Study of Addition of Panitumumab to Chemoradiation Therapy in Patients With Locally Advanced Head and Neck Cancer

• Sponsor: Amgen (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00500760
• Collaborator: (none)
• Enrollment: 153
• Arms: 2
• Actual Duration (Months): 42.8

Study Details

Study Description

Brief Summary

The addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. The study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer; Squamous Cell Carcinoma	Drug: Cisplatin; Radiation: Standard Fractionation Radiotherapy; Drug: Panitumumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 153 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
• Actual Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Mar 29, 2011
• Actual Study Completion Date: Apr 26, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Panitumumab Plus Chemoradiation Participants received standard radiation therapy for 7 weeks and cisplatin 75 mg/m^2 and panitumumab 9 mg/kg on Days 1, 22 and 43.	Drug: Cisplatin; Administered intravenously (IV; in a vein); Radiation: Standard Fractionation Radiotherapy; 70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions); Drug: Panitumumab; Administered intravenously; Other Names: Vectibix®
Active Comparator: Chemoradiotherapy Alone Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.	Drug: Cisplatin; Administered intravenously (IV; in a vein); Radiation: Standard Fractionation Radiotherapy; 70 Gy administered in 2 Gy fractions daily for 5 days a week for 7 weeks (35 fractions)

Outcome Measures

Primary Outcome Measures

1. Local Regional Control Rate at 2 Years [2 years]

   In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.

Secondary Outcome Measures

1. Local Regional Control Rate at 6 Months and 12 Months [6 months and 12 months]

   Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.

2. Duration of Local-regional Control [From first dose up to 37 months]

   Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.

3. Progression-Free Survival [From first dose date to 37 months]

   Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date.

4. Overall Survival [From first dose date up to 37 months]

   Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.

5. Percentage of Participants With an Objective Response at 6 Months [6 months]

   Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions.

6. Percentage of Participants With a Complete Response at 6 Months [6 months]

   Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy)

• You must be at least 18 years of age

• Your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant

• You must have measurable disease

Exclusion Criteria:

• Cancer of the nasopharynx, sinus, salivary gland or skin

• History of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer

• Previous treatment with anti-endothelial growth factor receptor (EGFr) antibody therapy or EGFr inhibitors

• Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy

• Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study

• Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening

• History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis)

• Major surgery within 28 days of screening

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Amgen

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

None provided.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT00500760
• Other Study ID Numbers: 20062080
• First Posted: Jul 13, 2007
• Last Update Posted: Oct 17, 2018
• Last Verified: Sep 1, 2018

• Keywords provided by Amgen: Head and Neck Cancer; panitumumab
• Additional relevant MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Panitumumab

Study Results

Participant Flow

Recruitment Details	153 patients were enrolled with 89 patients on panitumumab plus chemoradiation arm, and 64 patients on chemoradiotherapy alone arm.

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Period Title: Overall Study
STARTED	89	64
Received Treatment	87	63
COMPLETED	46	40
NOT COMPLETED	43	24

Baseline Characteristics

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone	Total
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.	Total of all reporting groups
Overall Participants	89	64	153
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	58.0 (8.4)	56.6 (8.8)	57.4 (8.5)
Sex: Female, Male (Count of Participants)
Female	13 14.6%	7 10.9%	20 13.1%
Male	76 85.4%	57 89.1%	133 86.9%
Race/Ethnicity, Customized (Number) [Number]
White or Caucasian	82 92.1%	55 85.9%	137 89.5%
Black or African American	0 0%	1 1.6%	1 0.7%
Hispanic or Latino	3 3.4%	0 0%	3 2%
Asian	4 4.5%	8 12.5%	12 7.8%
Radiotherapy delivery modality (Number) [Number]
IMRT	52 58.4%	42 65.6%	94 61.4%
3D-CRT	35 39.3%	21 32.8%	56 36.6%
Missing	2 2.2%	1 1.6%	3 2%
Primary tumor site (Number) [Number]
Oropharynx/Larynx	68 76.4%	41 64.1%	109 71.2%
Oral Cavity/Hypopharynx	21 23.6%	23 35.9%	44 28.8%
Nodal status (Number) [Number]
N0	12 13.5%	9 14.1%	21 13.7%
N+	77 86.5%	55 85.9%	132 86.3%
Tumor stage (Number) [Number]
T1-3	64 71.9%	45 70.3%	109 71.2%
T4	25 28.1%	19 29.7%	44 28.8%

Outcome Measures

1. Primary Outcome

Title	Local Regional Control Rate at 2 Years
Description	In this study participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set (all randomized participants who received at least 1 dose of protocol-specified treatment according to treatment randomization regardless of treatment received.)

