Pine Street Foundation's Ten-Year Follow-up Survival Study on Breast,
Lung, & Colon Cancers
Pine Street Foundation's Ten-Year Follow-up Survival
Study on Breast, Lung, & Colon Cancers
How You Can Help
Levels of Evidence
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Pine Street Foundation's Ten-Year
Follow-up Survival Study on Breast, Lung, & Colon Cancers
Researchers at the Pine Street Foundation have launched a landmark cancer
survival study in collaboration with Kaiser Permanente, the Northern
California Cancer Center, and the University of California at Berkeley.
This research project encompasses three different survival studies and
will address the question of whether complementary and alternative medical
therapy in combination with standard treatments can help extend survival
in people with breast, lung, and colon cancers. By using data about these
patients gathered over a ten-year period, this study will explore the
potential survival benefits associated with long-term use of an herbal-vitamin
combination protocol.
Why This Study is Important
Large numbers of people throughout the United States - as many
as 36% of adults - are using complementary and alternative medicine (CAM).2
Among cancer patients specifically, CAM is used by 64% of patients with
breast cancer,4 11% of patients with lung cancer, and 14% of patients
with colorectal cancer.1 While CAM is often defined as including modalities
such as acupuncture and yoga, the Pine Street Survival Study will specifically
investigate the use of vitamin and herbal therapies in combination with
standard cancer therapies.
The use of vitamins by the general public has increased 42% from 1990
to 1997 and the use of herbal medicine has increased five-fold during
this same period.3 Despite this trend, very little research has been
conducted to investigate whether CAM therapy can actually help people
with cancer live longer. Such research could contribute important information
about the potential survival advantage offered by using herbal medicine
and vitamin therapy as an adjunct to conventional treatment.
Data Sources
The primary data being used for the Pine Street Foundation's
Survival Study is a large database developed from ten years of follow-up
records on 720 patients treated between 1989 and 1993 at the Pine Street
Clinic in San Anselmo, California. This database contains follow-up results
on 288 patients with breast cancer, 239 patients with lung cancer, and
193 patients with colon cancer. Because these data were recorded in a
consecutive case series (See "Levels of Evidence"),
they contain the records of all patients with these conditions treated
by the Pine Street Clinic. This is important because the survival data
from this set of patients are a complete representation of the treatment
experience at the Pine Street Clinic and not simply a set of handpicked "best
case" records. Our methodology seeks to minimize bias and maximize the
applicability of our final results.
The common variables examined for each patient include how long they
received a specific therapy as well as specific dosage schedules of herbal-vitamin
products. Data has also been collected on the most important characteristics
of patients treated, including age, gender, biopsy results (cell type),
stage of disease, menopausal status (for breast cancer), type of conventional
treatment received, and whether they were being treated for the first
time or for recurring disease. These data will allow us to analyze the
impact of specific herbs and vitamins on survival and also correct for
treatment protocol deviations among the Pine Street Clinic patients.
Using these data, survival among the Pine Street Clinic patients — those
using CAM — will be compared to the survival of patients who did
not use CAM. The comparison patient data will be obtained from databases
at local Kaiser Permanente hospitals as well as from the National Cancer
Institute's Surveillance, Epidemiology, and End Results (SEER) database.
Study design is being supervised by epidemiologists at the University
of California at Berkeley's School of Public Health.
Value of this Study
Because of the lack of current research on this subject, very
little is presently known about the impact of individual herbal-vitamin
products on patient survival. The Pine Street Foundation's Survival Study
will investigate:
» Whether patients who continued with long-term use of herbal
and vitamin therapy survive longer than those who did not.
» The clinical value of long-term maintenance of vitamin-herbal combinations
following cancer treatment with conventional therapy.
» Which patients at which stage of disease may be most helped by combining
vitamin-herbal medicine with their standard therapy.
» Whether patients with first diagnosis have a different response to
treatment with vitamin-herbal combinations than those with recurrent disease.
» Whether patients within the Pine Street Clinic database were similar
to patients from the general population.
This study will also serve as the foundation for a future prospective,
double-blinded clinical trial in which we will test, using the most rigorous
type of clinical trial design, whether the Pine Street Clinic's protocol
in combination with chemotherapy can help patients live longer following
standard chemotherapy treatment. A prospective trial is also superior
to retrospective studies in that this research design can be used to
measure other important variables such as patients' quality of life and
potential toxicities of the treatment combinations being tested.
