Looks good, now if I could only understand what it means...
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Data from XYOTAX(TM) STELLAR Trials Presented at 2006 Meeting of American Society of Clinical Oncology
Gender-Specific Survival Benefit Reported in Women Treated with XYOTAX
ATLANTA, June 4 /PRNewswire-FirstCall/ -- At the 2006 Annual Meeting of
the American Society of Clinical Oncology (ASCO), data from Cell Therapeutics,
Inc.'s (CTI) (Nasdaq: CTIC; MTAX) phase III STELLAR trials of XYOTAX(TM)
(paclitaxel poliglumex) in patients with non-small cell lung cancer (NSCLC)
were presented.
Effect of Gender on Outcome in the STELLAR 3 and 4 Trials (Abstract #7039)
In a poster discussion presentation Helen Ross, M.D., Medical Oncologist
at the Oregon Clinic and Director of Lung Cancer Research at the Earle A.
Chiles Research Institute in Portland, Oregon, presented a composite analysis
of the STELLAR 3 and 4 studies, which demonstrated that XYOTAX had a
significant impact on survival in women compared to those on the control arms,
while men had similar survival in both arms of the studies. In addition, in
women younger than 55 years old, overall survival was prolonged for patients
on the XYOTAX arm compared to the control arm (HR: 0.51, p=0.03), whereas in
women 55 years and older, overall survival was similar between treatment
groups (HR: 0.75, p=0.134). In STELLAR 3, estrogen levels were available for
the majority (92 percent) of women on the trial. Patients with pre-menopausal
estrogen levels (serum estrogen >30 pg/mL), regardless of age, had a
significant improvement in survival when treated with XYOTAX in combination
with carboplatin compared to patients treated with paclitaxel plus carboplatin
(HR: 0.54, p=0.039), but survival was similar between the two arms of the
study in patients with post-menopausal estrogen levels (HR: 1.20, p=0.676).
"Most women think that breast cancer is more of a threat than lung cancer,
but more women are expected to die from lung cancer than from breast, ovarian,
uterine and cervical cancers combined. It is a serious health crisis that most
women are unaware of," said Dr. Ross.
"This presentation highlights the importance of gender and genetics on the
differential response to treatment for lung cancer. Lung cancer in women is
often diagnosed late, making it much more difficult to treat. More awareness
of lung cancer and factors such as estrogen that might explain the impact on
outcome is needed," Ross concluded.
Table 1. Comparison of survival (days) in pre- and post-menopausal women
MEDIAN
OVERALL SURVIVAL 1-YEAR SURVIVAL
XYOTAX Control HR pP-value XYOTAX Control
Pre-menopausal
STELLAR 3 239 167 0.66 0.011 38% 22%
STELLAR 4 NE 188 0.38 0.146 51% 16%
Composite 309 181 0.56 0.008 43% 19%
Post-menopausal
STELLAR 3 NE 347 0.71 0.523 50% 36%
STELLAR 4 320 163 0.47 0.312 40% 17%
Composite 320 263 0.62 0.256 47% 30%
Analysis of Prognostic Factors using Cox Regression Analysis in the
STELLAR 3 and 4 Trials (Abstract #7113)
In a poster presentation Mary O'Brien, M.D., Consultant Medical Oncologist
at The Royal Marsden Hospital in London, presented an analysis of prognostic
factors using Cox regression analysis. O'Brien concluded that weight loss,
presence of extra-thoracic metastasis, low LCS (lung cancer symptom) scores,
and high LDH (lactate dehydrogenase -- a tumor marker) were significant
negative prognostic factors for PS2 (ECOG performance status 2) patients with
NSCLC. Significant differences in survival based on geographic region seen in
STELLAR 3 highlighted the importance of stratification by region. Subgroup
analysis by randomization strata showed no difference in survival between
treatment arms, however trends toward improved survival for women receiving
XYOTAX were observed in STELLAR 3 and 4.
Analysis of Prognostic Factors using Cox Regression Analysis in the
STELLAR 2 Trial (Abstract #7040)
In a poster discussion presentation Philip D. Bonomi, M.D., Director of
Medical Oncology, Rush-Presbyterian-St. Luke's Medical Center in Chicago,
presented an analysis of prognostic factors using Cox regression analysis.
Both overall survival and response were similar between the treatment arms.
Patients in the XYOTAX arm had significantly less anemia, neutropenia, febrile
neutropenia, infection, hair loss, fatigue, mucositis, and gastrointestinal
and respiratory symptoms, and a reduced requirement for supportive measures to
manage the effects of myelosuppression. Overall, grade 3 neurotoxicity was
significantly increased in the XYOTAX arm; however, in patients receiving
XYOTAX at a dose of 175 mg/m2, grade 3 neuropathy was equivalent to the
control.
Bonomi concluded that the prognostic factors for this group of second-line
patients were virtually identical to those seen in chemo-naive NSCLC patients,
reported by O'Brien (above). In addition, shorter interval from previous
chemotherapy was also an important negative prognostic factor and it was
recommended that in the future the interval from previous systemic
chemotherapy be described in phase II trials and included as a stratification
factor in phase III studies.
For more information about this presentation, please visit our website at
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