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	63
Number (95% Confidence Interval) [proportion of paticipants]	0.61	0.68

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Kaplan-Meier estimate
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 95%; -0.23 to 0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments	The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.

2. Secondary Outcome

Title	Local Regional Control Rate at 6 Months and 12 Months
Description	Participants were considered to be in local regional control (LRC) if there was no evidence of active disease in the previously affected/irradiated head-and-neck area. LRC could be achieved at any time following completion of treatment unless disease progression in the local-regional area occurred or the participant received subsequent anti-tumor therapy. Local regional control rate is defined as the Kaplan-Meier (KM) estimate of the proportion of participants with local regional control.
Time Frame	6 months and 12 months

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	63
6 months	0.70	0.73
12 months	0.66	0.70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments	Difference between treatment groups at 6 months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Kaplan-Meier estimate
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments	Difference between treatment groups at 12 months
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in Kaplan-Meier estimate
	Estimated Value	-0.03
	Confidence Interval	(2-Sided) 95%; -1.09 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments	The difference between the treatment groups is calculated as panitumumab plus chemoradiation minus chemoradiotherapy alone.

3. Secondary Outcome

Title	Duration of Local-regional Control
Description	Duration of local regional control is calculated from the first day of any study treatment (radiotherapy, chemotherapy, or panitumumab) administration to the date of first local-regional failure or to death due to any cause (whichever occurs first). Local-regional failure includes persistent disease and local-regional recurrence of disease. Participants who did not meet the criteria for LRC recurrence after achieving a response by the analysis data cutoff date were censored at their last evaluable disease assessment date. Participants who never achieved LRC were considered to have a duration of 0.
Time Frame	From first dose up to 37 months

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	63
Median (95% Confidence Interval) [months]	33.7	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3106
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.328
	Confidence Interval	(2-Sided) 95%; 0.767 to 2.299
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.

4. Secondary Outcome

Title	Progression-Free Survival
Description	Progression-free survival time is defined as time from the first day of any study treatment to date of first progresive disease using a modified version of the World Health Organization (WHO) criteria or death. Progressive Disease is defined as at least a 25% increase in the size of index lesions or unequivocal progression of existing non-index lesions or the presence of one or more new lesions. Participants not meeting these criteria by the cutoff date were censored at their last evaluable disease assessment date.
Time Frame	From first dose date to 37 months

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	63
Median (95% Confidence Interval) [months]	NA	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.6069
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.150
	Confidence Interval	(2-Sided) 95%; 0.675 to 1.961
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.

5. Secondary Outcome

Title	Overall Survival
Description	Survival time is defined as time from the first day of any study treatment to date of death. Participants who had not died by the cutoff date were censored at their last contact date.
Time Frame	From first dose date up to 37 months

Outcome Measure Data

Analysis Population Description

Efficacy Analysis Set

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	63
Median (95% Confidence Interval) [months]	33.7	NA

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1223
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.628
	Confidence Interval	(2-Sided) 95%; 0.877 to 3.019
	Parameter Dispersion	Type: Value:
	Estimation Comments	Hazard ratio is presented as panitumumab plus chemoradiation:chemoradiotherapy alone.

