SCCA Network News, Issue 19 Summer 2013
In this issue:
- 2013 Network Summit
- Olympic Medical Cancer Center
- Simultaneous Colorectal-Liver Surgery Improves Outcomes for Selected Stage IV Colon Cancer Patients
- MultiCare Regional Cancer Center
- Uma Chandavarkar, MD
- SCCA Network Research Office to Launch Two New Clinical Trials This Summer
- Chemotherapy for MDS Patients Prior to Donor Stem Cell Transplant
The Seattle Cancer Care Alliance (SCCA) Network, though small in comparison to other network programs around the country, showed its strength at our annual Network Members Summit on June 14. The agenda was packed, but we even squeezed in approximately two hours of clinical research training and a marketing breakout session.
Summit attendees saw how our Network Clinical Quality Performance portfolio continues to mature and expand. Examples included:
- Introducing the ASCO Choosing Wisely initiative, our third project with the Hutchinson Institute for Cancer Outcomes Research (HICOR)
- Sharing our clinical pathway development, further enforcing its importance in our practices
- Presenting an overview of the new National Cancer Institute (NCI) Cooperative Group structure
- Relaying information about SCCA’s efforts to continue performance improvements and, showing how it can affect change, including the development of a new model-line structure
- Learning about the Referring Provider Communication Improvement work group, whose members include SCCA Network physicians and the seamless care coordination communication flow project the group is undertaking
Other topics at the summit included Psychosocial Care to prepare for the new Commission on Cancer requirement and the UW-Oncoplex program.
Lastly, guest speaker Christian Downs, executive director of the Association of Community Cancer Centers, who took attendees down a very interactive path regarding the challenges facing community cancer centers today.
Where to next?
The SCCA Network will continue to expand its quality performance portfolio, launch the “choosing wisely project,” improve clinical research activities, and, with the onset of a new “central door” for cooperative studies, improve our clinical trial enrollment numbers. We will evaluate new opportunities for collaboration and partnerships as we move forward together.
We would like to thank of you for participating in this educational event.
Cec Zapata, MS
Director, Regional/Global Network and Physician Educational Outreach
Ben Greer, MD
Network Medical Director
In March of this year, the American College of Radiology (ACR) awarded Olympic Medical Cancer Center (OMCC) a three-year accreditation term in radiation oncology.
“The ACR accreditation is the best measuring stick to know that what we are doing at OMCC is the very best work possible,” says Rena Zimmerman, MD, radiation oncologist. “This is the most stringent review on the market and through this we demonstrated that we are one of the best.”
The ACR seal of accreditation represents the highest level of quality and patient safety. It is awarded only to facilities meeting specific practice guidelines and technical standards developed by the ACR after a peer-review evaluation by board-certified radiation oncologists and medical physicists who are experts in the field. Patient care and treatment, patient safety, personnel qualifications, adequacy of facility equipment, quality control procedures, and quality assurance programs are assessed.
“Between our physician leadership, dosimetrists, physicists, radiation therapists, and information technology there is a huge amount of work that goes into earning this certification,” says Michael Shevach, MD, medical director of radiation oncology at Olympic Medical Cancer Center. “Our staff’s dedication to patient safety and providing quality care is outstanding.”
Clinicians have long questioned which surgery should come first in stage IV colorectal cancer metastatic to the liver: the primary colorectal surgery or the liver metastasis surgery. In an innovative approach that may reduce patient morbidity and offer improved outcomes for patients, UW Medical Center (UWMC) colorectal and liver tumor surgeons offer combined surgical approaches for carefully selected patients.
Liver metastases most commonly arise from colorectal cancer. An estimated 60 to 70 percent of colorectal cancer patients develop liver metastises, and liver is the only site of metastasis in up to 35 percent of these patients.
If stage IV colorectal cancer metastatic to the liver cannot be surgically resected and is treated with chemotherapy alone, the five-year survival rate is only 5 to 10 percent. When surgery clears the primary disease and metastases, the five-year survival rate with adjuvant chemotherapy can be as high as 58 percent.
“Often times, patients with colorectal cancer metastatic to the liver are young, active, and high-functioning folks,” said James Park, MD, UW Medicine associate professor of Hepatobiliary Surgical Oncology. “These stage IV patients have the best chance at being cured through a team-based approach. UWMC surgeons, in coordination with SCCA, are treating many of these patients with one simultaneous operation, where both colorectal and liver procedures are performed concurrently, often through the same incision(s).”
