[MOL] Hycamtin a Therapy for Small Cell Lung Cancer [12766] Medicine On Line


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[MOL] Hycamtin a Therapy for Small Cell Lung Cancer



Good Morning my Friends. Thought would be of some interest for those
with this disease.

God Bless
marty auslander


STUDY SHOWS HYCAMTIN PROVIDES BETTER CONTROL OF SMALL CELL LUNG CANCER
SYMPTOMS THAN COMMONLY USED COMBINATION THERAPY

Single Agent Hycamtin Offers Efficacy Comparable to Triple-Agent Regimen
in Relapsed Lung Cancer Patients

Los Angeles, May 18, 1998 - Hycamtin (topotecan hydrochloride for
injection,
SmithKline Beecham) as a single-agent therapy offers better control of
disease-related symptoms than CAV (a commonly used second-line treatment
regimen consisting of cyclophosphamide, doxorubicin, and vincristine) in
relapsed small cell lung cancer patients, according to a study presented
today at the 34th annual meeting of the American Society of Clinical
Oncology
(ASCO).  In this study, Hycamtin as a single-agent showed comparable
efficacy
to CAV.  Median survival and time to progression were also comparable
for
both treatment groups.  Lung cancer is the leading cause of cancer death
in
the United States.  Nearly 180,000 people are diagnosed each year; 25
percent
of these diagnoses are small cell lung cancer cases.

"There are currently only limited options for treating small cell lung
cancer, one of the most deadly malignancies among both men and women,"
said
Joan Schiller, M.D., associate professor, University of Wisconsin
Comprehensive Cancer Center in Madison, Wisconsin and the lead U.S.
study
investigator.  "Since most small cell lung cancer patients will
eventually
relapse and become difficult to treat, there is a need for new agents
that
can be used to treat patients, particularly those who have failed
first-line
therapy.  The ability of Hycamtin alone to offer the same anti-tumor
activity
and better symptom control than a commonly used multi-drug regimen is
very
encouraging."


Hycamtin Shows Promising Results in Multinational Study

This phase III, randomized clinical trial was conducted at 44 centers in
North America, Europe, and South Africa and involved 211 patients who
had
relapsed at least 60 days after their initial treatment.  Patients
received
either an intravenous infusion of Hycamtin 1.5mg/m2 as a single agent
therapy
for five consecutive days every three weeks or a combination therapy
including cyclophosphamide 1,000 mg/m2, doxorubicin 45 mg/m2, and
vincristine
2 mg administered intravenously on day one every three weeks.

More patients treated with Hycamtin reported improvement in
disease-related
symptoms than patients treated with CAV.  A significantly higher
percentage
of patients who were treated with Hycamtin versus CAV reported an
improvement
in the following symptoms: shortness of breath (p=0.002), fatigue
(p=0.032),
hoarseness (p=0.043), and anorexia (p=0.042). Improvement was defined as
improvement over baseline sustained for at least two consecutive
courses.  In
addition, interference with daily activities, which is a general measure
of a
patient's well-being, was also significantly reduced in patients treated
with
Hycamtin (p=0.023).  Of the other four symptoms measured, improvements
were
numerically superior for Hycamtin-treated patients (chest pain, cough,
insomnia; p=ns), while improvement in hemoptysis was numerically
superior for
patients treated with CAV (p=ns).

Furthermore, a greater percentage of Hycamtin-treated patients responded
to
treatment (24.3 percent vs. 18.3 percent), although this difference was
not
statistically significant.  Tumors were assessed by radiologic
evaluation and
required independent confirmation.  Median survival and time to
progression
were comparable for both treatment groups.

"The ability of Hycamtin to significantly improve several
disease-related
symptoms is important because most advanced stage lung cancer patients
are so
sick that they can't go about their daily routine.  Results from this
study
and several others suggest that Hycamtin, either alone or in combination
with
other agents, may be a promising treatment option for this patient
population," said Dr. Schiller.

As with many chemotherapeutic agents, the main side effect experienced
by
Hycamtin and CAV-treated patients was neutropenia (suppression of white
blood cells), which was predictable and manageable.  Seven deaths (four
among
Hycamtin-treated patients and three among CAV-treated patients) were
associated with treatment-induced myelosuppression with infection.
Thrombocytopenia and anemia were more common in patients treated with
Hycamtin, and neurotoxicity was more common among CAV-treated patients.

Of all the new chemotherapy agents used in small cell lung cancer,
Hycamtin
has undergone the most extensive evaluation.  SmithKline Beecham
recently
filed a supplemental new drug application (SNDA) with the U.S. Food and
Drug
Administration (FDA) for the use of Hycamtin in the second-line
treatment of
small cell lung cancer.  Hycamtin is currently available for the
treatment of
ovarian cancer after failure of initial or subsequent chemotherapy.


Small Cell Lung Cancer: A Deadly Disease

Small cell lung cancer is most common among current or past smokers.
Compared to other types of lung cancer, small cell lung cancer has a
greater
tendency to have already spread (metastasized) to other parts of the
body by
the time a patient is diagnosed with the disease.  Three-quarters of all
small cell lung cancer patients have extensive metastases at the time of
diagnosis.  Patients with advanced stage disease have a median survival
time
of nine months.

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