6. Secondary Outcome

Title	Percentage of Participants With an Objective Response at 6 Months
Description	Objective response by 6 months is defined as a complete response or partial response based on central review of scans using a a modification of the WHO criteria during the first 6 months. Complete Response (CR): Disappearance of all index and non-index lesions and no new lesions. Partial Response (PR): At least a 50% decrease in the size of index lesions with no progression in non-index lesions, or the disappearance of all index lesions and persistence of 1 or more non-index lesions not qualifying for either CR or progressive disease and no new lesions.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Evaluable for Central Tumor Response Analysis Set: the subset of participants in the Efficacy Analysis Set with at least one bi-dimensionally measurable lesion at baseline using a modified version of the WHO criteria per blinded central review.

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	62
Number (95% Confidence Interval) [percentage of participants]	71.26 80.1%	82.26 128.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1737
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.535
	Confidence Interval	(2-Sided) 95%; 0.217 to 1.262
	Parameter Dispersion	Type: Value:
	Estimation Comments	The odds ratio is defined as the odds of having an overall response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in rate
	Estimated Value	-10.99
	Confidence Interval	(2-Sided) 95%; -24.56 to 4.14
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.

7. Secondary Outcome

Title	Percentage of Participants With a Complete Response at 6 Months
Description	Response assessment based on central review of scans using a a modification of the WHO criteria, during the first 6 months. Complete Response is defined as the disappearance of all index and non-index lesions and no new lesions.
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Evaluable for Central Tumor Response Analysis Set

Arm/Group Title	Panitumumab Plus Chemoradiation	Chemoradiotherapy Alone
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.	Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
Measure Participants	87	62
Number (95% Confidence Interval) [percentage of participants]	20.69 23.2%	19.35 30.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.0000
	Comments
	Method	Regression, Logistic
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.087
	Confidence Interval	(2-Sided) 95%; 0.448 to 2.712
	Parameter Dispersion	Type: Value:
	Estimation Comments	The odds ratio is defined as the odds of having a complete response in the panitumumab plus chemoradiation arm relative to the odds in the chemoradiotherapy alone arm.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Panitumumab Plus Chemoradiation, Chemoradiotherapy Alone
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in rate
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 95%; -13.23 to 14.71
	Parameter Dispersion	Type: Value:
	Estimation Comments	Difference is presented as the rate in panitumumab plus chemoradiation arm minus the rate in chemoradiotherapy alone arm.

