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Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

4834 - Safety of belotecan as second-line treatment for recurrent small cell lung cancer: a phase IIb randomized multicenter study

Date

20 Oct 2018

Session

Poster display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC - early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research

Presenters

Jin Hyoung Kang

Citation

Annals of Oncology (2018) 29 (suppl_8): viii596-viii602. 10.1093/annonc/mdy298

Authors

J.H. Kang1, H.T. Kim2, K.H. Lee3, D. Kim4, S. Kim5, H.R. Kim6, J. Kim7, J.H. Choi8, H.J. An9, J. Kim10, J.S. Jang11, B. Kim12

Author affiliations

  • 1 Department Of Oncology, Seoul St. Mary’s Hospital, 00000 - Seoul/KR
  • 2 Center For Lung Cancer, National Cancer Center, 410-769 - Goyang/KR
  • 3 Department Of Oncology, Chungbuk University Hospital, Cheongju/KR
  • 4 Department Of Oncology, Seoul National University Hospital, Seoul/KR
  • 5 Department Of Oncology, Asan Medical Center, Seoul/KR
  • 6 Yonsei University College Of Medicine, Yonsei Cancer Center, Seoul/KR
  • 7 Cha University, CHA Bundang Medical Center, Seongnam/KR
  • 8 Department Of Oncology, Ajou University Hospital, Suwon/KR
  • 9 Department Of Oncology, St. Vincent’s Hospital, Suwon/KR
  • 10 Department Of Oncology, Seoul National University Boramae Medical Center, Seoul/KR
  • 11 Department Of Oncology, Chung-Ang University Hospital, Seoul/KR
  • 12 Department Of Oncology, Veterans Health Service Medical Center, Seoul/KR
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Resources

Abstract 4834

Background

For extensive-stage small cell lung cancer (ES-SCLC) patients with progressive or recurrent disease after platinum-based combination chemotherapy, topotecan is recommended as second-line treatment. However, although some patients may achieve at least an objective response with topotecan, response duration is often short. Belotecan, a camptothecin derivative, inhibits topoisomerase I. Previous studies have demonstrated that belotecan has active antitumor activity against advanced SCLC and ovarian cancers. We report safety data from a phase IIb randomized multicenter study of belotecan as second-line treatment for progressive/recurrent limited-disease (LD)- or ES-SCLC.

Methods

This study, conducted from March 2010 to March 2018, was designed to prove the non-inferiority of belotecan to topotecan. Patients with recurrent ES-SCLC were randomized (1:1 ratio) to belotecan 0.5 mg/m2 or topotecan 1.5 mg/m2 intravenously for 5 consecutive days every 3 weeks for 6 cycles or until disease progression. Adverse events (AEs) were reported according to NCI-CTCAE (ver. 4.0) and categorized by System Organ Class and Preferred Term.

Results

Overall, 161 patients (belotecan, n = 80; topotecan, n = 81) were evaluable in the safety analysis set. Clinical characteristics were well balanced between the treatment arms. Although belotecan recipients received significantly more treatment cycles than topotecan recipients (p = 0.0210), there were no between-group differences in the number of patients who required dose reductions or who omitted treatment in each cycle. There were no statistically significant between-group differences in safety results: any AEs (including grade 3 or 4 AEs), adverse drug reactions (ADRs), severe AEs (SAEs) or severe ADRs (SADRs). The most common AEs in the belotecan and topotecan groups, respectively, were decreased neutrophil count (61 patients [76.3%] vs. 67 patients [82.7%]), anemia (37 [46.3% vs. 44 [54.3%]), decreased platelet count (33 [41.3%] vs. 43 [53.1%]), nausea (35 [43.8%] vs. 30 [37.0%), and anorexia (32 [40.0% vs. 36 [44.4%]).

Conclusions

Our study indicates that belotecan is a safe second-line treatment option for patients with progressive/recurrent LD- or ES-SCLC.

Clinical trial identification

NCT01497873.

Legal entity responsible for the study

Chong Kun Dang Pharmaceutical Corp.

Funding

Chong Kun Dang Pharmaceutical Corp.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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