CONFERENCE REPORT ESMO 2014

EUROPEAN SOCIETY FOR
MEDICAL ONCOLOGy
MADRID,
SPAIN
SEPTEMBER 26-30
2014
CONFERENCE REPORT
ESMO 2014
Canadian Perspectives
Commentary and Content Provided by the CARE Oncology Faculty
LUNG CANCER
BREAST CANCER
GASTROINTESTINAL CANCER
GENITOURINARY CANCER
HEAD & NECK CANCER
Palliative Care
WITH UPDATES ON IMMUNO-ONCOLOGY
www.careeducation.ca
905 891 1900
November 2014
ESMO 2014 — CONFERENCE HIGHLIGHTS — 1
Conference Report
ESMO 2014
Highlights from ESMO 2014
Including supporting commentary from the CARE Oncology Faculty
Members of the CARE Oncology Faculty recently attended a CARE working group meeting
during the annual ESMO 2014 conference held in Madrid, Spain from September 26-30 2014.
In attendance were a number of CARE Faculty Members representing a variety of tumour
sites. What follows is an overview of the key abstracts and sessions from ESMO discussed
at this meeting, with Canadian perspectives provided by Faculty.
The report content that follows is drawn from ESMO 2014 and is augmented with the CARE
Oncology Faculty perspective and commentary.
CARE ONCOLOGY Faculty who have contributed to this report:
Dr. Normand Blais
Dr. Anil Abraham Joy
Centre Hospitalier de L'Université de Montréal
University of Alberta
Dr. Winson Cheung
Dr. Ernie Mak
BC Cancer Agency
Princess Margaret Cancer Centre
Dr. Stephen Chia
Dr. Barbara Melosky
BC Cancer Agency
BC Cancer Agency
Dr. Rob El-Maraghi
Dr. Ralph Wong
Simcoe Muskoka Regional Cancer Centre
CancerCare Manitoba
Lung Cancer
The abstract content/visuals that follow are drawn from the ESMO
2014 meeting, with Canadian perspectives provided by the CARE
Lung Cancer Faculty.
Contents
Lung Cancer1
Breast Cancer
4
Gastrointestinal Cancer
6
Genitourinary Cancer 8
Head and Neck Cancer
11
Spotlight on: Palliative Care
12
Immuno-Oncology (I-O) is an exciting
topic with positive data in a number of
tumour areas. Storylines covering I-O
content are included in this report and
are identified throughout.
By reading this report, you may be eligible for credit from the Royal College of Physicians and Surgeons of Canada under Section 2: Self Learning.
Non-Small Cell Lung Cancer
ESMO 2014. Abstract 1266P. Quality of life (QoL) results from
the phase 3 REVEL study of ramucirumab+docetaxel (RAM+DTX)
versus placebo+docetaxel (PL+DTX) in advanced/metastatic
NSCLC patients (pts) with progression after platinum based
chemotherapy.
ESMO 2014. Abstract 1232P. Squire, a randomized, multicenter,
open-label, phase III study of gemcitabine-cisplatin (GC)
chemotherapy plus necitumumab (IMC-11F8/LY3012211) vs GC
alone in the first-line treatment of patients (pts) with stage IV
squamous non-small cell lung cancer (sq-NSCLC) update on key
subgroups.
M. Socinski et al
Aim: EGFR is detectable in most pts with sq-NSCLC tumors. Efficacy
and safety of necitumumab (N), a human IgG1 anti-EGFR monoclonal antibody that inhibits ligand-binding and receptor activation,
were evaluated in pts with advanced sq-NSCLC tumors.
Results:
N
mOS, GC + N*
N
mOS, GC*
HR†
ITT population
545
11.5
548
9.9
0.84
E. Garon et al
Subgroups
Aim: RAM + DTX significantly improved overall survival and
progression-free survival in pts with locally advanced or metastatic
NSCLC with progression after platinum based chemotherapy. QoL
data was obtained.
Conclusions: In addition to the improvement of clinical outcomes
demonstrated in REVEL, the primary QoL analyses suggest that
there was no detriment in QoL and pt functioning by adding RAM
to DTX second line chemotherapy.
'QoL is an important element to consider when managing patients
with advanced lung cancer, particularly in the second-line
setting, as they often have a heavy burden of symptoms. Even
though there was no improvement in QoL with the addition of
ramucirumab, it is encouraging to see that the benefits gained
in OS were not at the expense of a detriment in QoL or patient
functioning. However, there was no discussion regarding the
use of concomitant supportive care medications or access to
palliative care personnel nor how these may have affected the
results. In addition, it is unknown what effect on the outcome
may be attributed to the high level of patient censoring. Although
targeting the VEGF-receptor pathway in NSCLC appears to have
clinical activity, the benefit is modest and it remains to be seen
whether this strategy will gain popularity in a tumour site where
VEGF inhibitors did not.'
— CARE Faculty Commentary
Age, y
<75
520
11.5
529
9.9
0.84
≥75
25
10.3
19
7.4
0.98
ECOG PS
0
164
13.8
180
12.9
0.82
1
332
10.7
320
9.2
0.85
2
49
9.5
47
6.9
0.78
Gender
Female
95
13.0
90
11.4
0.88
Male
450
11.1
458
9.7
0.84
Race
Caucasian
457
11.4
456
9.7
0.86
Non-Caucasian
88
12.6
92
11.8
0.78
*Data = median (months) estimated by the Kaplan-Meier method.
mOS = median overall survival.
†HR <1 favors GC + N.
Conclusion: This study met its primary endpoint. GC + N demonstrated
improved OS, with an acceptable safety profile, across all subgroups.
2 — ESMO 2014 — CONFERENCE HIGHLIGHTS
ESMO 2014 — CONFERENCE HIGHLIGHTS — 3
ESMO 2014. Abstract LBA43. Antitumor activity of
pembrolizumab (PEMBRO; MK-3475) and correlation with
programmed death ligand 1 (PD-L1) expression in a pooled analysis
of patients (pts) with advanced non-small cell lung carcinoma
(NSCLC).
Garon, E.B. et al.
Introduction: Pembrolizumab (Pembro) is an anti-PD-1 antibody
that has shown activity in advanced NSCLC. The correlation
between tumor PD-L1 expression and antitumor continues to evolve.
Most interesting is the duration of benefit in patients who respond.
