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Hwa Sik Moon - One of the best experts on this subject based on the ideXlab platform.
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A multicenter phase II study of Belotecan, a new camptothecin analogue, in elderly patients with previously untreated, extensive-stage small cell lung cancer
Cancer Chemotherapy and Pharmacology, 2013Co-Authors: Chang Dong Yeo, Sang Haak Lee, Ju Sang Kim, Seung Joon Kim, Seok Chan Kim, Young Kyoon Kim, Jeong Sup Song, Hyeon Hui Kang, Hyung Kyu Yoon, Hwa Sik MoonAbstract:Purpose Belotecan is a new camptothecin analogue and a potent topoisomerase I inhibitor. The aim of this phase II study was to investigate the efficacy and toxicity of Belotecan in previously untreated elderly patients with small cell lung cancer (SCLC). Methods A total of 26 patients, aged ≥65 years, with previously untreated, extensive-stage SCLC were enrolled in the study. Belotecan was administered by daily intravenous infusion at 0.5 mg/m^2/day for 5 consecutive days every 3 weeks. Results The overall response rate and disease control rate of chemotherapy on an intention-to-treat basis were 35 and 54 %, respectively. The median overall survival was 6.4 months, and the median time to progression was 2.8 months. The most common toxicity was hematologic. Grade 3 or 4 neutropenia occurred in 80.8 % of patients, and grade 3 or 4 thrombocytopenia in 15.3 %. Non-hematologic toxic effects of grade 3 or 4 were uncommon. Conclusion Belotecan had modest efficacy and well-tolerated toxicity in previously untreated, elderly SCLC patients. Single Belotecan could be a promising treatment option, considering its lower toxicity in elderly patients who are unsuitable candidates for platinum plus etoposide chemotherapy.
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A multicenter phase II study of Belotecan, a new camptothecin analogue, in elderly patients with previously untreated, extensive-stage small cell lung cancer.
Cancer chemotherapy and pharmacology, 2013Co-Authors: Chang Dong Yeo, Sang Haak Lee, Ju Sang Kim, Seung Joon Kim, Seok Chan Kim, Young Kyoon Kim, Jeong Sup Song, Hyeon Hui Kang, Hyung Kyu Yoon, Hwa Sik MoonAbstract:Purpose Belotecan is a new camptothecin analogue and a potent topoisomerase I inhibitor. The aim of this phase II study was to investigate the efficacy and toxicity of Belotecan in previously untreated elderly patients with small cell lung cancer (SCLC).
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A multicenter phase II study of Belotecan, a new camptothecin analogue, as a second-line therapy in patients with small cell lung cancer.
Lung cancer (Amsterdam Netherlands), 2010Co-Authors: Chin Kook Rhee, Sang Haak Lee, Ju Sang Kim, Seung Joon Kim, Seok Chan Kim, Young Kyoon Kim, Hyun Hee Kang, Hyoung Kyu Yoon, Jeong Sup Song, Hwa Sik MoonAbstract:Belotecan (Camtobell, CKD602) is a new camptothecin derivative antitumor agent that belongs to the topoisomerase inhibitors. The aim of this phase II study was to evaluate the efficacy and safety of single agent Belotecan as a second-line therapy in patients with small cell lung cancer (SCLC). Patients who were previously treated for SCLC were entered into the study. Belotecan was given by daily intravenous infusion for five consecutive days, every three weeks. Twenty-five patients were enrolled in this study. On an intention-to-treat basis, Belotecan induced an overall response rate of 24%, a median overall survival of 9.9 months, a median time to progression of 2.2 months, and a 1-year survival rate of 38.3%. Grade 3/4 neutropenia developed in 88.0% of patients and grade 3/4 thrombocytopenia in 40.0%. Nonhematologic toxicity of grade 3 or 4 was low. The results suggest that Belotecan is relatively active and well tolerated as a second-line agent in patients with SCLC.
