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PNTM

Cancer Type: Gastrointestinal, Colorectal, Small bowel and appendix  Intent: Palliative
Regimen Category: Evidence-Informed
Funding:
New Drug Funding Program
    Panitumumab - Metastatic Colorectal Small Bowel or Appendiceal Cancer
A - Regimen Name

PNTM Regimen
Panitumumab


Disease Site
Gastrointestinal - Colorectal
Gastrointestinal - Small bowel and appendix

Intent
Palliative

Regimen Category
Evidence-Informed :

Regimen is considered appropriate as part of the standard care of patients; meaningfully improves outcomes (survival, quality of life), tolerability or costs compared to alternatives (recommended by the Disease Site Team and national consensus body e.g. pan-Canadian Oncology Drug Review, pCODR).  Recommendation is based on an appropriately conducted phase III clinical trial relevant to the Canadian context OR (where phase III trials are not feasible) an appropriately sized phase II trial. Regimens where one or more drugs are not approved by Health Canada for any indication will be identified under Rationale and Use.


Rationale and Uses
Third-line treatment for patients with RAS wild-type metastatic colorectal, small bowel or appendiceal cancer, after failure of standard regimens containing fluoropyrimidine, oxaliplatin, and irinotecan.
 
RAS testing must be complete prior to dosing. Panitumumab is not indicated for patients with RAS mutant mCRC or for whom RAS mutation status is unknown.

Supplementary Public Funding

PANitumumab
New Drug Funding Program (Panitumumab - Metastatic Colorectal Small Bowel or Appendiceal Cancer) (NDFP Website)

 
B - Drug Regimen

PANitumumab
6 mg /kg IV Day 1
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C - Cycle Frequency

REPEAT EVERY 14 DAYS

Continue until evidence of disease progression or unacceptable toxicity

 
D - Premedication and Supportive Measures

Antiemetic Regimen:

Minimal

Other Supportive Care:

The following has been shown to be of benefit (in a randomized phase 2 study for prevention of rash) when used from day -1 to week 6:

  • Skin moisturizer applied to the face, hands, feet, neck, back and chest in the morning
  • Sunscreen to exposed areas (SPF 30, UVA and UVB) in the morning
  • Hydrocortisone cream (1%) to the face, hands, feet, neck, back and chest at bedtime
  • Doxycycline (or minocycline) PO
 
E - Dose Modifications

Doses should be modified according to the protocol by which the patient is being treated.

Dosage with toxicity

Toxicity

Action

Dose Modification (% previous dose)

≥ grade 3 skin (1st occurrence)

Hold until ≤ grade 2*

Restart at 100%

≥ grade 3 skin (2nd occurrence) Hold until ≤ grade 2* Restart at 80%
≥ grade 3 skin (3rd occurrence) Hold until ≤ grade 2* Restart at 60%
≥ grade 3 skin (4th occurrence) Discontinue n/a

Skin or soft tissue with severe or life-threatening inflammatory or infectious complications

Hold or discontinue, depending on severity

n/a

SJS/TEN                    Discontinue n/a

≥ grade 3 diarrhea or dehydration

Hold until ≤ grade 2

Consider dose reduction, if appropriate

ILD/pneumonitis

Hold and investigate

If confirmed, discontinue. 

Keratitis or ulcerative keratitis

Hold or discontinue, depending on severity or persistence

n/a

*Hold for 1 to 2 doses until recovery. Discontinue if no recovery within 4 weeks.

 

Management of Infusion Reactions

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions.
 

Grade Management Re-challenge
1 or 2
  • Stop the infusion.
  • Manage the symptoms.

Restart:

  • Restart the infusion at 50% of the rate at which the IR occurred.
  • Re-challenge the infusion at 50% of the rate at which the IR occurred.
3 or 4
  • Stop the infusion
  • Aggressively manage symptoms.
  • Discontinue permanently (do not re-challenge).



Hepatic Impairment

The safety and efficacy of panitumumab have not been studied in hepatic impairment.


Renal Impairment

The safety and efficacy of panitumumab have not been studied in renal impairment. Acute renal failure has been observed in patients experiencing severe diarrhea and dehydration (see dosage with toxicity table for management).