KEYNOTE -001 was presented in the oral session metastatic NSCLC
as a late breaking abstract. With a large sample of 282 patients, it
expands our understanding of immunotherapy in metastatic NSCLC.
Kaplan-Meier Estimates of Survival
'This is a complicated area that we are moving quickly into with
metastatic NSCLC. The KEYNOTE-001 had three different doses,
two different ways to assess response, and two different assays
used for the PD-L1 biomarker. Although the number of patients
treated at 2mg/kg were few, their responses seem as robust
and durable as the higher dose, so this is the dose moving
forward. (The response rate ranges between 20 and 26% for
previously treated and treatment naïve respectively. Responses
are durable. Side effects are few-mostly fatigue). Overall survival
is impressive at 8.2 months for the heavily pretreated group and
O/S is not even reached for the treatment naïve. What biomarker
will be used? Likely the CTA assay with a cut off of >50% staining
for pembrolizumab. We await Phase lll data!'
— CARE Faculty Commentary
EGFR Mutation
PFS (RECIST v1.1, Central Review)
Progression - Free Survival %
100
90
ESMO 2014. Abstract 1251P. Updated analysis of response and
patient-reported outcomes (PRO) in two large open-label, phase
III studies (LUX-Lung 3 [LL3] and LUX-Lung 6 [LL6]) of afatinib (A)
versus chemotherapy (CT) in patients (pts) with advanced NSCLC
harboring EGFR mutations (mut).
Treatment Naive
Previously Treated
80
70
60
50
40
Y. Wu et al.
30
20
10
0
8
16
24
Time, Weeks
32
40
48
n at risk
Treatment Naive 45
39
25
11
4
2
0
Previously Treated 217
159
81
33
13
2
0
Previously Treated
Treatment naive
•Median PFS: 27 weeks (95% CI, 14-45) •Median PFS: 10 weeks (9.1-15.3)
•24-week PFS: 26%
•24-week PFS: 51%
0S
Aim: A, an oral, irreversible ErbB family blocker of EGFR, HER2,
ErbB3 and ErbB4 signalling, improved progression-free survival
(PFS), showed higher objective response rates (ORR), faster time
to response (TTR) and favourable trends in PROs versus cisplatin/
pemetrexed (LL3; 345 pts recruited globally) and cisplatin/
gemcitabine (LL6; 364 Asian pts) in treatment-naïve pts with stage
IIIB/IV EGFR mut positive NSCLC. We present an updated analysis
of PFS, response and PRO data.
Results:
0
100
90
0
50
0
40
0
0
30
0
20
Treatment Naive
10
0
Previously Treated
0
0
2
4
6
8
Time, Months
10
12
14
n at risk
Treatment Naive 45
41
38
24
13
7
2
0
Previously Treated 217
192
146
77
33
8
0
0
Treatment naive
•Median OS: NR (95% CI, NE-NE)
•6 month OS: 86%
Previously Treated
•Median OS: 8.2 months (7.3-NR)
•6 month OS: 59%
Analysis cutoff date: March 31/14
Conclusions: Pembro is tolerable and provides antitumor activity
in treatment-naïve or previously treated advanced NSCLC. Patients
with strong PD-L1 tumor expression may derive particular benefit.
Common mutations All randomised
Overall Survival %
60
0
LL6
C/P
HR;
p-value
A
G/C
HR;
p-value
Cough
27.0
8.0
0.59;
0.006
31.1
10.3
0.46;
<0.001
Dyspnea
10.4
2.9
0.68;
0.013
7.7
1.7
0.53;
<0.001
Pain
4.2
3.1
0.83;
0.188
6.9
3.4
0.70;
0.022
Cough
Not
10.2
0.51;
0.001
31.1
Not
0.43;
<0.001
estimable
Aim: Most patients (pts) with EGFR mutation-positive NSCLC
respond to 1st-line EGFR tyrosine kinase inhibitors, but later acquire
resistance. The Phase III, double-blind IRESSA Mutation Positive
Multicentre Treatment Beyond ProgRESsion Study (IMPRESS;
NCT01544179) evaluated the efficacy/safety of continuing gefitinib
plus cisplatin/pemetrexed (cis/pem) (G) vs placebo plus cis/pem
(P) in pts with acquired resistance to 1st-line gefitinib.
Conclusions: IMPRESS is the first and only randomised Phase III
study to confirm continuation of gefitinib in addition to cis/pem
would be of no clinical benefit for pts with acquired resistance to
gefitinib; thus the standard of care should remain doublet chemotherapy alone. The safety profile for gefitinib plus cis/pem was in
line with that known.
'The use of chemotherapy has not been formally shown to improve
overall survival in the post-TKI setting but has been considered a
standard by experts. Considering the biology of this disease, many
experts believed that chemotherapy may be effective against
resistant clones and that continuation of the TKI during chemotherapy may prevent the reappearance of the EGFR-sensitive
clones, leading to greater benefit than with chemotherapy
alone. In this regard, the results of the IMPRESS study seem
counter-intuitive and surprising. Although PFS was not negatively
impacted by the use of chemotherapy with gefitinib, the reasons
why OS may be impaired by this combination were debated after
the presentation of IMPRESS. Potential explanations may include
the immaturity of the OS results, the imbalances in the treatment
arms, as well as toxicity of the triple drug combination, perhaps
leading to increased decline in performance status and/or less
access to third line treatment for this group. Of note, the phase II
LUX-LUNG 5 studied paclitaxel vs paclitaxel+afatinib in this setting
and did not show differences in OS between both arms.'
— CARE Faculty Commentary
A
0
80
0
70
LL3
T. Mok et al
14.5
2.7
0.54;
<0.001
8.3
1.7
0.53;
<0.001
Pain
4.8
3.1
0.74;
0.052
6.4
2.7
0.67;
0.016
Conclusions: In addition to significant delay in disease progression,
A induces a superior and faster response in pts with EGFR mutation
NSCLC and leads to long-lasting control and delay in worsening of
lung cancer symptoms vs CT.
ESMO 2014. Abstract 1222O. A randomized, open-label, phase
III trial of afatinib (A) vs erlotinib (E) as second-line treatment
of patients (pts) with advanced squamous cell carcinoma (SCC)
of the lung following first-line platinum-based chemotherapy:
LUX-Lung 8 (LL8)
G.Goss et al.
Aim: A is an irreversible ErbB family blocker that has shown promising clinical activity in pts with SCC of the head/neck and lung.
