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(Chest. 1994;106:307S-309S.)
© 1994 American College of Chest Physicians

Adjuvant Chemotherapy With Cyclophosphamide, Doxorubicin, and Cisplatin in Patients With Completely Resected Stage I Non-small Cell Lung Cancer

An LCSG Trial

Ronald Feld MD1; L. Rubinstein MD2; and Paul A. Thomas MD, FCCP3

1 From the Princess Margaret Hospital, Toronto, Canada
2 From the National Cancer Institute, Bethesda, Md
3 From the Illinois Cancer Council, Chicago

Objective: Two recent studies in resectable non-small cell lung cancer by the Lung Cancer Study Group (LCSG) suggested an advantage to adjuvant therapy with cyclophosphamide, doxorubicin (Adriamycin), and cisplatin CAP). Neither study had a no-treatment control arm. The purpose of this study was to compare the CAP regimen with no treatment in patients with resectable early-stage non-small cell lung cancer.

Methods: After complete resection, eligible patients with T1N1 or T2N0 non-small cell lung cancer were randomly assigned to receive or not to receive four courses of CAP at 3-week intervals beginning on day 30 after surgery after stratification for histology, preoperative white blood cell count, and Karnofsky performance status before surgery. The CAP regimen consisted of 400 mg/m2 of cyclophosphamide, 40 mg/m2 of doxorubicin, and 60 mg/m2 of cisplatin. Of the 269 eligible patients entered in the study, 101 had recurrence and 127 had died at the time of analysis. The mean time since randomization is 6.4 years; mean follow-up is 3.8 years. There were no differences in time to recurrence or overall survival between the two groups even when analyses were adjusted for prognostic variables. Only 53% of the eligible patients received all four courses of CAP, and only 57% of such patients received all four cycles on time. Among the patients who had recurrences, 74% had their initial recurrence at a distant site.

Conclusion: No survival benefit for CAP vs no-treatment control was found in this study. Therefore, adjuvant therapy with CAP should not be recommended for patients with resected early-stage non-small cell lung cancer. Further trials to test adjuvant therapy are indicated, but investigators should use better antiemetics to improve patient compliance as well as more active cisplatin-based chemotherapy regimens.






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Copyright © 1994 by the American College of Chest Physicians.