Reducing the number of surgeries is easier on patients
The innovative combined operation to simultaneously remove colorectal cancer and liver metastases is increasingly employed by surgeons at UWMC. “Thanks to refined surgical and anesthesia techniques, technological advances, and specialized post-operative care, even the most complex liver operations have become routine,” Park said. “In selected cases where colon or rectal with liver surgery can safely be combined, the patient experiences fewer operations and hence, less trauma.”
Patients with more complex surgical needs may also benefit. For example, patients with multifocal disease involving both sides of the liver often require a staged liver operation, first to clear one side of the liver and then the other. Combining one of these two stages with the colorectal procedure reduces the overall number of procedures that the patient undergoes from three to two.
Temporary ostomies and ostomy reversals can also be performed in this simultaneous fashion. As an example, by performing the ostomy takedown with the operation for one side of the liver, what once took four operations — one rectal with ostomy, one liver, another liver, and one ostomy takedown — can now be done as one liver with rectal, and one liver with the ostomy takedown, resulting in two operations instead of four.
“The idea is to minimize morbidity for the individual patient,” said Alessandro Fichera, MD, UW Medicine professor of General Surgery and director of the Colorectal Surgical Oncology Program at UWMC/SCCA. “We take an individualized approach for each cancer and each patient, taking into consideration also their social concerns.”
Reducing the number of operations improves coordination of care for the patient. By combining the colorectal and liver surgeries, chemotherapy is discontinued only once, and the patient has to recover only once from surgery.
“The surgical management of colorectal liver metastases is evolving,” Park said.
“With the advent of more effective chemotherapeutic agents, we are able to offer liver surgery to patients who were once considered inoperable. As more patients become candidates for liver surgery, more will benefit from having the primary and metastatic disease treated simultaneously.”
Chemotherapy needs to be timed perfectly so the patient can go into surgery at the right time to minimize disruption to the patient’s life, minimize morbidity, and minimize recovery time.
“Patients who are candidates for surgery often get referred after progression on chemotherapy when surgery is no longer feasible or after many cycles of chemotherapy, which can damage the liver,” Park said. “We’d like referring physicians to know the option for simultaneous surgery exists for their patients. We have successfully coordinated the timing of chemotherapy and/or radiation with several patients’ medical oncologists and radiation oncologists near home.”
The Secondary Liver Tumor Clinic at UWMC is the longest-running dedicated liver tumor clinic in the Northwest. In 1998, Raymond Yeung, MD, professor of Surgery at UWMC, created the clinic to address this important patient population.
Contact the Secondary Liver Tumor Clinic’s Jan Thomas with questions or to set up a case review at (206) 598-8710. To make an appointment, contactTee Florence by phone at (206) 598-2352 or fax (206) 598-1984.
MultiCare Regional Cancer Center welcomed Chris Bredeson as administrator in January 2013. MultiCare Regional Cancer Center has four comprehensive clinic locations in Tacoma, Gig Harbor, Puyallup, and Auburn.
Prior to joining MultiCare, Bredeson served as the chief executive officer of a physician-owned multi-specialty practice with several locations in Lewis and Thurston Counties for more than 12 years. He also has more than 11 years of experience providing leadership to large, hospital-based physician groups in the Northwest and Florida.
Bredeson completed his MBA (emphasis in health care administration) at City University in Bellevue, Wash. in 1993. He and his wife, Darla, along with their three children, live in Olympia. Born at Northgate Hospital in Seattle, Bredeson is a Northwest native and was raised in Pierce County.
MultiCare Regional Cancer Center
Uma Chandavarkar, MD is a board-eligible gynecologic oncologist at MultiCare Regional Cancer Center with expertise in minimally invasive surgery techniques and treatment of all stages of cancer of the female reproductive tract.
Chandavarkar earned her medical degree from the University of California, San Diego School of Medicine. She completed her internship and residency in obstetrics and gynecology at the Los Angeles County Medical Center/ University of Southern California (USC). While there, she completed her three-year subspecialty fellowship in gynecologic oncology.
Recipient of the Outstanding Scientific Research Endeavor Award from the USC Obstetrics & Gynecology Fellowships for her work in epigenetics and ovarian cancer, in 2008, Chandavarkar was awarded the Leadership Award from the USC Obstetrics & Gynecology Residency Program, where she served as a chief resident. She is a current candidate member of the Society of Gynecologic Oncology and an active candidate of the American Board of Obstetrics and Gynecology.
In addition to her rewarding career, Chandavarkar enjoys hiking, cooking, and spending time with her family and friends.