Here, we report results of LL8, a phase III trial that prospectively
compared A and E in pts with SCC of the lung following failure of
first-line chemotherapy.
Results:
LUX-Lung 8: PFS, independent review
1.0
Afatinib
Erlotinib
335 (100)
202 (60)
2.4
334 (100)
212 (64)
1.9
Total randomised, n (%)
Patients progressed/died
Median PFS, months
0.8
HR 0.82
95% CI (0.68-1.00)
Log-rank p value 0.0427
0.6
0.4
0.2
0
0
1
2
3
4
5
6
266
256
127
112
96
72
54
43
45
34
28
15
7
8
Time (months)
9
10
11
12
13
14
15
15
5
8
0
8
0
4
0
2
0
2
0
1
0
No. of patients
Afatinib 335
Erlotinib 334
25
12
16
6
CI, confidence interval; HR, hazard ratio
Conclusions: LL8 is the largest prospective trial to compare EGFR
TKIs in pts with relapsed/refractory SCC. PFS and DCR were significantly better for A than E. AEs were comparable and consistent
with the mechanistic profile of EGFR inhibition.
'Although the improvement in survival is short, this is an important
trial to take note of. EGFR TKIs are restricted in many countries
to only patients with an EGFR mutation. The NCIC BR 21 trial
showed this class of drugs is active in a non-mutated population
after a platinum doublet. LUX Lung 8 confirms this.
Afatinib is an option in the second and third line setting in an EGFR
WT patient and confers a survival advantage over the standard of
care of erlotinib in this setting.'
estimable
Dyspnea
Squamous Cell Carcinoma
Estimated PFS probability
ESMO 2014. Abstract LBA2_PR. Gefitinib/chemotherapy vs
chemotherapy in epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC) after progression
on first-line gefitinib: the Phase III, randomised IMPRESS study.
— CARE Faculty Commentary
The CARE Lung Cancer Faculty
will next meet at CLCCO 2015 in
Vancouver, BC from February 5th-6th.
More news to follow in the
CARE at CLCCO 2015 report!
4 — ESMO 2014 — CONFERENCE HIGHLIGHTS
ESMO 2014 — CONFERENCE HIGHLIGHTS — 5
HER2+ Breast Cancer
ESMO 2014. Abstract 350O_PR. Final overall survival (OS)
analysis from the CLEOPATRA study of first-line (1L) pertuzumab
Final OS Analysis of CLEOPATRA
sets a new
(Ptz), trastuzumab (T), and docetaxel (D) in patients (pts) with
paradigm of treatment of HER2-positive
HER2+ MBCmetastatic breast cancer (MBC).
Swain SM
al.
Ptz + T + D: median
56.5et
months
100
Breast Cancer
15.7
months
Pla + T + D: median
40.8 months
Background:
808 pts with
HER2-positive MBC were randomized to
90
80
OS (%)
The abstract content/visuals that follow are drawn from the ESMO 2014 meeting, with Canadian perspectives
70
provided by the CARE Breast Cancer Faculty.
60
ER+ and HER2
Metastatic Breast Cancer
50
40
30
HR 0.68
95% CI = 0.56, 0.84
p =0.0002
20
10
0
0
ESMO 2014. Abstract LBA9. Breast Cancer Treatment With Everolimus (EVE) and Exemestane (EXE) for ER+
Women: Results of the 2nd Interim Analysis of the Non-interventional Trial, BRAWO.
10
20
receive first line docetaxel, trastuzumab +/- pertuzumab. At primary
analysisi, pertuzumab was shown to increase progression-free
survival significantly, with a strong trend to OS benefit. At a second
interim analysis (May 2012)ii, OS was improved to a degree, which
was both statistically significant and clinically meaningful (HR = 0.66,
95% CI 0.52–0.84; P = 0.0008) but the median OS in patients who
received pertuzumab was not reached. The results of a subsequent
pre-specified OS analysis were reported at ESMO 2014.
Results: Here we present for the first time efficacy data on EVE/EXE
under real world conditions. The data confirm the efficacy results
pivotal phase
30
40 of the 50
60 3 trial
70BOLERO-2 (median PFS vs placebo
+EXE: 7.8 months vs 3.2 months, respectively by local radiologic
Time (months)
assessment).
Fasching PA et al.
Final OS Analysis of CLEOPATRA sets a new
paradigm of treatment of HER2+ MBC
Aim: BRAWO is a German non-interventional study of 3000 patients (pts) with advanced or metastatic, hormonereceptor-positive and HER2-negative breast cancer treated with everolimus (EVE) and exemestane (EXE). Data is
collected at about 400 sites. Main objectives are to extend the knowledge on a) the impact of physical activity on
efficiency and quality of life, b) prophylaxis and management of stomatitis in clinical routine, and c) the sequence
of therapy, when EVE is used in daily clinical practice. We report the results of the 2nd preplanned interim analysis
(IA) which was defined to take place 12 months after the inclusion of the 500th patient into the documentation.
The use of EVE and EXE in a ‘real world’ scenario (as demonstrated in the BRAWO study) reproduces the
clinical benefit seen in the original clinical trial (BOLERO-2). This type of demonstration is important as there is
a general concern that clinical trial populations may not be truly representative of a general population of MBC
patients and thus the associated benefits garnered with the study treatment. Earlier use of this combination, and
effective education and early management of associated toxicities is associated with lower adverse event rates.
Future targeted therapies (CDK 4/5 inhibitors, PIK3CA inhibitors, AKT inhibitors, HDAC inhibitors…) are generally
being studied in combination with hormonal therapy in ER+ MBC, and a need exists to identify predictive
biomarkers for response and toxicity to move the field forward towards precision medicine.'
— CARE Faculty Commentary
15.7
months
Pla + T + D: median 40.8 months
0
90
0
80
OS (%)
0
70
Conclusions: Here we present for the first time efficacy data on EVE/EXE under real world conditions. The data
confirm the efficacy results of the pivotal phase 3 trial BOLERO-2 (median PFS vs placebo +EXE: 7.8 months vs 3.2
months, respectively by local radiologic assessment).
'Efficacious treatment strategies for the management of ER+ HER2-MBC is important as this is the largest subtype
cohort seen (in both early and advanced stage disease). The combination of EVE and EXE provides a treatment
option for ER+ HER2- MBC with clinically meaningful improvements in PFS over hormonal therapy alone.
