The Rush University Lung Cancer Translational research group evaluated the expression of insulin-like growth factor 1 (IGFR-1) and its correlation with clinical and other selected molecular parameters in advanced non-small cell lung cancer (NSCLC) patients.

As the background information, the epidermal growth factor receptor (EGFR) signaling pathway has become an important target in lung cancer with the success of EGFR tyrosine kinase inhibitors (TKI). The IGFR-1 signaling pathway has also been implicated in oncogenesis and cancer cell survival. The aim of our study was to determine the correlation of IGFR-1 expression with both clinical features of previously treated advanced NSCLC patients and molecular markers in the EGFR pathways in patients treated with gefitinib.

In this Consecutive Expanded Access Trial, patients treated with gefitinib for at least 1 week duration were included for analysis. Eighty three patients had tissue evaluated for IGFR-1 immunohistochemistry (IHC). IGFR-1 positivity was defined as presence of any staining. 81 patients were evaluated for EGFR protein expression by IHC; EGFR gene copy number, and chromosome 7 copy number (c7) by fluorescence in situ hybridization (FISH), FISH positivity as defined by Cappuzzo et al, JNCI, 2005.

We found that 78 patients had tissue with both IGFR-1 expression and FISH analyses available. Our patients’ median age was 66 years; there were 36(46.2%) men, 48(61.5%) with adenocarcinoma, 12(15.4%) never smokers, and 71(91.0%) patients had performance status(PS) of 0. The response rate (including complete response (CR) and partial response (PR)) to gefitinib was 15.38%. Median progression free survival was 3.0 months. Median overall survival was 7.3 months. Positive IGFR-1 score (> 0) was seen in 71.08% of tissue samples. Positive IGFR-1 was marginally associated with smoking (p<0.1). We found no significant association between IGFR-1 score and age, gender, histology, or PS. However, there was a significant association between IGFR-1 positivity and the following parameters: EGFR IHC (p=0.002), c7 (p=0.03), and EGFR gene amplification (p-0.01).

We concluded that IGFR-1 expression is relatively frequent in NSCLC. In this group of NSCLC patients, IGFR expression by IHC did not correlate with clinical parameters. The significant correlations between IGFR expression by IHC and increased EGFR protein expression, EGFR gene amplification and c7 polysomy, suggest that combining an IGFR inhibitor with an EGFR TKI might improve outcomes in selected NSCLC patients.

Marta Batus, MD, was the primary investigator of this research during her recent Fellowship in hematology/medical oncology at the Rush University Medical Center. In July 2008, she joined the Rush medical oncology faculty with primary clinical and research interest in sarcoma and lung cancer. She received her undergraduate degree at the University of Illinois at Urbana-Champaign and attended medical school at Rush Medical College. She completed her residency in Internal Medicine at Rush University. Emigrating from Poland when she was in high school, she is fluent in Polish, English, and Russian.

In caring for stem cell transplant patients at Northwestern Memorial Hospital, staff nurses have long recognized that timing is everything, and that they must provide strict attention to detail when administering their care. Because of the unique needs of these patients, staff determined that a manual, which would provide detailed and accurate information regarding patient treatment and care, would be a welcome addition.

Through a grant from the Chapman family, three of us have been creating a manual that will provide a unit-specific, evidence-based compilation of all the necessary information to manage this highly specialized group according to expectations from the stem cell transplant team and current available research. The manual will provide definitions and recommend procedures and policies relating to the care of the stem cell transplant patient. This includes processes that are very specific to the transplant patient, such as use of anti-rejection medications, pre-transplant testing, chemotherapy regimens, etc. The manual will be used by staff nurses on our unit, as well as nurses who will float to our unit who have little or no transplant experience.

A survey will be disseminated before and after we distribute the manuals to assess the effectiveness and appropriateness of the information, as well as to guide us in our revisions. Our goal it to continually update and revise the manual, ideally every two years, to ensure that the contents are based on current available research.