Adverse Events

Time Frame	The median reporting period was around 82 days in the Panitumumab Plus Chemoradiation arm, and around 80 days in the Chemoradiotherapy Alone arm.
Adverse Event Reporting Description	The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in either treatment arm.
Arm/Group Title	Panitumumab Plus Chemoradiation		Chemotherapy Plus Radiotherapy
Arm/Group Description	Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
All Cause Mortality
	Panitumumab Plus Chemoradiation		Chemotherapy Plus Radiotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Panitumumab Plus Chemoradiation		Chemotherapy Plus Radiotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	37/87 (42.5%)		20/63 (31.7%)
Blood and lymphatic system disorders
Anaemia	2/87 (2.3%)		1/63 (1.6%)
Febrile neutropenia	1/87 (1.1%)		1/63 (1.6%)
Cardiac disorders
Cardio-respiratory arrest	1/87 (1.1%)		0/63 (0%)
Myocardial infarction	0/87 (0%)		1/63 (1.6%)
Gastrointestinal disorders
Colitis	1/87 (1.1%)		0/63 (0%)
Constipation	1/87 (1.1%)		0/63 (0%)
Dysphagia	6/87 (6.9%)		4/63 (6.3%)
Glossitis	1/87 (1.1%)		0/63 (0%)
Nausea	6/87 (6.9%)		4/63 (6.3%)
Odynophagia	1/87 (1.1%)		2/63 (3.2%)
Stomatitis	1/87 (1.1%)		0/63 (0%)
Vomiting	5/87 (5.7%)		4/63 (6.3%)
General disorders
Asthenia	1/87 (1.1%)		0/63 (0%)
Chest pain	0/87 (0%)		1/63 (1.6%)
General physical health deterioration	3/87 (3.4%)		1/63 (1.6%)
Mucosal inflammation	6/87 (6.9%)		1/63 (1.6%)
Pyrexia	5/87 (5.7%)		1/63 (1.6%)
Infections and infestations
Bacteraemia	2/87 (2.3%)		1/63 (1.6%)
Bronchitis	1/87 (1.1%)		0/63 (0%)
Candidiasis	1/87 (1.1%)		0/63 (0%)
Device related infection	0/87 (0%)		1/63 (1.6%)
Diverticulitis	1/87 (1.1%)		0/63 (0%)
Febrile infection	0/87 (0%)		1/63 (1.6%)
Infection	2/87 (2.3%)		0/63 (0%)
Pneumonia	3/87 (3.4%)		2/63 (3.2%)
Pneumonia bacterial	1/87 (1.1%)		0/63 (0%)
Pulmonary sepsis	1/87 (1.1%)		0/63 (0%)
Sialoadenitis	1/87 (1.1%)		0/63 (0%)
Staphylococcal sepsis	1/87 (1.1%)		0/63 (0%)
Injury, poisoning and procedural complications
Femur fracture	1/87 (1.1%)		0/63 (0%)
Radiation skin injury	5/87 (5.7%)		0/63 (0%)
Stomatitis radiation	1/87 (1.1%)		0/63 (0%)
Investigations
Blood sodium decreased	1/87 (1.1%)		0/63 (0%)
Neutrophil count decreased	0/87 (0%)		1/63 (1.6%)
Weight decreased	1/87 (1.1%)		1/63 (1.6%)
Metabolism and nutrition disorders
Dehydration	5/87 (5.7%)		2/63 (3.2%)
Hyperkalaemia	0/87 (0%)		1/63 (1.6%)
Hyponatraemia	1/87 (1.1%)		0/63 (0%)
Malnutrition	0/87 (0%)		1/63 (1.6%)
Musculoskeletal and connective tissue disorders
Muscular weakness	0/87 (0%)		1/63 (1.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage	1/87 (1.1%)		0/63 (0%)
Nervous system disorders
Cerebrovascular accident	1/87 (1.1%)		0/63 (0%)
Diabetic ketoacidotic hyperglycaemic coma	1/87 (1.1%)		0/63 (0%)
Encephalopathy	0/87 (0%)		1/63 (1.6%)
Presyncope	0/87 (0%)		1/63 (1.6%)
Psychiatric disorders
Confusional state	1/87 (1.1%)		0/63 (0%)
Disorientation	1/87 (1.1%)		0/63 (0%)
Renal and urinary disorders
Renal failure	0/87 (0%)		3/63 (4.8%)
Renal failure acute	0/87 (0%)		2/63 (3.2%)
Respiratory, thoracic and mediastinal disorders
Aspiration	1/87 (1.1%)		0/63 (0%)
Dyspnoea	1/87 (1.1%)		0/63 (0%)
Obstructive airways disorder	1/87 (1.1%)		0/63 (0%)
Pneumonia aspiration	0/87 (0%)		1/63 (1.6%)
