB/II NSCLC are warranted.
AB - Preoperative chemotherapy is a promising strategy in patients with early-stage resectable non-small-cell lung cancer (NSCLC); optimal chemotherapy remains unclear. Clinical (c-) stage IB/II NSCLC patients were randomised to receive either two cycles of docetaxel (D)-cisplatin (P) combination chemotherapy (D 60 mg m-2 and P 80 mg m-2 on day 1) every 3-4 weeks or three cycles of D monotherapy (70 mg m-2) every 3weeks. Thoracotomy was performed 4-5 weeks (DP) or 3-4 weeks (D) after chemotherapy. The primary end point was 1-year disease-free survival (DFS). From October 2002 to November 2003, 80 patients were randomised. Chemotherapy toxicities were mainly haematologic and well tolerated. There were two early postoperative deaths with DP (one intraoperative bleeding and one empyema). Pathologic complete response was observed in two DP patients. Docetaxel-cisplatin was superior to D in terms of response rate (45 vs 15%) and complete resection rate (95 vs 87%). Both DFS and overall survival were better in DP. Disease-free survival at 1, 2 and 4 years were 78, 65 and 57% with DP, and were 62, 44 and 36% with D, respectively. Preoperative DP was associated with encouraging resection rate and DFS data, and phase III trials for c-stage IB/II NSCLC are warranted.
KW - Cisplatin
KW - Docetaxel
KW - Lung cancer
KW - Non-small cell
KW - Preoperative chemotherapy
KW - Stage IB/II
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U2 - 10.1038/sj.bjc.6604613
DO - 10.1038/sj.bjc.6604613
M3 - Article
C2 - 18728643
AN - SCOPUS:51449089204
VL - 99
SP - 852
EP - 857
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 6
ER -