Chemotherapy plus Cetuximab as First-Line Treatment for ...



Supplementary data

Methods

Medical Dictionary for Regulatory Activities preferred terms included in the special adverse event categories reported in the current study are as follows:

Acne-like rash

Acne, acne pustular, dermatitis acneiform, dry skin, erythema, folliculitis, pruritus, rash, rash erythematous, rash follicular, rash generalized, rash macular, rash maculo-papular, rash popular, rash pruritic, rash pustular, skin exfoliation, skin hyperpigmentation, telangiectasia, xerosis.

Thromboembolic events

Angiogram pulmonary, angiogram pulmonary abnormal, aortic embolus, aortic thrombosis, arterial thrombosis, arterial thrombosis limb, axillary vein thrombosis, deep vein thrombosis, embolism, fibrin D-dimer, fibrin D-dimer increased, jugular vein thrombosis, pelvic venous thrombosis, pulmonary artery thrombosis, pulmonary embolism, pulmonary infarction, pulmonary microemboli, pulmonary thrombosis, pulmonary veno-occlusive disease, pulmonary venous thrombosis, subclavian vein thrombosis, thrombosis, thrombophlebitis, venous thrombosis, venous thrombosis limb, ventilation/perfusion scan, ventilation/perfusion scan abnormal.

Cardiac events

Cardiac arrest, cardio-respiratory arrest, respiratory arrest, Adams-Stokes syndrome, anomalous atrioventricular excitation, arrhythmia, arrhythmia supraventricular, atrial conduction time prolongation, atrial fibrillation, atrial flutter, atrial tachycardia, atrioventricular block, atrioventricular block first degree, atrioventricular block second degree, atrioventricular block third degree, atrioventricular extrasystoles, AV dissociation, bifascicular block, bradyarrhythmia, bradycardia, bundle branch block, bundle branch block bilateral, bundle branch block left, bundle branch block right, cardiac fibrillation, cardiac flutter, conduction disorder, electrocardiogram PQ interval prolonged, electrocardiogram PR prolongation, electrocardiogram PR shortened, electrocardiogram QRS complex prolonged, electrocardiogram QT corrected interval prolonged, electrocardiogram QT interval abnormal, electrocardiogram QT prolonged, electrocardiogram repolarization abnormality, electrocardiogram U-wave abnormality, electrocardiogram U-wave biphasic, electromechanical dissociation, extrasystoles, gallop rhythm present, heart rate abnormal, heart rate decreased, heart rate increased, heart rate irregular, long QT syndrome, nodal arrhythmia, nodal rhythm, parasystole, paroxysmal arrhythmia, sick sinus syndrome, sinoatrial block, sinus arrest, sinus arrhythmia, sinus bradycardia, sinus tachycardia, supraventricular extrasystoles, supraventricular tachyarrhythmia, supraventricular tachycardia, tachyarrhythmia, tachycardia, tachycardia paroxysmal, torsade de pointes, trifascicular block, ventricular arrhythmia, ventricular asystole, ventricular extrasystoles, ventricular fibrillation, ventricular flutter, ventricular pre-excitation, ventricular tachyarrhythmia, ventricular tachycardia, acute left ventricular failure, acute right ventricular failure, cardiac failure, cardiac failure acute, cardiac failure chronic, cardiac failure congestive, cardiac failure high output, cardiogenic shock, cardiopulmonary failure, cardio-respiratory distress, chronic left ventricular failure,

chronic right ventricular failure, left ventricular failure, low cardiac output syndrome, right ventricular failure, ventricular failure, acute coronary syndrome, acute myocardial infarction, angina pectoris, angina unstable, arteriogram coronary abnormal, arteriosclerosis coronary artery, arteriospasm coronary, blood creatine phosphokinase MB abnormal, blood creatine phosphokinase MB increased, cardiac enzymes increased, cardiac stress test abnormal, cardiovascular insufficiency, computerized tomogram coronary artery abnormal, coronary artery disease, coronary artery embolism, coronary artery insufficiency, coronary artery occlusion, coronary artery reocclusion, coronary artery restenosis, coronary artery stenosis, coronary artery thrombosis, ECG signs of myocardial ischemia, electrocardiogram Q wave abnormal, electrocardiogram ST segment abnormal, electrocardiogram ST segment depression, electrocardiogram ST segment elevation, electrocardiogram ST-T segment abnormal, electrocardiogram ST-T segment depression, electrocardiogram ST-T segment elevation, exercise electrocardiogram abnormal, ischemic cardiomyopathy, microvascular angina, myocardial infarction, myocardial ischemia, papillary muscle infarction, postinfarction angina, Prinzmetal angina, scan myocardial perfusion abnormal, silent myocardial infarction, stress cardiomyopathy, subendocardial ischemia, troponin I increased, troponin increased, troponin T increased, cardiac death, death, sudden cardiac death, sudden death.

Septic events

Abdominal sepsis, acinetobacter bacteremia, amniotic infection syndrome of Blane, bacteremia, bacterial sepsis, bacterial toxemia, bacteroides bacteremia, catheter bacteremia, catheter sepsis, endotoxic shock, fungemia, fungal sepsis neutropenic sepsis, pelvic sepsis, post procedural sepsis, postpartum sepsis, pulmonary sepsis, sepsis, sepsis neonatal, sepsis syndrome, septic embolus, septic necrosis, septic phlebitis, septic rash, septic shock, staphylococcal sepsis, streptococcal sepsis, thrombophlebitis septic, urosepsis, viremia, wound sepsis.

Infusion-related reactions

Acute respiratory failure, apnea, asthma, bronchial obstruction, bronchospasm, cyanosis, dyspnea, dyspnea at rest, dyspnea exertional, hypoxia, orthopnea, respiratory distress, respiratory failure, chills, hyperpyrexia, pyrexia, acute myocardial infarction, angina pectoris, blood pressure decreased, cardiac failure, cardiopulmonary failure, cardiovascular insufficiency, clonus, convulsion, epilepsy, hypotension, infusion related reaction, loss of consciousness, myocardial infarction, myocardial ischemia, shock, sudden death and syncope, occurring on the first day of treatment; and anaphylactic reaction, anaphylactic shock, anaphylactoid reaction, anaphylactoid shock, drug hypersensitivity, drug rash with eosinophilia and systemic symptoms and hypersensitivity, occurring at any time during treatment.

Table 1

Overall survival according to subgroups of interest (adjusted analysis).

|Subgroup |Patient numbersa |Chemotherapy + cetuximab |Chemotherapy alone |Hazard ratioa |p-valueb |

| | | | |[95% CI] | |

| | |Median (95% CI) |Median (95% CI) | |Treatment |Interaction |

|Histology | | | | | |0.28 |

|Adenocarcinoma |478 vs 506 |11.6 |10.7 |0.94 |0.43 | |

| | |(9.6–12.8) |(9.5–11.8) |(0.82–1.09) | | |

|Squamous cell carcinoma |289 vs 284 |9.9 |9.0 |0.77 |0.0056 | |

| | |(8.9–11.4) |(8.0–9.9) |(0.64–0.93) | | |

|Other |236 vs 225 |9.4 |7.9 |0.88 |0.23 | |

| | |(7.8–11.3) |(7.0–9.5) |(0.72–1.08) | | |

|Age | | | | | |0.89 |

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