SWOG Update
November 2010

all-in-one page for printing
Contents  
Welcome to the November 2010 SWOG Update.

For all members and friends of SWOG, the SWOG Update will keep you informed of what's happening with the group. News to report? Send it to communications@swog.org.

View a one-page version for printing.
 
Chair's Corner  
Nurturing cancer survivorship research in the CCOPs
Laurence H. Baker photo Community Clinical Oncology Programs (CCOPs) are ideally suited to conduct the sort of long-term follow-up with patients that is needed to answer questions about the late effects of treatment, toxicity, and disease. [more]

Study Updates  

notched fly wings S0933: Taking a Notch out of melanoma
The Notch receptor is a key piece of the system cells use to communicate to their neighbors and is believed to be important in cell development and differentiation. SWOG's newest study aims to interfere with the control of Notch-based function on gene expression in melanoma cells. [more]

 
In the News  
You, your colleagues, and your cooperative group in the media ...
  • The October 1, 2010 Cancer Letter reported that David Alberts, M.D., director of the Arizona Cancer Center and until August vice-chair of SWOG's Gynecologic Committee, received the Association of Community Cancer Centers' 2010 Clinical Research Award at that group's 27th National Oncology Economics Conference. Alberts was honored for his extensive research, leadership, and commitment to individuals with cancer.
  • Laurence Baker, D.O., SWOG group chair, was quoted in the November 16 issue of the NCI Cancer Bulletin in a story on the difficulties of moving a promising treatment for Ewing sarcoma into later-phase trials, in spite of its promise. Baker said "The extent of [Roche 1507's] activity in Ewing sarcoma is nearly identical to what was seen with trastuzumab (Herceptin) in breast cancer when it first went into phase II testing."

Spotlight

South(, )west(, east, and north) oncology group

new SWOG logo
SWOG's new logo updates the look of the old while maintaining the recognizability of the DNA spiral in the blue circle. Versions of the logo and a new Powerpoint presentation template are downloadable by members.

SWOG has been a nationwide network of institutions and researchers for several decades, and has in recent years become international. The signifier "southwest" in the group's name has been at best inaccurate, at worst misleading, for some time.

So it's only fitting that the term finally be retired. SWOG Group Chair Laurence Baker, D.O., announced at the Chicago group meeting in October that the Southwest Oncology Group would henceforth be known simply as "SWOG."

"It's what most of the research world and many of the patients who participate in our trials already know us as," Baker points out.

As part of the process of updating and clarifying the group's image, SWOG sent a survey to all members in late summer asking them to vote on several candidates for a new graphical mark, or logo, for the group and a new tag line -- the most succinct statement of the group's mission or vision -- to accompany that new logo.

And the winner was ...

SWOG members overwhelmingly chose a version of the group's existing graphical mark -- the white double helix in a blue circle -- to use going forward. That mark now appears to the right of and slightly above the term "SWOG."

The choice lets the group keep the many years of equity we've built up in the existing logo while still letting us present it in an updated context.

Leading cancer research. Together.

Votes for a new tag line for the group were somewhat more equivocal, but the line that emerged as the favorite conveys, in satisfyingly concise form, what SWOG does and how it does it: Leading cancer research. Together.

In coming weeks you'll see the term "SWOG" replace most uses of "Southwest Oncology Group." Don't be alarmed. We're simply acknowledging who we are.

Versions of the new SWOG logo and a new Powerpoint presentation template are available to members on the SWOG website.



Chair's Corner

Nurturing cancer survivorship research in the CCOPs

 -- by Laurence Baker, D.O., SWOG chair

Laurence H. Baker, D.O., SWOG Group Chair

I attended several strategic planning meetings during the spring and summer for the National Cancer Institute's Community Clinical Oncology Program (CCOP), serving as a member of the CCOP Core Committee.

The primary question we addressed was this: What are the areas of potential research that lend themselves to clinical trials for the CCOP/Research Base network?

By the close of the meeting, cancer survivorship had found its way to the top of our research agenda as our highest priority area for study. We recognized that the CCOPs are ideally suited to conduct the sort of long-term follow-up with patients that is needed to answer questions about the late effects of treatment, toxicity, and disease.

These would include longitudinal studies of symptoms and toxicities and would integrate measures of patient-reported outcomes and the collection of biospecimens to develop means of predicting toxicities.

