Topotecan (T) vs. Observation (OB) Following Cisplatin (P) Plus Etoposide (E) in Extensive Stage Small Cell Lung Cancer (ES SCLC) (E7593): A Phase III Trial of the Eastern Cooperative Oncology Group (ECOG)
Diana Stripp, MD
OncoLink Assistant Editor
Last Modified: May 22, 2000
Presenter: D. H. Johnson
Affiliation: Vanderbilt University
Topotecan, a topoisomerase I inhibitor, has a 40%
response rate as a first line agent in SCLC and
moderate activity in chemoresistant SCLC. This
Phase III trial was designed to determine
Topotecan?s efficacy in combination with standard
Materials and Methods:
- Eligibility: patients with histologically
confirmed SCLC, extensive stage, no previous
treatment, no prior malignancy, performance
status 0-2, age ³ 18y.o., normal organ function,
stable brain metastases were allowed.
- All pts received 4 cycles of P (60mg/m2 IV, D1)
and E (120mg/m2 IV, D 1-3) q3 wks. Pts with
stable or responding disease were then randomized
- Observation (Ob)
- 4 cycles of T (1.5mg/m2/dx5days, q3wk).
- 402 eligible pts were registered to Step 1 and
242 eligible pts to Step 2 (Ob 120 and T 122).
- The 2 groups were well balanced for demographic
characteristics, usual prognostic factors.
- The CR and PR rates to induction PE were 3% and
- With T, an additional 2% CR and 5% PR were
- Median survival for all 402 eligible pts was
- Progression Free Survival (PFS) from date of
Step 2 randomization was significantly better for
T compared to Ob (3.6 vs. 2.6 mos, p= 0.0001).
However, there were no significant differences
between the 2 groups in overall survival, median
survival (T 9.3mos and Ob 8.9) or 1-yr survival
(T 27% and Ob 25%).
- Toxicity: Grade 4 neutropenia and
thrombocytopenia occurred in 50% and 3%
respectively in Step 1 and 58% and 12% of T pts
in Step 2. Grade 3-5 infection was observed in
8% Step 1 pts and 4.5% T pts in Step 2. Grade 3-4
anemia developed in 21% of pts receiving T.
- Quality of Life data analysis showed no
differences in pts who received T vs. those on Ob.
- 4 cycles of PE induction therapy followed by 4
cycles of T improved PFS but failed to improve
overall survival in ES SCLC.
- T did not improve QOL and was associated with
- 4 cycles of standard PE remains an appropriate
first-line treatment for good performance status
extensive stage SCLC pts.
- Though topotecan has modest activity as a first
line or 2nd line agent in SCLC, topotecan
following standard PE chemotherapy not only did
not improve overall survival or quality of life
but also was associated with increased
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