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Key Publications & Reprints
Key Publications and Reprints provides a central resource for downloadable BioOncology reference and informational materials. Please see below for a list of select key BioOncology clinical data reprints.
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Title |
Product |
Tumor |
Author |
Publication Date |
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Herceptin (trastuzumab) |
Breast Cancer |
Jo Anne Zujewski |
June 2002 |
All reasonable precautions have been taken by the authors, editors and publishers to verify drug names and doses, the results of experimental work and the clinical findings published in this article. The opinions expressed are those of the authors, and not necessarily those of the editors or publishers. The ultimate responsibility for the use and dosage of drugs mentioned in the article and in the interpretation of published material lies with the medical practitioner and the editors and publishers can accept no liability whatsoever in respect of any claim for damages arising therefrom. Please inform the editors of any errors. |
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Herceptin (trastuzumab) |
Breast Cancer |
Tan-Chiu E, Yothers G,Romond E |
November 2005 |
Results of the B31 pivotal trial as reported in the Herceptin full Prescribing Information differs from those reported by Tan Chiu et. al. due to the analyses having been conducted at different time points, with resultant differences in patient numbers and length of follow-up, as well as the pooling of data from both B31 and N 9831 studies for certain analyses. The numbers, safety, conclusions and opinions expressed in the attached article are those of the authors only. One or more authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. |
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Association of k-ras, b-raf and p53 status with the treatment effect of bevacizumab |
Avastin (bevacizumab) |
Colorectal Cancer |
William L. Ince |
July 2005 |
This article presents information about a retrospective subset analysis of a phase III trial showing the addition of bevacizumab to first-line irinotecan, 5-fluorouracil, and leucovorin (IFL) prolongs median survival in patients with MCRC. The information that is contained in the full Prescribing Information is based on data from combined Phase II and Phase III studies. The numbers and/or safety information presented in the article may, therefore, differ from those presented in the full Prescribing Information. The conclusions and opinions expressed in the attached article are those of the authors only. |
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Avastin (bevacizumab) |
Colorectal Cancer |
Bruce J. Giantonio, Paul J. Catalano, Neal J. Meropol, Peter J. O'Dwyer, Edith P. Mitchell, Steven R. Alberts, Michael A. Schwartz, Al B. Benson, III |
2007 | ||
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Bevacizumab plus Irinotecan, Fluorouracil, and Leucovorin for Metastatic Colorectal Cancer |
Avastin (bevacizumab) |
Colorectal Cancer |
Herbert Hurwitz, Louis Fehrenbacher, William Novotny, Thomas |
June 2004 | |
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Cardiac Dysfunction in the Trastuzumab Clinical Trials Experience |
Herceptin (trastuzumab) |
Breast Cancer |
Seidman A,Hudis C,Pierri MK |
March 2002 |
Results of this pivotal trial as reported in the Herceptin full Prescribing Information may differ from those reported by Seidman et al due to FDA reanalysis in label development. The ideas, numbers, safety, conclusions, and opinions expressed in the accompanying article are those of the authors only and do not necessarily reflect those of Genentech, Inc. One or more authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. |
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Cardiac toxicity in breast cancer survivors: review of potential cardiac problems. |
Herceptin (trastuzumab) |
Breast Cancer |
Bird |
2008 |
The information discussed in this reprint concerns uses that have not been approved by the U.S. Food and Drug Administration. Reimbursement under public and private health care programs may not be available for unapproved product use. It is your responsibility to check applicable reimbursement policies before submitting claims for coverage. This reprint is being distributed by Genentech, Inc. who markets Herceptin® (Trastuzumab) in the United States. The opinions expressed in this reprint do not necessarily reflect those of Genentech, Inc. Readers are encouraged to contact the primary authors with questions regarding the content of the reprint. This reprint contains a discussion of products not marketed by Genentech, Inc. Please consult each product's full prescribing information and refer questions to the product manufacturer. Genentech, Inc. does not assume responsibility for any injury and/or damage to persons or property out of or related to any use of the information contained in this reprint. Please see the accompanying prescribing information for Herceptin. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
