Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Elsevier Global Medical News. 2011 Mar 15, P Wendling

SAN ANTONIO (EGMN) - The literature is somewhat checkered over who can claim bragging rights for improved breast cancer outcomes, but the overall trend has favored surgical oncologists over general surgeons.

What's driving the improved outcomes isn't entirely clear, but a new analysis suggests that a key mechanism is that patients treated by surgical oncologists participate in clinical trials at dramatically higher rates, lead author Dr. William Dooley said during a plenary session at a symposium sponsored by the Society of Surgical Oncology.

Among 1,220 women analyzed for the period of 2001-2008, 56% of 777 patients treated by a surgical oncologist participated in a clinical trial, compared with only 7% of 443 general surgery patients (P value = .000).

Patients in a clinical trial were more likely to stay connected with the system and followed by their treating physician, said Dr. Dooley, the G. Rainey Williams Professor and chair of surgical breast oncology at the University of Oklahoma Breast Institute, Oklahoma City. The average follow-up was 44.6 months for the 468 trial participants vs. 38.5 months for the 752 nonparticipants (P = .000).

Participation in a clinical trial was associated with a significant survival advantage, increasing overall survival from 26% to 31% at 5 years (P = .000).

The benefits of clinical trial involvement cut across the entire health care team, Dr. Dooley said. Radiologists and pathologists receive outside review of and feedback for their work, while outside monitoring tracks the actions of the treatment team, patient progress through the treatment plan, and adherence of all elements of care to the system.

"When we begin to think about clinical trials and groups like ACOSOG [American College of Surgeons Oncology Group], we need to bring forth the spectrum of clinical trials to cover the whole spectrum of breast disease and encourage all surgeons in the country to be involved," he said. "This may be a very dramatic way that we can improve the quality of breast cancer care nationally."

The entire analysis included 2,191 women who received primary breast cancer treatment from 1995 to 2008 at the Breast Institute, with 752 under the care of a surgical oncologist and 1,439 cared for by a general surgeon. The average age of the women was 54 years and 57 years, respectively.

When the researchers compared their outcomes using standardized measures, the case mix included 25% more late-stage disease than the national population. General surgeons performed right at the national average, while additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline-compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

Breast conservation rates were significantly higher for surgical oncology patients than for general surgery patients overall (53% vs. 38%, P less than .001), and for stage 0-II disease (66% vs. 54%, P less than .01).

Radiation therapy for breast conservation was completed by 97% of patients treated by a surgical oncologist and 67% of general surgery patients, and by 99% vs. 74% for stage III disease (P less than .001 for each), Dr. Dooley said.

"Good intentions don't get us very far," he said. "The Commission on Cancer is starting a program to help us monitor initiation of treatment. It's not the initiation that counts. It's whether the patients actually finish that treatment completely."

There were no survival differences for women with stage 0 or IV disease, and their data were excluded from the presentation.

During a discussion of the study, an audience member questioned the presence of comorbidities in each group, observing that patients enrolled in clinical trials tend to be healthier. Dr. Dooley responded that details on comorbidities were limited, but that Charlson Index scores were similar in both groups. In addition, he noted that the same beneficial effect of clinical trial participation has been observed even in trials with just tissue banking.
Rates of stage I, IIA, and IIB disease were similar at 20.5%, 30.5%, and 17% in the surgical oncology group and 19.6%, 32%, and 24% in the general surgery group. Chemotherapy, however, was significantly more common among patients treated by a surgical oncologist than among those in the general surgery group (69% vs. 56%).

Another attendee pointed out that the Rapid Reporting System sends out an alert if cancer patients are not completing therapy. Dr. Dooley said the system was not in place for the entire study period.

Dr. Dooley and his coauthors reported no relevant conflicts of interest.

Hopeful

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

This information is very interesting and important. Nowadays so many women dying from breast cancer and that is a big problem. I think every state, city and country should take steps to find an effective solution for breast cancer. http://health.usnews.com/top-doctors...lahoma-city-ok, Here is the list of Oklahoma Doctors who are qualified and experienced.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Hopeful,

I am looking at the numbers and this article is somewhat confusing.

I love the idea of more women participating in a clinical trial. My personal experience was that the follow up is better with a trial, then when I was not in a clinical trial.

I like the idea of additional training for oncology surgery, and making it easier for all surgeons to have access to clinical trials.

I'm not so thrilled about trying to force all women into radiation or chemotherapy. And if they are dreaming about getting an alert when women don't complete chemo - they can be alerted all they want, not every person can tolerate chemo.

How about something more useful for our dollars, like tracking who is recurring?

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

'lizabeth,

The key point of the article/research is that Clinical Trial Participation is tied to improved outcome for breast cancer patients.

1) ... additional oncologic training for surgeons provided a 28% improvement in workup and treatment.

But most significantly, the additional training reduced deaths for stage I-III breast cancer from 39% for stage IIIb disease to 57% for stage I disease, Dr. Dooley said.

