Paula Muehlbauer, RN, MSN, OCN^®
Arlington, VA
pmuehlbauer@nih.gov

Hello, SIG colleagues! I hope that you have enjoyed the holiday season. 2007 was a very productive year for our SIG. We had a presence at the annual meeting of the American Society for Therapeutic Radiology and Oncology in Los Angeles, CA, where we copresented with the Radiation Oncology SIG at the nurses’ meeting. We also copresented a session at the ONS Congress in Las Vegas, NV, titled “Radiation Therapy and Targeted Therapies: The Dynamic Duo.” In addition, we had representation at the Institutes of Learning in Chicago, IL, with a session titled “Update on the Side Effects of Targeted and Biologic Therapy: There's More Than Rash and Diarrhea.” 

We also met one of our SIG’s goals with publication of an article in the Clinical Journal of Oncology Nursing. SIG member Peg Esper, MSN, RN, APRN-BC, AOCN^®, and colleagues wrote “What Kind of Rash Is It? Deciphering the Dermatologic Toxicities of Biologic and Targeted Therapies,” which was published in the October issue. The article was a SIG-driven project to provide education about skin side effects and management with newer drugs.

Last but not least, we received word from ONS that funding has been secured to develop an interactive educational activity on targeted and biologic therapies. Our SIG is in an excellent position to serve as educators and ambassadors as these novel therapies continue to be investigated and approved for clinical indications. Please consider how the SIG can help you with your own professional goals.

Patient Education Is Key When Starting Patients on Lapatinib/Capecitabine Combination Therapy

Heather K. Laurent, RN, BSN, OCN^®
Park Ridge, IL
hlaurent@oncmed.net

Breast cancer is the most frequently diagnosed cancer in women, accounting for an estimated 180,510 new cases in the United States and 40,910 deaths (American Cancer Society, 2007). Women with breast cancer that overexpress human epidermal growth factor receptor type 2 (HER2) can experience greater risk for disease progression and death. Traztuzumab was the first drug approved that blocks this receptor, and recently lapatinib (Tykerb®, GlaxoSmithKine, Research Triangle Park, NC) has become available to also block the HER2 receptor (Geyer et al., 2006). Numerous trials currently are investigating the use of lapatinib for patients with breast cancer who overexpress HER2. Clinical trials also are being conducted to look at indications for head and neck cancer, ovarian cancer, glioblastoma multiforme or gliosarcoma, peritoneal cavity carcinoma, cervical cancer, prostate cancer, and other advanced solid tumors (www.cancer.gov).

Lapatinib is the ditosylate salt of a synthetic, orally active quinazoline with potential antineoplastic properties. Lapatinib reversibly blocks phosphorylation of the epidermal growth factor receptor (EGFR [ErbB1]), HER2 (ErbB2), and the Erk-1 and –2 and AKT kinases (www.cancer.gov). Lapatinib is classified as a kinase inhibitor and currently is indicated in combination with capecitabine (Xeloda^®, Roche Laboratories, Nutley, NJ) for the treatment of patients with advanced or metastatic breast cancer whose tumors overexpress HER2 and who have received prior therapy including an anthracycline, a taxane, and trastuzumab (GlaxoSmithKline, 2007a).

A phase 3, randomized, open-label study comparing lapatinib plus capecitabine with capecitabine alone in women with progressive, HER2-positive, locally advanced or metastatic breast cancer was the turning point to get lapatinib approved by the U.S. Food and Drug Administration (FDA) (Geyer et al., 2006). The recommended dosage of lapatinib is 1,250 mg given orally once daily on days 1–21 continuously in combination with capecitabine 2,000 mg/m²/day (administered orally in two doses approximately 12 hours apart) on days 1–14 in a repeating 21-day cycle (GlaxoSmithKline, 2007a). The median time to progression in the combination group was 8.4 months as shown in the study results compared to 4.4 months in the capecitabine alone group. The interim analysis showed that the addition of lapatinib to capecitabine showed a 51% reduction in the risk of disease progression (Geyer et al.).  