That the CCOP Core Committee highlighted survivorship research is further evidence that SWOG was again ahead of the curve in forming our Cancer Survivorship Committee as part of the reorganization of the Cancer Control and Prevention committees under Dr. Frank Meyskens in 2007. Advances in cancer treatment mean we have more cancer survivors than ever before, survivors often living with functional impairments due to treatment toxicities. This population is going to garner an ever larger proportion of the attention of cancer researchers in the coming years.

One of the critical issues the CCOP Core Committee addressed was how to attract new researchers to explore cancer control and prevention topics. We agreed we need to expand training and mentorship programs for younger investigators planning cancer control and prevention studies.

The committee's report specifically mentions SWOG's Young Investigators (YI) Training Course program as a model to be emulated. In fact, seven of the protocol proposals that have been critiqued and refined in recent YI sessions have been cancer control studies.

A number of SWOG leaders were active in formulating the strategic plan for cancer control research that came out of these meetings, including Dr. Christine Ambrosone, co-chair of SWOG's Molecular Epidemiology Committee; Dr. Frank Meyskens, SWOG associate chair for cancer control and prevention; and Dr. James Wade, co-chair of SWOG's Symptom Control and Quality of Life Committee.

Here are a few others from our group who also contributed to these discussions (apologies if I've missed any names):

  • Jeffrey Berenberg, M.D., Hawaii MBCCOP
  • Elise Cook, M.D., MD Anderson Cancer Center
  • Joyce Nancarrow Tull, R.N., B.S.N., C.C.R.P., Beaumont CCOP
  • Clair Verschraegen, M.D., New Mexico MBCCOP

One final word on CCOPs: congratulations to all of those SWOG-affiliated CCOPs that have had their funding renewed for another grant cycle (see the list elsewhere in this Update).

These programs are a vital part of what SWOG is and does. As a group, their average accrual of patients to SWOG studies is second only to that of our U10 institutions. Their work brings clinical cancer research to communities that might not otherwise have access, but it also helps ensure that the population we draw on for our studies is more representative of the population of the United States at large.



Study Update

S0933: Taking a Notch out of melanoma

photo of multiple fly wings, most of which have notches and/or are deformed
The Notch receptor takes its name from where its effects were first observed -- the notched wings that flies developed (shown here) when researchers interfered with the gene that encodes the receptor. The Notch receptor is now seen as part of an evolutionarily ancient signaling pathway important in cell differentiation, proliferation, and apoptosis and is a site of intense focus in oncology research.
Credit: J. Cell. Biol. (CC)

"Phase II study of RO4929097 (NSC-749225) in advanced melanoma"

SWOG's newest trial, S0933, is a phase II study testing the effect of an investigational drug known as RO4929097 on survival in stage IV melanoma patients. The drug, a selective gamma-secretase inhibitor, interferes with the Notch receptor signaling pathway, which is thought to promote cell proliferation in melanoma.

The Notch receptor is a key piece of the system cells use to communicate to their neighbors and is believed to be important in cell development and differentiation.

Recent work by study coordinator Thomas Gajewski, M.D., Ph.D., of the University of Chicago and others has shown that by interfering with the control of Notch-based function on gene expression in the melanoma cell, gamma-secretase inhibitors can limit proliferation and increase apoptosis, or programmed cell death, among melanoma cells grown in the lab. 

"After 48 hours of drug exposure, no viable cells were detected, indicating a very powerful anti-tumor activity in vitro," says S0933 lead study coordinator Kim A. Margolin, M.D., of the Seattle Cancer Care Alliance.

Gajewski's lab worked with melanoma cell lines that have high levels of Notch activation, thus making them particularly sensitive to treatments that interfere with Notch function.

In the clinic, a recently-completed phase I study treated patients with advanced solid tumors using RO4929097, the same gamma-secretase inhibitor to be used in S0933. A 2009 report by that phase I study's investigator stated that of 71 treated patients, 15 had shown clinical benefit from the treatment.

The phase II S0933 uses the dose of study drug determined in this phase I trial to be most likely to inhibit Notch signaling while still maintaining an acceptable safety profile. S0933 patients will take 20 mg of RO4929097 daily for 3 consecutive days each week until the cancer grows or until side effects or laboratory toxicities are not tolerable at the same or a reduced drug dose.

The primary objective is to assess the six-month progression-free survival and one-year overall survival probability in stage IV melanoma patients who have had no prior chemotherapy and who undergo this treatment with RO4929097.

Secondary objectives include investigating how Notch activation status and gene expression profile as well as immune system parameters relate to clinical outcomes, including tumor regression and toxicities.