Dosage in the Elderly

No overall differences in safety or efficacy were observed in patients aged 65 and older compared to younger patients. No dose modifications are required, however patients ≥ 65 years have more eye, skin, GI toxicities and fatigue, compared to younger patients when receiving panitumumab as a single agent or in combination with FOLFOX.


 
F - Adverse Effects

Refer to panitumumab drug monograph(s) for additional details of adverse effects

 


Very common (≥ 50%)

Common (25-49%)

Less common (10-24%)

Uncommon (< 10%),

but may be severe or life-threatening

  • Rash and/or soft tissue toxicity (may be severe)

 

  • Abnormal electrolytes (hypo-magnesemia/calcemia/kalemia)
  • Fatigue
  • Paronychia
  • Anorexia
  • Abdominal pain
  • Constipation
  • Diarrhea (may be severe)
  • Cough, dyspnea
  • Nausea, vomiting
  • Musculoskeletal pain
  • Edema
  • Abnormal eyelash growth
  • Skin fissures

 

  • Pneumonitis
  • Venous thromboembolism
  • Hypersensitivity
  • Renal failure
  • GI obstruction
  • Hemorrhage
  • Ulcerative keratitis
  • Soft tissue necrosis
 
G - Interactions

Refer to panitumumab drug monograph(s) for additional details


Interactions with other drugs, food, herbal products, and laboratory tests have not been established.

 
H - Drug Administration and Special Precautions

Refer to panitumumab drug monograph(s) for additional details


Administration:

  • DO NOT ADMINISTER AS AN IV PUSH OR BOLUS; MUST be administered using an IV infusion pump.
  • Diluted with 0.9% sodium chloride only.  Do not mix with other drugs or IV solutions. 
  • Dilute in a total volume of 100mL in sodium chloride 0.9% (Final concentration must be less than 10mg/mL). Infuse IV over 60 minutes. May give via peripheral line or in-dwelling catheter. If the first infusion is tolerated, subsequent infusions may be given over 30 to 60 minutes.
  • Doses higher than 1000mg should be diluted in 150mL 0.9% sodium chloride injection, and infused IV over 90 minutes.
  • Compatible with 0.9% sodium chloride in PVC bags or polyolefin bags
  • Administer using a low-protein binding 0.2 micron or 0.22 micron in-line filter.
  • Solution may contain a small amount of visible, amorphous, panitumumab particulates that will be removed by the low protein binding in-line filter during infusion.
  • Do not shake. Mix diluted solution by gentle inversion.
  • Flush line before and after administration with 0.9% sodium chloride.
  • Keep vials refrigerated in the original carton. Protect from direct sunlight and do not freeze.
  • The manufacturer recommends diluted solutions to be used within 6 hours of preparation if stored at room temperature, or within 24 hours of dilution if stored at 2° to 8°C.

Also refer to the CCO guideline for detailed description of Management of Cancer Medication-Related Infusion Reactions

 

Contraindications:

  • Patients who have a hypersensitivity to this drug or any of its components
     

Warnings/precautions:

  • Use with caution in patients with a history of pulmonary fibrosis or ILD.
  • It should not be used in combination with bevacizumab and chemotherapy due to unacceptable toxicity, including deaths and shorter survival.
  • In a phase III panitumumab trial, patients with ECOG 2 had increased toxicity and shortened survival compared to those with ECOG 0-1. Assess risk vs. benefit prior to treatment in patients with ECOG 2.
  • Use with caution in patients with a history of keratitis, ulcerative keratitis, or severe dry eye. Contact lens use is also a risk factor for keratitis and ulceration.
  • If patients experience treatment-related effects on vision and/or ability to concentrate and react, they should not drive or operate machinery until the effect subsides.
  • The panitumumab formulation contains 0.15 mmol sodium (= 3.45 mg sodium) per mL of concentrate. This sodium content should be taken into consideration in patients on sodium restriction.

 

Pregnancy & lactation:

Panitumumab is CONTRAINDICATED in pregnancy as it may cause fetal harm.  Adequate contraception should be used by both sexes during treatment, and for at least 6 months after the last dose. Breastfeeding is not recommended.

 
I - Recommended Clinical Monitoring

Treating physicians may decide to monitor more or less frequently for individual patients but should always consider recommendations from the product monograph.

