Rao 2010.
Methods | Multicenter RCT (22 centres in the UK and Europe), Phase II | |
Participants |
Number of participants: 72 (Auguest 2005 to November 2006) Number randomised: Experimental group: 36 Control group: 36 Number evaluated: Experimental group: 35, age (median and range): 59 (29 ‐ 79) years Control group: 36, age (median and range): 64 (36 ‐ 76) years Diagnosis: patients with previously untreated, histopathologically‐confirmed metastatic gastric adenocarcinoma or adenocarcinoma of the lower third of the esophagus; Only patients with EGFR‐positive tumors were enrolled into the study Inclusion: eligible patients should: be > 18 years; ECOG performance status 0/1; normal cardiac function (left ventricular ejection fraction within the institutional normal range); a minimum 12‐month interval from completion of any neoadjuvant or adjuvant chemotherapy; a minimum 4‐week interval from completion of radiotherapy; and adequate liver, bone marrow and renal function |
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Interventions |
Experimental group : 800 mg matuzumab weekly; epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21‐day cycle Control group: epirubicin 50 mg/m², cisplatin 60 mg/m² on day 1 and capecitabine 1250 mg/m² daily in a 21‐day cycle Treatment cycles were repeated every 3 weeks for a maximum of 8 cycles of ECX unless there was evidence of disease progression or unacceptable toxicity, death occurred or consent was withdrawn. Matuzumab was continued as a single agent after the 8 cycles of ECX unless there was evidence of disease progression or unacceptable toxicity, death occurred or consent was withdrawn |
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Outcomes |
Duration of follow‐up (median): 28.5 months for experimental group, and 23 months for control group OS, PFS, overall response, quality of life, adverse events (reported by different symptoms, no data for any adverse event) |
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Notes | Sponsor: Merck KGaA The sponsor involved in the study design, data collection, and data analysis |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random sequence was generated by a computer programme |
Allocation concealment (selection bias) | Low risk | Randomization was carried out centrally in a blinded manner by telephone using an interactive voice response system |
Blinding of participants and personnel (performance bias) All outcomes | High risk | The open‐label design may introduce performance bias (e.g. through stress‐related mechanisms). |
Blinding of outcome assessment (detection bias) OS, Serious adverse events | Low risk | These outcomes were unlikely to be affected by the blinding status of assessors |
Blinding of outcome assessment (detection bias) PFS, Response, quality of life & adverse events | Low risk | Blinded radiological review was performed |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 71 participants included in the analysis (98.6%); ITT was used |
Selective reporting (reporting bias) | Low risk | No prior protocol was available but all important outcomes were reported |
Other bias | Low risk | No obvious potential source of bias |