Protocol SPI-ZEV-11-301: A Phase III, Open-Label, Multicenter, Randomized Study of Sequential Zevalin (Ibritumomab Tiuxetan) Versus Observation in Patients at Least 60 Years of Age with Newly Diagnosed Diffuse Large B-Cell Lymphoma in PET-Negative Complete Remission After R-CHOP or R-CHOP-Like Therapy
Ajay Gopal, MD, associate professor of medical oncology at the University of Washington School of Medicine, is the lead principal investigator for this industry-sponsored trial which will evaluate the efficacy and safety of Zevalin given with rituximab compared to observation alone in patients who are in PET-negative complete remission after first-line R-CHOP or R-CHOP-like therapy.
Patients are eligible if they are at least 60 years of age, diagnosed with diffuse large B-cell lymphoma , stage II, III, or IV, or follicular lymphoma grade 3B, who are in PET-negative complete response after six cycles of first-line treatment with anthracycline-based chemotherapy in combination with rituximab (R-CHOP or R-CHOP-like regimen).
Approximately 490 patients, 245 per treatment group, will be accrued at approximately 80 centers worldwide. Patients will be randomization in a one-to-one manner. Patients randomized to the treatment arm will receive Rituximab on day one and again one week later (day seven, eight, or nine) followed by Zevalin.
Zevalin is a radioimmunotherapy that targets B-lymphocytes and lymphoma cells of B-cellular origin, which are inherently sensitive to radiotherapy. Patients who have achieved a clinical complete response after standard therapy, but who may be in a state of minimal residual disease and may later relapse, may benefit from Zevalin. To optimize biodistribution, rituximab is given prior to the radiolabeled antibody. The trial sponsor will provide both agents free of charge.
The primary endpoint is overall survival. Investigators estimate that they will follow patients for a median observation period of five years.
Read more more about this trial.
Protocol I4C-MC-JTBC: A Randomized, Open-Label Phase II Study Evaluating LY2875358 plus Erlotinib and LY2875358 Monotherapy in MET Diagnostic Positive NSCLC Patients with Acquired Resistance to Erlotinib
Renato Martins, MD, associate professor of medical oncology at UW School of Medicine and medical director for SCCA Thoracic/Head and Neck Oncology, is the lead investigator for this Lilly-sponsored trial for patients with metastatic nonsmall cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) diagnostic-positive tumors. Patients must demonstrate disease progression by RECIST criteria while on erlotinib to be eligible.
The use of erlotinib in advanced NSCLC patients with tumors harboring epidermal growth factor receptor (EGFR) mutations has demonstrated clinically significant progression-free survival and overall response rates. However, the overwhelming majority of patients inevitably develop resistance to erlotinib. Mechanisms considered to be responsible for this phenotype of “acquired resistance” to first-generation EGFR tyrosine kinase inhibitors in EGFRmt NSCLC patients include secondary T790M mutations of EGFR and activation of the MET signaling pathway.
LY2875358 is a humanized IgG4 monoclonal bivalent antibody (mAb) developed to block signaling of the HGF/MET pathway via two modes of action. Ligand-dependent activation of the MET pathway is impaired when LY2875358 binds to MET by limiting HGF interaction with the receptor. In addition, binding of LY2875358 to MET causes receptor internalization and degradation resulting in suppression of ligand-independent activation of MET.
This study will test whether acquired resistance to erlotinib in MET diagnostic-positive NSCLC patients can be overcome by treatment with LY2875358 plus erlotinib. The study will also explore whether LY2875358 monotherapy has clinical activity in this patient population. Randomization to LY2875358 plus erlotinib versus LY2875358 alone will be performed in a threeto-one manner.
To be eligible, patients must have archival tumor tissue available for testing and must be MET diagnostic(+). In addition, a post-erlotinib progression tumor sample, or willingness to undergo a tumor biopsy post-erlotinib progression, is mandatory. Lilly will cover the cost of the required biopsy if not performed as part of standard care.
Note: We will offer this trial at the same time we are offering Network Member participation in the Phase II trial of weekly Abraxane for patients with advanced NSCLC with EGFR mutations following front-line therapy with EGFR tyrosine kinase inhibitors by Christine Baik, MD, MPH. While these trials may appear to compete for the same patient population , we are offering both trials for following reason:
- Patients who test negative for MET are not eligible for the LY2875358 trial but are eligible for the Abraxane trial.
- Patients who are MET-positive and are treated with LY2875358 plus erlotinib may be eligible for the Abraxane trial at progression.
Thanks Network Member investigators and research staff for participating in the Esperance ovarian cancer trial, which will close to accrual within the next month. With your help we met our accrual goal and had at least one patient enrolled from each participating site.