Eligibility for study participation

Patients must have Stage IV, histologically confirmed, measurable melanoma, a Zubrod performance status of 0-1, and adequate bone marrow, liver, and renal function.

Patients may not have a history of, or current evidence of, brain metastases. They may have received cytotoxic drugs as part of adjuvant therapy if completed at least 180 days prior to registration, and they may have received prior radiation therapy if completed at least 28 days prior to registration and if there remains measurable tumor outside of radiation ports.

The study has an accrual target of 72 eligible patients. The first local IRB approval of the trial took place in mid November, 2010, at the Columbus (OH) CCOP.

Please review the detailed eligibility criteria. Eligible patients can find the nearest participating institution online or by contacting the Southwest Oncology Group at (210) 614-8808 or at protocols@swog.org.

 



Fall 2010 SWOG Meeting: Cancer science "done in a hotel room in Chicago"

photo of Chicago's Water Tower
Credit: Freefoto.com

The fall 2010 SWOG semiannual group meeting was held in Chicago over three days in late October, and in numerous committee sessions and more intimate working group sessions, scientific priorities were agreed on, trials were proposed and developed, issues with ongoing studies were settled, reports on completed trials were made, and the science of cancer treatment and prevention was advanced.

In opening the meeting's well attended plenary session, Group Chair Laurence Baker, D.O., gave a special welcome to the director of the Instituto Nacional de Cancerologia (INCan) of Mexico, Alejandro Mohar Betancourt, M.D., Sc.D., who was there representing his organization as SWOG's newest member institution. INCan is Mexico's equivalent of the US's National Cancer Institute.

After pitching three studies struggling with low accrual (S0702, S0337, and S0709), Baker recognized the achievement of accrual champion Stanley J. Vogel, M.D., of Stormont-Vail Healthcare in Kansas, who had recently enrolled his 1,000th patient to a SWOG clinical trial.

The chair also thanked several departing committee leaders for their service to SWOG. These included Kathy Albain, M.D., who stepped down as co-chair of the Cancer Survivorship Committee; Lisa Rimsza, M.D., outgoing chair of the Lymphoma Translational Medicine Subcommittee; Jeffrey Sosman, M.D., outgoing chair of the Melanoma Translational Medicine Subcommittee; and Maurie Markman, M.D., who resigned as chair of SWOG's Gynecologic Committee.

Robert Krouse, M.D., was welcomed as new co-chair of the Cancer Survivorship Committee.

Plenary: SWOG's past, present, and future

plenary session graphic: Past, present, future SWOG's position in the rapidly shifting landscape for cooperative groups, a focus of much informal conversation in Chicago, was also the focus of the meeting's plenary session presentations.

Richard Schilsky, M.D., until recently chair of the Cancer and Leukemia Group B (CALGB), presented the recommendations and implications of the Institute of Medicine's (IOM's) April report on the future of NCI clinical trials and the cooperative groups. As one of the report's authors, Schilsky was able to highlight both what the document said and what it did not, noting for example that the report recommended consolidation of certain back office and front office operations of the cooperative groups, not the consolidation of the groups themselves.

"What it says," Schilsky pointed out, "is that based on peer review and quality, that some cooperative group scientific activities should potentially be consolidated, which I think will inevitably lead to the formation of perhaps more intergroup committees."

SWOG Group Chair Laurence Baker, D.O., then spoke, outlining steps SWOG has taken and will take to achieve the goals set in the IOM report, arguing for the importance of maintaining a vigorous publicly funded clinical trial system, and highlighting the recent launch of SWOG's Genomic Medicine Task Force and its early work helping set directions and priorities for biomarker driven trials.

Baker closed with a list of goals for the group:

  • using the momentum of the IOM report and NCAB review to improve ourselves,
  • using public funding as a strategic advantage and developing approaches more independent of industry,
  • emphasizing more biomarker and biology driven trials, and
  • working toward the development of a Latin American cooperative group a la the European Organisation for Research and Treatment of Cancer (EORTC) and the National Cancer Institute of Canada (NCIC).

The third plenary presentation, given by SWOG Group Statistician John Crowley, Ph.D., was a lesson in adaptive clinical trial design -- the development of trials with prospectively planned changes in schema or analysis based on data accumulated as the trial progresses. Crowley examined the role such design strategies should, or in some cases should not, play in SWOG's future portfolio of studies.

Audio and slides for all three of the plenary presentations are available online.