Ptz + T + D: median 56.5 months
100
0
50
0
40
0
HR 0.68
95% CI = 0.56, 0.84
p =0.0002
20
0
10
0
•How will the positive CLEOPATRA trial results, with docetaxel,
trastuzumab and pertuzumab, be compared to other yet to be
reported HER2+MBC 1st line studies that do not have a similar
comparator study arm (e.g. MARIANNE trial)?
•Would similar efficacy have been demonstrated in a more heavily
pretreated HER2+ MBC population (as only ~10% had received
adjuvant trastuzumab, and <50% had received prior adjuvant/
neo-adjuvant chemotherapy)?
•Can similar results and lesser toxicity be achieved with an alternate
non-docetaxel chemotherapy regimen when combined with dual
anti-HER2 targeted antibody therapy (e.g. vinorelbine)?
•Would additional benefit have been observed in ER+/HER2+
subgroup if additional concomitant endocrine therapy was
allowed after the docetaxel portion of treatment (median 8
cycles in both arms) was discontinued?
•As was seen in the NeoSphereiii neo-adjuvant HER2+ breast
cancer trial, can we prospectively identify a group of HER2+ MBC
patients who could be adequately treated with dual anti-HER2
antibody therapy alone, thereby avoiding chemotherapy
associated potential side effects? Molecular correlates (e.g.
PIKCA mutation status) and immune correlates (e.g. PD1/PDL1)
from the CLEOPATRA study have yet to be reported.
— CARE Faculty Commentary
0
0
10
20
30
Ptz + T + D
402
371
318
268
Pla + T + D
406
350
289
230
n at Risk
There are still outstanding questions, including:
•Lastly, while no clear advantage has been observed yet with the
addition of oral TKI (lapatinib) to trastuzumab in the adjuvant
setting (ALTTOiv), will additional benefit with dual targeted
anti-HER2 antibody therapy be observed (APHINITY)?
0
60
30
0
'CLEOPATRA clearly establishes docetaxel, and dual antibody
targeted therapy with trastuzumab and pertuzumab, as the
current standard of care in first line treatment of HER2+ MBC.
The 56.5 month median OS in the pertuzumab containing arm is
indeed exceptional in any MBC setting, be it HER2+ or not. The 15.7
month improvement in median OS with the addition of pertuzumab
may also be an underestimate of benefit given the crossover of
patients from the placebo arm. No unexpected adverse effects
were seen and were similar to previous reports (increased febrile
neutropenia and diarrhea observed in the pertuzumab containing
arm). No increase was observed in terms of cardiotoxicity with
dual anti-HER2 antibody blockade.
40
50
60
70
226
104
28
1
179
91
23
0
References are listed on the back page.
Time (months)
ITT population, Stratified by geographic region and neo/adjuvant chemotherapy
CI, confidence interval; Pla, placebo, Ptz, pertuzumab.
Conclusions: 1L treatment with Ptz + T + D significantly improved OS
for pts with HER2-positive MBC compared with Pla + T + D, providing
a 15.7 mo increase in the median values. The 56.5 mo median OS
is unprecedented in 1L MBC and this substantial improvement
confirms the Ptz regimen as 1L standard of care for pts with HER2positive MBC.
The CARE Breast Cancer Faculty will next
meet at SABCS 2014 in San Antonio, TX
from December 9th-13th.
More news to follow
in the CARE at SABCS 2014 report!
6 — ESMO 2014 — CONFERENCE HIGHLIGHTS
ESMO 2014 — CONFERENCE HIGHLIGHTS — 7
ESMO 2014. Abstract 547P. Impact of baseline age on efficacy
and safety of first-line panitumumab (pmab) + FOLFOX4 vs
FOLFOX4 treatment.
Colorectal Cancer
H. Lenz et al.
Results:
ESMO 2014. Abstract LBA11. Independent radiological
evaluation of objective response, early tumor shrinkage, and depth
of response in FIRE-3 in the final RAS evaluable population.
S. Stintzing et al.
Aim: FIRE-3 compared 1st-line therapy with FOLFIRI plus either
cetuximab or bevacizumab in 592 KRAS exon 2 wild-type mCRC
patients. An independent radiological review was carried out to
evaluate tumor response according to RECIST 1.1 and to define early
tumor shrinkage (ETS) and depth of response (DpR).
Conclusion: Based on an independent radiological review, FOLFIRI
plus cetuximab induced a significantly higher ORR, a greater rate of
ETS, and an increased DpR compared to FOLFIRI plus bevacizumab.
These response-related outcomes may in part explain the significant
OS advantage of FOLFIRI plus cetuximab observed in FIRE-3.
Aim: Data from PRIME showed pmab + FOLFOX4 to be an effec- A. Zhu et al.
tive and tolerable first-line treatment for patients (pts) with RAS
WT metastatic colorectal cancer (mCRC). However, treatment Aim: Vascular endothelial growth factor (VEGF) and VEGFoutcomes can differ in pts of differing age.
receptor 2-mediated signaling and angiogenesis likely contribute
to HCC pathogenesis. RAM is a fully human IgG1 monoclonal
antibody and a VEGF-receptor 2 antagonist.
Results:
Age <65 yr
Age ≥65 yr
N
Arm
(Events)
Chemo
256
+ Bev
(178)
Median
(95% Cl)
31.2
(26.9-34.3)
Chemo
+Cetux
32.0
(27.6-38.5)
270
(177)
Pmab +
FOLFOX4
FOLFOX4
Pmab +
FOLFOX4
FOLFOX4
N
156
155
94
94
ORR %
65
47
53
46
HR
(95% Cl)
p
PFS HR 95% CI
0.655 0.516–0.832
0.879 0.648–1.193
0.9
(0.7-1.1)
0.40
OS HR 95% CI
0.748 0.584–0.957
0.797 0.581–1.092
Conclusions: No new safety signals were observed. The
primary end point was not met. In a selected patient population with an elevated baseline AFP, a meaningful OS
improvement in the RAM arm was observed. The relationship
between AFP and RAM benefit warrants further investigation.
Conclusions: In subgroup analyses of RAS WT pts from PRIME, pmab
+ FOLFOX4 appears to offer benefit over FOLFOX4 alone both in
pts <65 and ≥65 yr. Analysis of efficacy in the >75 yr population
was limited by pt numbers and more research is needed to assess
treatment benefit in these pts.
