Journal of Clinical Oncology, Vol 11, 1230-1240, Copyright © 1993 by American Society of Clinical Oncology
Maintenance chemotherapy in small-cell lung cancer: long-term results of a randomized trial. European Organization for Research and Treatment of Cancer Lung Cancer Cooperative Group
G Giaccone, O Dalesio, GJ McVie, A Kirkpatrick, PE Postmus, JT Burghouts, W Bakker, MG Koolen, CP Vendrik and KJ Roozendaal
Ospedale S. Giovanni A.S., Torino, Italy.
PURPOSE: The present study investigates the role of short chemotherapy
(five cycles) versus prolonged (12 cycles) chemotherapy in small-cell lung
cancer (SCLC). PATIENTS AND METHODS: Six hundred eighty-seven patients with
SCLC were registered in a multicenter study to receive five cycles of
chemotherapy consisting of cyclophosphamide 1 g/m2 on day 1, doxorubicin 45
mg/m2 on day 1, and etoposide 100 mg/m2 on days 1, 3 and 5 (CDE), every 3
weeks. Four hundred thirty-four nonprogressing patients after five cycles
of chemotherapy were randomized either to receive seven further cycles of
the same chemotherapy or to follow-up. RESULTS: The response rate of 585
assessable patients was 79%, with 36% attaining a complete response.
Toxicity was mainly hematologic, with 16 toxic deaths (2.4% of all eligible
patients), 13 of which were due to sepsis. Median survival time from
registration of all patients was 326 days (396 and 267 days for limited and
extensive disease, respectively) with 3.2% of patients alive at 5 years. No
difference in survival between the two arms was observed, with the same
number of 5-year survivors in both arms. The patients randomized to the
maintenance arm had a progression-free survival (PFS) duration
approximately 2 months longer than the patients randomized to follow-up
(median of 177 days v 114 days from randomization; P = .0004). Among
patients with a partial response who were randomized to receive maintenance
chemotherapy, 12 achieved a complete response after 12 cycles. More
patients in the follow-up arm than in the maintenance arm received
subsequent treatment on progression and responded more frequently to that
treatment. Twelve patients developed second malignancies (seven
non-small-cell lung cancers). CONCLUSION: Prolonged chemotherapy does not
offer a better chance of cure than short chemotherapy (five cycles) and
does not prolong survival in patients with SCLC. Short, combination
chemotherapy appears to be a reasonable choice for standard treatment of
SCLC and for attempts to improve the cure rate of this disease.
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