In the session rooms

Breast cancer was the theme of the Nursing Committee Workshop, which featured presentations on the use of nanoparticles in breast cancer treatment, the toxicity of new breast cancer agents, and the recently launched S0800, which is studying the use of nanoparticle albumin bound paclitaxel (nab-paclitaxel) as part of neoadjuvant treatment of breast cancer.

The Clinical Research Associates (CRA) Committee plenary session included presentations on the use of genomics in treating early stage breast cancer, the perspectives of breast cancer patients themselves, and the specimen tracking system recently rolled out by the Cancer and Leukemia Group B (CALGB).

SWOG Breast Cancer Committee Chair Gabriel Hortobagyi, M.D., reviewed recent advances in personalized treatment of the disease at the CRA continuing education workshop.

At the Board of Governors meeting, new primary investigators were appointed for three sites: the Brooke Army Medical Center (Bradley McGregor, M.D.), the University of Michigan (Anne Schott, M.D.), and the University of Mississippi (Barbara Craft, M.D.).

Manuel Valdivieso, M.D., was named new chair of the Quality Assurance Committee and Robert Krouse, M.D., was approved as new co-chair of the Cancer Survivorship Committee.

The Board agreed to disband the Translational Medicine Committee. Translational Medicine Subcommittees within the disease committees remain, as does SWOG's commitment to the study of translational medicine. "We're not disbanding our efforts in translational medicine by any means," said Group Chair Baker.

The Board gave official sanction to the closing of the Gynecologic Cancer Committee and to the dissolution of the Scientific Advisory Board in favor of a more compact Scientific Leader Advisory Group that includes chairs from several of SWOG's disease and cancer control and prevention committees. Baker observed that this new group "really is the scientific leadership of SWOG."

The Hope Foundation reported to the Board on assets of $29.7 million and liabilities of $17.3 million as of the end of the third quarter of this year. Johanna Horn, director of the foundation, reported that the SWOG Clinical Trials Initiative, which is run as a limited liability corporation within The Hope Foundation, now maintains 43 correlate contracts with pharmaceutical companies in support of SWOG trials. Horn reported on the two recently appointed Coltman Fellows and reminded the group that the next application deadline for Coltman Fellowships is March 4, 2011.

SWOG's Board of Governors was told that The Hope Foundation Board had voted to allocate $1 million to support SWOG infrastructure, translational medicine, and clinical research projects over the coming year. Hope will issue a request for proposals for this funding by year's end. The application process will be open beyond SWOG, and the funding of such projects by Hope is "likely to be an ongoing process," said Baker. He pointed out that the foundation now has a board structure in place to better represent group interests, and they will begin using banked funds to support identified projects.

The Committee Chairs session on Saturday morning opened with an update from the Data and Safety Monitoring Committee, who reported they were concerned about slow accrual to study S0600, a study that has subsequently been permanently closed. They also reported futility findings for two of the four arms of study S0221, which has been temporarily closed to accrual while the protocol is updated in response to these findings. The DSMC also reported that interim analyses of studies S0727 and S0226 had been performed and those trials were continuing.

SWOG patient advocate for the Cancer Survivorship Committee, Anna Gottlieb, presented to the committee chairs on the topic of what patient advocates contribute, or can contribute, to the work of SWOG.

Nathan Eriksen, chief of administration, informed the board of updates to SWOG's data sharing policy, which in keeping with NCI dictates makes data more widely available to researchers outside of the group. The chairs agreed that this policy should stipulate that publications concerning SWOG data that lack SWOG authorship should include a disclaimer indicating that the views expressed do not represent those of SWOG.

Also discussed was an update to SWOG Policy 30 stipulating that patients on a SWOG study who transfer to another institution remain as SWOG-associated patients. Among other benefits, this should help the group develop a larger survivor database for potential survivorship studies.

Chairs engaged in a broad discussion of possible minimum accrual rates for CCOP component sites and SWOG affiliate members. While minimums for CCOP component sites were not adopted, the group chair did request that CCOP primary investigators review their component sites regularly to ensure they meet minimum participation guidelines.

Dana Sparks, director of operations and protocols, presented details of the protocol development timeline restrictions now being implemented based on the recommendations of the NCI's Operational Efficiency Working Group (OEWG). OEWG timeline requirements take full effect January 1, 2011. You can learn more about them at http://ccct.cancer.gov/files/OEWG-Report.pdf.

Further details and handouts from a number of the sessions are available on the fall 2010 SWOG group meeting page.