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A multicenter phase II study of Belotecan, new camptothecin analogue, in patients with previously untreated extensive stage disease small cell lung cancer
Lung cancer (Amsterdam Netherlands), 2009Co-Authors: Sung-rae Kim, Ju Sang Kim, Young Kyoon Kim, Hyoung Kyu Yoon, Hwa Sik Moon, Sung-yong Kim, Ji Young Kang, Joo-hyoun Song, Sug-hyung Lee, Jin-il KimAbstract:Belotecan (Camtobell, CKD602) is a new camptothecin derivative antitumor agent that belongs to the topoisomerase inhibitors. The aim of this phase II study was to evaluate the efficacy and safety of single agent Belotecan in patients with small cell lung cancer (SCLC). Patients with previously untreated extensive stage disease (ED) SCLC were entered into the study. Belotecan was given by daily intravenous infusion at 0.5mg/m(2)/day for 5 consecutive days, every 3 weeks. 62 patients were enrolled in this study. The overall response rate to chemotherapy on an intention-to-treat basis was 53.2%. The median overall survival was 10.4 months, the median time to progression 4.6 months, and the 1-year survival rate 49.9%. The most common toxicity was hematologic. Grade 3/4 neutropenia occurred in 71.0% of patients and grade 3/4 thrombocytopenia 12.9%. Non-hematologic toxicity of grade 3 or 4 was low. The results suggest that Belotecan is relatively active and well tolerable as single agent in patients with ED SCLC. Further investigations with platinum or other active agents are needed.
Jung-shin Lee - One of the best experts on this subject based on the ideXlab platform.
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1474PRANDOMIZED PHASE II STUDY OF Belotecan OR TOPOTECAN CHEMOTHERAPY AS SECOND-LINE CHEMOTHERAPY AFTER PLATINUM-BASED FIRST-LINE CHEMOTHERAPY FOR SMALL CELL LUNG CANCER
Annals of Oncology, 2014Co-Authors: Sun-young Yoon, Jung-shin Lee, Dongwhane Lee, Choong-gon Choi, Jee-ho Lee, S-w. KimAbstract:ABSTRACT Aim: 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. Methods: 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. Results: 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)]. Conclusions: Belotecan showed comparable efficacy to that with topotecan and more favorable toxicity profiles for neutropenia. Disclosure: All authors have declared no conflicts of interest.
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Multicenter phase 2 study of Belotecan, a new camptothecin analog, and cisplatin for chemotherapy‐naive patients with extensive‐disease small cell lung cancer
Cancer, 2010Co-Authors: Dae Ho Lee, Sangwe Kim, Jung-shin Lee, Cheolwon Suh, Jin Seok Ahn, Myung-ju Ahn, Keunchil Park, Jae Cheol Lee, Baek Yeol RyooAbstract:BACKGROUND: The objective of this study was to investigate the efficacy of Belotecan, a new camptothecin analog, combined with cisplatin for the treatment of chemotherapy-naive patients with extensive-disease small cell lung cancer (ED SCLC). METHODS: Treatment consisted of Belotecan 0.5 mg/m2 daily on Days 1 through 4 and cisplatin 60 mg/m2 on Day 1 of a 3-week cycle for up to 6 cycles unless there was disease progression, unacceptable toxicity, or patient refusal. Response assessment was done every 2 cycles using the Response Evaluation Criteria in Solid Tumors, and toxicity assessment was done every cycle using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. RESULTS: Between September 2006 and March 2008, 30 patients participated in the study. Among them, 21 patients achieved a partial response, and the response rate was 70% (95% confidence interval [CI], 50.6%-85.3%); and, after a median follow-up of 20.2 months, the median progression-free survival was 6.9 months (95% CI, 6.3-7.5 months), and the overall survival was 19.2 months (95% CI, 13.3-25.2 months). Grade 3 and 4 adverse events included neutropenia in 23 patients, thrombocytopenia in 8 patients, febrile neutropenia in 9 patients, nausea in 3 patients, and pneumonia in 3 patients. There was 1 treatment-related death from pneumonia. However, nonhematologic toxicity generally was mild and manageable. CONCLUSIONS: The Belotecan and cisplatin combination that was studied demonstrated promising response rates and survival outcomes with a manageable toxicity profile for chemotherapy-naive patients who had ED SCLC. The authors concluded that the combination warrants further randomized trials. Cancer 2010. © 2010 American Cancer Society.
