Rl. Souhami et al., RANDOMIZED TRIAL COMPARING WEEKLY VERSUS 3-WEEK CHEMOTHERAPY IN SMALL-CELL LUNG-CANCER - A CANCER-RESEARCH CAMPAIGN TRIAL, Journal of clinical oncology, 12(9), 1994, pp. 1806-1813
Purpose: A randomized trial of chemotherapy, given on either a 1-week
or a 9 week schedule, was performed in small-cell long cancer (SCLC) p
atients. The aim was to determine if weekly scheduling produced surviv
al superior to conventional treatment. Patients and Methods: four hund
red thirty-eight patients with SCLC with either limited disease (LD; 2
76 patients) or good-prognosis extensive disease (ED; 162 patients) we
re randomized. Weekly chemotherapy was 12 alternating cycles of ifosfa
mide/doxorubicin and cisplatin/etoposide (PE), while 3-week treatment
was six alternating cycles of cyclophosphamide/doxorubicin/vincristine
(CAV) and PE. Thoracic irradiation was administered 3 weeks after com
pletion of chemotherapy to LD patients who attained a complete respons
e (CR) or partial response (PR). Patients were well marched for clinic
al characteristics and prognostic factors. Results: Overall response w
as the same in both arms: 82.3% (39.4% CR) with weekly and 81.1% (36.9
% CR) with 3-week treatment. The median survival (MS) durations were 1
0.8 and 10.6 months for weekly and 3-week chemotherapy, respectively.
The 2-year survival rates were 11.8% and 11.7% in the weekly and 3-wee
k arms, respectively. Received dose-intensity (DI) was 73.9% of projec
ted for weekly treatment and 92.7% for 3-week treatment. Hematologic t
oxicity wets the major dose-limiting toxicity for the weekly treatment
. Conclusion: This trial excludes at 90% power a benefit of greater th
en 10% for 2-year survival for weekly treatment. The received DI was r
educed to a greater extent with weekly treatment, mainly due to hemato
logic toxicity. (C) 1994 by American Society of Clinical Oncology.