Study for Patients With Lung Metastatic Advanced Gastric Cancer and NSCLC Treated With Apatinib

Completed

• Conditions: Lung Cancer; Gastric Cancer Metastatic to Lung
• Interventions: Other: lung cavitation

• Registration Number: NCT03629691
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.

Detailed Description

Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database. All patients were with Karnofsky performance status ≥70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions. Cardiac disease and hemorrhagic disease were excluded. All patients had pre-therapy chest computed tomography (CT) prior to apatinib treatment, and follow-up chest CT at least every 4 weeks. The primary end point was progression-free survival (PFS), secondary end points included duration of locoregional control (LRC), overall survival (OS), quality of life and safety. For metastatic lung cancer, LRC is the local control of metastatic lung tumor here. Other patient demographic and clinical data, including age, gender; stage of disease, apatinib administered inclusion and withdrawal date, adverse events, oncologic clinical response, comorbid conditions, and smoking history, were retrieved from the CRIS database.

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2018-05-19
• Study Completion: 2018-05-19
• Status Verified: 2018-07
• Study First Submitted: 2018-07-04
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Last Update Submitted: 2018-08-14
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. Between February 1, 2015 and May 19, 2018, 433 adult patients with gastric adenocarcinoma, lung adenocarcinoma and lung squamous cell carcinoma
2. Multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University.
3. Histologically proven were identified retrospectively using the Clinical Research Information Systems (CRIS) database.
4. All patients were with Karnofsky performance status over 70% or an Eastern Cooperative Oncology Group performance status of 0 to 1, with stable hepatic, hematologic, and renal functions.

Exclusion Criteria

1. Cardiac disease and hemorrhagic disease were excluded.
2. Patients with lung cavitation before apatinib treated.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
gastric cancer lung metastatic	lung cavitation	One of the study tumors.Between February 1, 2015 and May 19, 2018, 356adult patients with gastric adenocarcinoma, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University, of them, 110 patients with lung metastasis. 28 patients with lung cavitation
NSCLC	lung cavitation	One of the study tumors.Between February 1, 2015 and May 19, 2018, 77 adult patients with primary lung cancer, multiline chemotherapy failure and lack of standard treatment, received oral apatinib 250 mg daily at the Affiliated Hospital of Qingdao University. 30 of 77 were squamous cell carcinoma and 47 of 77 were adenocarcinoma. 28 patients with lung cavitation.

Primary Outcome Measures

Name	Time	Method
PFS (progression-free survival)	From February 1, 2015 to May 19, 2018 ,about 27 months	Evaluation of the oncologic clinical response was based on the alternate, modified method. We concluded that incorporating an assessment of cavitation when measuring target lesions might more accurately reflect changes in tumor volume. It was used for target lesions in which the longest diameter of any cavitation (zero if no cavity presented) was subtracted from the longest total diameter of the lesion, with each measurement taken in the same plane, to provide an alternate measure that was used to calculate the sum of measurements for all target lesions.

Secondary Outcome Measures

Name	Time	Method
LRC (duration of locoregional control )	From February 1, 2015 to May 19, 2018 , about 27 months	For metastatic lung cancer, LRC is the local control of metastatic lung tumor here.