Support Links
Corporate Websites
Genentech BioOncology
Offers detailed information about Genentech Oncology products.
www.biooncology.com
Astellas Pharma US, Inc.
Find out more about Astellas Pharma US, Inc., its oncology products, and clinical and research programs.
http://www.astellas.us/therapeutic/product/oncology.html
Resource Links
This list includes just some of the organizations that offer support to those who are living with cancer.
Genentech, Inc. and Astellas Pharma US, Inc. are neither affiliated with nor endorse any of the following organizations. The information provided by Genentech, Inc., Astellas Pharma US, Inc., or these organizations is meant for informational purposes only and is not meant to replace your physician's medical advice.
By selecting any of the links below, you will be leaving Tarceva.com and going to a site that is not controlled by or affiliated with Genentech, Inc. or Astellas Pharma US, Inc.
Sections:
- Lung Cancer Resources
- General Cancer and Support Resources
- Associations and Societies
- Clinical Trials Information
Lung Cancer Resources
The Bonnie J. Addario Lung Cancer Foundation
1 (415) 357-1278
BJALCF works with a diverse group of physicians, organizations and individuals to identify solutions and make timely and meaningful change through research, early detection, education, prevention, and treatment.
www.thelungcancerfoundation.org
Lung Cancer Alliance
1 (800) 298-2436
A national organization that supports research, education, advocacy and services related to cancer. The LCA hosts an online support community for patients and caregivers. For professionals, it offers cancer reference information, cancer facts and figures, research program/funding, and news updates.
www.lungcanceralliance.org
Lung Cancer.org
1 (877) 646-LUNG
A program of CancerCare, Lungcancer.org provides free, professional support services to anyone affected by lung cancer. Services, including counseling, education, financial assistance and practical help, are provided by trained oncology social workers and are completely free of charge.
www.lungcancer.org
Lung Cancer Online Foundation
Lungcanceronline.org is a comprehensive, annotated directory to internet information and resources for patients and families.The mission of The Lung Cancer Online Foundation (LCOF) is to improve the quality of care and quality of life for people with lung cancer by funding lung cancer research and providing information to patients and families.
www.lungcanceronline.org
Lung Cancer Research Foundation
1 (212) 332-4403
The mission of the Lung Cancer Research Foundation is to support national research studies and activities focused on developing innovative strategies for better treatments, screening, and prevention of all cancers of the lung.
www.lungcancerresearchfoundation.org
LUNGevity Foundation
1 (312) 464-0716
LUNGevity Foundation is dedicated to funding lung cancer research and providing support to people living with lung cancer. It hosts the Lung Cancer Support Community, an online community for patients and caregivers.
www.lungevity.org
National Lung Cancer Partnership
1 (608) 233-7905
NLCP works to decrease deaths due to lung cancer and help patients live longer, and better, through research, awareness and advocacy. The site includes resources for patients and caregivers as well as information about grants for healthcare professionals.
www.nationallungcancerpartnership.org
Uniting Against Lung Cancer
1 (212) 627-5500
Uniting Against Lung Cancer (formerly known as Joan's Legacy) is committed to fight lung cancer by funding innovative research into its diagnosis and treatment and increasing awareness of the disease and all those affected by it, including never smokers.
www.unitingagainstlungcancer.org
General Cancer and Support Resources
American Cancer Society
1 (800) ACS-2345 (24-hour access)
A nationwide community-based voluntary organization that supports research, education, advocacy and services related to cancer. For professionals, it offers cancer reference information, cancer facts and figures, research program/funding and news updates.
www.cancer.org
American Pain Foundation
1 (888) 615-7246
An independent nonprofit organization serving people with pain through information, advocacy, and support. Its mission is to improve the quality of life of people with pain by raising public awareness, providing practical information, promoting research, and advocating removing barriers and increasing access to effective pain management.
www.painfoundation.com
Association of Cancer Online Resources
ACOR offers access to mailing lists that provide support, information and community to everyone affected by cancer and related disorders.
www.acor.org
Cancer Net
1 (888) 651-3038
The patient information website of the American Society of Clinical Oncology (ASCO); provides
oncologist-approved information on more than 50 types of cancer and their treatments, clinical trials, coping and side effects.
www.cancer.net
CancerCare
1 (800) 813-HOPE
CancerCare is a national non-profit organization whose mission is to provide free professional help to people with all cancers through counseling, education, information and referral, and direct financial assistance.
www.cancercare.org
Gilda's Club
1 (888) GILDA-4-U
Free of charge, Gilda's Clubs across the country offer support and networking groups to people living with cancer and their loved ones. They also host seminars, workshops, specialized children's programs and social events, in a nonresidential and home-like setting.
www.gildasclub.org
Lance Armstrong Foundation
1 (866) 467-7205
The mission of the Lance Armstrong Foundation (LAF) is to inspire and empower people affected by cancer by providing practical information and tools focused on prevention, access to screening and care, improved quality of life for survivors and research.