SWOG is 13 for 13 at ASH 2010

ASH logo

SWOG blood cancer researchers are batting a thousand at this year's ASH meeting. Of thirteen SWOG abstracts submitted for December's American Society of Hematology (ASH) 2010 annual meeting -- the premier conference for research in cancers of the blood -- thirteen SWOG abstracts have been accepted for presentation.

These include ten abstracts accepted for oral presentation and one accepted as a late-breaking abstract. All thirteen accepted abstracts are listed below.

* = accepted for oral presentation

icon-sized image of journal article face page

2010 ASH Meeting Abstracts Accepted

Leukemia

*S0325

A randomized phase II trial of dasatinib 100 mg vs. imatinib 400 mg in newly diagnosed chronic myeloid leukemia in chronic phase (CML0cP): the S0325 intergroup trial. JP Radich, KJ Kopecky, S Kamel-Reid, W Stock, E Paietta, M Wadleigh, RA Larson, PD Emanuel, MS Tallman, J Lipton, S Couban, MW Deininger, FR Appelbaum, BJ Druker. American Society of Hematology 2010 Annual Meeting, submitted as "late breaking" abstract; accepted for oral presentation.

*S0333, S9400

Analysis of CRLF2/JAK expression and mutation status in adult ALL patients. O Sala-Torra, G Pogosov, E Pogosova-Agadjanyan, H Gundacker, S Forman, S O'Donnell, F Appelbaum, C Willman, JP Radich. American Society of Hematology 2010 Annual Meeting, accepted as oral presentation.

*S0605

A phase II study of lenalidomide for previously untreated deletion (del) 5q acute myeloid leukemia (AML) patients age 60 or older who are not candidates for remission induction chemotherapy (Southwest Oncology Group study S0605). M Sekeres, H Gundacker, J Lancet, A Advani, S Petersdorf, J Liesveld, D Mulford, T Norwood, C Willman, A List, F Appelbaum. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

S9031, S9123, S9333, S9500

Over-expression of novel IRF8 splice variants is with a significant decrease in relapse-free survival in adult AML patients. E Pogosov-Agadjanyan, K Kopecky, H Lee, J Anderson, J Godwin, A List, S Meshinchi, V Oehler, S Petersdorf, C Willman, F Appelbaum, JP Radich, D Stirewalt. American Society of Hematology 2010 Annual Meeting, accepted as poster presentation.

S9031

Prognostic implications of the IDH1 synonymous SNP rs11554137 in pediatric and adult AML: a Children's Oncology Group and Southwest Oncology Group study. P Ho, T Alonzo, K Kopecky, K Miller, J Kuhn, R Zeng, R Ries, R Gerbing, W Fan, S Raimondi, B Hirsch, V Oehler, CA Hurwitz, J Franklin, A Gamis, S Petersdorf, J Anderson, J Godwin, GH Reaman, C Willman, LP Zhao, I Berstein, J Radich, F Appelbaum, D Stirewalt, S Meshinchi. American Society of Hematology 2010 accepted as poster presentation.

C9710

Clonal markers in relapsed acute promyelocytic leukemia (APL): clinicopathological associations and relation to all-trans retinoic acid (ATRA) treatment on intergroup phase III trial C9710. R Gallagher, B Moser, J Racevskis, X Poire, C Bloomfield, A Carroll, R Ketterling, D Ralston, E Schachter-Tokarz, D Zhou, I Chen, R Harvey, G Koval, D Sher, J Feusner, M Tallman, F Appelbaum, R Larson, B Powell, E Paietta, C Willman, W Stock. American Society Hematology 2010 Annual Meeting, accepted for poster presentation.

*E1905

Prolonged administration of azacitidine with or without entinostat increases rate of hematologic normalization or myelodysplastic syndrome and acute myeloid leukemia with trilineage dysplasia: results of the E1905 trial. T Prebet, S Gore, Z Sun, P Greenberg, M Juckett, L Malick, M Smith, E Paietta, M Czader, J Gabrilove, H Erba, M Tallman. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

*E1905

A 10 day schedule of azacitidine induces more complete cytogenetic remissions than the standard schedule: results of the E1905 study. T Prebet, Z Sun, R Ketterling, G Hicks CL Beach, P Greenberg, E Paietta, M Czader, J Gabrilove, H Erba, M Tallman, S Gore. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

 

Lymphoma

*S0433

R-CHOP with iodine-131 tositumomab consolidation for advanced stage diffuse large B-cell lymphoma (DLBCL): Southwest Oncology Group protocol S0433. J Friedberg, J Unger, WR Burack, AK Gopal, M LeBlanc, O Press, TP Miller, RI Fisher. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