Coiffier B |
2002 |
The following information is provided by Genentech BioOncology and Biogen Idec, co-marketers of Rituxan (rituximab), for consideration as you review the accompanying publication. The clinical significance of clearing detectable bcl-2 positive cells is unknown. The results of subgroup analyses (i.e. response rate in patients with bone marrow involvement or extranodal disease and effects of tumor size) are reported in a way that is inconsistent with prescribing information. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
Michael Pfreundschuh, Lorenz Trumper, Anders Osterborg, Ruth Pettengell, Marek Trneny, Kevin Imrie, David Ma, Devinder Gill, Jan Walweski, Pier-Luigi Zinzani, Rolf Stahel, Stein Kvaloy, Ofer Shpilberg, Ulrich Jaeger, Mads Hansen, Tuula Lehtinen, Armando Lopez-Guillermo, Claudia Corrado, Adriana Scheliga, Noel Milpied, Myriam Mendila, Michelle Rashford, Evelyn Kuhnt, Markus Loeffler |
April 2006 |
IMPORTANT INFORMATION |
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Avastin (bevacizumab) |
Colorectal Cancer |
Fairooz F. Kabbinavar, Julie Hambleton, Robert D. Mass, Herbert I. Hurwitz, Emily Bergsland, Somnath Sarkar |
2005 |
This article presents data from one Phase III trial and two Phase II trials of Avastin in the firstline treatment of metastatic colorectal cancer. Avastin, used in combination with intravenous 5-fluorouracil-based chemotherapy, is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum. Data contained in the full Prescribing Information may differ from those presented in this article. The conclusions and opinions expressed in this article are those of the authors only. Please refer to the full Prescribing Information for more comprehensive information on the efficacy and safety of Avastin. Please note that one or more authors are present or former employees of Genentech, Inc., and have received compensation from the company. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
Robert Marcus, Kevin Imrie, Andrew Belch, David Cunningham, Eduardo Flores, John Catalano, Philippe Solal-Celigny, Fritz Offner, Jan Walewski, Joäo Raposo, Andrew Jack, and Paul Smith |
February 2005 |
These study results represent a longer follow-up than reported in the RITUXAN prescribing information. At 18 months’ median follow-up, median progression-free survival was 29 months with R-CVP vs 17 months for CVP alone (hazard ratio 0.44). Please see enclosed full prescribing information, including BOXED WARNINGS. |
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Tarceva (erlotinib) |
Lung Cancer |
Frances A Shepard |
July 2005 |
The article contains data from the Phase III clinical trial for Tarceva® (erlotinib). Tarceva is indicated for the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) 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, and its use is not recommended in that setting. The data in the full Prescribing Information is based on data from combined Phase II and Phase III studies. The numbers and/or safety as well as the authors’ conclusions presented in the article may differ from those presented in the full Prescribing Information. The conclusions and opinions expressed in the attached article are those of the authors only. Please see full Prescribing Information before making treatment decisions. Please note that the clinical trial was supported by a grant from OSI Pharmaceuticals, Inc. One or more authors may be a present or former employee of Genentech Inc. or OSI Pharmaceuticals, Inc., or may have received compensation from the companies. |
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Tarceva (erlotinib) |
Pancreatic Cancer |
Moore |
May 2007 |
The article contains data from the Phase III clinical trial for Tarceva® (erlotinib). Tarceva in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. The results of this pivotal trial as presented in the Tarcevafull Prescribing Information may differ from those reported by Moore et al due to analyses based on the intent-to-treat study population that was randomized to receive Tarceva (100 mg) and gemcitabine versus placebo (100 mg) and gemcitabine. The results presented by Moore et al are for both dose cohorts combined except when indicated. Therefore, the results and/or safety information, as well as the authors conclusions presented in the article, may differ from those presented in the full Prescribing Information. Additionally, the association between rash and improved efficacy with Tarceva has not been established. The conclusions and opinions expressed in the attached article are those of the authors only. Please see full Prescribing Information before making treatment decisions. Please note that the clinical trial was supported by a grant from OSI Pharmaceuticals, Inc. One or more authors may be a present or former employee of Genentech Inc. or OSI Pharmaceuticals, Inc., or may have received compensation from the companies. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