Through the use of this manual, we are seeking to improve the accuracy and quality of care we deliver to our stem cell transplant patients. We are looking forward to receiving feedback from nursing and medical staff about the manual, as well as presenting information about the manual at a national conference in the future.

Sarah Witt, RN, BSN, OCN, is the staff educator for the stem cell transplant unit at Northwestern Memorial Hospital. Her responsibilities include educating new nurses in weekly classes, keeping staff up-to-date on their certifications, coordinating staff educational opportunities, and managing unit-based competencies. She is chair of the patient education committee and teaches classes for the Living with Cancer series. She was awarded the “Compassionate Care” award for the Department of Oncology for her work with cancer patients. Additionally, she is a volunteer for the American Red Cross Health Services Department and assists with medication refills for disaster victims. She is a graduate of Michigan State University.

It’s hard to believe that the integration of Part A and Part B Medicare payers is in the last procurement cycle for choosing administrative contractors. Within the structure, 15 primary Regional MAC A/B contracts will be awarded. These Regions are also called Jurisdictions. It is expected that all Regional contracts will be awarded by the end of 2008, with the transfer of the current workload to occur in 2009. The actual transition and implementation will take longer to accomplish, perhaps as long as 18 months, once the awards are announced.

The primary objectives for the MACs, as mandated in the Medicare Modernization Act (MMA) of 2003, are: 1) financial management and administrative cost savings; 2) improved allocation of the claims processing workload; 3) consistency in claims processing activities and decisions; and 4) delivering better service through open competition. CMS' vision is to create a premier health plan that allows for comprehensive, quality care and first-rate provider and beneficiary service.

MACs are expected to interface with existing CMS contracted entities that perform medical review or benefit integrity work including agreements with beneficiary contract centers (BCC), qualified independent contractors (QIC), quality improvement organizations (QIO), and recovery audit contractors (RAC).

CMS will evaluate the performance of each MAC by setting up operational standards. Standards will focus on enhanced provider customer service, increased payment accuracy, and improved provider education and training. Specifically, the standards will measure accuracy, consistency, and timeliness. If the standards are not met, CMS will be allowed to terminate and/or transfer functions from one MAC to another at any time during the 5 year contract period.

To date the following Regional contracts have been awarded:

• Region 1 – Palmetto GBA
• Region 2 – National Heritage Insurance Corporation (under protest)
• Region 3 – Noridian Administrative Services
• Region 4 – Trailblazer Health Enterprises
• Region 5 – Wisconsin Physicians Services Health Insurance Corporation
• Region 7 – Pinnacle Business Solutions (under protest)
• Region 12 – Highmark Medical Services, Inc.
• Region 13 – National Government Services

The oncology community is fortunate to have the invaluable support and partnership of many of the pharmaceutical companies who have joined state oncology societies as annual corporate members. State societies want these companies to be engaged, involved and committed. Their generous resources provide significant revenue streams for state societies to use in providing and expanding their educational programs and legislative/economic efforts.

In its partnership with pharmaceutical companies, state society leaders and members have a responsibility to interact, discover, and explore companies' information and displays at state society conferences. Pharmaceutical representatives want the opportunity to dialogue with physicians, practice managers, and other providers outside the purview of medical offices and hospitals.

In this ever changing world, there are new restraints on pharmaceutical companies’ interaction with physicians, other cancer care providers, and leaders in oncology. In particular, access to providers in the workplace--offices and hospitals—is being severely scaled back.

Conferences and meetings, therefore, provide neutral arenas for providers to explore and learn about new drugs, clinical trials, and research in the pharmaceutical arena. State society conferences are an ideal opportunity to mingle and learn about the latest oncology updates. Please attend the state societies’ 2008 fall conferences and visit the pharmaceutical companies’ displays.

See you in the Exhibit Hall!

The summer time is a time of major change in the field of healthcare reimbursement and policy. Even though Congress may be on recess for the month of August, the Centers for Medicare and Medicaid Services (CMS) and other Federal agencies are busy getting ready for 2009.

