This is a single-arm, real-world study in Chinese patients with extensive stage small cell lung cancer. The purpose of this study was to evaluate Trilaciclib's protection against chemotherapy-induced bone marrow suppression, the safety and the impact on the antitumor effects of the combination with chemotherapy in Chinese patients with ES-SCLC in the real world. Patients with ES-SCLC who already use or plan to use Trilaciclib will be invited to participate in the study. Data were collected from 28 days prior to initial chemotherapy (platinum/etoposide or topotecan systemic chemotherapy) after patients signed informed consent until patients died, dropped out of the study, lost to follow-up, informed withdrawal, or study termination. The end time of the study was defined as withdrawal of information, loss of follow-up or death of all enrolled patients, or 12 months after the last patient was enrolled, whichever happened earlier.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
* Carboplatin combined with Etoposide (ES-SCLC patients) * plus Topotecan (second/third line ES-SCLC patients)
Hainan General Hospital
Haikou, Hainan, China
Incidence of severe neutropenia (SN)
Incidence of severe neutropenia (SN)
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of grade 3 and 4 hematologic toxicity
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of intravenous or oral antibiotic administration in treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of G-CSF treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Changes of absolute neutrophil count, platelet count, absolute lymphocyte count (ALC) and hemoglobin over time
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of red blood cell (RBC) transfusions at or after week 5
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of ESA administration in treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of TPO administration in treatment
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of platelet transfusion
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The number and frequency of all-caused chemotherapy drugs reduction
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
composite end point - Significant hematologic adverse event (occurrence of any of the following events:all-cause hospitalization; all-cause dose reduction; Febrile neutropenia; Severe neutropenia )
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of infectious serious adverse events
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Incidence of pulmonary infection serious adverse events
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
The incidence of febrile neutropenia
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Objective response rate
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
duration of response
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Progression-free survival time
Time frame: during Trilaciclib plus chemotherapy assessed up to 6 months
Disease control rate
Time frame: during chemotherapy assessed up to 6 months
verall survival
Time frame: maximun up to 1.5 years
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