L. D. Piro |
June 1999 |
There are differences between the results and discussions presented in this publication and the approved prescribing information for RITUXAN. Please see enclosed full prescribing information, including BOXED WARNINGS. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
Feugier P, Van Hoof A, Sebban C, Solal-Celigny P, Bouabdallah R, Fermé C, Christian B, Lepage E, Tilly H, Morschhauser F, Gaulard P, Salles G, Bosly A, Gisselbrecht C, Reyes F, Coiffier B, J Clin Oncol |
May 2005 |
The following information is provided by Genentech BioOncology and Biogen Idec, co-marketers of Rituxan (rituximab), for consideration as you review the accompanying publication. The clinical significance of clearing detectable bcl-2 positive cells is unknown. The results of subgroup analyses (i.e. response rate in patients with bone marrow involvement or extranodal disease and effects of tumor size) are reported in a way that is inconsistent with prescribing information. |
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Paclitaxel plus Bevacizumab versus Paclitaxel Alone for Metastatic Breast Cancer |
Avastin (bevacizumab) |
Breast Cancer |
Miller K,Wang M |
2007 |
This article contains data from the Phase III clinical trial for Avastin® (bevacizumab) plus paclitaxel or paclitaxel alone in the first-line treatment of locally recurrent or metastatic breast cancer. The data and/or safety information presented in this article may differ from those included in the full Prescribing Information. Avastin, in combination with paclitaxel, is indicated for the treatment of patients who have not received chemotherapy for metastatic HER2-negative breast cancer. The effectiveness of Avastin in metastatic breast cancer is based on an improvement in progression-free survival. Avastin is not indicated for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. Currently, no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Avastin in breast cancer. The conclusions and opinions expressed in this article are those of the authors only. Please note that the clinical trial was supported by grants from Genentech, Inc., and one or more of the authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. |
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Paclitaxel Carboplatin Alone or with Bevacizumab for NonSmall-Cell Lung Cancer |
Avastin (bevacizumab) |
Lung Cancer |
Sandler, A |
2006 |
This article contains data from the Phase III clinical trial for Avastin® (bevacizumab) with or without carboplatin and paclitaxel in the treatment of non-small cell lung cancer. The numbers and/or safety information presented in the article may differ from those in the full Prescribing Information. Avastin, in combination with carboplatin and paclitaxel, is indicated for first-line treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous, non-small cell lung cancer. The conclusions and opinions expressed in the attached article are those of the authors only. Please note that the clinical trial was supported by grants from Genentech, Inc., and one or more of the authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
Thomas A. Davis, Antonio J. Grillo-L—pez, Christine A. White, Peter McLaughlin, Myron S. Czuczman, Brian K. Link, David G. Maloney, Robin L. Weaver, Jay Rosenberg, Ronald Levy, Tripathy |
September 1999 | ||
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
P McLaughlin, AJ Grillo-Lopez, BK Link, R Levy, MS Czuczman, ME Williams, MR Heyman, I Bence-Bruckler, CA White, F Cabanillas, V Jain, AD Ho, J Lister, K Wey, D Shen and BK Dallaire Journal of Clinical Oncology |
1998 |
The following information is provided by Genentech BioOncology and Biogen Idec, co-marketers of Rituxan (rituximab), for consideration as you review the accompanying publication. There are differences between the results and discussion as presented in this publication and the approved prescribing information. These include the following: there are no results from controlled studies comparing Rituxan (rituximab) with chemotherapy or other monoclonal antibodies or in which Rituxan was used in combination with chemotherapy. The clinical significance of clearance of detectable bcl-2 positive cells is unknown. The results of subgroup analyses (i.e. response rate in patients with bone marrow involvement or extranodal disease and effects of tumor size) are reported in a way that is inconsistent with prescribing information. |
