1474P - Randomized phase II study of belotecan or topotecan chemotherapy as second-line chemotherapy after platinum-based first-line chemotherapy for small...

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Small Cell Lung Cancer
Biological Therapy
Presenter Shinkyo Yoon
Citation Annals of Oncology (2014) 25 (suppl_4): iv511-iv516. 10.1093/annonc/mdu355
Authors S. Yoon, D.H. Lee, C. Choi, J.C. Lee, J.S. Lee, S. Kim
  • Medical Oncology, Asan Medical Center, 138736 - Seoul/KR



Topotecan has been accepted as second-line therapy for small cell lung cancer (SCLC), in addition, belotecan also been reported to have a significant response rate. Based on these results, we designed prospective randomized phase II trial of belotecan as a second-line treatment in patients with SCLC, who experienced disease progression within 6 months after first-line platinum-containing chemotherapy or chemo-radiotherapy.


We randomly assigned patients to belotecan 0.5 mg/m2 (n=61) or topotecan 1.5 mg/m2 (n=55) for 5 days every 21 days, stratified by response to first-line chemotherapy. The primary end point was response rate (RR). The secondary end points were progression-free survival (PFS), overall survival (OS) and safety profiles.


From August 2006 to December 2013, a total of 116 patients were enrolled. The median age was 64 years (range, 28-82), and the ratio of males to females was 0.89. In total, 186 cycles of topotecan (median 2, range 1-9) and 180 cycles of belotecan (median 2, range 1-8) were administered. Median follow-up was 5.6 months. RR of belotecan and topotecan was 19.7% (12/61) and 18.2% (10/55), respectively (p=0.92). Median PFS and OS of belotecan and topotecan was 2.1 months (95% CI 1.43-2.72) versus 2.3 months (1.46-3.07) and 11.2 months (10.2-12.1) versus 12.1 months (10.1-14.0), respectively (p=0.167, 0.659). Grade 3/4 hematologic adverse events with belotecan and topotecan were anemia [13.1% versus 14.5% (p=1.000)] thrombocytopenia [3.3% versus 7.3% (p=0.421)], neutropenia [21.3% versus 43.6% (p=0.016)].


Belotecan showed comparable efficacy to that with topotecan and more favorable toxicity profiles for neutropenia.


All authors have declared no conflicts of interest.