July/AuguSt 2012
www.theoBgynnurSe.Com
Vol 4, no 2
The OncOlOgy Issue
ONS ANNUAL CONGRESS
OVARIAN CANCER new Agents Prove Potent Against her2-Positive Breast Screening for ovarian Cancer Cancer
Researchers seek to resolve outstanding issues regarding testing By Caroline Helwick
By D. “Jeff” Nordquist, RN, MS, CS, FNP, Nurse Practitioner Karin Goodman, RN, CNP, Adult Nurse Practitioner Mayo Clinic, Rochester, Minnesota
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varian cancer is said to “whisper,” because the symptoms are seldom obvious. The most frequent symptoms seen in women diagnosed with ovarian cancer are abdominal bloating, pelvic or abdominal pain, difficulty eating/feeling full fast, or urinary symptoms. These are often passed off as nothing other than symptoms of getting older, gaining weight, or related to menopause. However, this whispering disease is the most lethal of all the breast and gynecologic cancers and accounts for more deaths than any other cancer of the female reproductive system.1
The American Cancer Society estimates that about 22,280 women will be diagnosed with ovarian cancer in 2012, and 15,500 women will die of ovarian cancer.1 Approximately 75% of women will survive 1 year after diagnosis and treatment. The 5-year survival rate is 46%, an increase of less than 10% since 1974, when the survival rate was 37%. Those diagnosed at an early stage (stage I) have a 5-year survival rate of 94%; however, only about 15% of all ovarian cancers are diagnosed at this early stage. One in 71 women will have a diagnosis of ovarian cancer in her lifetime, Continued on page 7
BLADDER CANCER Images representing a HER2 gene amplified specimen to the left and a nonamplified specimen to the right.
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rastuzumab changed the course of HER2-positive breast cancer, and future anti-HER2 therapies may have an even greater impact, said Kristine Abueg, RN, MSN, OCN,
clinical research nurse at Kaiser Permanente in Roseville, California, who discussed “What’s New in HER2?” at the 37th Annual Congress of the Oncology Nursing Society. Continued on page 6
Cultivating Personalized medicine Clinical Acumen in the management of Breast Cancer An interview with Edith Perez, MD
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f any cancer can be said to have launched personalized medicine into orbit and establish it as the standard for all cancer therapy to aspire toward, it
is breast cancer. The discovery of the estrogen receptor (ER) and HER2 biomarkers has astonished healthcare professionals and the public alike and raised Continued on page 12
The Publicationof of The Official Offical Publication
We thank Watson Pharmaceuticals, Inc., for their gold level support. ©2012 Novellus Healthcare Communications, LLC
Screening for Bladder Cancer By Gary Shelton, MSN, NP, ANP-BC, AOCNP NYU Cancer Institute, New York, New York
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lthough the increased incidence of bladder cancer (BC) has softened in recent years, proposed to be due in part to smoking cessation strategies, BC remains a significant healthcare problem with high recurrence rates.1,2 Currently, there is inadequate evidence that screening for BC in the asymptomatic population promotes improved overall morbidity or mortality.3 Despite this current state of the science, there is great interest in bettering the gold standard for early diagnosis – cystoscopy, cytology, and imaging – as these are expensive, uncomfortable, and not suggested for low-risk individuals or for those without hematuria.4
Background BC is projected to be the fourth most common cancer diagnosed in American men in 2012, with an expected incidence of over 55,000 cases; for women, the incidence is estimated to be just under 18,000 new cases. More than 10,000 men are expected to die of the disease in 2012, with an estimated 4000 women succumbing as well. BC occurs 4 times more commonly in men than in women and in twice as many white men as African American men.5 Efforts should be made to promote smoking cessation, as smoking is the most well-established risk factor for BC. Other risk factors include workrelated exposures to dyes, rubber, and Continued on page 9
INS IDE MAle FeRTIlITy . . . . . . . . . . . . . . . .
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Age and semen characteristics affect the achievement of pregnancy in in vitro fertilization treatments with donated oocytes
IVF In sAMe-seX cOuPles . . .