The most reported adverse events in the combination group were diarrhea (60% for all grades, 13% for grades 3 and 4), nausea (44%), and hand–foot syndrome (49% for grades 1–3). Other reported side effects include vomiting, stomatitis, abdominal pain, constipation, dyspepsia, rash, dry skin, fatigue, mucosal inflammation, asthenia, headache, pain (extremity or back), anorexia, and dyspnea (Geyer et al., 2006). Decreases in left ventricular ejection fraction (LVEF) also have been reported, so baseline LVEF is recommended along with periodic reevaluation. According to National Cancer Institute Common Terminology Criteria for Adverse Events, lapatinib should be discontinued in patients with an LVEF that is grade 2 or higher and in patients with an LVEF that drops below the institutions’s lower limit of normal (GlaxoSmithKline, 2007a). No standard has been set at this time regarding how often to monitor LVEF.

Because oral chemotherapy agents are becoming more commonplace, it will become more challenging for oncology nurses to monitor side effects. Therefore, patient education will be a priority when starting patients on oral agents. Many important points need to be given to patients starting lapatinib/capecitabine combination therapy. Lapatinib instructions state that tablets must be taken on an empty stomach at least one hour before or one hour after eating; grapefruit products must be avoided; tablets should not be crushed, split, or dissolved; and the medication should be taken at the same time every day. Patients also will need to be educated on side effects and dosing of capecitabine (GlaxoSmithKline, 2007b).

Many medication interactions are noted with lapatinib, so oncologists must be made aware of all prescription and over-the-counter medications that patients are taking (GlaxoSmithKline, 2007a). Lapatinib is metabolized via the CYP3A4 liver pathway, so concomitant strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, St. John’s wort) and inhibitors (e.g., ketoconazole, clarithromycin) should be avoided. See the full prescribing information for further details and guidelines on dose adjustments (GlaxoSmithKline, 2007a).

As stated previously, compliance and management of oral agents can be a challenging part of oncology nursing. Our clinic has formed an oral chemotherapy task force to look at ways to improve outcomes in the management of these patients. We have written a checklist for each agent (see the example for lapatinib that follows) so that all nurses are aware of common side effects, specific management standards, drug interactions, the class of drug, dosing, reasons a patient would need to stop taking the drug and/or call for advice, and whether specialty pharmacy is required. We also have developed a customized teaching sheet that patients must sign and date to document that all items have been reviewed with them. In addition, we send patients home with a safe-handling instruction sheet, applicable education materials, and a calendar requiring them to document the times they take their oral agents at home as well as any side effects they are experiencing. Patients then bring the calendar back to the clinic, where the information is put in their charts for documentation purposes. We believe that this method is the best way to achieve patient compliance with oral agents and can make patients accountable for their treatment. Our oncologists are required to write prescriptions for one cycle at a time, so patients must return to the clinic for follow-up appointments to continue treatment.

As oral agents become increasingly used, oncology nurses will need to evolve their practice to deal with side effect management for patients being “treated” at home. We have found that patients are compliant with their medications and documentation if we stress from the start of therapy that they need to keep a record for their safety. Information regarding management of oral agent therapy will continue to be published, but nurses educating patients will remain the most important tool. Within our practice, we are attempting to standardize what we teach our patients.

References

American Cancer Society. (2007). Cancer facts and figures 2007. Atlanta, GA: Author.

Geyer, C.E., Forster, J., Lindquist, D., Chan, S., Romieu, C.G., Pienkowski, T., et al. (2006). Lapatinib plus capecitabine for HER2-positive advanced breast cancer. New England Journal of Medicine, 355, 2733–2743.

GlaxoSmithKline. (2007b). More options surround me: Your treatment with Tykerb^®. Research Triangle Park, NC: Author.

Editor’s Message
Share Your Expertise by Writing a Newsletter Article

Laurel Barbour, RN, MSN, APN, AOCN^®
Naperville, IL
lbarbour@oncmed.net

It is my hope that the ONS Targeted and Biological Therapies SIG Newsletter will become the mainstay of cancer care, as new drugs are reaching usage approval at a steady pace. This edition carries a review of lapatinib written by my colleague, Heather K. Laurent, RN, BSN, OCN^®. The article provides the basics of the medication as well as how the drug will be used in combination with other chemotherapies and targeted therapies in the future.

Welcome, New SIG Members!

