Institute of Medicine Releases Report on Needs Facing Cancer Survivors
The Institute of Medicine (IOM), under the direction of the National Academy
of Sciences, released a comprehensive report on November 7, 2005 detailing the
needs and issues facing cancer patients as they complete their primary treatments
and transition into survivorship. The IOM simultaneously hosted a meeting with
the cancer community – including the Research Advocacy Network – to discuss the
report in detail and answer any questions pertaining to the findings.
According to the report, entitled From Cancer Patient to Cancer Survivor: Lost
in Transition, there are currently ten million American adults who have a personal
history with cancer, and that number could grow as the U.S. population ages and
as new treatments increase survival outcomes. With such a large number of post-treatment
cancer patients, this is an important and growing population that should not be
overlooked by the healthcare system.
Unfortunately, the IOM report reveals gaps in the follow-up care for cancer survivors
once their primary treatment ends. To address these gaps in the system, the report
focuses on increasing awareness of the medical and psycho-social needs of cancer
survivors; defining what quality healthcare means for survivors as well as specific
strategies to achieve it; and aiming to improve the quality of life for survivors
by advocating for policies which promote equal access to insurance and ensure
fair employment practices.
Key recommendations from the report include the following:
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Defining “cancer survivorship” as a distinct phase of the cancer journey, in
order to increase awareness of survivorship issues
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Developing a comprehensive care plan for all cancer patients after primary treatment
ends, including a summary of care received and specific recommendations for medical
follow-up
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Bringing together the National Cancer Institute (NCI), Centers for Medicare and
Medicaid Services (CMS), Department of Veterans’ Affairs (VA), and other relevant
organizations to coordinate multi-disciplinary efforts and develop new models
to ensure the delivery of appropriate follow-up care for all cancer survivors
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Increasing education and resources for healthcare providers on the needs of cancer
survivors so they can address and support those quality-of-life issues
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Reducing and ultimately eliminating discrimination against cancer survivors in
the work place, while supporting survivors’ short-term and long-term limitations
in their ability to work
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Ensuring that survivors have access to adequate healthcare through changes to
federal and state policies
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Conducting long-term research on cancer survivors to better understand and address
their unique needs
Although the IOM report provides a disconcerting look at the lack of consistency
in care for cancer survivors in the United States, it does go on to create a comprehensive
overview of the resources and services that are needed to support this population
and increase their chances at staying cancer-free. Hopefully the ideas and recommendations
contained within the report will be taken seriously by policy makers, healthcare
providers, government organizations, and patient advocacy groups so that these
concepts can be translated into actions that will positively impact the lives
of cancer survivors.
An executive summary and more information on the IOM report is available at www.iom.edu.
San Antonio Breast Cancer Symposium 2005
The 28th Annual San Antonio Breast Cancer Symposium (SABCS) was held December 8-11. The
SABCS is unique in that basic, translational and clinical research are all presented
to the same audience. Participants interested in one area can get more information
by attending poster sessions, which included over 1000 abstracts. This recap will
focus on clinical research that has implications for changing treatment. For more
information on these and other SABCS presentations go to http://www.abstracts2view.com/sabcs05/
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To assist you with the drug names these terms are keyed for reference the first
time they are used in the articles:
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Brand name
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Generic Name
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1Herceptin
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1trastuzamab
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2Adriamycin, Rubex
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2doxorubicin
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3Cytosan, Neosar
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3cyclophosphamide
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4Taxotere
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4docetaxel
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5Paraplatin
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5carboplatin
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6Nolvadex
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6tamoxifen
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7Arimidex
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7anastrozole
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8Taxol
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8paclitaxel
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9Anthracycline: A member of a family of chemotherapy drugs that are also antibiotics. The anthracyclines
act to prevent cell division by disrupting the structure of the DNA. The anthracyclines
include daunorubicin (Cerubidine), doxorubicin (Adriamycin, Rubex), epirubicin
(Ellence, Pharmorubicin), and idarubicin (Idamycin).
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Dr. Slamon, Director, Clinical and Translational Research, Jonsson Comprehensive
Cancer Center, University of California, reported on the Breast Cancer International
Research Group (BCIRG) trial 006 that compared doxorubicin2 and cyclophosphamide3 followed by docetaxel4 (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel and trastuzumab1 (AC→TH) with docetaxel, carboplatin5 and trastuzumab1 (TCH) in HER2 positive early breast cancer patients.
As expected from the Herceptin studies reported on in May at ASCO, participants
receiving trastuzumab did better that those receiving only the standard AC→T.
At 23 month median follow up the relapse-free rate was 73% for AC→T, 80% for TCH
and 84% for AC→TH. The difference between the anthracycline9 arms was not statistically significant.
The issue of sorting out the cause of cardiac toxicity associated with Herceptin
and an anthracycline was addressed in this study. At this early point in the trial
it appears that Herceptin alone may not be the cause of the toxicity. The standard
(AC→T) and the non-anthracycline (TCH) arms had fewer adverse cardiac events than
the AC→TH arm. More research will be needed to fully understand the best way to
use Herceptin in the treatment of women who are HER2 positive.
Phase III randomized trial comparing doxorubicin and cyclophosphamide followed
by docetaxel (AC→T) with doxorubicin and cyclophosphamide followed by docetaxel
and trastuzumab (AC→TH) with docetaxel, carboplatin and trastuzumab (TCH) in HER2
positive early breast cancer patients: BCIRG 006 study. Abstract 1.