*S0515

Phase II trial of standard dose cyclophosphamide, doxorubicin, vincristine, prednisone (CHOP) and rituximab (R-large B-cell (DLBCL) NHL: Southwest Oncology Group study S0515. A Stopeck, J Unger, L Rimsza, B Farnsworth, M LeBlanc, M Iannone, RI Fisher, TP Miller. America Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

*S8819

Genetic polymorphisms in oxidative stress-related genes correlated with outcome following anthracycline-based therapy for aggressive B-cell non-Hodgkins lymphomas. H Tardif, S Yao, B Goldman, C Spier, M LeBlanc, L Rimsza, D Persky, T Miller, RI Fisher, C Ambrosone, M Briehl. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

*E2496

A randomized phase III trial of ABVD vs. Stanford V +/- radiation therapy in locally extensive and advanced stage Hodgkin's lymphoma: an intergroup study coordinated by the Eastern Cooperative Oncology Group (E2496). L Gordon, F Hong, RI Fisher, N Bartlett, JM Connors, R Gascoyne, H Wagner, P Stiff, B Cheson, M Gospodarowicz, R Advani, B Kahl, J Friedberg, K Blum, T Habermann, J Tuscano, R Hoppe, R Horning. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.

*E4494/C9793

R-CHOP versus (vs) CHOP followed by maintenance rituximab (MR) vs observation in older diffuse large B-cell lymphoma (DLBCL) patients (pts): long-term follow-up of Intergroup E4494/C9793. V Morrison, F Hong, T Haberman, RI Fisher, B Cheson, B Kahl, SJ Horning, B Peterson. American Society of Hematology 2010 Annual Meeting, accepted for oral presentation.



SWOG pilots on-site training sessions

photo of D. Sparks
Dana Sparks, M.A.T., SWOG director of operations and protocols

Dana Sparks, director of operations and protocols for SWOG, traveled to the Cleveland Clinic in late September for a half-day face-to-face training session for about 20 research staff.

Her trip was triggered by a request for targeted training from Derek Raghavan, M.D., Ph.D., chair of the Taussig Cancer Institute and the primary investigator for the Cleveland Clinic's membership in SWOG. His query happened to coincide with efforts then underway within SWOG's quality initiative.

"As part of our quality initiative discussions, we talked about providing more, very specific training opportunities for institutions that asked for it," says Sparks. Raghavan's request was a chance for a trial run at this sort of targeted training.

Sparks worked with Cleveland Clinic research coordinator Kristie Moffett to develop an agenda customized to the site's needs. While she used online modules from SWOG's Clinical Trials Training Course as jumping off points for some of the topics she addressed, she also covered local concerns.

"Some specific issues that had caused long-standing frustrations at the institution were resolved during the meeting," says Sparks. These included procedures for long-term follow-up, questions about precisely whom to contact at which SWOG office for which purposes, and a specific protocol issue that resulted in an update to a study calendar.

Sparks expects to do more such trips in the future.

"We would like the impetus for such a trip to come from the site PI," says Sparks, although SWOG will determine which institutions could most benefit from the support and should be given priority. "We'll no longer be doing the Clinical Trials Training Course in person twice a year, so this is a different opportunity to get targeted answers to specific questions."



Accrual Success: Wichita CCOP and S0702

S0702 patient brochure image
If you didn't get copies of the new S0702 patient brochure at the October meeting in Chicago (or even if you did), your head CRA should be getting a stack in the mail soon. You can also download a copy. From the S0702 protocol Web page, follow the directions for the S0702 support page under the heading "Intergroup Access."

Why do some sites accrue well to a given trial while others accrue minimally or not at all? A subject ripe for research, no doubt, but it may be instructive to look at one site accruing well to one trial.

Take the Wichita Community Clinical Oncology Program and study S0702, the observational study assessing the risk of ONJ in patients getting zoledronic acid.

Wichita has accrued 89 patients to the study as of early November. To put their accomplishment in context, if the 282 SWOG sites with IRB approval for S0702 were ranked in order of accrual to the study, top-ranking Wichita CCOP would account for as many patients as the bottom 267 sites combined.

We spoke to Crystal Watson, R.N., research nurse in cancer control for the Wichita CCOP, to see if we could learn some of the secrets of their success with S0702.

 

What strategies do you use to maximize accrual to this trial?

