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Small cell lung cancer (SCLC) is a highly invasive cancer with early metastasis and poor prognostication, characterized by lower differentiation, high mutation load and high number of circulating tumor cells.
Although most SCLC patients initially had some chemotherapy response to first-line platinum drugs, 80% of patients with limited-term disease (LD) relapsed within one year of treatment, as did almost all patients with extensive period disease (ED).
SCLC treatment options are very limited due to drug resistance.
isomerase I inhibitor Topotecan is currently a single drug approved by the U.S. Food and Drug Administration (FDA) as a second-line treatment for relapsed SCLC.
the efficacy was more prominent in patients with a drug-resistant recurrence (relapse time of 3 months) than in patients with sensitive recurrence (recurrence time ≥3 months after the completion of first-line chemotherapy).
Belotecan as a new type of hemassine topology isomer I inhibitor.
in animal models, Beloticon showed more significant anti-tumor efficacy and broader therapeutic efficiency than topological tycon.
previous studies have shown that in a number of Phase 2 clinical trials, belotticon monotherapy has shown initial efficacy and good safety for relapsed SCLC.
the survival curve of Belotticon and Topological Tycon therapy, but there is currently no positive comparison between Belotticon and Topological Tycon.
, this randomized clinical trial aims to compare the efficacy and safety of topological tycon with beloticon as a monotherapy for relapsed small cell lung cancer.
researchers randomly assigned 144 patients (1:1) to two groups that received continuous daily intravenous drip topology (1.5 mg/m2) or beloticon (0.5 m/m2) five times every three weeks for a total of six cycles.
the main outcomes of the study were objective mitigation rate (ORR), disease control rate (DCR), progression-free lifetime (PFS), total lifetime (OS), toerability, and drug toxicity.
the statistical endpoint of the study was non-inefficient ORR.
OS HR forest map results compared to Topology in different subgroups show that in belodycon and Topology, ORR (primary endpoint) is 33% to 21%, and DCR is 85% to 70%.
there is no significant difference in PFS between the two groups.
The median OS in the
Belotticon group was significantly longer than in the topologically edicon group (13.2 vs. 8.2 months), especially in patients aged < 65 with more advanced diseases (i.e., widespread diseases, recurrence time: 3 to 6 months) or ECOG (Eastern Cancer Collaboration Group, Eastern Cooperative Oncology Group) with a rating of 1 or 2.
found that more patients who received Belotticon completed all treatment cycles (53 percent to 35 percent).
in general, the efficacy and safety of belotticon need to be further evaluated in Phase 3 clinical trials.
and above, belotticon may be a therapeutic alternative to small cell lung cancer patients with a recurrence of topologic sensitivity, especially in patients with advanced stages younger than 65.
In addition, last month a two-drug comparison found that belothicon is better in ovarian cancer: Br J Cancer: A phase 2b clinical study of the treatment of relapsed ovarian cancer by Belotticon and Topotycon gradually showed that in the future Beloticon is expected to replace topological tetycon in chemotherapy for multiple solid tumors.