BC Cancer Protocol Summary for Second- or Later-Line
Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
with Erlotinib
Protocol Code: LUAVERL
Tumour Group: Lung
Contact Physician: Dr. Barbara Melosky
ELIGIBILITY:
Advanced non-small-cell lung cancer.
Ambulatory performance status.
Second- or later-line monotherapy for disease progression after prior
chemotherapy
Note. Patients must have progressive disease on or after first- or second-line
therapy. Patients should not switch over between gefitinib (LUAVGEFF) or
AFAtinib (LUAVAFAT) and erlotinib.
For first-line therapy, or indications other than the above, BC Cancer
Compassionate Access Program (CAP) approval must be obtained
EXCLUSIONS:
Prior treatment with maintenance erlotinib (LUAVMTNE)
Patients with moderate or severe hepatic impairment should not be treated with
Erlotinib
TESTS:
Baseline: alkaline phosphatase, ALT, total bilirubin, LDH, chest X-ray.
C-reactive protein and albumin (optional, and results do not have to be
available to proceed with first treatment)
During treatment: alkaline phosphatase, ALT, total bilirubin and LDH should be
checked two weeks after starting erlotinib and at each subsequent visit.
For patients with pre-existing liver disease or concomitant hepatotoxic
medications, hepatic function should be closely monitored throughout
treatment.
As required: chest X-ray and scans to monitor index lesions.
Chest radiographs should be performed for monitoring of dyspnea to rule out
development of interstitial pneumonitis.
PREMEDICATIONS:
At physician’s discretion, prophylaxis for rash: minocycline 100 mg PO BID.
BC Cancer Protocol Summary LUAVERL Page 1 of 2
Activated: 1 Sep 2005 Revised: 1 July 2018 (LFTs clarified)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician
seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of
these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/legal.htm
TREATMENT:
Drug Dose BC Cancer Administration Guideline
erlotinib 150 mg daily PO
Discontinue if no clinical benefit after four weeks.
Careful re-evaluation after initiation of therapy is essential as erlotinib should be
continued only if tumour regression continues or the disease is stable and
cancer-related symptoms have improved. Continued erlotinib for
“psychological” palliation in the face of progressive disease is inappropriate.
DOSE MODICATIONS:
1. Rash: generally improves with time but if severe, may require treatment
interruption and/or dose reduction.
2. Diarrhea: if severe, may require treatment interruption and/or dose reduction.
3. Elevated liver enzymes: no guidelines for dose modification, but if very high
may need to interrupt or stop therapy.
PRECAUTIONS:
1. Skin toxicity: rash, acne, dry skin and pruritus are common. They appear on
the face, neck and trunk, and commonly fade or improve despite continuing
erlotinib therapy. Interrupt or discontinue treatment if severe bullous, blistering
or exfoliating conditions develop as fatal cases suggestive of Stevens-Johnson
syndrome/toxic epidermal necrolysis have been reported.
2. Diarrhea: this is usually mild and self-limiting. No routine prophylactic
antidiarrheal medication is needed.
3. Gastrointestinal Perforation: patients receiving concomitant corticosteroids
and/or NSAID’s, or who have prior history of peptic ulceration or diverticular
disease are at increased risk for developing gastrointestinal perforation.
Permanently discontinue erlotinib in patients who develop gastrointestinal
perforation as fatalities have been reported.
4. Ocular Disorders: corneal perforation or ulceration have been reported.
Interrupt or discontinue therapy if patients present with acute/worsening of
ocular disorders such as eye pain.
Call Dr. Barbara Melosky or tumour group delegate at (604) 877-6000 or 1-
800-663-3333 with any problems or questions regarding this treatment
program.
Reference:
Shepherd FA, Pereira JR, Ciuleanu T, et al. Erlotinib in previously treated non-small-cell lung
cancer. N Engl J Med 2005;353:123-32.
BC Cancer Protocol Summary LUAVERL Page 2 of 2
Activated: 1 Sep 2005 Revised: 1 July 2018 (LFTs clarified)
Warning: The information contained in these documents are a statement of consensus of BC Cancer professionals regarding their views of currently accepted approaches to treatment. Any clinician
seeking to apply or consult these documents is expected to use independent medical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. Use of
these documents is at your own risk and is subject to BC Cancer's terms of use available at www.bccancer.bc.ca/legal.htm