www.Livestrong.org
National Coalition for Cancer Survivorship
1 (877) NCCS-YES
The National Coalition for Cancer Survivorship (NCCS) is the oldest survivor-led advocacy organization working on behalf of this country's nearly 10 million cancer survivors and the millions more touched by this disease. NCCS provides the Cancer Survival Toolbox® , a free audio program designed to help cancer survivors and caregivers develop practical tools to deal with the diagnosis, treatment and challenges of cancer.
www.canceradvocacy.org
Cancer Survival Toolbox®
http://www.canceradvocacy.org/toolbox/
National Comprehensive Cancer Network
1 (888) 909-6226
A not-for-profit alliance of 20 of the world's leading cancer centers, dedicated to improving the quality and effectiveness of care provided to patients with cancer.
www.nccn.org
Patient Advocate Foundation
1 (800) 532-5274
A national non-profit organization that serves as an active liaison between the patient and their insurer, employer and creditors to resolve insurance, job retention and debt crisis matters relative to their diagnosis through case managers, doctors and attorneys.
www.patientadvocate
Prevent Cancer Foundation
1 (800) 227-2732
The Foundation focuses its energies and resources on those cancers - including lung, breast, prostate, colorectal, cervical, skin, oral and testicular - that can be prevented through lifestyle changes or detection and treatment in their early stages.
www.preventcancer.org
The Wellness Community
1 (888) 793-9355
An international non-profit organization dedicated to providing support, education and hope for all people affected by cancer - at no cost. The Wellness Community offers professionally moderated support groups, face-to-face and virtual, for adults and teens.
www.thewellnesscommunity.org
Associations and Societies
National Family Caregivers Association
1 (800) 896-3650
1 (877) 658-8896 (Spanish Hotline)
The National Family Caregivers Association (NFCA) exists to support family caregivers and to speak out publicly for caregivers' needs.
www.nfcacares.org
National Hospice & Palliative Care Organization
1 (800) 658-8898
An organization dedicated to leading and mobilizing social change for improved care at the end of life.
www.nhpco.org
Clinical Trials Information
You may consider speaking with your doctor about taking part in a clinical trial either before or after you start treatment for your NSCLC. For more information on clinical trials, including locating ongoing clinical trials in your area, visit these websites:
ClinicalTrials.gov
This site provides regularly updated information about federally and privately supported clinical research in human volunteers.
www.ClinicalTrials.gov
Coalition of Cancer Cooperative Groups
1 (877) 520-4457
The Coalition of Cancer Cooperative Groups is a nonprofit organization whose mission is to improve the quality of life and survival of cancer patients by increasing participation in cancer clinical trials. They feature a variety of resources to educate and connect patients to clinical trials.
www.cancertrialshelp.org
National Cancer Institute
1 (800) 422-6237
The National Cancer Institute website has extensive information on cancer prevention, diagnosis, treatment, statistics, research, clinical trials, and news, as well as links to other NCI Web sites. Cancer information specialists have access to comprehensive, accurate information on a range of cancer topics, including the most recent advances in cancer treatment.
www.cancer.gov
The NCI also has a list of NCI-designated comprehensive cancer treatment centers, which are actively engaged in transdisciplinary research to reduce cancer incidence, morbidity, and mortality. http://cancercenters.cancer.gov/cancer_centers/cancer-centers-list.html
National Institutes of Health
1 (301) 496-4000
The nation's medical research agency - making important medical discoveries that improve health and save lives. The NIH provides a clinical trials registry of federally and privately supported clinical trials conducted in the United States and around the world.
www.nih.gov
Advanced Non-Small Cell Lung Cancer (NSCLC) Indications
Tarceva monotherapy is indicated for:
- the maintenance treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
- the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
Results from two, multicenter, placebo-controlled, randomized, Phase III trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of Tarceva with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting.
Important Safety Information
There have been reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva. In the NSCLC studies, the incidence of serious ILD-like events in the Tarceva treated patients versus placebo treated patients was 0.7% versus 0% in the maintenance study and 0.8% for both groups in the 2nd/3rd line study. The overall incidence of ILD-like events in approximately 32,000 Tarceva-treated patients from all studies (including uncontrolled studies and studies with concurrent chemotherapy) was approximately 1.1%.
Reported diagnoses in patients suspected of having ILD-like events included pneumonitis, radiation pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, ILD, obliterative bronchiolitis, pulmonary fibrosis, Acute Respiratory Distress Syndrome and lung infiltration. Symptoms started from 5 days to more than 9 months (median 39 days) after initiating Tarceva therapy.
Tarceva should be interrupted for acute onset of new or progressive unexplained pulmonary symptoms such as dyspnea, cough, and fever. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed.
