Journal of Clinical Oncology, Vol 15, 2840-2849, Copyright © 1997 by American Society of Clinical Oncology
Randomized trial of alternating versus sequential radiotherapy/chemotherapy in limited-disease patients with small-cell lung cancer: a European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group Study
A Gregor, P Drings, J Burghouts, PE Postmus, D Morgan, T Sahmoud, A Kirkpatrick, O Dalesio and G Giaccone
Department of Clinical Oncology, Western General Hospital National Health Service Trust, Edinburgh, United Kingdom.
PURPOSE: To evaluate the effectiveness of alternating or sequential
schedules of cyclophosphamide, doxorubicin, and etoposide (CDE)
chemotherapy and irradiation in patients with previously untreated
small-cell lung cancer (SCLC). MATERIALS AND METHODS: A total of 335
eligible patients were randomized between five courses of CDE chemotherapy
followed by thoracic irradiation 50 Gy in 20 daily fractions (S) and the
same total dose of chemotherapy and irradiation split into four courses of
five daily fractions delivered on days 14 to 21 of the second and
subsequent chemotherapy courses (A). Patients had a median age of 61 years
(range, 33 to 75); 224 (66%) were male; the Eastern Cooperative Oncology
Group (ECOG) performance status (PS) was 0 or 1 in 311; and 254 had weight
loss less than 10%. RESULTS: The overall median survival duration was 15
months, with 62% (95% confidence interval [CI], 57% to 67%) 1-year, 25%
(95% CI, 20% to 30%) 2-year, and 14% (95% CI, 10% to 18%) 3-year survival
rates. There was no significant difference between the arms. The median
survival time was 14 months in A and 15 months in S. One-year survival was
60% in A (95% CI, 53% to 67%) and 64% in S (95% CI, 57% to 71%); 2-year
survival was 26% in A (95% CI, 19% to 33%) and 23% in S (95% CI, 16% to
30%); and 3-year survival was 12% in A (95% CI, 6% to 18%) and 15% in S
(95% CI, 9% to 21%). World Health Organization (WHO) grade 3 and 4
neutropenia occurred in 90% of A and 77% of S patients (P < .001) and
WHO grade 3 and 4 thrombocytopenia in 33% of A and 20% of S patients (P
< .001). Rates of other acute and late toxicities were similar in both
arms. Hematologic toxicity compromised treatment dose delivery; less than
50% of A patients received greater than 95% of prescribed chemotherapy and
77% their full radiation course, compared with 60% and 93% for arm S (P
< .009). Local relapse was the site of first failure in 60% of all
patients and 75% of these suffered an in-field relapse; no difference could
be seen between the two arms. CONCLUSION: This trial failed to confirm the
superiority of an alternating schedule of delivery. For this combination of
chemotherapy and irradiation, hematologic toxicity compromised treatment
delivery and could have contributed to the overall result. The poor rates
of local control are disappointing and require intensification of the
radiation therapy strategy.
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