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multicenter phase 2 study of Belotecan a new camptothecin analog and cisplatin for chemotherapy naive patients with extensive disease small cell lung cancer
Cancer, 2009Co-Authors: Dae Ho Lee, Sangwe Kim, Jung-shin Lee, Cheolwon Suh, Baek Yeol Ryoo, Jin Seok Ahn, Myung-ju Ahn, Keunchil Park, Jae Cheol Lee, Sung Hyun YangAbstract:BACKGROUND: The objective of this study was to investigate the efficacy of Belotecan, a new camptothecin analog, combined with cisplatin for the treatment of chemotherapy-naive patients with extensive-disease small cell lung cancer (ED SCLC). METHODS: Treatment consisted of Belotecan 0.5 mg/m2 daily on Days 1 through 4 and cisplatin 60 mg/m2 on Day 1 of a 3-week cycle for up to 6 cycles unless there was disease progression, unacceptable toxicity, or patient refusal. Response assessment was done every 2 cycles using the Response Evaluation Criteria in Solid Tumors, and toxicity assessment was done every cycle using the National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.0. RESULTS: Between September 2006 and March 2008, 30 patients participated in the study. Among them, 21 patients achieved a partial response, and the response rate was 70% (95% confidence interval [CI], 50.6%-85.3%); and, after a median follow-up of 20.2 months, the median progression-free survival was 6.9 months (95% CI, 6.3-7.5 months), and the overall survival was 19.2 months (95% CI, 13.3-25.2 months). Grade 3 and 4 adverse events included neutropenia in 23 patients, thrombocytopenia in 8 patients, febrile neutropenia in 9 patients, nausea in 3 patients, and pneumonia in 3 patients. There was 1 treatment-related death from pneumonia. However, nonhematologic toxicity generally was mild and manageable. CONCLUSIONS: The Belotecan and cisplatin combination that was studied demonstrated promising response rates and survival outcomes with a manageable toxicity profile for chemotherapy-naive patients who had ED SCLC. The authors concluded that the combination warrants further randomized trials. Cancer 2010. © 2010 American Cancer Society.
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A phase I and pharmacologic study of Belotecan in combination with cisplatin in patients with previously untreated extensive-stage disease small cell lung cancer.
Clinical cancer research : an official journal of the American Association for Cancer Research, 2007Co-Authors: Dae Ho Lee, Sangwe Kim, Kyun-seop Bae, Yoon-koo Kang, Jeong-sook Hong, Cheolwon Suh, Jung-shin LeeAbstract:Purpose: Belotecan (Camtobell, CKD602) is a novel camptothecin derivative. This study was designed to determine the maximum tolerated dose (MTD), toxicity profile, and dose-limiting toxicity of Belotecan in combination with cisplatin in patients with previously untreated extensive-stage disease small cell lung cancer (SCLC). Furthermore, pharmacokinetics and preliminary antitumor activity against SCLC were evaluated. Experimental Design: Belotecan was administered i.v. as intermittent 30-min infusions on days 1 to 4, starting dose of 0.40 mg/m2/d with increment of 0.05 mg/m2/d. Intrapatient dose escalation was not allowed. Cisplatin (60 mg/m2) was given on day 1. The treatments were repeated every 3 weeks. Pharmacokinetics was determined during the first cycle using noncompartmental pharmacokinetic analysis. Results: Seventeen chemotherapy-naive patients with extensive-stage disease SCLC were treated. The MTD of Belotecan was 0.50 mg/m2/d with the dose-limiting toxicity of grade 4 neutropenia with fever. A partial response was seen in 13 of 17 patients (76.5%). The most common toxicity was neutropenia but nonhematologic toxicity was very favorable. Pharmacokinetic analysis revealed that, at the dose of 0.50 mg/m2/d, plasma clearance of Belotecan was 5.78 ± 1.32 L/h and terminal half-life was 8.55 ± 2.12 h. Fraction of excreted amount in urine was 37.36 ± 5.55%. Pharmacokinetics of Belotecan was not altered by administration of cisplatin compared with historical control. Conclusions: The MTD and recommended dose of Belotecan for phase II studies was 0.50 mg/m2/d on days 1 to 4 in combination with 60 mg/m2 cisplatin on day 1 every 3 weeks.