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Rituxan (rituximab) |
Non-Hodgkin's Lymphoma |
T. A. Davis, C. A. White, A. J. Grillo-L—pez, W. S. Vel‡squez, B. Link, D. G. Maloney, R. O. Dillman, M. E. Williams, A. Mohrbacher, R. Weaver, S. Dowden, R. Levy |
June 1999 |
There are differences between the results and discussions presented in this publication and the approved prescribing information for RITUXAN. Please see enclosed full prescribing information, including BOXED WARNINGS. |
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Trastuzumab After Adjuvant Chemotherapy in HER2-Positive Breast Cancer |
Herceptin (trastuzumab) |
Breast Cancer |
Piccart-Gebhart MJ,Procter MLeyland-Jones B |
October 2005 |
The information discussed in this reprint concerns uses that have not been approved by the U.S. Food and Drug Administration. Reimbursement under public and private health care programs may not be available for unapproved product use. It is your responsibility to check applicable reimbursement policies before submitting claims for coverage. This reprint is being distributed by Genentech, Inc. who markets Herceptin® (Trastuzumab). The opinions expressed in this reprint do not necessarily reflect those of Genentech, Inc. Readers are encouraged to contact the primary authors with questions regarding the content of this reprint. Genentech, Inc. does not assume responsibility for any injury and/or damage to persons or property out of or related to any use of the information contained in this reprint. Please see the accompanying prescribing information for Herceptin® (Trastuzumab). |
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Trastuzumab plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer |
Herceptin (trastuzumab) |
Breast Cancer |
Romond EH,Perez EA,Bryant J |
October 2005 |
The ideas, numbers, safety, conclusions, and opinions expressed in this reprint are those of the author(s) only and do not necessarily reflect those of Genentech. One or more authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. Results of the joint analysis of pivotal trials as reported in the Herceptin full Prescribing Information may differ from those reported in this reprint, due to reanalysis in label development and the analyses having been conducted at different time points, with resultant differences in patient numbers and length of follow-up. In the reprint, results are provided for overall survival as a secondary endpoint; however, the Herceptin PI indicates the endpoint analysis did not reach statistical significance. |
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Trastuzumab- Associated Cardiac Adverse Effects in the Herceptin Adjuvant Trial |
Herceptin (trastuzumab) |
Breast Cancer |
Thomas M. Suter, Marion Proter, Dirk J, van Veldhuisen |
September 2007 |
The ideas, numbers, safety, conclusions, and opinions expressed in the accompanying article are those of the authors only and do not necessarily reflect those of Genentech. One or more authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. Results of the trial as reported in the Herceptin full Prescribing Information may differ from those reported in this reprint, due to reanalysis in label development and criteria for confirmation of congestive heart failure. |
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Herceptin (trastuzumab) |
Breast Cancer |
Dennis J. Slamon,Leyland-Jones,Shak |
March 2001 |
Results of this pivotal trial as reported in the Herceptin full Prescribing Information may differ from those reported by Slamon et al due to FDA reanalysis in label development. The ideas, numbers, safety, conclusions, and opinions expressed in the accompanying article are those of the authors only and do not necessarily reflect those of Genentech, Inc. One or more authors may be a present or former employee of Genentech, Inc., or may have received compensation from the company. |
Avastin (bevacizumab)
Metastatic Colorectal Cancer (mCRC)
Avastin is indicated for the first- or second-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with intravenous 5-fluorouracil–based chemotherapy.
Non-Squamous Non–Small Cell Lung Cancer (NSCLC)
Avastin is indicated for the first-line treatment of unresectable, locally advanced, recurrent or metastatic non–squamous non–small cell lung cancer in combination with carboplatin and paclitaxel.
Metastatic Renal Cell Carcinoma (mRCC)
Avastin is indicated for the treatment of metastatic renal cell carcinoma in combination with interferon alfa.