An update on the HERceptin® Adjuvant Trial (HERA) that was originally presented
in May at ASCO was reported. HERA compared standard chemotherapies to standard
chemotherapies plus Herceptin for 1 or 2 years. After a median of 1.5 years of
follow-up, two-year cancer-free survival was 86% for patients treated with Herceptin
and 77% for patients who did not receive Herceptin. Additional follow-up will
be necessary to determine whether Herceptin significantly improves overall survival.
Significant adverse effects included severe heart problems, which developed in
0.5% of patients treated with Herceptin.
Trastuzumab (H: Herceptin) following adjuvant chemotherapy (CT) significantly
improves disease-free survival (DFS) in early breast cancer (BC) with HER2 overexpression:
the HERA Trial. Abstract 11.
Surgical Biopsy for Diagnosis of Breast Cancer
Stephen B. Edge, MD, from Roswell Park Cancer Institute in Buffalo, New York
reported for his colleagues affiliated with the National Comprehensive Cancer
Network (NCCN) on the comparison of needle to surgical biopsies for the diagnosis
of breast cancer.
The multicenter study recently conducted by the NCCN evaluated 6,282 women who
underwent needle biopsy (55%), open surgical biopsy (42%), or other (3%) for the
initial evaluation of possible breast cancer. Biopsies showed that 16% had stage
0 or ductal carcinoma in situ disease, 46% had stage I disease, and 38% had stage
II disease. Most patients (61%) underwent breast-conserving surgery and the rest
underwent mastectomy.
The conclusion of the study was that needle biopsy for the initial evaluation
of breast cancer is preferable to surgical biopsy. Of the 3481 women who underwent
needle biopsy, 23% had to have a breast re-excision compared with 92% of the 2650
women who underwent surgical biopsy. Patients who underwent a re-excision also
required more days to complete surgery compared with those who did not undergo
a re-excision (45 vs. 29 days, respectively).
Dr. Edge concluded that "the use of needle biopsy may be a useful quality benchmark
for breast cancer care”.
Surgical biopsy to diagnose breast cancer adversely affects outcomes of breast
cancer care; finding from the National Comprehensive Cancer Network. Abstract
#12.
Improved overall survival for women taking anastrozole7
Walter Jonat, Director, Obstetrics and Gynecology Clinic, University of Kiel,
Germany reported that a meta-analysis of three European trials: the Italian Tamoxifen
Anastrozole trial, the ARNO 95 trial, and the Austrian Breast and Colorectal Cancer
Study Group Trial 9. The results of the meta-analysis showed that women taking
anastrozole rather than tamoxifen6 had a 29% (P = .038) improvement in overall survival.
The analysis also found a 39% improvement in distant recurrence-free survival
and a 45% improvement in event-free survival in women on anastrozole. There was
also benefit in outcomes with anastrozole when looking at local recurrences, distant
recurrences, or appearance of cancer in the contralateral breast.
The results of this analysis are consistent with research comparing aromatase
inhibitors to tamoxifen.
Switching from Adjuvant Tamoxifen to Anastrozole in Postmenopausal Women with
Hormone-Responsive Early Breast Cancer: a Meta-Analysis of the ARNO 95 Trial,
ABCSG Trial 8, and the ITA Trial. Abstract 18
Treatment with Taxotere4
For more than a generation the combination of Adriamycin2 and cyclophosphamide3 (AC) had been the standard treatment for women with early stage breast cancer.
However, Adriamycin can cause cardiotoxicity, especially in the elderly or patients
with underlying heart problems. Also studies of women with advanced breast cancer
have suggested that Taxotere has greater anticancer activity than Adriamycin.
Based on the final analysis of the trial comparing TC (docetaxel/cyclophosphamide)
to standard AC (doxorubicin/cyclophosphamide) in women with early stage breast
cancer, physicians and patients may have another alternative. Stephen Jones, MD,
Medical Director, US Oncology Research, Houston, Texas reported that at a median
follow-up of 66 months, TC compared to AC was associated with 33% disease-free
survival (P = .015). There was also a 24% reduction in the risk of death, which
did not reach statistical significance [P = .13].
One serious drawback of this presentation was the lack of statistics about cardiotoxicity.
The presenter indicated only that TC had no more cardiotoxicity that AC.
Final analysis: TC (docetaxel/cyclophosphamide, 4 cycles) has a superior disease-free
survival compared to standard AC (doxorubicin/cyclophosphamide) in 1016 women
with early stage breast cancer. Abstract 40.
Dose-Dense Chemotherapy
Clifford Hudis, MD, Chief, Breast Cancer Medicine Service, Memorial Sloan-Kettering
Cancer Center, New York reported the five year follow-up for CALGB 9741 (Phase
III randomized study of sequential chemotherapy using doxorubicin2, paclitaxel8, and cyclophosphamide3 or concurrent doxorubicin and cyclophosphamide followed by paclitaxel at 14
and 21 day intervals in women with node positive stage II or IIIA breast cancer).
Dose dense scheduling of chemotherapy once every 2 weeks was superior to every
3 week treatment. There was a decreased hazard ratio of 25% for women who received
chemotherapy over a 22-week period rather than a standard 33-week schedule. However,
the study determined that the sequence in which breast cancer chemotherapy drugs
were administered to patients made little difference in outcomes.
Final analysis: TC (docetaxel/cyclophosphamide, 4 cycles) has a superior disease-free
survival compared to standard AC (doxorubicin/cyclophosphamide) in 1016 women
with early stage breast cancer. Abstract 41.
