Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer
Abstract Purpose To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second‐line monotherapy for treating small‐cell lung cancer (SCLC) patients. Methods According to the “3 + 3” dose‐escalation principle, patients received intraven...
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| Format: | Article |
| Language: | English |
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Wiley
2024-09-01
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| Series: | Cancer Medicine |
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| Online Access: | https://doi.org/10.1002/cam4.70059 |
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| author | Jieran Long Xuefei Li Lin Wu Guohua Yu Aimin Zang Yanqiu Zhao Jinsheng Shi Ligong Nie Xuan Zhao Jian Fang |
| author_facet | Jieran Long Xuefei Li Lin Wu Guohua Yu Aimin Zang Yanqiu Zhao Jinsheng Shi Ligong Nie Xuan Zhao Jian Fang |
| author_sort | Jieran Long |
| collection | DOAJ |
| description | Abstract Purpose To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second‐line monotherapy for treating small‐cell lung cancer (SCLC) patients. Methods According to the “3 + 3” dose‐escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression‐free survival (PFS), overall survival (OS), median progression‐free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan–Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS. Results This study included 29 patients with stage III–IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose‐limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively. Conclusion JK1201I exhibits promising efficacy and relatively low toxicities as a second‐line monotherapy for SCLC, warranting further large‐scale clinical studies to evaluate its efficacy in greater detail. |
| format | Article |
| id | doaj-art-c0eff1742b674608ab739db3cf6ba979 |
| institution | Kabale University |
| issn | 2045-7634 |
| language | English |
| publishDate | 2024-09-01 |
| publisher | Wiley |
| record_format | Article |
| series | Cancer Medicine |
| spelling | doaj-art-c0eff1742b674608ab739db3cf6ba9792025-02-07T09:08:08ZengWileyCancer Medicine2045-76342024-09-011317n/an/a10.1002/cam4.70059Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancerJieran Long0Xuefei Li1Lin Wu2Guohua Yu3Aimin Zang4Yanqiu Zhao5Jinsheng Shi6Ligong Nie7Xuan Zhao8Jian Fang9Department of Thoracic Oncology Beijing University Cancer Hospital Beijing ChinaDepartment of Clinical Medicine and Pharmacology JenKemTechnology Co., Ltd. (Tian Jin) Tianjin ChinaThoracic Medicine Department Hunan Cancer Hospital Changsha Hunan ChinaMedicine Oncology Department Weifang People's Hospital Weifang Shandong ChinaInternal Medicine Oncology Ward Affiliated Hospital of Hebei University Baoding Hebei ChinaDepartment of Respiratory Medicine Henan Cancer Hospital Zhengzhou Henan ChinaInternal Medicine Oncology Ward Cangzhou People's Hospital Cangzhou Hebei ChinaPulmonary and Critical Care Medicine Department, Beijing University First Hospital Beijing ChinaJenKem Technology Co., Ltd. (Tian Jin) Tianjin ChinaDepartment of Thoracic Oncology Beijing University Cancer Hospital Beijing ChinaAbstract Purpose To evaluate the safety, tolerability, and preliminary efficacy of multiple doses of pegylated irinotecan (JK1201I) as a second‐line monotherapy for treating small‐cell lung cancer (SCLC) patients. Methods According to the “3 + 3” dose‐escalation principle, patients received intravenous JK1201I at 180 or 220 mg/m2 once every 3 weeks for four cycles. Progression‐free survival (PFS), overall survival (OS), median progression‐free survival (mPFS), and median overall survival (mOS) were evaluated. The Kaplan–Meier method was used to analyze PFS and overall OS. Brookmeyer and Crowley's method was used for mPFS and mOS. Results This study included 29 patients with stage III–IV SCLC (stage IIIa, n = 1; stage IIIb, n = 1; and stage IV, n = 27). Of these, 26 patients were enrolled in the 180 mg/m2 dose group, and 3 patients were enrolled in the 220 mg/m2 dose group. No dose‐limiting toxicity (DLT) was noted during the first 28 days of treatment. Grade 3 or higher adverse events were recorded in the 180 mg/m2 group, including diarrhea (11.5%, 3/26), neutropenia (7.7%, 2/26), and leukopenia (7.7%, 2/26). In the 220 mg/m2 group, one patient (33.3%, 1/3) experienced neutropenia or leukopenia. In the 180 mg/m2 group, 38.5% (10/26) of patients achieved an objective response rate (ORR), with a disease control rate (DCR) of 73.1% (19/26). The mPFS and mOS were 3.4 and 12.1 months, respectively. In the 220 mg/m2 group, one patient had stable disease, and one had progressive disease (PD). The ORR, DCR, mPFS, and mOS were 0% (0/3) and 33.3% (1/3), 2.7 months and 2.7 months, respectively. Conclusion JK1201I exhibits promising efficacy and relatively low toxicities as a second‐line monotherapy for SCLC, warranting further large‐scale clinical studies to evaluate its efficacy in greater detail.https://doi.org/10.1002/cam4.70059overall survivalsafetysecond‐line monotherapysmall‐cell lung cancer |
| spellingShingle | Jieran Long Xuefei Li Lin Wu Guohua Yu Aimin Zang Yanqiu Zhao Jinsheng Shi Ligong Nie Xuan Zhao Jian Fang Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer Cancer Medicine overall survival safety second‐line monotherapy small‐cell lung cancer |
| title | Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer |
| title_full | Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer |
| title_fullStr | Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer |
| title_full_unstemmed | Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer |
| title_short | Phase Ib/II study on the safety, tolerability, and preliminary efficacy of pegylated irinotecan (JK1201I) as second‐line monotherapy for patients with small‐cell lung cancer |
| title_sort | phase ib ii study on the safety tolerability and preliminary efficacy of pegylated irinotecan jk1201i as second line monotherapy for patients with small cell lung cancer |
| topic | overall survival safety second‐line monotherapy small‐cell lung cancer |
| url | https://doi.org/10.1002/cam4.70059 |
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