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
Ultima Vez Modificado: 22 de mayo del 2000

Share article


English

Presenter: D. H. Johnson
Affiliation: Vanderbilt University

Background:
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 chemotherapy.

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 to: - Observation (Ob) - 4 cycles of T (1.5mg/m2/dx5days, q3wk).
Results:

  • 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 32%.

  • With T, an additional 2% CR and 5% PR were achieved.

  • Median survival for all 402 eligible pts was 9.6 mos.

  • 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.
Authors' Conclusions

  • 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 increased toxicity.

  • 4 cycles of standard PE remains an appropriate first-line treatment for good performance status extensive stage SCLC pts.
Clinical/Scientific Implications:

  • 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 toxicity profile.


View ASCO Abstract 1886

English
News
Gefitinib Outperforms Combo Therapy in Lung Cancer Trial

Nov 23, 2014 - In a phase III clinical trial, gefitinib was superior to carboplatin-paclitaxel in extending survival for patients with non-small-cell lung cancer, particularly those patients with epidermal growth factor receptor gene mutations, according to a study published online Aug. 19 in the New England Journal of Medicine.



I Wish You Knew

How cancer patients have changed my life

View More



Blogs and Web Chats

OncoLink Blogs give our readers a chance to react to and comment on key cancer news topics and provides a forum for OncoLink Experts and readers to share opinions and learn from each other.




OncoLink OncoPilot

Frente a un nuevo diagnóstico de cáncer o de cambiar el curso de su tratamiento actual? Deje que nuestro personal de enfermería cáncer que ayudan a pasar!

Más información