2) Another mechanism driving the improved outcomes is that patients treated by a surgical oncologist are far more likely to complete National Comprehensive Cancer Network guideline-compatible therapy in a timely fashion, he said. In all, 77% of stage I-III patients treated by a surgical oncologist completed chemotherapy or hormonal adjuvant therapy, compared with 68.5% of general surgery patients (P less than .02).

True, not everyone tolerate chemo the same way. There are trade-offs. Let's not scare off our fellow cancer fighters - especially the newly diagnosed. They are entitled to factual data and making wise decisions themselves.

My take of the article is that cancer patients are better off under the care of a trained surgical oncologist (instead of general surgeon) not only because of their special training, but because patients are more likely to undergo/follow through with adjuvant therapies such as chemo and radiation.

It's the 21st Century! Let's allow 21st Century thinking to work to our survival advantage.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Yes Jackie - I couldn't agree more, cancer patients are entitled to make decisions based on factual data.

I question why surgeons are making a power grab to get an alert system.

The information in the study is from 1995 through 2008, over 5 years old - which is prior to almost all targeted therapies for the stage I, IIa & IIb.

I appreciate seeing what the industry is up to, but I feel this study wasted valuable dollars that could be used for something more valuable - like identifying the 6 of 10 women who are currently suffering through chemo, believing it is "saving" their life - when they are actually receiving no benefit from the treatment.

I downloaded information Lani posted - that I hope to find progress in identifying more of these patients. I'm off to eagerly devour the news!

I have much higher expectations for advances in the 21st century, a century in which cancer patients should not have to suffer through radiation, chemotherapy and surgery as standard of care.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

The article was accessed in March, 2011. [Elsevier Global Medical News. 2011 Mar 15, P Wendling] There is usually a gap between data collection and the research publication date. Not sure if the investigators included those 2 years (between 2008 and 2010) in the 'survival' calculation.

The speed of telecommunication we have right now does make the 2, 3 years gap look 'huge'. But it's an retrospective study and the focus was to compare the outcome ...

I am not sure about your 'surgeons are making a power grab to get an alert system' statement. I've had five major surgeries so far and all my surgeons are extremely hard-working professionals who are dedicated to their work and their patients (the neurosurgeon operated 23 hours straight - drinking coffee and juice to sustain his energy; the breast surgeon squeezed my surgery into her busy schedule after a radiation oncologist friend talked [as a 2nd opinion doctor] to her on my behalf; the gynecological surgeon did the hyst/oo as soon as the proper instrument was received; the young doctor in the GKRS Center was cheerful and courteous ...) Perhaps I am a little biased as I love all my doctors... [My late Mother-in-law had told me back in 1990: "It's all right ... We all fall in love with our doctors." :)]

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Happened to see an abstract about the treatment of Her2-positive breast cancer [Notice the statement in the middle of the paragraph: "HER2-positive breast cancer in the setting of HER2-targeted therapy is no longer associated with poor prognosis" (Not sure if it's been posted before) Herceptin is a monoclonal 'antibody',and KADCYLA® (ado-trastuzumab emtansine = T-DM1) http://www.kadcyla.com/ is the new ‘antibody chemotherapy conjugate’]:

Breast. 2013 Dec 18. pii: S0960-9776(13)00300-7. doi: 10.1016/j.breast.2013.11.011. [Epub ahead of print]
Treatment of HER2-positive breast cancer.
Figueroa-Magalhães MC1, Jelovac D1, Connolly RM1, Wolff AC2.
Author information
Abstract
The human epidermal growth factor receptor 2 gene (HER2) is overexpressed and/or amplified in ∼15% of breast cancer patients and was identified a quarter century ago as a marker of poor prognosis. By 1998, antibody therapy targeting the HER2 pathway was shown to demonstrably improve progression-free and overall survival in metastatic disease, and in 2005 evidence of improvement in disease-free and overall survival from the first generation of trastuzumab adjuvant trials became available. However, not all patients with HER2 overexpression benefit from trastuzumab. Second-generation studies in metastatic disease led to the approval of several new HER2-targeted therapies using small molecule tyrosine kinase inhibitors such as lapatinib, new HER2/HER3 antibodies such as pertuzumab, and the new antibody chemotherapy conjugate ado-trastuzumab emtansine. These successes supported the launch of second-generation adjuvant trials testing single and dual HER2-targeted agents, administered concomitantly or sequentially with chemotherapy that will soon complete accrual. HER2-positive breast cancer in the setting of HER2-targeted therapy is no longer associated with poor prognosis, and recent guidance by the US Food and Drug Administration suggests that pathologic response to HER2-targeted therapy given preoperatively may allow an earlier assessment of their clinical benefit in the adjuvant setting. An adjuvant trial of trastuzumab in patient whose tumors express normal levels of HER2 and trials of single/dual HER2-targeting without chemotherapy are also ongoing. In this article, we review the current data on the therapeutic management of HER2-positive breast cancer.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Jackie,

Well I don't fall in love with my doctors . . . I'm paying them to be part of my professional health care team. I appreciate them for what they do to help me maintain good health.