0
20
% Event Free
80
A. Venook et al.
Conclusions: 130 of 1137 pts enrolled on study reached NED after
chemotherapy and surgery. The median OS in these patients was
60 months although many have recurred. We anticipate all-RAS
status and plan on analyzing the subset of patients who underwent
surgery to identify possible predictive characteristics and also to
determine if there is an explanation for the fact that more patients
on CET went to surgery than did pts on BV.
Overall Survival By Arm
(All RAS Wild Type Patients)
100
ESMO 2014. Abstract LBA10. CALGB/SWOG 80405: Analysis
of patients undergoing surgery as part of treatment strategy.
Aim: Patients with metastatic colorectal cancer may be cured with
multimodality therapy. The goal of this subset analysis is to determine the characteristics and the long-term outcome of patients
enrolled on this first-line treatment study for metastatic disease but
who underwent surgery following chemotherapy.
J. Douillard et al.
AIM: FOLFIRI or mFOLFOX6, combined with BV or CET, are 1st-line
treatments for mCRC. The optimal antibody combination is unknown.
60
The abstract content/visuals that follow are drawn from the ESMO
2014 meeting, with Canadian perspectives provided by the CARE GI
Cancer Faculty.
40
Gastrointestinal Cancer
ESMO 2014. Abstract 501O. CALGB/SWOG 80405. PHASE III
trial of irinotecan/5-FU/leucovorin (FOLFIRI) or oxaliplatin/5-FU/
leucovorin (mFOLFOX6) with bevacizumab (BV) or cetuximab
(CET) for patients (pts) with expanded ras analyses untreated
metastatic adenocarcinoma of the colon or rectum.
ESMO 2014. Abstract LBA16. Ramucirumab (RAM) as
Second-Line Treatment in Patients (pts) with Advanced
Hepatocellular Carcinoma (HCC) Following First-Line Therapy
with Sorafenib: Results from the Randomized Phase III REACH
Study.
0
12
24
36
48
60
72
84
96
Hepatocellular Carcinoma
Months From Study Entry
'These two abstracts (LBA 11 and Abstract 501O) attempted
to enhance our understanding of RAS status in guiding the
management of metastatic colorectal cancer. The smaller FIRE 3
study demonstrated a notable overall survival advantage with the
addition of cetuximab to FOLFIRI among patients with all RAS wild
type tumours. However, overall survival was a secondary endpoint
whereas response rate (the primary endpoint) did not show
any significant differences. Conversely, findings from the larger
CALGB/SWOG study did not reveal an overall survival difference
with cetuximab versus bevacizumab. The latter study is the first
to use overall survival as the primary endpoint. The conflicting
results between the 2 trials indicate that molecular testing of
RAS status and using this parameter alone to base treatment
decisions is unlikely to be sufficient to guide management at
this point in time. Currently, both cetuximab and bevacizumab
represent reasonable first-line options, at least until we are more
successful in finding a consistent predictive biomarker for the
selection of an optimal regimen.'
— CARE Faculty Commentary
ESMO 2014. Abstract 728P. Final analysis of overall survival per
subgroups of HCC patients in the prospective, non-interventional
INSIGHT study treated with sorafenib.
T. Ganten et al.
Aim: INSIGHT is a prospective, non-interventional study, conducted
in Germany and Austria in pts with hepatocellular carcinoma HCC.
The objectives of this study are the evaluation of safety and efficacy
under practice conditions in both hospitals and private practices.
Enrollment into INSIGHT is not restricted to a particular tumor stage.
Conclusions: Results of mOS in pts with HCC treated under daily
practice conditions in hospitals and private practices confirms the
general efficacy of Sorafenib and gives further insight into survival
of pts with CHILD B, BCLC stage A/B, age ≥65, etiology of HCC and a
relevant subgroup of patients treated longer than 40 weeks. Further
demographic data, efficacy and safety results will be presented.
The CARE GI Cancer Faculty will
next meet at the ASCO GI Cancers
Symposium (GICS) in San Francisco, CA
from January 15th-17th.
More news to follow in the
CARE at GICS 2015 report!
8 — ESMO 2014 — CONFERENCE HIGHLIGHTS
ESMO 2014 — CONFERENCE HIGHLIGHTS — 9
CARE GU Faculty Update - mCRPC
ESMO 2014. Abstract 771P. Analysis of overall survival (OS)
for patients (pts) with different prognostic risk factors treated
with cabazitaxel and prednisone (Cbz + P) after docetaxel (D) in
the TROPIC trial.
Genitourinary Cancer
The abstract content/visuals that follow are drawn from the ESMO
2014 meeting, with Canadian perspectives provided by the CARE
GU Cancer Faculty.
Metastatic Castration Resistant
Prostate Cancer (mCRPC)
ESMO 2014. Abstract 768P. External-beam radiation therapy
(EBRT) use and safety with radium-223 dichloride (Ra) in patients
(pts) with castration-resistant prostate cancer (CRPC) and
symptomatic bone metastases (mets) from the ALSYMPCA trial.
J. O'Sullivan et al.
Aim: Bone mets in CRPC frequently cause symptomatic skeletal
events (SSEs) requiring EBRT for pain. In ALSYMPCA, Ra, a first-inclass a -emitter, improved overall survival and delayed time to first
SSE (Parker NEJM 2013). This post hoc study analyzed ALSYMPCA
pts with EBRT for bone pain before randomization and during
treatment (tx).
Conclusions: Ra delays the need for EBRT for bone pain vs pbo. Prior
EBRT does not appear to affect need for EBRT for bone pain in pts
receiving Ra. EBRT use does not affect the Ra favorable safety profile.
The CARE GU Faculty has met over the course of the year at
conferences including ASCO GU, ASCO, and ESMO. They meet with
the intent of reviewing key news and data from these conferences,
considering how they apply to the Canadian landscape. The main
focus of the group has predominantly been on the management
and treatment of mCRPC. Work to date by the group includes the
development of educational initiatives such as conference outputs,
needs assessments and a CARE Suggested Treatment Algorithm/
Guidance for mCRPC (see below for more details).