Boxed WARNINGS and additional important safety information
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Gastrointestinal (GI) perforation: Serious and sometimes fatal gastrointestinal perforation occurs at a higher incidence in Avastin-treated patients compared to controls. The incidences of GI perforation ranged from 0.3% to 2.4% across clinical studies. Discontinue Avastin in patients with GI perforation
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Surgery and wound healing complications: The incidence of wound healing and surgical complications, including serious and fatal complications, is increased in Avastin-treated patients. Do not initiate Avastin for at least 28 days after surgery and until the surgical wound is fully healed. The appropriate interval between termination of Avastin and subsequent elective surgery required to reduce the risks of impaired wound healing/wound dehiscence has not been determined. Discontinue Avastin at least 28 days prior to elective surgery and in patients with wound dehiscence requiring medical intervention
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Hemorrhage: Severe or fatal hemorrhage, including hemoptysis, GI bleeding, hematemesis, central nervous system hemorrhage, epistaxis, and vaginal bleeding, occurred up to 5-fold more frequently in patients receiving Avastin. Across indications, the incidence of grade ≥3 hemorrhagic events among patients receiving Avastin ranged from 1.2% to 4.6%. Do not administer Avastin to patients with serious hemorrhage or recent hemoptysis (≥1/2 tsp of red blood). Discontinue Avastin in patients with serious hemorrhage (ie, requiring medical intervention)
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Additional serious and sometimes fatal adverse events for which the incidence was increased in the Avastin-treated arm vs control included non-GI fistula formation (≤0.3%), arterial thromboembolic events (grade ≥3, 2.4%), and proteinuria including nephrotic syndrome (<1%). Additional serious adverse events for which the incidence was increased in the Avastin-treated arm vs control included hypertension (grade 3–4, 5%–18%) and reversible posterior leukoencephalopathy syndrome (RPLS) (<0.1%). Infusion reactions with the first dose of Avastin were uncommon (<3%), and severe reactions occurred in 0.2% of patients
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The most common adverse reactions observed in Avastin patients at a rate >10% and at least twice the control arm rate were epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain, and exfoliative dermatitis. Across all studies, Avastin was discontinued in 8.4% to 21% of patients because of adverse reactions
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The most common grade 3–4 events in Study 2107, which occurred at a ≥2% higher incidence in the Avastin plus IFL vs IFL groups, were asthenia (10% vs 7%), abdominal pain (8% vs 5%), pain (8% vs 5%), hypertension (12% vs 2%), deep vein thrombosis (9% vs 5%), intra-abdominal thrombosis (3% vs 1%), syncope (3% vs 1%), diarrhea (34% vs 25%), constipation (4% vs 2%), leukopenia (37% vs 31%), and neutropenia (21% vs 14%)
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The most common grade 3–5 (nonhematologic) and 4–5 (hematologic) events in Study E3200, which occurred at a higher incidence (≥2%) in the Avastin plus FOLFOX4 vs FOLFOX4 groups, were diarrhea (18% vs 13%), nausea (12% vs 5%), vomiting (11% vs 4%), dehydration (10% vs 5%), ileus (4% vs 1%), neuropathy–sensory (17% vs 9%), neurologic–other (5% vs 3%), fatigue (19% vs 13%), abdominal pain (8% vs 5%), headache (3% vs 0%), hypertension (9% vs 2%), and hemorrhage (5% vs 1%)
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Grade 3–5 (nonhematologic) and grade 4–5 (hematologic) adverse events occurring at a ≥2% higher incidence in Avastin-treated patients vs controls were neutropenia (27% vs 17%), fatigue (16% vs 13%), hypertension (8% vs 0.7%), infection without neutropenia (7% vs 3%), venous thrombus/embolism (5% vs 3%), febrile neutropenia (5% vs 2%), pneumonitis/pulmonary infiltrates (5% vs 3%), infection with grade 3 or 4 neutropenia (4% vs 2%), hyponatremia (4% vs 1%), headache (3% vs 1%), and proteinuria (3% vs 0%)
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The most common grade 3–5 adverse events in AVOREN, occurring at a ≥2% higher incidence in Avastin-treated patients vs controls, were fatigue (13% vs 8%), asthenia (10% vs 7%), proteinuria (7% vs 0%), hypertension (6% vs 1%), and hemorrhage (3% vs 0.3%)
Please see full Prescribing Information, including Boxed WARNINGS for additional safety information.
Herceptin (trastuzumab)
Adjuvant indications
Herceptin is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:
- As part of a treatment regimen containing doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel
- With docetaxel and carboplatin
- As a single agent following multi-modality anthracycline-based therapy
* ER/PR-negative, tumor size >2 cm, age <35 years, or histological and/or nuclear grade 2 or 3.