We get a list of every patient doctors are going to see, and someone screens every record to identify which patients are starting or likely to start Zometa, and we present the study to them. We miss very few patients.

How do you present the study to the patient? Do you have a set of talking points?

We present the study to patients, explain what it's about, and tell them it's an observational study.  We explain what ONJ is and tell them 'Patients taking Zometa are at risk for ONJ, but we don't know the exact percent of patients that get ONJ. With this study we're trying to see what that risk level is and see which patients are at higher risk.'

We also point out that this is the same thing that would happen if they weren't on the study -- there's no increased risk by being on the study.

 

If the 282 SWOG sites with IRB approval for S0702 were ranked in order of accrual ... Wichita CCOP would account for as many patients as the bottom 267 sites combined.

Do you talk about dental cost reimbursement if they lack sufficient insurance for the initial exam?

After we present the study we ask 'Do you routinely see a dentist?' We tell them there is some additional funding for people who don't have insurance to cover their dental exam. And we tell them that if by chance they do get ONJ, there are more funds available.

We really see resistance to the initial dental exam only with patients who haven't seen a dentist and have no funds at all to see one. Even with the available funds, some patients are scared of the financial burden -- that $200 won't be enough.

We tell patients 'We highly recommend you go to the dentist every 6 months, but it's not required to be on the study.'

C. Watson
"We can leave the consent form with patients and tell them 'Take the form and we can talk about the study the next time you come in to the clinic.'"
 -- Crystal Watson, R.N., Wichita CCOP

 

Whom have you had to educate about the trial?

We've worked with treatment nurses at the cancer center. We put a little note on the treatment plan order sheet for Zometa and treatment nurses will call a research nurse to say 'Hey, we have a patient getting their first Zometa shot,' and we will go and present the study to that patient.

Dentists often aren't familiar with the research, so we're educating them.

We tell patients 'I will call your dentist and explain this to them, and make sure the dental office can fill out the form.'

With some dentists we have to do more education than others, such as sending them literature -- usually the Zometa drug brochure and study schema.

 

What barriers to accrual to this trial have you had to overcome?

One of the challenges is that patients are just being told that they have cancer that has spread to their bones, so they're dealing with a new diagnosis of metastatic disease at the same time we're approaching them with this study.

SWOG's been good about giving us as much as 90 days after the start of treatment to enroll, and Zometa treatments are usually every four weeks, so it helps that we can leave the consent form with patients and tell them 'Take the form and we can talk about the study the next time you come in to the clinic.'

 

Have you started to use the new S0702 patient brochure?

We haven't used it yet, because we're not having trouble recruiting.



One advocate's perspective

R. Bangs
Rick Bangs, SWOG patient advocate for bladder cancer

What follows is an excerpt from a brief talk given in August to the Bladder Cancer Think Tank, a group of leading researchers in the field, by Rick Bangs, SWOG bladder cancer patient advocate.

My transformation started four years ago this very month when I noticed faint traces of blood in my urine. My journey, like 25% of my brethren, started with muscle-invasion or what I call the Fast Track. I quickly made decisions about where I would go, what I would do, and who would do it. I have no regrets about any of these decisions, and I received exceptional care.

I remember being in the waiting area outside the clinic, completing the myriad of forms that were provided. I was asked to participate in some studies being done on bladder cancer: quality of life with a neobladder versus an ileal conduit, and some tissue bank/genetic studies.

Permission granted? Check.
Permission granted? Check.
Permission granted? Check.

I did not think twice about participating; I would gladly have signed up for more. I vowed at that moment that "some good must come of this."
"Some good must come of this" has been my mantra, my North Star, since that time.

 



Bienvenidos! SWOG welcomes INCan

INCan logo

At the Chicago group meeting in October, SWOG welcomed its newest member, the Instituto Nacional de Cancerologia of Mexico, or INCan.

INCan is the Mexican equivalent of the US's National Cancer Institute, and the alliance brings formal Latin American representation into SWOG, expanding the group's scope in the Americas. SWOG also recently added Canada's University of British Columbia as a U10 grant-funded member institution.

SWOG's international initiatives continued with an early November meeting in Costa Rica to plan follow-up studies to the 1,480-patient trial conducted across seven nations in Central and South America that tested alternative antibiotic regimens against infection with Helicobacter pylori bacteria, which is associated with gastric cancer. The hope is that better control of H. pylori will reduce rates of this cancer, one of Latin America's deadliest. The trial reached its accrual goal earlier this year and is now awaiting one-year follow-up testing for many participants.