Contact SCCA Network Clinical Research at (888) 201-0060 with any questions.
Clinical Trial Opportunities
- ECOG E3F05: Phase III Study of Radiation Therapy with or without Temozolomide for Symptomatic or Progressive Low-Grade Gliomas www.seattlecca.org/clinical-trials/braincancer- NCT00978458.cfm
- RTOG 0834/EORTC 26053_22054: Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1p/19q Deleted Anaplastic Glioma. The CATNON Intergroup Trial www.seattlecca.org/clinical-trials/brain-NCT00626990.cfm
- RTOG 1005: A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost Versus Standard Whole Breast Irradiation Plus Sequential Boost for Early-Stage Breast Cancer www.seattlecca.org/clinical-trials/breastcancer- NCT01349322.cfm
- FHCRC 6628: Combined Targeted Therapies for Triple Negative Advanced Breast Cancer—A Phase II Trial of Weekly Nab-Paclitaxel and Bevacizumab Followed by Maintenance Targeted Therapy with Bevacizumab and Erlotinib www.seattlecca.org/clinical-trials/breastcancer- NCT00733408.cfm
- RTOG 0926: A Phase II Protocol for Patients with Stage TI Bladder Cancer to Evaluate Selective Bladder Preserving Treatment by Radiation Therapy Concurrent with Radiosensitizing Chemotherapy Following a Thorough Transurethral Surgical Re-Staging www.seattlecca.org/clinical-trials/bladder-cancer- NCT00981656.cfm
- FHCRC 7048: Phase II Trial of Radiation with Androgen Deprivation (AbiRAD): Abiraterone Acetate, Prednisone, and LHRH Agonist Prior to and Concurrent with Radiation Therapy www.seattlecca.org/clinical-trials/prostate-7048.cfm
Head & Neck
- RTOG 0920: A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally Advanced Resected Head and Neck Cancer
- Endocyte EC-FV-06: A Randomized Double-Blind Phase III Trial Comparing EC145 and Pegylated Liposomal Doxorubicin (Pld/Doxil®/Caelyx®) in Combination Versus PLD in Subjects with Platinum-Resistant Ovarian Cancer www.seattlecca.org/clinical-trials/gyncancer- NCT01170650.cfm
The incidence of myelodysplastic syndrome (MDS) is increasing, with rates as high as 10 per 100,000 people per year. Given the curative potential of allogeneic hematopoietic cell transplantation (HCT), MDS is currently the third most common indication for allogeneic HCT. However, posttransplant relapse remains the major cause of failure. Pre-HCT cytoreductive therapy has reduced post-HCT relapse. At SCCA, 130 out of 141 MDS patients transplanted over the past three years (92 percent) received prior chemotherapy, but the optimum modality and the impact on post-HCT outcomes are not clear. The American Society for Blood and Marrow Transplantation has identified this as a critical area for further investigation.
Until 2004, the mainstay of cytoreductive therapy was an intensive regimen used for induction therapy in acute myeloid leukemia. Since MDS is primarily a disease of older age, often complicated by medical comorbidities, a major concern is toxicity and mortality related to treatment. Treatment related toxicities are likely to affect patients’ candidacy for and capacity to tolerate subsequent HCT. More recently, many patients have received pre-HCT cytoreduction with the hypomethylating agents azacitidine and decitabine, which were attractive because of their ease of administration and low-toxicity profile. Although there is a growing body of retrospective literature describing this approach, no randomized prospective trials comparing induction chemotherapy (IC) with hypomethylation have been carried out.
With the ICT-HCT study, we are conducting a randomized, prospective trial comparing pre-HCT hypomethylating therapy to IC in 60 patients with intermediate or higher-risk MDS who are HCT candidates. The innovated design of this trial is based on the principles of practice-based research, allowing for flexibility and physician discretion in formulating the treatment plan after randomization. Patients can either receive regimens considered the standard of care at their home cancer center or participate in internal review board-approved clinical trials that fit within the parameters of the assigned study arm. The primary goal is to prospectively assess the impact of IC versus hypomethylating therapy on the failure-free survival in the study population. The trial will assess response, transplantation rate, peri-transplant mortality, relapse, and quality of life. Results from this study will provide controlled, prospective data on the impact of pre-HCT IC versus hypomethylating therapy on transplantability and transplant outcome, thereby guiding clinical practice.
Investigator: Bart Lee Scott, MD, MS
To learn more about this study, visit www.seattlecca.org/ clinical-trials/transplant-NCT01812252.cfm.