CARE Suggested mCRPC Treatment Algorithm/Guidance
Expanded and updated from data presented at ASCO 2014 from Saad
F, Hotte S, Chi K., et al. CUA-CUOG guidelines for the management of
castration resistant prostate cancer (CRPC): 2013 update (June)
Clinical Metastases
B. Tombal et al.
YES
Aim: TROPIC (NCT00417079) showed improved OS for Cbz + P vs.
mitoxantrone (Mtx) + P in pts with metastatic castration-resistant
prostate cancer (mCRPC). Cbz + P had a manageable safety profile
similar to other chemotherapies (ctx). A novel prognostic model
using TROPIC and SPARC trial data was developed to predict and
validate OS in men with mCRPC progressing during/after D and
scheduled to receive second-line ctx. The model identified 9 factors:
presence of pain, measurable disease or visceral disease; ECOG PS;
time since last D; time from first hormone therapy; haemoglobin
(Hb); prostate-specific antigen (PSA); and alkaline phosphatase
(ALP). The aim of this study was to explore the activity of Cbz + P in
pts with different numbers of prognostic factors.
1ST LINE
Docetaxel
Radium-223
- No visceral or >3 cm lymph
node metastases
- Docetaxel ineligible
Abiraterone
Cabazitaxel
Abiraterone
Enzalutamide
Radium-223
Abiraterone
Enzalutamide
Cabazitaxel
3RD LINE
ESMO 2014. Abstract 767P. Response rates and outcomes
with enzalutamide for patients with metastatic castration resistant
prostate cancer and visceral disease in the PREVAIL trial.
Enzalutamide
Abiraterone
Docetaxel
Cabazitaxel
Enzalutamide
The optimal sequence of therapy is
unknown. Small retrospective series,
which is heavily subject to bias and
case selection, suggests to consider
the following:
- Cross resistance is common between
enzalutamide and abiraterone
C. Higano et al.
Conclusions: Visceral metastases were permitted in the PREVAIL
trial of men with chemotherapy-naïve mCRPC. Enzalutamide was
active in this small group of patients; post-hoc analyses showed
benefit vs placebo on OS, rPFS, and secondary endpoints. Response
rates were higher for lung vs liver metastases. These results support
androgen receptor signaling as an important target in prostate
cancer with visceral metastases.
NO
2ND LINE
Conclusions: Increasing numbers of poor prognostic factors were
associated with worse OS. Cbz + P improved OS vs Mtx +P regardless
of the number of poor prognostic factors present.
Aim: In the PREVAIL trial, enzalutamide, an androgen receptor
signaling inhibitor, significantly improved overall survival (OS) (HR,
071; p < 0.0001) and radiographic progression-free survival (rPFS)
(HR, 0.19; p < 0.0001) compared to placebo in chemotherapy-naïve
men with metastatic castrate-resistant prostate cancer (mCRPC).
Patients with visceral metastases have worse prognosis, may have
a distinct biology and typically have been excluded from Phase 3
trials in chemotherapy-naïve men. Here we describe outcomes from
patients with baseline visceral disease in PREVAIL.
Symptoms or Visceral Mets
Best
Supportive Care
1
- The response to docetaxel after ABI
and/or ENZA may be decreased.
Docetaxel:
2
with symptoms. 2nd line treatment of
mCRPC without symptoms
Investigated For: Treatment with ADT
Approved In: 1st line treatment of mCRPC
Food Interactions:
Grapefruit or Grapefruit Juice
For further information go to:
www.drugs.com/mtm/docetaxel.html
Radium-223
Approved In: Treatment for patients with
mCRPC symptomatic bone metastases and
no known visceral metastatic disease.
Common Side Effects to look out for:
• Bone Marrow Suppression
For further information go to:
www.drugs.com/cons/radium-ra-223-dichloride-intravenous.html
without symptoms. 2nd line treatment for
mCRPC with symptoms.
Common Side Effects to look out for:
•Hypetension
•Hypokalemia
•Adrenocortical insufficiency
•Hepatotoxicity
Drug-Drug Interactions:
Bosutinib & pomalidomide
Food Interactions:
No food should be eaten 2 hours before and
1 hour after taking.
Swallow tablets whole. Do not crush or chew.
Take tablets with water.
For further information go to:
www.drugs.com/mtm/abiraterone.html
Best
Supportive Care
- The response to cabazitaxel after ABI
and/or ENZA may be maintained
Abiraterone
Approved In: 1st line treatment for mCRPC
5
- The response rate of ABI after ENZA
may be lower than ENZA after ABI
3
Cabazitaxel
Approved In: Treatment for patients with
mCRPC resistant to docetaxel.
Should not be used in patients with:
Hepatic dysfunction
Common Side Effects to look out for:
•Neutropenia
•Hypersensitivity Reactions
•Gastrointestinal Symptoms
•Renal Failure
Food Interactions:
Grapefruit or Grapefruit Juice
For further information go to:
www.drugs.com/mtm/cabazitaxel.html
4
Enzalutamide
Approved In: Treatment for patients with
mCRPC resistant to docetaxel.
Common Side Effects to look out for:
•Seizure
Drug-Drug Interactions:
Warafarin
For further information go to:
www.drugs.com/xtandi.html
10 — ESMO 2014 — CONFERENCE HIGHLIGHTS
ESMO 2014 — CONFERENCE HIGHLIGHTS — 11
Renal Cell Carcinoma
ESMO 2014. Abstract 810O. Randomized, dose-ranging phase
II trial of nivolumab for metastatic renal cell carcinoma (mRCC)
R.J. Motzer et al.
Aim: Nivolumab, a fully human IgG4 programmed death-1 immune
checkpoint inhibitor antibody, has shown encouraging survival and
manageable safety in pretreated mRCC patients (pts). This phase
II trial (NCT01354431) assesses 3 nivolumab doses in mRCC pts
pretreated with targeted VEGF pathway agents. We previously
reported no dose response relationship with 3 doses of nivolumab
(primary objective). Here we present updated overall survival (OS)
and duration of response (DOR) data.
Conclusions: In this phase II trial nivolumab was associated with
encouraging efficacy, with no dose response relationship observed for
PFS or ORR. Median OS range was 18.2-25.5 months; longer median
OS was reported at 2 and 10 mg/kg. The safety profile of nivolumab
was acceptable for all doses with no grade 3-4 pneumonitis observed.
ESMO 2014. Abstract 835P. Updated OS analysis, multivariate
and QTWIST analysis of a randomized sequential open-label study
(SWITCH) to evaluate efficacy and safety of sorafenib (SO) /
sunitinib (SU) versus SU/SO in the treatment of metastatic renal
cell cancer (mRCC) (ID 5193).