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The challenges of IVF are unique for same-sex couples and range from legal and contractual hurdles to treatment coordination
In This Issue WWW.THEOBGYNNURSE.COM PUBLISHING STAFF
Publisher Russell Hennessy russell@novellushc.com 732-992-1888 Editorial Director Kristin Siyahian kristin@greenhillhc.com Editorial Assistant Jennifer Brandt Senior Copy Editor Bjarne Hansen Senior Production Manager Marie RS Borrelli
new AgentS ProVe Potent AgAInSt her2-PoSItIVe BreASt CAnCer Researchers seek to resolve outstanding issues regarding testing
CultIVAtIng PerSonAlIZeD meDICIne ClInICAl ACumen In the mAnAgement oF BreASt CAnCer An interview with Edith Perez, MD
SCreenIng For oVArIAn CAnCer Symptoms are often passed off as nothing other than symptoms of getting older, gaining weight, or related to menopause
mAle FertIlIty Age and semen characteristics affect the achievement of pregnancy in in vitro fertilization treatments with donated oocytes
SCreenIng For BlADDer CAnCer Bladder cancer remains a significant healthcare problem with high recurrence rates
IVF In SAme-SeX CouPleS The challenges of IVF are unique for same-sex couples and range from legal and contractual hurdles to treatment coordination
Quality Control Director Barbara Marino Business Manager Blanche Marchitto Editorial Contact: Telephone: 732-992-1536 Fax: 732-656-7938 MISSION STATEMENT The OB/GYN Nurse-NP/PA is the official publication of the American Academy of OB/GYN and Infertility Nurses. The OB/GYN Nurse-NP/PA provides practical, authoritative, cutting-edge information on the physiologic, medical, and psychological aspects of women’s health, focusing on the role of the OB/GYN practitioner, including nurses, NPs, and PAs, in patient care. Our journal offers a forum for nurses, NPs, PAs, administrators, researchers, and all others involved in OB/GYN and women’s health to discuss the entire scope of current and emerging diagnostic and therapeutic options, as well as counseling and patient follow-up for women throughout their reproductive years and beyond. Written by nurses for nurses, The OB/GYN Nurse-NP/PA promotes peer-to-peer collaboration among all nursing professionals toward the advancement of integrated services for optimal delivery of patient care and offers continuing education for all nurses, NPs, and PAs involved in these interrelated fields of women’s health. The OB/GYN Nurse, ISSN 2153-6562 (print); ISSN 2153-6546 (online), is published by Novellus Healthcare Communications, LLC, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831. Copyright ©2012 by Novellus Healthcare Communications, LLC. All rights reserved. The OB/GYN Nurse is a trademark of Novellus Healthcare Communications, LLC. No part of this publication may be reproduced or transmitted in any form or by any means now or hereafter known, electronic or mechanical, including photocopy, recording, or any informational storage and retrieval system, without written permission from the Publisher. Printed in the United States of America. The ideas and opinions expressed in The OB/GYN Nurse do not necessarily reflect those of the Editorial Board, the Editors, or the Publisher. Publication of an advertisement or other product mentioned in The OB/GYN Nurse should not be construed as an endorsement of the product or the manufacturer’s claims. Readers are encouraged to contact the manufacturers about any features or limitations of products mentioned. Neither the Editors nor the Publisher assume any responsibility for any injury and/or damage to persons or property arising out of or related to any use of the material mentioned in this publication. SUBSCRIPTIONS/CHANGE OF ADDRESS should be directed to CIRCULATION DIRECTOR, The OB/GYN Nurse, 241 Forsgate Drive, Suite 205D, Monroe Twp, NJ 08831; Fax: 732-656-7938
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ONS Annual Congress