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A phase I and pharmacologic study of Belotecan in combination with cisplatin in patients with previously untreated extensive-stage disease small cell lung cancer
Journal of Clinical Oncology, 2007Co-Authors: Jung-shin Lee, Dong Ho Lee, Kyun-seop Bae, Seung-mi Kim, Chong Hyun Suh, Ji Hoon Shin, Jun Hyuk Hong, Yoon-koo KangAbstract:18053 Background: Belotecan (CKD602) is a novel camptothecin derivative antitumor agent. This phase I study was designed to determine the maximum-tolerated dose (MTD), toxicity profile, and dose-limiting toxicity (DLT) of Belotecan in combination with cisplatin in patients with previously untreated extensive-stage disease small-cell lung cancer (ED SCLC). Furthermore, pharmacokinetics (PK) and preliminary antitumor activity of Belotecan against SCLC were evaluated. Methods: Patients with ED SCLC, age 18–70, ECOG PS 0–2, no prior chemotherapy and adequate organ function were eligible. Cisplatin with fixed dose of 60 mg/m2 was administered intravenously (i.v.) over 2 hours on day 1. Belotecan was administered iv as intermittent 30-minute infusions on days 1 to 4, starting dose of 0.40 mg/m2/day with increment of 0.05 mg/m2/day. Modified Fibonacci escalation was used (3 to 6 patients per cohort) and intra-patient dose escalation was not allowed. PK of Belotecan was determined during the first treatment using...
Kyu Sik Kim - One of the best experts on this subject based on the ideXlab platform.
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Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial.
BMC cancer, 2016Co-Authors: Kyu Sik Kim, Young-chul Kim, Jeong Eun Lee, Sun Young Kim, Cheol-kyu Park, Kwan-ho Lee, Jin-hong Jeong, Kye-chul Shin, Tae-won JangAbstract:No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of Belotecan/cisplatin (BP) and EP regimens in chemotherapy- and radiotherapy-naive patients with previously untreated ES-SCLC. We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP (n = 71) or EP (n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0.3–26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naive patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen. ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.
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Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial
BMC Cancer, 2016Co-Authors: Kyu Sik Kim, Young-chul Kim, Jeong Eun Lee, Sun Young Kim, Cheol-kyu Park, Kwan-ho Lee, Jin-hong Jeong, Kye-chul Shin, Tae-won Jang, Hyun-kyung LeeAbstract:Background No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of Belotecan/cisplatin (BP) and EP regimens in chemotherapy- and radiotherapy-naïve patients with previously untreated ES-SCLC. Methods We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP ( n = 71) or EP ( n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0.3–26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. Conclusions The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naïve patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen. Trial registration ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.
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Belotecan cisplatin versus etoposide cisplatin in previously untreated patients with extensive stage small cell lung carcinoma a multi center randomized phase iii trial
BMC Cancer, 2016Co-Authors: Kyu Sik Kim, Young-chul Kim, Jeong Eun Lee, Sun Young Kim, Cheol-kyu Park, Kwan-ho Lee, Jin-hong Jeong, Kye-chul Shin, Tae-won Jang, Hyun-kyung LeeAbstract:No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of Belotecan/cisplatin (BP) and EP regimens in chemotherapy- and radiotherapy-naive patients with previously untreated ES-SCLC. We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP (n = 71) or EP (n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0.3–26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naive patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen. ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.
