first study, Iressa, 500 mg (single daily

oral dose), was administered in a non-

randomized, open-label Phase II study

to 63 women with metastatic advanced

breast cancer, ages 34 to 80 years old,

who had continued to progress follow-

ing multiple breast cancer treatments.

Overall, the vast majority of trial par-

ticipants had tried all major treatment

options for advanced breast cancer and

their disease was actively progressing

when they entered the trial. Following

treatment with Iressa, one patient

achieved a partial response lasting five

months and eight women experienced

stabilization of their disease. Despite

active progression of disease at the

time of study entry, 15 percent of the

study population remained on Iressa

for four to eight months or longer. In

addition, others noted marked reduc-

tion in bone pain and several were able

to stop all pain medications.

In the second study, early data were

presented from a study of 22 women

where Iressa was administered in a

nonrandomized, open-label Phase II

study in patients with breast cancer

who became clinically resistant to

tamoxifen or were inappropriate for

tamoxifen treatment. At four weeks, 10

patients (46 percent) had not pro-

gressed, two patients (9 percent)

demonstrated a partial response and

five patients (23 percent) had progres-

sive disease. One patient with stable

disease has been treated beyond six

months to date.

All study patients were given 500

mg/day of Iressa. The median patient

age was 61 years old (range 32 to 85

years old). Side effects were experi-

enced by 59 percent of study patients.

Eight patients (36 percent) had a sig-

nificant facial rash, and four patients

(18 percent) each had nausea, vomit-

ing, alopecia and diarrhea. Eight

patients (36 percent) had a dose inter-

ruption followed by a dose reduction.

SIDS Risks IdentifiedAmong American IndianInfants

Astudy of Northern Plains Indi-

ans found that infants were less

likely to die of sudden infant death

syndrome (SIDS) if their mothers

received visits from public health nurs-

es before and after giving birth.

The Aberdeen Area Infant

Mortality Study, which appeared in the

December 4, 2002, edition of the

Journal of the American Medical

Association, also found that binge

drinking (five or more drinks at a

time) during the mother’s first

trimester of pregnancy made it eight

times more likely that her infant would

die of SIDS. Any maternal alcohol use

during the periconceptional period

20 AWHONN Lifelines Volume 7 Issue 1

Reports from a recent state of

the science conference pre-

sented on lupus by the Lupus Foun-

dation of America in conjunction

with health care providers and

researchers demonstrate that signifi-

cant progress has been made in the

research and treatment of lupus in

recent years. Lupus, a devastating

autoimmune disease, affects an esti-

mated 1 million people in the U.S.

and Europe, 90 percent of whom are

women. Through the presentations

the following facts emerged:

• Lupus affects mostly women: 90

percent of lupus patients are

women

• Lupus disproportionately affects

women who are Asian, Hispanic

or African American: the inci-

dence of lupus is two to three

times more prevalent among

these patient populations

• Lupus can be life threaten-

ing: Over a 20-year period,

the death rate in older

African American women

with lupus has increased

by 70 percent. Deaths in

lupus are typically related to

renal failure and opportunistic

infections that occur with the

use of the immunosuppressant

drugs that are often used to treat

the disease

• Patients with lupus can suffer a

very low quality of life: Pain,

lifestyle changes and emotional

problems were cited in a survey as

the most difficult factors for cop-

ing with the disease

Additionally, progress is being made

in the treatment of lupus: two

experimental new drugs for the

treatment of lupus are in late-stage

clinical testing. A drug for lupus-

related bone loss being developed by

Genelabs Technologies, Inc., and a

drug for lupus renal disease being

developed by La Jolla Pharmaceutical

are currently undergoing Phase III

clinical trials. These drug candidates

may be the first treatments for lupus

developed in more than 30 years.

For more information, go

to www.lupus.org.

Lupus: State of the Science Presented

(three months before pregnancy or

during the first trimester) was associ-

ated with a sixfold increased risk of

SIDS. The study also found that

infants were more likely to die of SIDS

if they wore two or more layers of

clothing while they slept.

