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Joo-Hang Kim
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P2.12 - Small Cell Lung Cancer/NET (Not CME Accredited Session) (ID 961)
- Event: WCLC 2018
- Type: Poster Viewing in the Exhibit Hall
- Track:
- Presentations: 1
- Moderators:
- Coordinates: 9/25/2018, 16:45 - 18:00, Exhibit Hall
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P2.12-01 - Efficacy of Belotecan as Second-Line Treatment for Recurrent Small Cell Lung Cancer: A Phase IIb Randomized Multicenter Study (ID 13658)
16:45 - 18:00 | Author(s): Joo-Hang Kim
- Abstract
Background
Topotecan is recommended as second-line treatment for patients with progressive/recurrent extensive-stage small cell lung cancer (ES-SCLC) after platinum-based combination chemotherapy. Although some topotecan-treated patients may have at least an objective response (OR), response duration is often short. Belotecan, a camptothecin derivative topoisomerase I inhibitor, has shown promising antitumor activity and modest toxicities against advanced SCLC and ovarian cancers. We report efficacy data from a phase IIb randomized multicenter study of belotecan as second-line treatment for progressive/recurrent limited-disease (LD)- or ES-SCLC.
a9ded1e5ce5d75814730bb4caaf49419 Method
This study, conducted from March 2010 to March 2018, was designed to prove the non-inferiority of belotecan to topotecan. Patients were randomized (1:1) 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. The primary endpoint was objective response rate (ORR; complete response [CR] or partial response [PR]) based on RECIST criteria; secondary endpoints were progression-free survival (PFS), overall survival (OS).
4c3880bb027f159e801041b1021e88e8 Result
Overall, 148 patients (belotecan, n=72; topotecan, n=76) were eligible in the full analysis set (FAS; patients who received at least one dose); 113 patients (belotecan, n=62; topotecan; n=51) were evaluable in the per-protocol set (PPS; patients who completed the study protocol). Clinical characteristics were well balanced between the two treatment arms. In the FAS, ORR was 33.33% (belotecan) and 21.05% (topotecan), respectively (95% CI: −0.0195 to 0.2651, p=0.0927). One belotecan recipient had a CR. Median OS was 396 days (belotecan) and 247 days (topotecan), respectively (p=0.0178); median PFS was 144 and 115 days, respectively (p=0.9608). Similar efficacy outcomes were observed in the PPS.
Our data met the hypothesis that the antitumor efficacy of belotecan is non-inferior to that of topotecan as second-line treatment for patients with progressive/recurrent LD- or ES-SCLC. Belotecan was also associated with significantly longer OS. (ClinicalTrials.gov. ID: NCT01497873; https://clinicaltrials.gov/ct2/show/NCT01497873)
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