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Clinical Efficacy of Belotecan (CKD-602), Newly Developed Camptothecin Analog, in the 2nd Line Treatment of Relapsed Small Cell Lung Cancer
Tuberculosis and Respiratory Diseases, 2009Co-Authors: Hee Jung Ban, Kyu Sik Kim, Yong Soo Kwon, Yu Il Kim, Sung Chul Lim, Young-chul KimAbstract:연구배경: Belotecan (Camtobell, CKD-602, Chongkundang Pharm., Korea)은 camptothecin의 치환체로 topoisomerase I 효소를 억제하여 항암효과를 나타내는 것으로 알려져 있다. 이에 2차 항암화학요법에 치료제로써 Belotecan의 효과, 생존율 및 부작용에 대해 연구하였다. 방법: 이에 소세포폐암에서 etoposide와 platinum을 사용한 1차 항암화학요법에서 실패한 49명의 환자들을 대상으로 2차 항암화학요법에 Belotecan을 투약하였다. 결과: 전체 반응률은 25%였으며, 11명의 환자에서 partial response를 보였다. 또한 1차 항암화학요법 이후 90일 이내에 재발한 군과 90일 이상 경과한 군간에 유의한 차이는 보이지 않았다. 전체 환자의 중심생존기간은 10.3개월(290일)이었고, 비반응군에서는 186일(95% CI; 67~305)로 반응군의 471일(95% CI; 234~568)에 비해 생존기간의 감소 유의하게 있음을 확인하였다(p=0.07). 결론: 2차 항암화학요법의 치료제로써 Belotecan의 효능과 부작용에 대해서는 향후 무작위 비교 연구가 필요할 것으로 사료된다.
Bongseog Kim - One of the best experts on this subject based on the ideXlab platform.
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a randomised phase 2b study comparing the efficacy and safety of Belotecan vs topotecan as monotherapy for sensitive relapsed small cell lung cancer
British Journal of Cancer, 2021Co-Authors: Jinhyoung Kang, K H Lee, Dongwan Kim, Sangwe Kim, Hye Ryun Kim, Joo Hang Kim, Jinhyuk Choi, Jinsoo Kim, Joungsoon Jang, Bongseog KimAbstract:BACKGROUND This study compared the efficacy/safety of the camptothecin analogues Belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC). METHODS One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m2) or Belotecan (0.5 mg/m2), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint. RESULTS In the Belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% (p = 0.09) and DCR was 85% vs. 70% (p = 0.030). PFS was not different between groups. Median OS was significantly longer with Belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48-0.99), particularly in patients aged <65 years, with more advanced disease (i.e., extensive-stage disease, time to relapse: 3-6 months), or Eastern Cooperative Oncology Group performance status 1 or 2. More Belotecan recipients completed all treatment cycles (53% vs. 35%; p = 0.022). CONCLUSIONS The efficacy/safety of Belotecan warrants further evaluation in Phase 3 trials. Belotecan potentially offers an alternative to topotecan for sensitive-relapsed SCLC, particularly in patients aged <65 years, with more advanced disease, or poor performance.