C. Eichelberg et al.
Aim: Results of the sequential randomized phase III SWITCH study
comparing SO/SU and SU/SO have been reported previously
(ASCO GU 2014, abstract 393) showing no significant difference in
the primary endpoint, total PFS (T-PFS, Hazard Ratio [HR] 1.01) nor
the secondary endpoints, overall survival (OS, HR 1.0) and 1st-line
PFS (HR 1.19). We report here the results of an updated overall
survival (OS) analysis, a multivariate analysis and QTWIST analysis
(all post-hoc).
Conclusions: In this updated OS analysis there was no significant
difference between the two sequential treatments concerning OS.
In addition, the time without specific AEs of grade 3/4 (QTWIST)
was not significantly different. A multivariate analysis showed that
slowly progressing pts and those who started on sorafenib were
more likely to reach 2nd line on study treatment.
Head & Neck Cancer
The abstract content/visuals that follow are drawn from the ESMO 2014 meeting, with Canadian
perspectives provided by the CARE Oncology Faculty.
ESMO 2014. Abstract LBA29_PR. Afatinib versus methotrexate as second-line treatment for
patients with recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
who progressed after platinum-based therapy: results of the randomised, open-label, phase III trial
LUX-Head & Neck 1
J. Machiels et al.
Aim: Pts with R/M HNSC C who progress after first-line platinum-based therapy have a poor prognosis
with no defined standard treatment. Afatinib is an orally available ErbB family blocker that irreversibly blocks EGFR, HER2, ErbB3 and ErbB4 signalling. In a randomised, proof-of-concept phase II trial,
afatinib showed promising anti-tumor activity in pts with R/M HNSC C progressing after platinum
regimens. LUX-Head & Neck 1 is a phase III trial designed to compare afatinib with methotrexate in R/M
HNSC C pts following progression on platinum-based chemotherapy.
Conclusions: In this phase III trial, second-line afatinib significantly improved the primary endpoint of
PFS and delayed deterioration of PROs vs MTX, with a manageable safety profile, in patients with R/M
HNSCC after failure of platinum-based therapy. Machiels JPH, Haddad RI and Fayette J contributed
equally to this work.
ESMO 2014. LBA31. A phase Ib study of pembrolizumab (Pembro; MK-3475) in patients (Pts) with
human papiilloma virus (HPV)-positive and negative head and neck cancer (HNC).
L. Chow et al.
Aim: The highly selective, anti-PD-1 humanized monoclonal antibody pembro has shown antitumor
activity in several solid tumors, including HNC. We present updated safety, tolerability, and antitumor
activity of pembro for recurrent/metastatic HNC (Clinicaltrials.gov: NCT01848834).
Overall N = 61*
HPV+n = 23*
HPV– n = 38*
ORR, n (%)
11 (20)
4 (20)
7 (19)
Median PFS
(95% CI), wk
9.3 (8.0-20.1)
17.2 (8.0-41.7)
8.1 (7.9-15.6)
Median OS
(95% CI), mo
12.6 (8.2-12.6)
NR (9.6-NR)
9.5 (3.9-12.6)
Results:
*ORR and PFS were evaluated in the 56 pts (20 HPV+, 36 HPV−) who received ≥ 1
The CARE GU Faculty will next meet at the ASCO GU Cancers Symposium being held in Orlando, FL
from February 26th-28th 2015 to continue development/update this and other CARE GU initiatives.
More news to follow in the CARE at GUCS 2015 report!
pembro dose and had measurable disease per RECIST v1.1 by investigator review
Conclusions: Pembro is safe and tolerable and shows antitumor activity in both HPV+ and HPV− advanced
HNC. These findings support further development of pembro in advanced HNC.
SPOTLIGHT
One of the primary goals of the various CARE Faculties has
been the consideration of therapy to optimize patient outcomes.
In alignment with this goal, CARE Faculty has begun to focus/
build on palliative care concepts and the positive impact it has
on patient QoL.
Palliative care was also a prominent topic at the ESMO 2014
conference. Key storylines, as identified and covered by CARE
Faculty member Dr. Ernie Mak can be found below:
Palliative Care
at multi-centre trials in the future to elucidate the true benefit
of early Palliative Care referral. The second study highlights the
disparity between the need for and the actually provided support
in Palliative Care. Although there is likely recall bias in this sample,
there remains a very real service gap due to available resource.
Future studies can help to determine which components in early
Palliative Care generate the largest impact so interventions can be
prioritized according to support in the region.'
— CARE Faculty Commentary
ESMO 2014. Abstract 1342P. Early palliative care in cancer
patients. Systematic review of literature, with meta-analysis of
randomized clinical trials.
A. Affatato et al.
Background. Recently many authors have hypothesized that early palliative
care (EPC) in patients with cancer could improve survival, quality of life or
symptoms control. To confirm this datum, we have recently completed a
systematic review of literature with meta-analysis of randomized clinical
trials.
Conclusions: Our data confirm that EPC could improve quality of life of
patients with advanced cancer. The datum, that is significant by a statistical
point of view, is modest by a clinical point of view, with a negligible impact
in the comprehensive assessment of the patient. Nevertheless, many methodological and clinical limits reduce the definitive meaning of our results,
and make our conclusion controversial. Further trials, are probably needed
to better define the role of EPC in the comprehensive care of cancer patients
with advanced disease.
ESMO 2014. Abstract 1347P. Key Interventions of Palliative
Cancer Care (KI-PCC) - patient perceived need and remembered
delivery by health-care professionals (HCP): A prospective,
longitudinal, multicenter study.
N. Magaya-Kalbermatten et al.
Aim: The integration of PC in oncology is challenging, particularly in
resource-restricted and regulatory disperse settings with variable
training of HCPs. To identify gaps and in a second step to improve
care of advanced, incurable cancer patients (pts), we collect a
“reality map” of KI-PCCs and quality indicators (QI).
Conclusions: Our data suggest a substantial gap between perceived
need for and delivered KI-PCCs, without rapid change after 1 month.
'This review confirms that early Palliative Care has the potential to
improve quality of life. The modest clinical significance may be due
to the relatively well status of these patients. Also the inevitable
variability in service or support provided from different Palliative
Care programs may have an impact. It would be important to look
ESMO 2014. Abstract 1348P. A nationwide survey on palliative
sedation for terminally ill cancer patients by the Austrian Palliative
Care (AUPAC) study group.
Abstract 1352P. continued...