new Agents Prove Potent... In spite of a decade or so of established treatment with trastuzumab, questions still remain regarding the appropriate population to treat. In addition, many patients who respond to the drug eventually experience drug resistance and recurrence. Researchers are seeking to better understand resistance, and the pipeline is rife with agents that are effective upon trastuzumab failure, said Abueg. Four proteins make up the members of the HER family of cell surface receptors: HER1, HER2, HER3, and HER4. Trastuzumab targets HER2, the preferred partner for binding with the other members (heterodimerization) or itself (homodimerization) to create a signaling cascade. Trastuzumab’s dual-kill mechanism includes antibody-dependent cellular toxicity and the prevention of intracellular cell signaling, which induces apoptosis and prevents proliferation. Resistance that develops is associated with alternate signaling pathways, which are being targeted by new agents in development. “The key to understanding and ultimately mitigating this resistance lies in the HER2 signaling pathway,” she said. her2 testing: Issues of Concern The accuracy of immunohistochemical (IHC) staining and scoring by fluorescence in situ hybridization (FISH) has become questionable, and provocative data are leading to a reexamination of current practice patterns, she said. In the pivotal studies, community pathology and central reference lab results have been discordant some 18% to 34% of the time. The implication is that a “fairly good number” of patients either receive trastuzumab unnecessarily or miss out on its benefits altogether, she said. The American Society of Clinical
July/AugusT 2012 l VOLUME 4, NUMBER 2
Oncology and the College of American Pathologists have issued revised guidelines for HER2 testing. The most recent recommendation is to prescribe antiHER2 treatment when the FISH result is ≥2.0, and to retest when FISH is 1.8 to 2.2. This recommendation is now, however, compulsory. The other testing issue is the level of predictability of IHC and FISH, according to information from the pivotal trastuzumab studies. Consistent benefit from trastuzumab was observed in every subset (including patients who were actually HER2 negative), and FISH score strength was not predictive of this. Even some FISH-negative patients benefited from the drug. “The clinical implication is whether the HER2 ‘sensitive’ population can be expanded,” Abueg explained. Clinical trials are evaluating trastuzumab in the IHC 1+ and FISH-negative populations. overcoming resistance with new Agents The powerful new agents under investigation are designed specifically to attack the proposed mechanisms of trastuzumab resistance. Lapatinib, of course, is already established for use after progression with trastuzumab. The ALTTO study is evaluating whether the adjuvant use of lapatinib in combination with trastuzumab, prior to the development of resistance, will be more effective than either agent alone. In the neoadjuvant NeoALLTO trial, the combination produced a 51% pathologic complete response rate,1 and the hope is that this type of activity will be observed in the adjuvant setting, she said. Even more promising could be 4 investigational agents: • Neratinib, which works similarly to lapatinib, blocks HER2, HER1, and
Continued from page 1
HER4, and inhibits intracellular cell signaling • Everolimus, an mTOR inhibitor proven in other cancers • Pertuzumab, a monoclonal antibody that blocks HER2/HER1 and HER2/ HER3 dimerization and binds at a different site than trastuzumab • T-DM1 (trastuzumab emtansine), an antibody-drug conjugate with highly targeted delivery Each is backed by very encouraging data, but T-DM1 has elicited the most excitement, and for good reason, she noted. In a phase 2 open-label study, T-DM1 resulted in a median progression-free survival of 14 months versus 9 months with trastuzumab and docetaxel, reducing the risk of disease progression by 41% and proving to be very well tolerated.2 In 2010, the FDA declined to grant accelerated approval and called for phase 3 trials to be completed. Additional studies (EMILIA, MARIANNE, THERESA) are under way. “I have a patient on one of these trials who had an 11-cm liver metastasis and pulmonary nodules after multiple lines of treatment. Last week, she received her 47th cycle of T-DM1. Her tumor is now 1.1 cm and has been stable for two and a half years,” Abueg reported. While thrombocytopenia can be problematic, it has remained grade 1 for this patient. “I think this is a stunning result,” she commented. n references 1. Baselga J, Bradbury I, Eidtmann H, et al; NeoALTTO Study Team. Lapatinib with trastuzumab for HER2-positive early breast cancer (NeoALTTO): a randomised, open-label, multicentre, phase 3 trial. Lancet. 2012;379: 633-640. 2. Hurvitz S, Dirix L, Kocsis J, et al. Trastuzumab emtansine (T-DM1) vs trastuzumab plus docetaxel (H+T) in previously untreated HER2-positive metastatic breast cancer (MBC): primary results of a randomized, multicenter, open-label phase II study (TDM4450g /BO21976). Presented at the 2011 European Multidisciplinary Cancer Conference. Stockholm, Sweden. September 23-27, 2011. Abstract 5001.