Pneumonitis	2/87 (2.3%)		0/63 (0%)
Stridor	1/87 (1.1%)		0/63 (0%)
Skin and subcutaneous tissue disorders
Acne	1/87 (1.1%)		0/63 (0%)
Dermatitis	1/87 (1.1%)		0/63 (0%)
Erythema	1/87 (1.1%)		0/63 (0%)
Exfoliative rash	1/87 (1.1%)		0/63 (0%)
Vascular disorders
Circulatory collapse	2/87 (2.3%)		0/63 (0%)
Deep vein thrombosis	1/87 (1.1%)		0/63 (0%)
Haemorrhage	1/87 (1.1%)		0/63 (0%)
Hypotension	1/87 (1.1%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Panitumumab Plus Chemoradiation		Chemotherapy Plus Radiotherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	87/87 (100%)		63/63 (100%)
Blood and lymphatic system disorders
Anaemia	21/87 (24.1%)		13/63 (20.6%)
Neutropenia	6/87 (6.9%)		8/63 (12.7%)
Ear and labyrinth disorders
Deafness	4/87 (4.6%)		7/63 (11.1%)
Tinnitus	8/87 (9.2%)		12/63 (19%)
Gastrointestinal disorders
Constipation	34/87 (39.1%)		21/63 (33.3%)
Diarrhoea	18/87 (20.7%)		7/63 (11.1%)
Dry mouth	41/87 (47.1%)		33/63 (52.4%)
Dyspepsia	12/87 (13.8%)		6/63 (9.5%)
Dysphagia	55/87 (63.2%)		40/63 (63.5%)
Nausea	45/87 (51.7%)		36/63 (57.1%)
Odynophagia	21/87 (24.1%)		19/63 (30.2%)
Oral pain	9/87 (10.3%)		3/63 (4.8%)
Stomatitis	15/87 (17.2%)		11/63 (17.5%)
Vomiting	29/87 (33.3%)		21/63 (33.3%)
General disorders
Asthenia	12/87 (13.8%)		7/63 (11.1%)
Fatigue	19/87 (21.8%)		18/63 (28.6%)
Mucosal inflammation	71/87 (81.6%)		45/63 (71.4%)
Oedema peripheral	5/87 (5.7%)		2/63 (3.2%)
Pain	8/87 (9.2%)		1/63 (1.6%)
Pyrexia	10/87 (11.5%)		7/63 (11.1%)
Infections and infestations
Candidiasis	11/87 (12.6%)		1/63 (1.6%)
Device related infection	5/87 (5.7%)		0/63 (0%)
Infection	9/87 (10.3%)		0/63 (0%)
Oral candidiasis	10/87 (11.5%)		7/63 (11.1%)
Injury, poisoning and procedural complications
Radiation skin injury	58/87 (66.7%)		52/63 (82.5%)
Investigations
Blood creatinine increased	6/87 (6.9%)		5/63 (7.9%)
Haemoglobin decreased	0/87 (0%)		5/63 (7.9%)
Weight decreased	37/87 (42.5%)		28/63 (44.4%)
Metabolism and nutrition disorders
Decreased appetite	20/87 (23%)		19/63 (30.2%)
Dehydration	6/87 (6.9%)		9/63 (14.3%)
Hypocalcaemia	10/87 (11.5%)		4/63 (6.3%)
Hypokalaemia	12/87 (13.8%)		11/63 (17.5%)
Hypomagnesaemia	14/87 (16.1%)		6/63 (9.5%)
Hyponatraemia	7/87 (8%)		3/63 (4.8%)
Musculoskeletal and connective tissue disorders
Neck pain	4/87 (4.6%)		5/63 (7.9%)
Nervous system disorders
Dizziness	5/87 (5.7%)		7/63 (11.1%)
Dysgeusia	21/87 (24.1%)		27/63 (42.9%)
Headache	5/87 (5.7%)		4/63 (6.3%)
Peripheral sensory neuropathy	5/87 (5.7%)		3/63 (4.8%)
Psychiatric disorders
Anxiety	5/87 (5.7%)		3/63 (4.8%)
Depression	6/87 (6.9%)		0/63 (0%)
Insomnia	13/87 (14.9%)		12/63 (19%)
Respiratory, thoracic and mediastinal disorders
Cough	7/87 (8%)		9/63 (14.3%)
Dysphonia	17/87 (19.5%)		12/63 (19%)
Hiccups	4/87 (4.6%)		6/63 (9.5%)
Oropharyngeal pain	5/87 (5.7%)		7/63 (11.1%)
Skin and subcutaneous tissue disorders
Acne	16/87 (18.4%)		1/63 (1.6%)
Alopecia	9/87 (10.3%)		8/63 (12.7%)
Dermatitis	10/87 (11.5%)		0/63 (0%)
Dermatitis acneiform	13/87 (14.9%)		1/63 (1.6%)
Dry skin	11/87 (12.6%)		1/63 (1.6%)
Erythema	6/87 (6.9%)		0/63 (0%)
Pruritus	13/87 (14.9%)		0/63 (0%)
Rash	40/87 (46%)		1/63 (1.6%)
Skin toxicity	5/87 (5.7%)		0/63 (0%)
Vascular disorders
Hypotension	7/87 (8%)		2/63 (3.2%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.