Trastuzumab Based Therapy in HER2 Positive AGC

Sponsor

Shanghai Zhongshan Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03024450

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Trastuzumab plus chemotherapy is an effective therapy in HER2 positive advanced gastric cancer (AGC). However, the efficacy of routine trastuzumab therapy and its association with clinicopathologic factors remain unclear. The object of the study is to determine whether the addition of trastuzumab to first-line chemotherapy improves efficacy compared with chemotherapy alone in HER2 positive AGC.

Condition or Disease	Intervention/Treatment	Phase
Gastric Adenocarcinoma	Drug: H+CT

Detailed Description

A total of 98 patients with HER2 positive AGC were enrolled in this prospective observational study. All patients were treated with trastuzumab plus chemotherapy as the first line therapy. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

98 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Efficacy and Prognostic Factors of Trastuzumab Based Therapy in HER2 Positive Advanced Gastric Cancer: a Single Center Prospective Observational Study

Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
HER2 positive AGC treated with H+CT HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.	Drug: H+CT All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival. Other Names: trastuzumab plus chemotherapy

Arm

Intervention/Treatment

HER2 positive AGC treated with H+CT

HER2 expression was assessed by IHC first. In the cases with IHC 2+, fluorescence in situ hybridization (FISH) was used to detect HER2/neu amplification levels. Only patients with high level of HER2 expression (IHC 3+ or IHC 2+ plus FISH positive) were eligible in this study.

Drug: H+CT

All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.

Other Names:

trastuzumab plus chemotherapy

Outcome Measures

Primary Outcome Measures

OS [8 years]
OS was defined as time from the beginning of first line therapy to death
PFS [8 years]
PFS was measured from the start of first line therapy to the date of progressive disease or death, with censoring of patients who were lost to follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

pathology and medical imageology proven advanced gastric adenocarcinoma, inoperable;
received trastuzumab plus chemotherapy as the first-line palliative chemotherapy;
with measurable lesion with a diameter 20 mm using conventional computed tomography (CT) or magnetic resonance imaging (MRI) scans or 10 mm using spiral CT scans;
Eastern Cooperative Oncology Group performance status (ECOG PS ) of 0-2;
left ventricular ejection fraction(LVEF) more than 50 percents;
sufficient bone marrow, liver and renal function.

Exclusion Criteria:

received previous systemic therapy for advanced disease (except adjuvant/neoadjuvant chemotherapy completed at least 6 months before enrollment);
trastuzumab based adjuvant/neoadjuvant therapy;
treatment with any other anticancer therapy (lapatinib, immunotherapy, etc);
patients with heart failure, coronary artery disease or myocardial infarction within the previous 6 months.
trastuzumab based first line therapy started beyond 4 weeks from the first diagnoses of AGC.