Journal of Clinical Oncology, Vol 5, 1880-1889, Copyright © 1987 by American Society of Clinical Oncology
Cisplatin/etoposide versus ifosfamide/etoposide combination chemotherapy in small-cell lung cancer: a multicenter German randomized trial
M Wolf, K Havemann, R Holle, C Gropp, P Drings, K Hans, M Schroeder, M Heim, M Dommes and S Mende
Department of Internal Medicine, Philipps-University of Marburg, Federal Republic of Germany.
A total of 144 patients with small-cell lung cancer (SCLC) were randomized
to receive cisplatin/etoposide (PE) or ifosfamide/etoposide (IE)
combination chemotherapy. PE consisted of cisplatin, 80 mg/m2,
intravenously (IV) on day 1, and etoposide, 150 mg/m2, IV on days 3 through
5. IE consisted of ifosfamide, 1,500 mg/m2, IV on days 1 through 5, and
etoposide, 120 mg/m2, IV on days 3 through 5. Six cycles were administered
in 3-week intervals. Nonresponders were switched immediately to CAV,
consisting of cyclophosphamide, 600 mg/m2, IV on days 1 and 2, Adriamycin
(Adria Laboratories, Columbus, OH), 50 mg/m2, IV on day 1, and vincristine,
2 mg, IV on day 1. Patients obtaining complete remission (CR) received
prophylactic cranial irradiation with 30 Gy. After completion of
chemotherapy, patients with limited disease received chest irradiation with
45 Gy. No maintenance therapy was given to patients in CR. Minimum
follow-up was 2 years. Of the 141 patients evaluable, the overall response
rate was 65% in PE therapy and 68% in IE therapy. The CR rate was 32% v 20%
for all patients, 50% v 24% for limited disease, and 22% v 18% for
extensive disease, all in favor of PE therapy. Median survival for all
patients was 11.6 months v 9.4 months, for limited disease 14.8 months v
11.0 months, and for extensive disease 8.9 months v 7.5 months, all
preferring PE therapy. The 2-year survival rate was higher in PE therapy
than in IE therapy for all patients (12% v 9%) and for limited disease (23%
v 10%), but not for extensive disease (5% v 9%). Median progression-free
survival was 7.5 months v 6.0 months for all patients, 12.2 months v 8.8
months for limited disease, and 5.9 months v 4.4 months for extensive
disease, all in favor of PE. Relapse in the area of the primary tumor was
found less often after PE than after IE therapy (25% v 38%). Response to
second-line CAV was seen in 30% of patients with prior PE and 43% with
prior IE therapy, but was usually short lasting, and only one patient
achieved CR. Toxicity included three lethal complications. Nausea,
vomiting, diarrhea, and skin lesions occurred more often after PE than
after IE therapy. These results suggest that PE is superior to IE
chemotherapy in limited-stage, but not in extensive-stage SCLC, and that
CAV is cross-resistant to PE, as well as to IE in the majority of patients.
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