National Cancer Institute - NCI Division of Cancer Treatment and ...

who received letrozole versus placebo
following five years of adjuvant tamoxifen,
results from the MA.17 clinical trial were
announced a year ahead of schedule.
At that time, participants in the placebo
group were unblinded and offered letrozole.
In September 2005, the study team
released a more detailed analysis of the
drug’s efficacy and toxicity up to the time
of unblinding.
The updated data from 5170 postmenopausal
patients show that after four years
of follow-up, 94.4 percent of women who
received letrozole survived without disease
recurrence, compared with 89.8 percent
of those who received the placebo.
In general, women who received letrozole
and women who took the placebo saw
no difference in OS, though the drug did
seem to improve overall survival among a
subset of women who had positive axillary
lymph nodes, as well as those who had
taken tamoxifen for more than five years.
Letrozole after tamoxifen is well tolerated,
but toxic side effects of concern included
those related to bone metabolism and cardiovascular
disease. However, bone fractures
and cardiovascular events occurred
equally between the two study groups.
Goss PE, Ingle JN, Martino S, Robert NJ, Muss
HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE,
Pritchard KI, Livingston RB, Davidson NE, Norton
L, Perez EA, Abrams JS, Cameron DA, Palmer MJ,
Pater JL. Randomized trial of letrozole following
tamoxifen as extended adjuvant therapy
in receptor-positive breast cancer: updated
findings from NCIC CTG MA.17. J Natl Cancer Inst
2005:97;1262–71.
Goss PE, Ingle JN, Martino S, Robert NJ, Muss
HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE,
Pritchard KI, Livingston RB, Davidson NE, Norton
L, Perez EA, Abrams JS, Therasse P, Palmer MJ,
Pater JL. A randomized trial of letrozole in postmenopausal
women after five years of tamoxifen
therapy for early-stage breast cancer. N Engl J
Med 2003:349;1793–802.
Paclitaxel-Carboplatin-Bevacizumab
Represents New Treatment
Standard for Metastatic Non-
Squamous Non-Small Cell
Lung Cancer
A CTEP-sponsored phase III study in
patients with advanced non-squamous,
non-small cell lung cancer (NSCLC)
showed that adding bevacizumab to
standard chemotherapy for patients with
NSCLC provides a statistically and clinically
significant survival advantage with tolerable
toxicity.
The study, known as E4599, involved randomizing
842 patients to one of two treatment
arms. One patient group received
standard treatment—six cycles of paclitaxel
and carboplatin. The second group
received the same six-cycle chemotherapy
regimen with the addition of bevacizumab,
followed by bevacizumab alone
until disease progression.
Patients who received bevacizumab
in combination with standard chemotherapy
had a median OS of 12.5 months,
compared to patients treated with the
standard chemotherapy alone, who had a
median survival of 10.2 months. This finding
sets a new treatment standard in this
population of patients with metastatic
NSCLC.
Sandler AB, Gray R, Brahmer J, Dowlati A, Schiller
JH, Perry MC, Johnson DH. Randomized phase
II/III trial of paclitaxel (P) plus carboplatin (C)
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