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Journal of Clinical Oncology, Vol 17, Issue 2 (February), 1999: 658
© 1999 American Society for Clinical Oncology

Topotecan Versus Cyclophosphamide, Doxorubicin, and Vincristine for the Treatment of Recurrent Small-Cell Lung Cancer

Joachim von Pawel, Joan H. Schiller, Frances A. Shepherd, Scott Z. Fields, J.P. Kleisbauer, Nick G. Chrysson, David J. Stewart, Peter I. Clark, Martin C. Palmer, Alain Depierre, James Carmichael, Jacqueline B. Krebs, Graham Ross, Stephen R. Lane, Richard Gralla

From the Zentralkrankenhaus Gauting, Abteilung Onkologie, Gauting bei Muenchen, Germany; University of Wisconsin Comprehensive Cancer Center, Madison, WI; The Toronto Hospital, Toronto, Canada; SmithKline Beecham Pharmaceuticals, Collegeville, PA; Groupe Français de Pneumo Cancerologie, Hopital Sainte Marguerite, Marseille, France; Salem Research, Winston-Salem, NC; Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada; Clatterbridge Centre for Oncology, Wirral, Merseyside, United Kingdom; Cross-Cancer Institute, Edmonton, Alberta, Canada; Hopital Saint Jacques, Besancon, France; Nottingham City Hospital, Nottingham, United Kingdom; SmithKline Beecham Pharmaceuticals, Harlow, United Kingdom; and Alton Ochsner Medical Foundation, New Orleans, LA.

Address reprint requests to Joachim von Pawel, MD, Zentralkrankenhaus Gauting, Abteilung Onkologie, Unterbrunner Str 85, Gauting bei Muenchen, Germany, 82131.

PURPOSE: Topotecan and cyclophosphamide, doxorubicin, and vincristine (CAV) were evaluated in a randomized, multicenter study of patients with small-cell lung cancer (SCLC) who had relapsed at least 60 days after completion of first-line therapy.

PATIENTS AND METHODS: Patients received either topotecan (1.5 mg/m2) as a 30-minute infusion daily for 5 days every 21 days (n = 107) or CAV (cyclophosphamide 1,000 mg/m2, doxorubicin 45 mg/m2, and vincristine 2 mg) infused on day 1 every 21 days (n = 104). Eligibility included the following: bidimensionally measurable disease, Eastern Cooperative Oncology Group performance status of less than or equal to 2, and adequate marrow, liver, and renal function. Response was confirmed by blinded independent radiologic review.

RESULTS: Response rate was 26 of 107 patients (24.3%) treated with topotecan and 19 of 104 patients (18.3%) treated with CAV (P = .285). Median times to progression were 13.3 weeks (topotecan) and 12.3 weeks (CAV) (P = .552). Median survival was 25.0 weeks for topotecan and 24.7 weeks for CAV (P = .795). The proportion of patients who experienced symptom improvement was greater in the topotecan group than in the CAV group for four of eight symptoms evaluated, including dyspnea, anorexia, hoarseness, and fatigue, as well as interference with daily activity (P <= .043). Grade 4 neutropenia occurred in 37.8% of topotecan courses versus 51.4% of CAV courses (P < .001). Grade 4 thrombocytopenia and grade 3/4 anemia occurred more frequently with topotecan, occurring in 9.8% and 17.7% of topotecan courses versus 1.4% and 7.2% of CAV courses, respectively (P < .001 for both). Nonhematologic toxicities were generally grade 1 to 2 for both regimens.

CONCLUSION: Topotecan was at least as effective as CAV in the treatment of patients with recurrent SCLC and resulted in improved control of several symptoms.

This study was supported by a grant from SmithKline Beecham Pharmaceuticals (study no. 104864/090).

S.Z.F., J.B.K., G.R., and S.R.L. are employees of SmithKline Beecham Pharmaceuticals.




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