Metastatic indications
Herceptin is indicated:
- In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
- As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Boxed WARNINGS and Additional Important Safety Information
Herceptin administration can result in sub-clinical and clinical cardiac failure manifesting as congestive heart failure and decreased left ventricular ejection fraction. Serious infusion reactions and pulmonary toxicity have occurred; fatal infusion reactions have been reported. Exacerbation of chemotherapy-induced neutropenia has also occurred. Herceptin can cause oligohydramnios and fetal harm when administered to a pregnant woman. The most common adverse reactions associated with Herceptin use were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia.
Please see the Herceptin full prescribing information including Boxed WARNINGS and additional important safety information.
Rituxan (rituximab)
INDICATIONS AND USAGE
Rituxan® is indicated for the treatment of patients with:
- Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
- Previously untreated follicular, CD20‑positive, B-cell NHL in combination with CVP chemotherapy
- Non-progressing (including stable disease), low‑grade, CD20‑positive, B‑cell NHL, as a single agent, after first‑line CVP chemotherapy
- Previously untreated diffuse large B‑cell, CD20‑positive, NHL in combination with CHOP or other anthracycline‑based chemotherapy regimens
BOXED WARNINGS and Additional Important Safety Information
The most important serious adverse reactions of Rituxan are fatal infusion reactions, tumor lysis syndrome (TLS), severe mucocutaneous reactions, progressive multifocal leukoencephalopathy (PML), hepatitis B reactivation with fulminant hepatitis, other viral infections, cardiovascular events, renal toxicity, and bowel obstruction and perforation. The most common adverse reactions of Rituxan (incidence ≥25%) observed in patients with NHL are infusion reactions, fever, chills, infection, asthenia, and lymphopenia.
Attention healthcare provider: Provide Medication Guide to patient prior to Rituxan infusion.
For additional safety information, please see the full prescribing information, including BOXED WARNINGS and Medication Guide.
Tarceva (erlotinib)
Indication and Use in second-line Advanced NSCLC
Tarceva monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) 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, and its use is not recommended in that setting.
Indication and Use in first-line Advanced Pancreatic Cancer
Tarceva in combination with gemcitabine is indicated for first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.
Important Safety Information
There have been infrequent reports of serious Interstitial Lung Disease (ILD)-like events, including fatalities, in patients receiving Tarceva for treatment of NSCLC, pancreatic cancer or other advanced solid tumors. In the event of an acute onset of new or progressive, unexplained pulmonary symptoms such as dyspnea, cough and fever, Tarceva therapy should be interrupted pending diagnostic evaluation. If ILD is diagnosed, Tarceva should be discontinued and appropriate treatment instituted as needed.
Cases of hepatic failure, hepatorenal syndrome, acute renal failure (all including fatalities), and renal insufficiency have been reported during use of Tarceva. Treatment with Tarceva should be used with extra caution in patients with total bilirubin > 3 x ULN. Tarceva dosing should be interrupted or discontinued if changes in liver function are severe. Patients should be closely monitored during therapy with Tarceva.
Gastrointestinal perforation (including fatalities) has been reported in patients receiving Tarceva. 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.
In the pancreatic cancer trial, other serious adverse reactions associated with Tarceva plus gemcitabine and which may have included fatalities, were myocardial infarction/ischemia, cerebrovascular accident and microangiopathic hemolytic anemia with thrombocytopenia.
Corneal perforation and ulceration have been reported during use of Tarceva. Interrupt or discontinue Tarceva therapy if patients present with acute/worsening ocular disorders such as eye pain.
When receiving Tarceva therapy, women should be advised against becoming pregnant or breastfeeding. Tarceva is pregnancy category D.
The most common adverse reactions in patients with NSCLC receiving Tarceva monotherapy 150 mg were mild to moderate rash and diarrhea. 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 during the single-agent Phase III trial.
The most common adverse reactions in patients with pancreatic cancer receiving Tarceva 100 mg plus gemcitabine were fatigue, rash, nausea, anorexia and diarrhea. Severe rash and diarrhea (5% and 5% NCI-CTC Grades 3-4, respectively) were reported. Rash and diarrhea each resulted in dose reductions in 2% of patients, and discontinuation in up to 1% of patients receiving Tarceva plus gemcitabine.
Please see the Tarceva full prescribing information for complete safety information.