The Targeted and Biological Therapies SIG welcomed 153 new members from February–September 2007. Please join the SIG leadership in welcoming the following new members.

Article of Interest
Targeted and Biological Therapies SIG Members May Enjoy This Recently Published Article

Check out the Oncology Nursing Forum (ONF) for an interesting article about the Targeted and Biological Therapies SIG’s focus.

• “Nursing Considerations of Bevacizumab Use in Multiple Tumor Types,” by Barbara Holmes Gobel, RN, MS, AOCN^® (ONF, Vol. 34, pp. 693–701)

The SIGs Virtual Community Keeps You Connected

Jenny Shinsky
Pittsburgh, PA
jshinsky@ons.org

The SIGs Virtual Community was developed to improve
communication among SIG leaders and members. Visiting your
SIG’s Web page on the Virtual Community keeps you updated
about SIG activities by providing you with important
information and resources.

To navigate to your SIG’s page, visit the SIGs Virtual Community at http://sig.vc.ons.org and select “Find a SIG” from the top navigation.

Many features in the SIGs Virtual Community are useful to all members. The following is an outline of the information that can be found on your SIG’s page.

From your SIG’s main page, you can subscribe to SIG announcements, calendar events, and the discussion forum. Once you are subscribed to the areas, an e-mail will be sent to you every time an announcement, event, or discussion has been posted.

Announcements are added frequently with important information pertaining to your SIG, such as scholarship, leadership, and meeting information.

SIG events on the SIG calendar are showcased on the main page for your convenience. Simply click on an event for detailed information.

About Us: The About Us area features information about your SIG leaders.

News: The News section provides important information, such as minutes from past meetings and newsletters. Educational news and photos also can be found here.

Discussions: The Discussions area is very similar to the ONS List Serve, which can be found at http://listserv.vc.ons.org. Click the Discussions button at the top of your SIG’s page to access the area. You can post a message, thought, or questions and fellow SIG members can read your message and respond.

ONS National Announcements: Check this section every month for updated information from ONS such as continuing nursing education offerings, events, and important information.

News From ONS National

Your Vote Counts!
Remember to exercise your right to vote in the 2008 ONS National (January 2–February 14, 2008) and Targeted and Biological Therapies SIG (January 2–February 10, 2008) Elections!

Get Online-Only Special Pricing on New Pharmacology CD
Pharmacology Update–Volume 1 is the first of a new series of in-depth, self-paced CD-ROMs designed to present detailed information on pharmacotherapy in cancer care. Order your copy now to take advantage of special online-only pricing! For more information, click here.

Oncology Nurse Practitioner Competencies Available
The 2007 Oncology Nurse Practitioner Competencies outlines specialty entry-level competencies for oncology nurse practitioners (ONPs) who care for adult and late adolescent patients throughout the continuum of cancer care. It should be used by nurse practitioners, educators, employers, physicians, nurses, and anyone else who seeks to understand the role of the ONP.

This important guide was developed by a multi-organizational national panel convened by ONS that used a nationally vetted process to develop, review, and revise the document. The competencies then were reviewed and critiqued by 127 ONPs as well as 20 members of a national validation panel comprised of representatives of nursing organizations and National Cancer Institute-designated comprehensive cancer centers. To learn more, click here.

ONS State Health Policy Liaisons Needed in Select States
ONS state health policy liaisons (SHPLs) help coordinate health policy and grassroots activities at the local, state, and national levels to help advance the ONS Health Policy Agenda. ONS currently is recruiting an SHPL in each of the following states: Kansas, Montana, New Jersey, Oklahoma, Rhode Island, South Dakota, West Virginia, and Wisconsin. For more information, click here.

CJON Seeks Reviewers

Put your knowledge and expertise to work by becoming a reviewer for the Clinical Journal of Oncology Nursing. For more information, click here.

