Journal of Clinical Oncology, Vol 15, 3378-3387, Copyright © 1997 by American Society of Clinical Oncology
Randomized trial of chemotherapy and radiation therapy with or without warfarin for limited-stage small-cell lung cancer: a Cancer and Leukemia Group B study
LH Maurer, JE Herndon 2nd, DR Hollis, J Aisner, RW Carey, AT Skarin, MC Perry, WL Eaton, LL Zacharski, S Hammond and MR Green
Dartmouth-Hitchcock Medical Center, Lebanon, NH 03756, USA. L.Herbert.Maurer@Hitchcock.ORG
PURPOSE: Studies by the Veterans Administration Cooperative Studies Program
and Cancer and Leukemia Group B (CALGB) suggested that the addition of
warfarin to chemotherapy might enhance response and/or survival in
small-cell lung cancer (SCLC). This randomized study evaluated the effect
of warfarin with chemotherapy and radiation therapy in limited-stage SCLC.
PATIENTS AND METHODS: Patients were randomized to receive warfarin or no
warfarin. All patients received three cycles of doxorubicin,
cyclophosphamide, and etoposide (ACE). Cycles 4 and 5 (cisplatin,
cyclophosphamide, and etoposide [PCE]) were given concurrently with
radiation therapy. Three cycles of ACE were given after chemoradiation
therapy, but were discontinued due to a high rate of pulmonary toxicity.
RESULTS: There were no significant differences in response rates, survival,
failure-free survival, disease- free survival, or patterns of relapse
between the warfarin-treated and control groups. In patients treated
according to the initial design, an increase in failure-free survival seen
with warfarin treatment approached significance (P = .07). Preamendment
results, while not significant, did not have superimposable treatment
survival curves. A landmark analysis at 8 months showed a median survival
time after the landmark for complete responders of 33 months with warfarin
treatment compared with < or = 13.75 months for complete or partial
responders not treated with warfarin (P = .05). Differences between the
complete responders in this preamendment population were not significant (P
= .103). CONCLUSION: Warfarin does not appear to improve outcome
significantly in limited-stage SCLC. However, the differences in some
variables between populations before the protocol amendment correspond to
the favorable effects of anticoagulants observed in previous studies.
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