One major change that occurred in June was the addition of three new compendia to the approved list for Medicare reimbursement. The new additions are: NCCN's Drugs & Biologics Compendium™, Thomson Micromedex's DrugDex®, and Elsevier Gold Standard’s Clinical Pharmacology. The American Hospital Formulary Service Drug Information (AHFS-DI), published by the American Society of Health-System Pharmacists, also is a recognized compendium. As we know from a recently completed survey of ACCC members, off-label use is a large component of oncology care in the physician office setting. ACCC will continue to monitor these changes and report on how CMS and local carriers are going to implement these changes.

In addition this summer saw the announcement of the proposed changes in both the CMS 2009 Physician Fee Schedule and the 2009 Hospital Outpatient Prospective Payment System. For more information on the proposals, click here. Release of the final rules is to occur at the end of October 2008.

Finally, in July, Congress acted to stop the potential 10.6% cut to physicians treating Medicare patients. This cut, due to the flawed SGR formula, was delayed for 18 months and replaced with another 0.5 percent update for the remainder of 2008 and a 0.6 percent cut for 2009. For more information, click here.

Zoledronic acid (Zometa) has been accepted by the American Hospital Formulary Service Drug Information (AHFS-DI) drug compendium as treatment for prevention of aromatase inhibitor-associated bone loss (AIBL) in postmenopausal women. The oncology determination table is available online. AHFS-DI is published by the American Society of Health-System Pharmacists (ASHP).

Nplate (romiplostim). Amgen Inc. announced on Aug. 22 that the U.S. Food and Drug Administration (FDA) has approved Nplate (romiplostim), the first and only platelet producer for the treatment of thrombocytopenia in splenectomized (spleen removed) and non-splenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate, the first FDA-approved peptibody protein, works by raising and sustaining platelet counts, representing a novel approach for the long-term treatment of this chronic disease.

The FDA approval of Nplate was based on efficacy and safety results from two pivotal Phase 3 studies of adult patients with chronic ITP, including both splenectomized and non-splenectomized patients. The overall response rate for Nplate was 83 percent (n=69/83, p less than 0.0001) of treated splenectomized and non-splenectomized patients, and platelet counts were raised and sustained in these six month studies. Additionally, patients treated with Nplate were able to reduce or discontinue their use of concomitant ITP medications and emergency medications (i.e., corticosteroids, IVIG, Win-Rho, Anti-D therapy).

On August 6, 2008, the Epogen/Procrit (epoetin alfa) and Aranesp (darbepoetin alfa) labeling were revised to strengthen the safety information for healthcare professionals and patients. The changes are summarized as follows:

• Safety-related labeling changes for cancer patients receiving chemotherapy. The prescribing information has been revised to clarify the FDA-approved conditions for use of erythropoiesis-stimulating agents (ESAs) in patients with cancer and revised directions for dosing to state the hemoglobin level (≥ 10 g/dL) at which treatment with an ESA should not be initiated. The new label states that ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
• Medication Guide and Patient Instructions for use for all indications. The new Medication Guide contains information that FDA has determined is necessary for patients’ safe and effective use of ESAs, and that could affect patients’ decision to take this drug. Federal regulations require that the Medication Guide be distributed to patients.

Vidaza (azacitidine for injection). Celgene Corporation announced that Vidaza (azacitidine for injection) has received approval from the FDA to include survival data for patients with higher-risk myelodysplastic syndromes (MDS) in its prescribing information. A PDF file of the updated Vidaza prescribing information is attached to this message. For more information, please visit www.vidaza.com.

Aloxi (palonosetron HCl). Eisai Corporation of North America and its partner Helsinn Healthcare SA announced that the FDA has approved a new oral formulation of Aloxi (palonosetron hydrochloride) for the prevention of chemotherapy-induced nausea and vomiting (CINV). Aloxi capsules 0.5 mg for oral administration is indicated for the prevention of acute nausea and vomiting following initial and repeat courses of moderately emetogenic chemotherapy. A single 0.5 mg Aloxi capsule is administered approximately one hour prior to the start of chemotherapy.