Back to SIG Newsletter front page

Membership Information

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• Network with colleagues in an identified subspecialty area around the country.
• Contribute articles for your SIG’s newsletter.
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Join a Virtual Community

A great way to stay connected to your SIG is to join its Virtual Community. It’s easy to do so. All you will need to do is

• Log on to the ONS Web site (http://www.ons.org/).
• Select "Membership" from the tabs above.
• Then, click on "ONS Chapters and Special Interest Groups."
• Scroll down to "Visit the ONS Special Interest Groups (SIG) Virtual Community" and click.
• Now, select "Find a SIG."
• Locate and click on the name of your SIG from the list of all ONS SIGs displayed.
• Once the front page of your SIG’s Virtual Community appears on screen, select "New User" from the top left. (This allows you to create log-in credentials.)
• Type the required information into the text fields as prompted.
• Click "Join Group" (at the bottom right of the text fields) when done.
  
  Special Notices
  
  
• If you already have log-in credentials generated from the ONS Web site, use this information instead of attempting to generate new information.
• If you created log-in credentials for the ONS Web site and wish to have different log-in information, you will not be able to use the same e-mail address to generate your new credentials. Instead, use an alternate e-mail address.

Subscribe to Your SIG’s Virtual Community Discussion Forum

All members are encouraged to participate in their SIG’s discussion forum. This area affords the opportunity for exchange of information between members and nonmembers on topics specific to all oncology subspecialties. Once you have your log-in credentials, you are ready to subscribe to your SIG’s Virtual Community discussion forum. To do so,

• Select "Log In," located next to "New User," and enter your information.
• Next, click on the "Discussion" tab on the top right of the title bar.
• Now, select "Featured Discussion" from the left drop-down menu.
• Locate and select "Subscribe to Discussion" inside the "Featured Discussion" section.
• Go to "Subscription Options" and select "Options."
• When you have selected and entered all required criteria, you will receive a confirmation message.
• Click "Finish."
• You are now ready to begin participating in your SIG’s discussion forum.

Participate in Your SIG’s Virtual Community Discussion Forum

• First, log in. (This allows others to identify you and enables you to receive notification [via e-mail] each time a response or new topic is posted.)
• Click on "Discussion" from the top title bar.
• Select "Featured Discussion" from the left drop-down menu.
• Click on any posted topic to view contents and post responses.

Sign Up to Receive Your SIG’s Virtual Community Announcements

As an added feature, members also are able to register to receive their SIG’s announcements by e-mail.

• From your SIG’s Virtual Community page, locate the "Sign Up Here to Receive Your SIG’s Announcements" section. This appears above the posted announcements section.
• Select the "Click Here" feature, which will take you to a link to subscribe.
• Once the "For Announcement Subscription Only" page appears on select how you wish to receive your announcements.
• As individual e-mails each time a new announcement is posted
• One e-mail per day comprised of all new daily announcements posted
• Opt-out, indicating that you will frequently browse your SIG’s Virtual Community page for new postings
• Enter your e-mail address.
• Click on "Next Page."
• Because you have already joined your SIG’s Virtual Community, you will receive a security prompt with your registered user name already listed. Enter your password at this prompt and click "Finish."
• This will bring up a listing of your SIG’s posted announcements. Click on "My SIG’s Page" to view all postings in their entirety or to conclude the registration process and begin browsing.

Know someone who would like to receive a print copy of this newsletter?
To print a copy of this newsletter from your home or office computer, click here or on the printer icon located on the SIG Newsletter front page. Print copies of each online SIG newsletter also are available through the ONS National Office. To have a copy mailed to you or another SIG member, contact Membership/Leadership Administrative Assistant Carol DeMarco at cdemarco@ons.org or 866-257-4ONS, ext. 6230.

To view past newsletters, click here.

ONS Membership/Leadership Team Contact Information

Angie Stengel, MS, CAE, Director of Membership/Leadership
astengel@ons.org
412-859-6244

Diane Scheuring, MBA, CMP, Manager of Member Services
dscheuring@ons.org
412-859-6256

Carol DeMarco, Membership/Leadership Administrative Assistant
cdemarco@ons.org
412-859-6230

The Oncology Nursing Society (ONS) does not assume responsibility for the opinions expressed and information provided by authors or by Special Interest Groups (SIGs). Acceptance of advertising or corporate support does not indicate or imply endorsement of the company or its products by ONS or the SIG. Web sites listed in the SIG newsletters are provided for information only. Hosts are responsible for their own content and availability.

Oncology Nursing Society
125 Enterprise Dr.
Pittsburgh, PA 15275-1214
866-257-4ONS
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