The Lancet Oncology
 2016
DOI: 10.1016/s1470-2045(15)00613-0
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Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial

Massimo Cristofanilli
1
,
Nicholas C. Turner
2
,
Igor Bondarenko
3
et al.

Abstract: Pfizer.

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Cited by 1,775 publications

(1,734 citation statements)
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“…The main limits of this study are represented by the short median follow up (only 6.3 months) and the fact that long term toxicities were not analyzed and local disease control was reported only for the five oligo-metastatic and oligo-progressive patients. The toxicities observed for combined treatment in these series and in our study are in line with published safety data of patients treated with CDK4/6 inhibitors alone [2][3][4][5][6][7] . Although high, the rate of grade 3-4 neutropenia we reported in the period between RT end and the three following cycles of CDK4/6 inhibitors (61.1%) is consistent with that described with palbociclib alone 3 .…”
Section: Resultssupporting
confidence: 91%
“…The toxicities observed for combined treatment in these series and in our study are in line with published safety data of patients treated with CDK4/6 inhibitors alone [2][3][4][5][6][7] . Although high, the rate of grade 3-4 neutropenia we reported in the period between RT end and the three following cycles of CDK4/6 inhibitors (61.1%) is consistent with that described with palbociclib alone 3 . Moreover, no patient needed permanent suspension in the following cycles, with median duration of temporary interruption of 7 days and permanent dose reduction in only 14.3% of patients.…”
Section: Resultssupporting
confidence: 91%
See 1 more Smart Citation
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
show abstract
“…The main limits of this study are represented by the short median follow up (only 6.3 months) and the fact that long term toxicities were not analyzed and local disease control was reported only for the five oligo-metastatic and oligo-progressive patients. The toxicities observed for combined treatment in these series and in our study are in line with published safety data of patients treated with CDK4/6 inhibitors alone [2][3][4][5][6][7] . Although high, the rate of grade 3-4 neutropenia we reported in the period between RT end and the three following cycles of CDK4/6 inhibitors (61.1%) is consistent with that described with palbociclib alone 3 .…”
Section: Resultssupporting
confidence: 91%
“…The toxicities observed for combined treatment in these series and in our study are in line with published safety data of patients treated with CDK4/6 inhibitors alone [2][3][4][5][6][7] . Although high, the rate of grade 3-4 neutropenia we reported in the period between RT end and the three following cycles of CDK4/6 inhibitors (61.1%) is consistent with that described with palbociclib alone 3 . Moreover, no patient needed permanent suspension in the following cycles, with median duration of temporary interruption of 7 days and permanent dose reduction in only 14.3% of patients.…”
Section: Resultssupporting
confidence: 91%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
show abstract
“…Compared to the PALOMA‐3, our second‐line cohort included 168 and 160 visceral metastases from the 380 control and treatment matched pairs, respectively. The estimated HRs were 0.49 (0.33‐0.74) and 0.53 (0.31‐0.9) for nonvisceral and visceral metastasis, which are consistent with those reported for PALOMA‐3 9,11,25‐27 …”
Section: Resultssupporting
confidence: 88%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
show abstract
“…This may suggest a different tumor biology, with higher proliferation rates for CTC positive compared to CTC negative MBC, warranting further investigation. With respect to mutations in ctDNA, we found a cumulative frequency of 30%, in line with other studies [ 25 – 27 ]. We found no correlation between TK1 activity and ESR1 / PIK3CA mutations in ctDNA, suggesting that mutant tumors do not quantitatively differ from wild type tumors in terms of proliferation.…”
Section: Discussionsupporting
confidence: 92%
Exaggerated anticipatory anxiety is common in social anxiety disorder (SAD). Neuroimaging studies have revealed altered neural activity in response to social stimuli in SAD, but fewer studies have examined neural activity during anticipation of feared social stimuli in SAD. The current study examined the time course and magnitude of activity in threat processing brain regions during speech anticipation in socially anxious individuals and healthy controls (HC). Method Participants (SAD n = 58; HC n = 16) underwent functional magnetic resonance imaging (fMRI) during which they completed a 90s control anticipation task and 90s speech anticipation task.
show abstract
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