Recommended Clinical Monitoring

  • CBC; baseline and before each dose
  • Clinical pulmonary exam; baseline and clinically as indicated
  • Electrolytes (including calcium, magnesium and potassium); baseline and at each visit, until 8 weeks after completion of therapy
  • Liver function tests; baseline and before each dose
  • Renal function tests; baseline and before each dose
  • Clinical toxicity assessment (including infusion reactions,  dermatological, gastrointestinal, pulmonary, ophthalmic); at each visit
  • Grade toxicity using the current NCI-CTCAE (Common Terminology Criteria for Adverse Events) version

Suggested Clinical Monitoring

  • Pulmonary function tests; baseline

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J - Administrative Information

Approximate Patient Visit
1 hour
Pharmacy Workload (average time per visit)
17.887 minutes
Nursing Workload (average time per visit)
40.75 minutes
 
K - References

Panitumumab drug monograph, Cancer Care Ontario.

Amado RG, Wolf M, Peeters M, et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol 2008; 26: 1626-34.

National Comprehensive Cancer Network. Colon Cancer (Version 2.2017). https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf. Accessed June 30, 2017.

Van Custem E, Siena S, Humblet Y, et al. An open-label, single-arm study assessing safety and efficacy of panitumumab in patients with metastatic colorectal cancer refractory to standard chemotherapy. Annals of Oncology 2008; 19: 92-8.

Van Cutsem E, Peeters M, Siena S, et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol 2007; 25: 1658-64.

November 2019 Updated infusion reaction information in dose modifications section


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M - Disclaimer

Regimen Abstracts
A Regimen Abstract is an abbreviated version of a Regimen Monograph and contains only top level information on usage, dosing, schedule, cycle length and special notes (if available). It is intended for healthcare providers and is to be used for informational purposes only. It is not intended to constitute or be a substitute for medical advice, and all uses of the Regimen Abstract are subject to clinical judgment. Such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability, and Cancer Care Ontario disclaims all liability for the use of this information, and for any claims, actions, demands or suits that arise from such use.
Information in regimen abstracts is accurate to the extent of the ST-QBP regimen master listings, and has not undergone the full review process of a regimen monograph.  Full regimen monographs will be published for each ST-QBP regimen as they are developed.
Regimen Monographs
Refer to the New Drug Funding Program or Ontario Public Drug Programs websites for the most up-to-date public funding information.
The information set out in the drug monographs, regimen monographs, appendices and symptom management information (for health professionals) contained in the Drug Formulary (the "Formulary") is intended for healthcare providers and is to be used for informational purposes only. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects of a particular drug, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for a given condition. The information in the Formulary is not intended to constitute or be a substitute for medical advice and should not be relied upon in any such regard. All uses of the Formulary are subject to clinical judgment and actual prescribing patterns may not follow the information provided in the Formulary.
The format and content of the drug monographs, regimen monographs, appendices and symptom management information contained in the Formulary will change as they are reviewed and revised on a periodic basis. The date of last revision will be visible on each page of the monograph and regimen. Since standards of usage are constantly evolving, it is advised that the Formulary not be used as the sole source of information. It is strongly recommended that original references or product monograph be consulted prior to using a chemotherapy regimen for the first time.
Some Formulary documents, such as the medication information sheets, regimen information sheets and symptom management information (for patients), are intended for patients. Patients should always consult with their healthcare provider if they have questions regarding any information set out in the Formulary documents.
While care has been taken in the preparation of the information contained in the Formulary, such information is provided on an “as-is” basis, without any representation, warranty, or condition, whether express, or implied, statutory or otherwise, as to the information’s quality, accuracy, currency, completeness, or reliability.
CCO and the Formulary’s content providers shall have no liability, whether direct, indirect, consequential, contingent, special, or incidental, related to or arising from the information in the Formulary or its use thereof, whether based on breach of contract or tort (including negligence), and even if advised of the possibility thereof. Anyone using the information in the Formulary does so at his or her own risk, and by using such information, agrees to indemnify CCO and its content providers from any and all liability, loss, damages, costs and expenses (including legal fees and expenses) arising from such person’s use of the information in the Formulary.