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A randomised phase 2b study comparing the efficacy and safety of Belotecan vs. topotecan as monotherapy for sensitive-relapsed small-cell lung cancer
British Journal of Cancer, 2020Co-Authors: Jinhyoung Kang, K H Lee, Dongwan Kim, Sangwe Kim, Hye Ryun Kim, Joo Hang Kim, Jinhyuk Choi, Jinsoo Kim, Joungsoon Jang, Bongseog KimAbstract:Background This study compared the efficacy/safety of the camptothecin analogues Belotecan and topotecan for sensitive-relapsed small-cell lung cancer (SCLC). Methods One-hundred-and-sixty-four patients were randomised (1:1) to receive five consecutive daily intravenous infusions of topotecan (1.5 mg/m^2) or Belotecan (0.5 mg/m^2), every 3 weeks, for six cycles. Main outcomes were objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), tolerability and toxicity. The study statistical plan was non-inferiority design with ORR as the endpoint. Results In the Belotecan vs. topotecan groups, ORR (primary endpoint) was 33% vs. 21% ( p = 0.09) and DCR was 85% vs. 70% ( p = 0.030). PFS was not different between groups. Median OS was significantly longer with Belotecan than with topotecan (13.2 vs. 8.2 months, HR = 0.69, 95% CI: 0.48–0.99), particularly in patients aged
Hyun-kyung Lee - One of the best experts on this subject based on the ideXlab platform.
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Belotecan/cisplatin versus etoposide/cisplatin in previously untreated patients with extensive-stage small cell lung carcinoma: a multi-center randomized phase III trial
BMC Cancer, 2016Co-Authors: Kyu Sik Kim, Young-chul Kim, Jeong Eun Lee, Sun Young Kim, Cheol-kyu Park, Kwan-ho Lee, Jin-hong Jeong, Kye-chul Shin, Tae-won Jang, Hyun-kyung LeeAbstract:Background No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of Belotecan/cisplatin (BP) and EP regimens in chemotherapy- and radiotherapy-naïve patients with previously untreated ES-SCLC. Methods We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP ( n = 71) or EP ( n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0.3–26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. Conclusions The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naïve patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen. Trial registration ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.
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Belotecan cisplatin versus etoposide cisplatin in previously untreated patients with extensive stage small cell lung carcinoma a multi center randomized phase iii trial
BMC Cancer, 2016Co-Authors: Kyu Sik Kim, Young-chul Kim, Jeong Eun Lee, Sun Young Kim, Cheol-kyu Park, Kwan-ho Lee, Jin-hong Jeong, Kye-chul Shin, Tae-won Jang, Hyun-kyung LeeAbstract:No novel chemotherapeutic combinations have demonstrated superior efficacy to etoposide/cisplatin (EP), a standard treatment regimen for extensive-stage small cell lung carcinoma (ES-SCLC) over the past decade. We aimed to compare the efficacy and safety of Belotecan/cisplatin (BP) and EP regimens in chemotherapy- and radiotherapy-naive patients with previously untreated ES-SCLC. We conducted a multi-center, randomized, open-label, parallel-group, phase III clinical study. A total of 157 patients were recruited at 14 centers with 147 patients meeting the inclusion/exclusion criteria and randomized to either BP (n = 71) or EP (n = 76) treatment arms. A non-inferior response rate (RR) in the BP arm, analyzed by intent-to-treat analysis according to Response Evaluation Criteria in Solid Tumors version 1.0 criteria, was used as the primary endpoint. The secondary endpoints were progression-free survival (PFS) and overall survival (OS). In the BP arm, one patient had a complete response, 41 had a partial response (PR), and 17 had stable disease (SD). In the EP arm, 35 patients had PR and 28 had SD. The RR in the BP arm was non-inferior to the EP regimen in patients with ES-SCLC (BP: 59.2 %, EP: 46.1 %, difference: 13.1 %, 90 % two-sided confidence interval: -0.3–26.5, meeting the predefined non-inferiority criterion of -15.0 %). No significant differences in OS or PFS were observed between the treatment arms. Hematologic toxicities, including grade 3/4 anemia and thrombocytopenia, were significantly more prevalent in the BP arm than the EP arm. The RR to the BP regimen was non-inferior to the EP regimen in chemotherapy- and radiotherapy-naive patients with previously untreated ES-SCLC. Hematologic toxicities were significantly more prevalent in the BP group, indicating that BP should be used with care, particularly in patients with a poor performance status. Further studies assessing PFS and OS are required to validate the superiority of the BP regimen. ClinicalTrials.gov identifier NCT00826644 . Date of Registration: January 21, 2009.