SWOG CCOPs get renewed NCI funding

Two dozen Community Clinical Oncology Programs (CCOPs) that identify SWOG as their primary research base have received National Cancer Institute funding for fiscal year 2011. These include the newly formed Boston Medical Center Minority-Based CCOP, which was formerly allied with SWOG as a member institution.

SWOG CCOPs with NCI funding for FY11

SWOG CCOP CCOP PI 
Atlanta Regional CCOP Thomas Seay, M.D.
Bay Area Tumor Institute CCOP Sharon Hiner, M.D.
Beaumont CCOP Gary Chmielewski, M.D.
Boston Medical Center MBCCOP Lisa Kachnic, M.D.
Cancer Research for the Ozarks Robert Carolla, M.D.
Central Illinois CCOP James Wade, M.D.
Columbia River Oncology Program Janet Ruzich, D.O.
Columbus CCOP J. Philip Kuebler, M.D., Ph.D.
Dayton Clinical Oncology Program Howard Gross, M.D.
Grand Rapids Clin Oncol Program Martin Bury, M.D.
Greenville CCOP Jeffrey Giguere, M.D.
Gulf Coast MBCCOP Thaddeus Beeker, M.D.
Kansas City Clinical Oncology Rakesh Gaur, M.D., M.P.H.
LSU Health Sciences Center Robert Veith, M.D.
LSUHSC-Shreveport Glenn Mills, M.D.
Montana Cancer Consortium CCOP Benjamin Marchello, M.D.
New Mexico MBCCOP Claire Verschraegen, M.D.
Northwest CCOP Lauren Colman, M.D.
Scott & White CCOP Lucas Wong, M.D.
St. Louis-Cape Girardeau CCOP Bethany Sleckman, M.D.
University of Hawaii MBCCOP Jeffrey Berenberg, M.D.
Upstate Carolina CCOP James Bearden, M.D.
Virginia Mason CCOP Jacqueline Vuky, M.D.
Wichita CCOP Shaker Dakhil, M.D.
Three additional CCOPs identify SWOG as a secondary research base: Southeast CCC CCOP, Michigan CRC CCOP, and Southern Nevada CCOP.  

Research proposals for SELECT and PCPT biospecimens requested

Researchers both within and outside of SWOG interested in working with the treasure trove of biospecimens and associated clinical data from two of the largest cancer prevention trials ever undertaken can now apply for access to these resources.

The proposal request for research projects involving SWOG PCPT and SELECT biorepository resources is available online, posted along with other pertinent material at swog.org/select and swog.org/pcpt.

PCPT logo The Prostate Cancer Prevention Trial, or PCPT, was a SWOG-coordinated study designed to test whether the drug finasteride (Proscar®) would prevent prostate cancer in men ages 55 and older. A total of 18,882 men gave informed consent for trial participation and use of biospecimens for research purposes. The results of the study, which did suggest a preventive benefit for the drug, were published as "The Influence of Finasteride on the Development of Prostate Cancer," in the New England Journal of Medicine on July 17, 2003.

SELECT logo The Selenium and Vitamin E Cancer Prevention Trial, or SELECT, was the largest cancer prevention trial ever undertaken, a phase III, double-blind, placebo-controlled 4-arm study of selenium, vitamin E, selenium and vitamin E together, and placebo designed to assess the effect of these supplements on the incidence of prostate cancer. Funded by the National Cancer Institute and conducted by SWOG, the study opened in August 2001 and quickly exceeded its accrual goal of 35,533 men. In the fall of 2008, the trial's Data and Safety Monitoring Committee recommended that participants discontinue taking study supplements based on an interim finding of no preventive benefit.

The specimens available are delineated in great detail at swog.org/select and swog.org/pcpt.

For researchers who would like to submit a proposal for a project that will use PCPT or SELECT biospecimens, a Letter of Intent is due on Monday, November 29, 2010. The full application will be due on Monday, January 10, 2011. The full RFA and the online application form are also available at swog.org/select or swog.org/pcpt.



PLCO Trial Biorepository issues RFP for sample use

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial's Etiologic and Early Marker Studies (EEMS) Program is requesting proposals for use of samples from its biorepository of 2.7 million specimens. Application deadline is January 14, 2011.

More details about PLCO EEMS are available on the PLCO website at plco.cancer.gov or at www.plcostars.com (you can request an account if you do not already have one). You can also contact the group at plco-eems@westat.com or 301-212-3723.






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