I don't want my surgeons to monitor my oncologist, or my radiologists. Oncologists and radiologists are highly trained professionals who can make their own professional decisions on my behalf.

I would prefer surgeons to focus on improving surgery, and not take on the supervision of other areas. An alert system for surgeons to let them know if patients don't complete treatment in other areas - no thank you. Stay out of the decisions that should be left up to myself and other professionals.

The information is over 5 years old. The outcome of the study shows the principal investigator's biases.

I see strong signs that the industry is moving towards personalized medicine, away from always including chemo and radiation therapy. New science is starting to show that "compliance" in these areas is not necessary to have good results.

Dr Dooley and his associates should look for a more constructive way to spend research money.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Perhaps you are thinking about a general surgeon instead of a surgical oncologist. The following article (abstract) does call for additional research on care coordination and delivery.

J Cancer Surviv. 2013 Dec 19. [Epub ahead of print]
Perspectives of cancer survivors on the role of different healthcare providers in an integrated delivery system.
Chubak J, Aiello Bowles EJ, Tuzzio L, Ludman E, Rutter CM, Reid RJ, Wagner EH.
Author information
Abstract
PURPOSE:
The purpose of this paper is to describe patient perspectives on survivorship care 1 year after cancer diagnosis.
METHODS:
The study was conducted at an integrated healthcare delivery system in western Washington State. Participants were patients with breast, colorectal, and lung cancer who had enrolled in a randomized control trial (RCT) of oncology nurse navigation to improve early cancer care. Those alive and enrolled in the healthcare system 1 year after diagnosis were eligible for this analysis. Participants completed surveys by phone. Questions focused on receipt of treatment summaries and care plans; discussions with different providers; patient opinions on who does and should provide their care; and patient perspectives primary care providers' (PCP) knowledge and skills related to caring for cancer survivors RESULTS: Of the 251 participants in the RCT, 230 (91.6 %) responded to the 12-month phone survey and were included in this analysis; most (n = 183, 79.6 %) had breast cancer. The majority (84.8 %) considered their cancer specialist (e.g., medical, radiation, surgical or gynecological oncologist) to be their main provider for cancer follow-up and most (69.4 %) had discussed follow-up care with that provider. Approximately half of patients were uncertain how well their PCP communicated with the oncologist and how knowledgeable s/he was in caring for cancer survivors.
CONCLUSIONS:
One year after diagnosis, cancer survivors continue to view cancer specialists as their main providers and are uncertain about their PCP's skills and knowledge in managing their care. Our findings present an opportunity to help patients understand what their PCPs can and cannot provide in the way of cancer follow-up care.
IMPLICATIONS FOR CANCER SURVIVORS:
Additional research on care coordination and delivery is necessary to help cancer survivors manage their care between primary care and specialty providers.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Another related issue (New Zealand's solution):

N Z Med J. 2013 Aug 30;126(1381):75-86.
Cancer care coordinators: what are they and what will they cost?
Collinson L, Foster RH, Stapleton M, Blakely T.
Author information
Abstract
Health care resources are scarce, and future funding increases are less likely than in the past; reorientation of health services to more efficient and effective delivery is as timely as ever. In this light, we consider the recent funding decision by the Government to provide $16 million over the next 4 years for cancer coordination nurses. While the intricacies of the role are still being defined, it is likely that cancer care coordinators could benefit patients in terms of access to and timeliness of care, and patient satisfaction. Our research into the role shows that many coordinating activities for cancer patients are already being done, but often in an ad hoc manner by a number of different personnel. Thus, we estimate that the likely 'true' incremental cost of cancer care coordinators is in fact relatively low when considered in opportunity cost terms because the cancer care coordinator will be able to free up time for other staff enabling them to provide care elsewhere in the health system and reduce tasks being unnecessarily repeated. The funding of cancer care coordinators is a great opportunity to improve the timeliness of care and improve the experience of patients through their cancer journey, but the success of these roles depends on the leadership provided, peer support, continual appraisal and the resources available.

Re: Clinical Trial Participation Tied to Improved Breast Cancer Outcomes
 

Well to be honest Jackie I had a huge group of specialists all working together with a breast health nurse who was the case manager. They all met for tumor board.

I actively did my own research and based my decisions on the latest studies I could find - many times the tumor board and my choices did not agree and I happily signed waivers.

My oncologist pulled his hair out, but was quite indulgent - if he found my logic to be sound, if not overuled, lol!

I did not follow up with surgeons but with oncology at my hospital. My PCMs turn over ever couple years (interns & residents usually) so don't rely on them for follow up.

Good points. Still don't want surgeons to be in charge of my oncology decisions - so am a pass on the alert system.