The study analyzed 33 SIDS infant

deaths between 1992 and 1996 and 66

control infants, who were matched for

postnatal age and community of resi-

dence. Infants in homes where a public

health nurse had visited before or after

birth were 80 percent less likely to die

from SIDS than babies in homes that

never had such visits—but the study’s

authors were unable to draw a conclu-

sion about what aspects of the nurse’s

visit helped. The IHS currently recom-

mends that public health nurses make

one prenatal home visit and visits at

one and six weeks postpartum.

Wearing two or more layers of

clothing (not including a diaper)

increased a baby’s risk for SIDS more

than sixfold, the researchers found.

This is consistent with other studies

showing that excess thermal insulation

for a specific room temperature was

associated with increased SIDS risk.

The rate of SIDS among American

Indians is the highest of any popula-

tion group and was slightly more than

double that of whites in 1999: 1.5 SIDS

deaths per 1,000 live births compared

with 0.7 per 1,000. The rate of SIDS in

the Aberdeen Area of the Indian

Health Service, which serves reserva-

tions in North and South Dakota,

Nebraska and Iowa, is the highest of all

of the 12 IHS regions. During 1996 to

1998, the most recent data on infants

available from the AAIHS, the rate of

SIDS was 3.5 deaths for every 1,000

live births.

New Carcinogens ListIncludes Estrogen Therapy

Steroidal estrogens, used in estro-

gen replacement therapy and

oral contraceptives, were recently

added to the federal government’s list

of known carcinogens reported in its

recent biennial “Report on Carcino-

gens.” This and 15 other new listings

bring the total of substances in the

report, “known” or “reasonably antici-

pated” to pose a cancer risk, to 228.

The report is prepared by the

National Toxicology Program, an arm

of the Department of Health and

Human Services located at the

National Institute of Environmental

Health Sciences, one of the National

Institutes of Health. The reports are

published every two years after lengthy

study and scientific reviews by three

successive expert panels of government

and nongovernment scientists.

The tenth report newly lists the

group of hormones known as steroidal

estrogens as “known human carcino-

gens.” A number of the individual

steroidal estrogens were already listed

as “reasonably anticipated carcino-

gens” in past editions, but this is the

first report to so list all these hor-

mones, as a group. As with all the

other medications listed, the “Report

on Carcinogens” does not address or

attempt to balance potential benefits

of use of these products.

Also newly listed as “known” caus-

es of cancer in humans are broad-

spectrum ultraviolet radiation,

whether generated by the sun or by

artificial sources; wood dust created in

cutting and shaping wood; nickel com-

pounds and beryllium and its com-

pounds commonly used in industry.

Beryllium and beryllium compounds

are not new to the list but were previ-

ously listed as “reasonably anticipated

to be a human carcinogen.”

Regarding steroidal estrogens, the

report cites data from human epidemi-

ology studies that show an association

between estrogen replacement therapy

and a consistent increase in the risk of

endometrial cancer (cancer of the

endometrial lining of the uterus) and a

less consistent increase in the risk of

breast cancer. As for other common

uses of steroidal estrogens, the report

says the evidence suggests estrogen-

containing oral contraceptives may be

February | March 2003 AWHONN Lifelines 21

JOGNN Now ISI Indexed

The Journal of Obstetric, Gynecologic, &

Neonatal Nursing, published by

AWHONN, has been accepted for indexing by

ISI (founded as the Institute for Scientific Infor-

mation) in Current Contents: Clinical Medicine

and Science Citation Index Expanded. The

ISI Science Citation Index Expanded pro-

vides access to bibliographic information,

author abstracts, and cited references

found in leading scholarly and technical

journals.

To be indexed in ISI, JOGNN was

reviewed by the ISI editorial staff in an extensive evaluation process. Among

the criteria used in the evaluation were timeliness of publication; application

of the peer review process; whether or not the journal followed international

editorial conventions so that source articles can be retrieved; and inclusion of

article titles, abstracts, and keywords in the English language. JOGNN will

receive its first ISI ranking in the summer of 2004. The mission of ISI is to

provide access to the world’s most important and influential journals.