Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer

被引:1008
作者
Noda, W
Nishiwaki, Y
Kawahara, M
Negoro, S
Sugiura, T
Yokoyama, A
Fukuoka, M
Mori, K
Watanabe, K
Tamura, T
Yamamoto, S
Saijo, N
机构
[1] Kanagawa Canc Ctr, Yokohama, Kanagawa, Japan
[2] Natl Canc Ctr Hosp E, Chiba, Japan
[3] Natl Kinki Cent Hosp Chest Dis, Osaka, Japan
[4] Osaka City Gen Hosp, Osaka, Japan
[5] Niigata Canc Ctr Hosp, Niigata, Japan
[6] Aichi Canc Ctr, Nagoya, Aichi 464, Japan
[7] Kinki Univ, Sch Med, Osaka 589, Japan
[8] Tochigi Canc Ctr, Utsunomiya, Tochigi, Japan
[9] Yokohama Municipal Citizens Hosp, Yokohama, Kanagawa, Japan
[10] Natl Canc Ctr, Cent Hosp, Tokyo 104, Japan
[11] Natl Canc Ctr, Res Inst, Canc Informat & Epidemiol Div, Tokyo 104, Japan
关键词
D O I
10.1056/NEJMoa003034
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
Background Irinotecan hydrochloride, a topoisomerase I inhibitor, is effective against small-cell lung cancer. In a phase 2 study of irinotecan plus cisplatin in patients with extensive small-cell lung cancer, there was a high response rate and a promising median survival time. Methods We conducted a multicenter, randomized, phase 3 study in which we compared irinotecan plus cisplatin with etoposide plus cisplatin in patients with extensive (metastatic) small-cell lung cancer. Results The planned size of the study population was 230 patients, but enrollment was terminated early because an interim analysis found a statistically significant difference in survival between the patients assigned to receive irinotecan and cisplatin and those assigned to receive etoposide and cisplatin; as a result, only 154 patients were enrolled. The median survival was 12.8 months in the irinotecan-plus-cisplatin group and 9.4 months in the etoposide-plus-cisplatin group (P=0.002 by the unadjusted log-rank test). At two years, the proportion of patients surviving was 19.5 percent in the irinotecan-plus-cisplatin group and 5.2 percent in the etoposide-plus-cisplatin group. Severe or life-threatening myelosuppression was more frequent in the etoposide-plus-cisplatin group than in the irinotecan-plus-cisplatin group, and severe or life-threatening diarrhea was more frequent in the irinotecan-plus-cisplatin group than in the etoposide-plus-cisplatin group. Conclusions Irinotecan plus cisplatin is an effective treatment for metastatic small-cell lung cancer. (N Engl J Med 2002;346:85-91.) Copyright (C) 2002 Massachusetts Medical Society.
引用
收藏
页码:85 / 91
页数:7
相关论文
共 12 条
  • [1] THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY
    AARONSON, NK
    AHMEDZAI, S
    BERGMAN, B
    BULLINGER, M
    CULL, A
    DUEZ, NJ
    FILIBERTI, A
    FLECHTNER, H
    FLEISHMAN, SB
    DEHAES, JCJM
    KAASA, S
    KLEE, M
    OSOBA, D
    RAZAVI, D
    ROFE, PB
    SCHRAUB, S
    SNEEUW, K
    SULLIVAN, M
    TAKEDA, F
    [J]. JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) : 365 - 376
  • [2] Extensive-disease small-cell lung cancer: The thrill of victory; The agony of defeat
    Aisner, J
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1996, 14 (02) : 658 - 665
  • [3] INTERIM ANALYSIS - THE ALPHA-SPENDING FUNCTION-APPROACH
    DEMETS, DL
    LAN, KKG
    [J]. STATISTICS IN MEDICINE, 1994, 13 (13-14) : 1341 - 1352
  • [4] RANDOMIZED TRIAL OF CYCLOPHOSPHAMIDE, DOXORUBICIN, AND VINCRISTINE VERSUS CISPLATIN AND ETOPOSIDE VERSUS ALTERNATION OF THESE REGIMENS IN SMALL-CELL LUNG-CANCER
    FUKUOKA, M
    FURUSE, K
    SAIJO, N
    NISHIWAKI, Y
    IKEGAMI, H
    TAMURA, T
    SHIMOYAMA, M
    SUEMASU, K
    [J]. JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1991, 83 (12) : 855 - 861
  • [5] IHDE DC, 1992, NEW ENGL J MED, V327, P1434
  • [6] NONPARAMETRIC-ESTIMATION FROM INCOMPLETE OBSERVATIONS
    KAPLAN, EL
    MEIER, P
    [J]. JOURNAL OF THE AMERICAN STATISTICAL ASSOCIATION, 1958, 53 (282) : 457 - 481
  • [7] Phase II study of irinotecan combined with cisplatin in patients with previously untreated small-cell lung cancer
    Kudoh, S
    Fujiwara, Y
    Takada, Y
    Yamamoto, H
    Kinoshita, A
    Ariyoshi, Y
    Furuse, K
    Fukuoka, M
    Takada, M
    Ikegami, H
    Nishikawa, H
    Nakajima, S
    Hoso, T
    Higashino, K
    Takahara, J
    Kamei, M
    Yamakido, M
    Ryu, S
    Hara, N
    Fukuda, M
    Kinuwaki, E
    Tanaka, F
    Senba, H
    Araki, J
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1998, 16 (03) : 1068 - 1074
  • [8] CPT-11 - A NEW DERIVATIVE OF CAMPTOTHECIN FOR THE TREATMENT OF REFRACTORY OR RELAPSED SMALL-CELL LUNG-CANCER
    MASUDA, N
    FUKUOKA, M
    KUSUNOKI, Y
    MATSUI, K
    TAKIFUJI, N
    KUDOH, S
    NEGORO, S
    NISHIOKA, M
    NAKAGAWA, K
    TAKADA, M
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1992, 10 (08) : 1225 - 1229
  • [9] REBOUSSIN DM, 2001, PROGRAMS COMPUTING G
  • [10] RANDOMIZED STUDY OF CYCLOPHOSPHAMIDE, DOXORUBICIN, AND VINCRISTINE VERSUS ETOPOSIDE AND CISPLATIN VERSUS ALTERNATION OF THESE 2 REGIMENS IN EXTENSIVE SMALL-CELL LUNG-CANCER - A PHASE-III TRIAL OF THE SOUTHEASTERN CANCER STUDY-GROUP
    ROTH, BJ
    JOHNSON, DH
    EINHORN, LH
    SCHACTER, LP
    CHERNG, NC
    COHEN, HJ
    CRAWFORD, J
    RANDOLPH, JA
    GOODLOW, JL
    BROUN, GO
    OMURA, GA
    GRECO, FA
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 1992, 10 (02) : 282 - 291