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ASPECCT: A Study of Panitumumab Efficacy and Safety Compared to Cetuximab in Patients With KRAS Wild-Type Metastatic Colorectal Cancer
Phase 3 trial testing Cetuximab in Metastatic Colorectal Cancer in 1,010 participants. Completed in 7 March 2017.
| Lead sponsor | Amgen |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1,010 |
| Start date | 2 February 2010 |
| Primary completion | 5 February 2013 |
| Estimated completion | 7 March 2017 |
| Sites | 152 locations across Hong Kong, Italy, Malaysia, Taiwan, Poland, South Korea, Philippines, Netherlands |
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18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall survival is the time from the date of randomization until the date of death. Participants who had not died by the analysis data cut-off date were censored at their last contact date.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 10.0 | 9.3 – 11.0 |
| Panitumumab | 10.4 | 9.4 – 11.6 |
Progression free survival (PFS) is the time from the date of randomization to the date of disease progression per the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 or death. Participants alive and not meeting criteria for progression by the analysis data cut-off date were censored at their last evaluable disease assessment date. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study based on all target lesions recorded since the treatment started (the sum must also demonstrate an absolute i
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 4.4 | 3.2 – 4.8 |
| Panitumumab | 4.1 | 3.2 – 4.8 |
Objective response is either a complete response (CR) or partial response (PR) per RECIST version 1.1. All participants that did not meet the criteria for an objective response by the analysis cut-off date were considered non-responders. CR: Disappearance of all target lesions, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm, and disappearance of all non-target lesions, and no new lesions. PR: Disappearance of all target lesions, persistence of one or more non-target lesions not qualifying for either CR or progressive disease, or, at lea
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 19.79 | 16.34 – 23.62 |
| Panitumumab | 22.02 | 18.41 – 25.97 |
Duration of response (DOR), calculated only for those participants with an objective response, is the time from first objective response to disease progression per the RECIST v1.1 or death. Participants not meeting criteria for progression or who died by the analysis data cutoff date were censored at their last evaluable disease assessment date.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 5.4 | 3.8 – 5.5 |
| Panitumumab | 3.8 | 3.7 – 4.8 |
Time to response (TTR), calculated for those participants with an objective response, is defined as the time from the randomization date to the date of first objective response.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 2.6 | 1.2 – 3.1 |
| Panitumumab | 1.5 | 1.2 – 3.0 |
Time to treatment failure (TTF) is the time from randomization date to date that the decision was made to end the treatment period for any reason; participants who remained in the treatment period at the time of analysis were censored at the date of the last on-study assessment.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 3.3 | 3.2 – 3.9 |
| Panitumumab | 3.4 | 3.2 – 4.6 |
The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The health state index measures the following 5 health dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension contains 3 levels of response to reflect degree of problems participants have experienced: no problem (1), some problem (2) and extreme problems (3). The health states for each respondent are converted into a single index number using a specified set of weights. Resulting scores can range from 1.0 and -0.594. A higher score indicates a more preferred
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | -0.0341 | -0.0806 – 0.0123 |
| Panitumumab | -0.0216 | -0.0691 – 0.0260 |
The EQ-5D is a standardized instrument for use as a generic measure of health outcome. The VAS asks respondents to rate their present health status on a 0 - 100 scale, with 0 labeled as "Worst imaginable health state" and 100 labeled as "Best imaginable health state." The VAS score is determined by observing the point at which the participant's hand drawn line intersects the scale.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 3.9782 | 0.8842 – 7.0722 |
| Panitumumab | 2.3037 | -0.8532 – 5.4605 |
The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 2.0101 | -1.1477 – 5.1679 |
| Panitumumab | 3.0473 | -0.1782 – 6.2728 |
The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 1.8778 | -1.5524 – 5.3080 |
| Panitumumab | 2.4614 | -1.0442 – 5.9670 |
The FCSI consists of 9 questions comprising the most important symptoms associated with colorectal cancer, including energy, pain, weight, diarrhea, nausea, swelling or cramps in the stomach area, appetite, ability to enjoy life, and overall quality of life. The 9 questions are combined in three algorithms to provide information for 3 domains: colorectal cancer symptoms, physical well-being, and functional well-being. Each of the 9 items are scored from "0" to "4" representing "Not at All" through to "Very Much True". The raw score for all items is transformed to a 0-100 scale, and the average
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 1.3567 | -4.1564 – 6.8697 |
| Panitumumab | 1.1569 | -4.4887 – 6.8025 |
Serious adverse events include any event that is fatal, life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or other significant medical hazard. Treatment-related AEs are those the investigator considered as a reasonable possibility to have been caused by study drug.
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 494 | |
| Panitumumab | 485 |
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 169 | |
| Panitumumab | 151 |
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 61 | |
| Panitumumab | 69 |
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 459 | |
| Panitumumab | 437 |
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 22 | |
| Panitumumab | 25 |
| Group | Value | 95% CI |
|---|---|---|
| Cetuximab | 15 | |
| Panitumumab | 14 |
Time frame: Median time was 117 days for panitumumab arm and 123 days for cetuximab arm.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Cetuximab | Panitumumab |
|---|---|---|---|
| Colorectal cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Intestinal obstruction | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Colorectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Urinary tract infection | Infections and infestations | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Pneumonia | Infections and infestations | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Asthenia | General disorders | — | — |
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Ascites | Gastrointestinal disorders | — | — |
| Ileus | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — |
| Small intestinal obstruction | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Hepatic function abnormal | Hepatobiliary disorders | — | — |
| Hyperbilirubinaemia | Hepatobiliary disorders | — | — |
| Hyperkalaemia | Metabolism and nutrition disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Reaction | System | Cetuximab | Panitumumab |
|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | — | — |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | — | — |
| Hypomagnesaemia | Metabolism and nutrition disorders | — | — |
| Diarrhoea | Gastrointestinal disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Fatigue | General disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Decreased appetite | Metabolism and nutrition disorders | — | — |
| Paronychia | Infections and infestations | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Acne | Skin and subcutaneous tissue disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Pyrexia | General disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Asthenia | General disorders | — | — |
| Skin fissures | Skin and subcutaneous tissue disorders | — | — |
| Hypokalaemia | Metabolism and nutrition disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Oedema peripheral | General disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Stomatitis | Gastrointestinal disorders | — | — |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | — | — |
| Nail disorder | Skin and subcutaneous tissue disorders | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — |
| Upper respiratory tract infection | Infections and infestations | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Weight decreased | Investigations | — | — |
| Hypocalcaemia | Metabolism and nutrition disorders | — | — |
Most-reported serious reactions: Colorectal cancer metastatic, Abdominal pain, Intestinal obstruction, Vomiting, Colorectal cancer, Urinary tract infection, Diarrhoea, Pyrexia.
Data from ClinicalTrials.gov NCT01001377 adverse events section.
The primary objective of this study is to compare the effect of panitumumab versus cetuximab on overall survival (OS) for chemorefractory metastatic colorectal cancer (mCRC) among patients with wild-type Kirsten rat Sarcoma-2 virus (KRAS) tumors.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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