Prognostic/predictive role of sex in advanced disease
insights from therapeutic trials : chemotherapy
though the potential prognostic influence of sex might be established
in surgical series alone or in those patients treated
with supportive care alone, beforehandd disease, sex might be
either prognostic or predictive of a better effectiveness of chemotherapy.
indeed, a prognostic issue mainly reflects the natural
history of the disease ( i. e., survival once dissection ), whereas
the predictive issue a lot of precisely reflects the impact of a
therapeutic intervention ( i. e., predicts response and/or survival
from chemotherapy or a biologic agent ). as an example, her-2
positive standing in breast cancer is related to poor prognosis,
other then this standing carries on a positive predictive value for
benefit from trastuzumab.
theoretically, as consequence of the prognostic significance,
a hypothetical clinical trial of a
brand new therapy that includes lower
stage patients, just ps 0-1, and a high share of girls
can yield favorable results based mostly on these selection factors alone
and this independently from the efficacy of therapy.
an oversized retrospective study reviewed thirteen swog trials in
that 2531 ladies were enrolled within the episode of time between
1974 and 1987. a survival advantage for ladies was
reported. the median survival time was five. seven and four. eight months
for ladies and men, respectively and 1-year survival rates were
19% versus 14% ( p 0. 01 ). this benefit, though, wasn't
maintained with a multivariate analysis. 127 similarly, a nonsignificant
distinction in survival by sex was reported within the setting
of multimodality therapy for locally advanced disease ( median
survival of 21 months for ladies vs. twelve months on behalf of men ) 128
( table 25. three ).
the european lung cancer operating party ( elcwp )
retrospectively analyzed 1052 patients treated between 1980
and 1991, for locally advanced or metastatic nsclc. the
statistical analysis included 23 pretreatment variables : female
sex was one in every of eight variables considerably related to
improved survival with an rr of death of zero. seven ( p zero. 03 ) at
the multivariate analysis. 129 survival advantage per
gender was too reported by o’connell et al. 130 in a very single
institution study, in 378 patients with advanced stage nsclc
treated with chemotherapy. female sex was one in every of four predictors
of improved survival at the multivariate analysis ( median
survival time for ladies was twelve. four months vs. eight. eight months for
men, p zero. 001 ).
most of the revealed randomized trials can't be pooled
attributable to survival differences between the arms, other then within the
eastern cooperative oncology cluster ( ecog ) 1594 study,
this analysis was potential, considering the shortage of survival
distinction among the four arms. 131 during this study, 1207 patients
were enrolled ( 1157 were eligible ) with stage iiib and that iv
nsclc and randomized to four completely different chemotherapy treatment
arms. 132 the median survival for all 1207 patients was
eight months, and all the opposite efficacy outcomes were comparable
among four arms within the study. consequently, it had been potential to
build a pooled analysis of this trial and to research the role of
sex in survival. men were a lot of probably to own weight loss ( 65%
on behalf of men vs. 58% for ladies, p zero. 02 ) and be slightly older
( mean age 61. nine vs. sixty. five years for ladies, p zero. 02 ). women
were a lot of probably to own adenocarcinoma histology ( 63% of
ladies vs. 53% of men, p zero. 003 ). there was no difference
in rr by sex ( 19% in each cohorts, p zero. fifteen ). median progression-
free survival ( pfs ) and median survival times ( mst )
were completely different by sex : median pfs for ladies was three. eight versus
three. five months on behalf of men ( p zero. 022 ) and mst nine. two months for
ladies and seven. three months on behalf of men, respectively ( p zero. 004 ).
survival was too higher at one, two, and three years being for ladies,
38%, 14%, and 7%, respectively, versus 31%, 11%, and 5%,
respectively, on behalf of men. this survival distinction remained statistically
significant once adjusting for performance standing, weight
loss 10%, presence of brain metastases and stage ( iiib vs.
iv ). no distinction in survival was found by chemotherapy regimen
for each sex cohorts. in terms of toxicity, ladies tended
to own a lot of nausea, vomiting, alopecia, neurosensory deficits,
and neuropsychiatric deficits.