It is our goal that the Pine Street Survival Study will contribute important
and useful information to the growing body of knowledge on cancer survival
and vitamin-herbal CAM therapies.
Study Progress
Ethical review of the study protocol is complete and we are
now actively seeking funding to complete the data gathering and analysis
phases. We need your support to complete this landmark study. See How
You Can Help.
This study is being conducted in collaboration with
Lawrence Kushi, ScD (Associate Director for Epidemiology at the Division
of Research, Kaiser Permanente), Cynthia O'Malley, PhD (research scientist
at the Northern California Cancer Center), Alan Kramer, MD (oncologist
at San Francisco Oncology), and Jack Colford, MD, PhD (Associate Professor
at the University of California at Berkeley). This study has received
approval from institutional review boards (IRBs) at the University
of California at Berkeley, the Northern California Cancer Center, Kaiser
Permanence Northern California, and the Pine Street Foundation's independent
external research ethics review board.
REFERENCES:
1. Bernstein, B. J. and T. Grasso (2001). “Prevalence of complementary
and alternative medicine use in cancer patients.” Oncology (Huntingt)
15(10): 1267-72; discussion 1272-8, 1283.
2. CDC (2004). “Complementary and Alternative Medicine Use Among
Adults: United States, 2002.”
3. Eisenberg, D. M., R. B. Davis, et al. (1998). “Trends in alternative
medicine use in the United States, 1990-1997: results of a follow-up
national survey.” Jama 280(18): 1569-75.
4. Glass, E. L. (2004). Use of complementary/alternative therapies during
chemotherapy for breast cancer. ASCO Annual Meeting, New Orleans, LA.
5. Jacobson, J. S., S. B. Workman, et al. (2000). “Research on
complementary/alternative medicine for patients with breast cancer: a
review of the biomedical literature.” J Clin Oncol 18(3): 668-83.
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How You Can Help
Your financial support is needed to complete the landmark Pine Street
Foundation Survival Study. Please consider making a contribution to this
important research today. Click here to
make a difference.
Pine Street Foundation’s Survival Study Budget
Data Acquisition: $56,320
Data Analysis: $29,300
Project Management: $26,018
Material Costs: $5,782
Data Reporting and Publishing: $17,000
TOTAL: $134,420
Click here to make an online donation now.
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Levels of Evidence
The National Cancer Institute has a classification system to rank human
cancer treatment studies according to statistical strength of the study
design and the scientific strength of the treatment outcomes measured.
This classification system is presented here in descending order of strength
of clinical evidence.
Randomized controlled clinical trials. Studies in
which participants are assigned by chance to separate groups for the
comparison of different treatments. It is the patient's choice to be
in a randomized trial, but neither the researchers nor the patient can
choose the group in which he or she will be placed. Using chance to assign
people helps to ensure that the groups will be similar and that the treatments
they receive can be compared objectively. At the time of a trial, there
is uncertainty about which of the treatments is best. These trials can
be "double-blinded" or "nonblinded." Double-blinded trials have a stronger
study design.
» Double-blinded: Neither the patients nor the researchers know
which patients are receiving the therapy under study or the comparison
(i.e., control) treatment. Double-blinded trials have a stronger study
design than nonblinded trials.
» Nonblinded: The researchers and the patients know what treatment is
being given.
Nonrandomized controlled clinical trials. Studies
in which participants are assigned to a treatment group based on criteria
that may be known to the researchers, such as the patient's birth date,
chart number, or day of clinic appointment. With this type of study design,
there is less confidence that the group receiving the treatment under
study and the control group are comparable.
Case series. Studies that describe results from a
group or series of patients who all received the treatment that is being
investigated. These studies have a weak design, due, in part, to the
absence of a control group. Different types of case series, in descending
order of strength, are as follows:
» Population-based, consecutive case series. The study population
is well-defined and is either the entire population of interest or a
representative random sample of the larger population from which it is
drawn. The study subjects receive treatment in the order in which they
are identified by the researchers.
» Consecutive case series. Studies describing a series of patients who
were not limited to a specific population and who received treatment in same
order in which they were identified by the researchers.
» Nonconsecutive case series. Studies describing a series of patients
who were not limited to a specific population and who do not represent a consecutive
series of patients identified and treated by the researchers.
» Best Case Series. From a larger series of patients, only the cases
that appear to have benefited from the treatment under study are reported.
These studies have the weakest design.
Source: National Cancer Institute's Levels of Evidence for Human
Studies of Cancer Complementary and Alternative Medicine.
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