Cases of hepatorenal syndrome, acute renal failure (including fatalities), and renal insufficiency have been reported. Some were secondary to baseline hepatic impairment while others were associated with severe dehydration due to diarrhea, vomiting, and/or anorexia or concurrent chemotherapy use. In the event of dehydration, particularly in patients with contributing risk factors for renal failure (eg, pre-existing renal disease, medical conditions or medications that may lead to renal disease, or other predisposing conditions including advanced age), Tarceva therapy should be interrupted and appropriate measures should be taken to intensively rehydrate the patient. Periodic monitoring of renal function and serum electrolytes is recommended in patients at risk of dehydration.
Cases of hepatic failure and hepatorenal syndrome (including fatalities) have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment. Therefore, periodic liver function testing (transaminases, bilirubin, and alkaline phosphatase) is recommended. In the setting of worsening liver function tests, dose interruption and/or dose reduction with frequent liver function test monitoring should be considered. Tarceva dosing should be interrupted or discontinued if total bilirubin is >3 x ULN and/or transaminases are >5 x ULN in the setting of normal pretreatment values.
Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Patients with hepatic impairment (total bilirubin > ULN or Child-Pugh A, B and C) should be closely monitored during therapy with Tarceva. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe such as doubling of total bilirubin and/or tripling of transaminases in the setting of pretreatment values outside normal range.
Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. Patients receiving concomitant anti-angiogenic agents, corticosteroids, NSAIDs, and/or taxane-based chemotherapy, or who have prior history of peptic ulceration or diverticular disease are at increased risk. Permanently discontinue Tarceva in patients who develop gastrointestinal perforation.
Bullous, blistering and exfoliative skin conditions have been reported including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, which in some cases were fatal. Interrupt or discontinue Tarceva treatment if the patient develops severe bullous, blistering or exfoliating conditions.
Corneal perforation and ulceration have been reported during use of Tarceva. Other ocular disorders including abnormal eyelash growth, keratoconjunctivitis sicca or keratitis have been observed with Tarceva treatment and are known risk factors for corneal ulceration/perforation. Interrupt or discontinue Tarceva therapy if patients present with acute/worsening ocular disorders such as eye pain.
International Normalized Ratio (INR) elevation and infrequent reports of bleeding events, including gastrointestinal and non-gastrointestinal bleeding, have been reported in clinical studies, some associated with concomitant warfarin administration. Patients taking warfarin or other coumarin-derivative anticoagulants should be monitored regularly for changes in prothrombin time or INR. Some infrequent cases of gastrointestinal bleeding were also associated with concomitant NSAID administration.
Tarceva is pregnancy category D. When receiving Tarceva, women of childbearing potential should be advised to avoid pregnancy and pregnant women apprised of the potential hazard to a fetus. Adequate contraception methods should be used during therapy, and for at least 2 weeks after completing therapy. Because of the potential for serious adverse reactions in nursing infants from Tarceva, a decision should be made whether to discontinue nursing or discontinue the drug.
Erlotinib is metabolized predominantly by CYP3A4, and inhibitors of CYP3A4 would be expected to increase exposure. Caution should be used during co-treatment with Tarceva and ketoconazole or other strong CYP3A4 inhibitors such as, but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin (TAO) and voriconazole, and grapefruit or grapefruit juice.
The CYP3A4 inducer rifampicin has been shown to decrease erlotinib AUC, thus, alternate treatments lacking CYP3A4 inducing activity are strongly recommended. In the absence of an alternative treatment, Tarceva dose modification should be considered. If the Tarceva dose is adjusted upward, the dose will need to be reduced immediately to the indicated starting dose upon discontinuation of rifampicin or other CYP3A4 inducers such as, but not limited to: rifabutin, rifapentine, phenytoin, carbamazepine, phenobarbital and St. John's Wort.
Drugs that alter the pH of the upper GI tract may alter the solubility of erlotinib and reduce its bioavailability. The concomitant use of proton pump inhibitors, such as omeprazole with Tarceva should be avoided if possible. If patients need to be treated with an H2-receptor antagonist such as ranitidine, it should be used in a staggered manner. Although the effect of antacids on erlotinib pharmacokinetics has not been evaluated, the antacid dose and the Tarceva dose should be separated by several hours, if an antacid is necessary.
Patients should be advised to stop smoking while taking Tarceva as cigarette smoking has been shown to reduce erlotinib AUC. However, if patients continue to smoke, a cautious increase in the dose of Tarceva, not to exceed 300 mg, may be considered while monitoring the patient's safety. If the Tarceva dose is adjusted upward, the dose should be reduced immediately to the indicated starting dose upon cessation of smoking.
The most common adverse reactions in patients with NSCLC receiving single-agent Tarceva 150 mg were rash and diarrhea. In the 2nd/3rd line study, severe rash and diarrhea (9% & 6% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea each resulted in dose reductions (6% and 1%, respectively) and discontinuation in 1% of Tarceva-treated patients. In the maintenance study, severe rash and diarrhea (6.0% & 1.8% NCI-CTC Grades 3/4, respectively) were reported. Rash and diarrhea resulted in dose reductions or interruption (5.1% and 2.8%, respectively) and discontinuation (1.2% and 0.5%, respectively) of Tarceva-treated patients.