insights from therapeutic trials : chemotherapy
though the potential prognostic influence of sex might be established
in surgical series alone or in those patients treated
with supportive care alone, beforehandd disease, sex might be
either prognostic or predictive of a better effectiveness of chemotherapy.
indeed, a prognostic issue mainly reflects the natural
history of the disease ( i. e., survival once dissection ), whereas
the predictive issue a lot of precisely reflects the impact of a
therapeutic intervention ( i. e., predicts response and/or survival
from chemotherapy or a biologic agent ). as an example, her-2
positive standing in breast cancer is related to poor prognosis,
other then this standing carries on a positive predictive value for
benefit from trastuzumab.
theoretically, as consequence of the prognostic significance,
a hypothetical clinical trial of a
brand new therapy that includes lower
stage patients, just ps 0-1, and a high share of girls
can yield favorable results based mostly on these selection factors alone
and this independently from the efficacy of therapy.
an oversized retrospective study reviewed thirteen swog trials in
that 2531 ladies were enrolled within the episode of time between
1974 and 1987. a survival advantage for ladies was
reported. the median survival time was five. seven and four. eight months
for ladies and men, respectively and 1-year survival rates were
19% versus 14% ( p 0. 01 ). this benefit, though, wasn't
maintained with a multivariate analysis. 127 similarly, a nonsignificant
distinction in survival by sex was reported within the setting
of multimodality therapy for locally advanced disease ( median
survival of 21 months for ladies vs. twelve months on behalf of men ) 128
( table 25. three ).
the european lung cancer operating party ( elcwp )
retrospectively analyzed 1052 patients treated between 1980
and 1991, for locally advanced or metastatic nsclc. the
statistical analysis included 23 pretreatment variables : female
sex was one in every of eight variables considerably related to
improved survival with an rr of death of zero. seven ( p zero. 03 ) at
the multivariate analysis. 129 survival advantage per
gender was too reported by o’connell et al. 130 in a very single
institution study, in 378 patients with advanced stage nsclc
treated with chemotherapy. female sex was one in every of four predictors
of improved survival at the multivariate analysis ( median
survival time for ladies was twelve. four months vs. eight. eight months for
men, p zero. 001 ).
most of the revealed randomized trials can't be pooled
attributable to survival differences between the arms, other then within the
eastern cooperative oncology cluster ( ecog ) 1594 study,
this analysis was potential, considering the shortage of survival
distinction among the four arms. 131 during this study, 1207 patients
were enrolled ( 1157 were eligible ) with stage iiib and that iv
nsclc and randomized to four completely different chemotherapy treatment
arms. 132 the median survival for all 1207 patients was
eight months, and all the opposite efficacy outcomes were comparable
among four arms within the study. consequently, it had been potential to
build a pooled analysis of this trial and to research the role of
sex in survival. men were a lot of probably to own weight loss ( 65%
on behalf of men vs. 58% for ladies, p zero. 02 ) and be slightly older
( mean age 61. nine vs. sixty. five years for ladies, p zero. 02 ). women
were a lot of probably to own adenocarcinoma histology ( 63% of
ladies vs. 53% of men, p zero. 003 ). there was no difference
in rr by sex ( 19% in each cohorts, p zero. fifteen ). median progression-
free survival ( pfs ) and median survival times ( mst )
were completely different by sex : median pfs for ladies was three. eight versus
three. five months on behalf of men ( p zero. 022 ) and mst nine. two months for
ladies and seven. three months on behalf of men, respectively ( p zero. 004 ).
survival was too higher at one, two, and three years being for ladies,
38%, 14%, and 7%, respectively, versus 31%, 11%, and 5%,
respectively, on behalf of men. this survival distinction remained statistically
significant once adjusting for performance standing, weight
loss 10%, presence of brain metastases and stage ( iiib vs.
iv ). no distinction in survival was found by chemotherapy regimen
for each sex cohorts. in terms of toxicity, ladies tended
to own a lot of nausea, vomiting, alopecia, neurosensory deficits,
and neuropsychiatric deficits.
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