Conclusion: The KM-CART system was considered easy to use
and very safe, and the recovery of large volumes of autologous
proteins was thought to have improved general status, nutrition,
and immune status, as well as subjective symptoms. In addition,
the recovered cancer cells were able to be used for drug sensitivity
tests and immune cell therapy, indicating the potential for new
treatment strategies for malignant ascites in the future.
'This is a very novel therapy and the results seem promising. Reinfusing
the recovered autologous proteins is a creative replacement to
albumin infusions commonly used. Using the cancer cells for
dendritic cell vaccine therapy is also quite ingenious. It would be
interesting to know of the cost of this therapy and further data from
multi-centre studies is eagerly awaited.'
S. Schur et al.
— CARE Faculty Commentary
Aim: Palliative sedation (PS) is defined as the controlled use of
sedative drugs to alleviate unbearable suffering caused by refractory symptoms. Intractable distress longing for subsequent sedating
treatment may frequently occur especially in oncological patients in
the terminal phase of illness. Application of this approach requires
special expertise but consensus on best practice is achieved incompletely. The aim of this study was to assess the current practice of
PS in Austria.
Conclusions: There is a considerable heterogeneity in the use of PS
in oncological patients in Austrian palliative care units which cannot
be explained by disease associated variables. Since the use of PS is
associated with significant ethical issues, training of physicians and
implementation of an Austrian nation-wide guideline is mandatory.
'Given the mounting discussion in euthanasia or physician-assisted
suicide, it is imperative palliative sedation is included as one of
the options to relieve suffering for patients. This study confirms
previous data that palliative sedation does not impact on survival.
It is interesting however that many patients in this study received
aggressive therapies such as iv antibiotics, hydration and nutrition
that normally would have been discontinued in terminal patients.
As mentioned by the authors, it may be helpful for guidelines to be
developed and training provided.'
— CARE Faculty Commentary
ESMO 2014. Abstract 1352P. Active palliation and new treatment
strategies for malignant ascites using KM-CART
K. Matsusaki et al.
Aim: To improve the symptoms of refractory ascites, we have
developed a novel cell-free and concentrated ascites reinfusion
therapy (KM-CART). KM-CART is easier to use and can be applied
for massive malignant ascites. The effectiveness of KM-CART in
alleviating symptoms, and the application of cancer cells recovered
by KM-CART in personalized medicine are hereby reported.
ESMO 2014. Abstract 1536P. Cancer cachexia: Perspectives of
health care professionals.
M. Muscaritoli et al.
Aim: The majority of cancer patients develop cancer cachexia
(CC). CC is a debilitating and life-threatening, multifactorial condition that is characterized by altered metabolism and reduced food
intake, contributing to weight loss (mainly lean body mass). Existing
treatment approaches are limited in their ability to treat CC, while
too little is currently done to prevent it. Surveys were carried out
to gain insights on the current perspectives of health care professionals (HCPs) on CC.
Conclusions: The results of these surveys indicate that, although CC
is still not equally defined among HCPs, it is perceived as a condition
which negatively impacts on QoL and risk of side effects, and is
in need of new, effective, preventative, and therapeutic strategies.
Furthermore, increasing awareness of CC and its detrimental
consequences appears mandatory among HCPs in order for new
treatments to be cost-effective.
'This report underscores the need to have better treatments
for cancer cachexia, a highly debilitating condition in patients
with advanced cancers. It is concerning that more than 10% of
respondents would delay treatment for cancer cachexia until
weight loss is >= 25% at which point the quality of life for patients
is likely severely affected. This highlights the need for standardized definition and screening as well as improved education for
health care professionals.'
— CARE Faculty Commentary
ESMo 2014. Abstract 1330PD. Phase II trial of epidermal growth
factor ointment for patients with erlotinib-related skin effects.
S. Oh et al.
Aim: The efficacy of the epidermal growth factor receptor (EGFR)
tyrosin kinase inhibitor erlotinib has been demonstrated in patients
with non-small cell lung cancer (NSCLC) and pancreatic cancer
(PC). Dermatologic reactions can be a surrogate marker for the
efficacy of erlotinib and they can result in dose modification. Such
reaction can cause significant physical and psycho-social discomfort to patients. In the present study, we evaluate the effect of
epidermal growth factor (EGF) onitment on erlotinib related skin
effects (ERSEs).
Conclusions: This is the first large-scale prospective study of the
treatment of ERSEs. Based on the results, the EGF ointment is
effective for ERSEs, regardless of gender, age, type of tumor, and
dosage of erlotinib, The EGF ointment evently improved all kinds of
symptoms of ERSEs (NCT01593995).
'Skin toxicity from erlotinib affects quality of life. The results from
this Korean group are encouraging. The twice daily dosing is not
cumbersome and there are no major adverse effects reported.
Results from randomized controlled trials will be interesting. One
wonders if the application can be extended to other types of skin
toxicity such as from capecitabine which may not be driven by the
same pathway.'
— CARE Faculty Commentary
ESMO 2014. Abstract 1545O. Fatigue (F) and anemia scores
for overall survival (OS) prognosis (ID 2554).
Y. Gornadha et al.
Background: F is an adverse reaction related both to disease and
treatment in cancer patients (pts). Incidence of F episodes and
anemia could be expressed using scores which association with OS
could be useful for treatment management.
Conclusion: A linear score of anemia and fatigue PSS were simple
and efficient predictors of overall survival. They could be monitored
to help clinicians in fatigue and anemia management.
'It would be interesting to see if the severity of fatigue is correlated
to the types and the number of previous chemotherapy. This
score may be a tool to prompt health care professionals to
initiate discussions on goals of care and encourage Palliative Care
referrals, especially in patients with a poor anticipated prognosis.'
— CARE Faculty Commentary
The CARE Faculty feels that palliative care is critically important. For this reason, a CARE Needs Assessment questionnaire has been
developed, led by Dr. Ernie Mak and involving other CARE Faculty members in various tumour sites. The objective of this program is to
share experiences, identify trends, discuss therapeutic issues and consider strategies based on the responses received.
The questionnaire will take less than five minutes. Please take a few minutes to complete the survey online at:
http://www.careeducation.ca/careneedsassessments
About The CARE Oncology Faculty
The CARE (Community Academic Research Education) Oncology Faculty is a national group of oncologists
from across Canada who gather, discuss and address gaps in knowledge, to develop education initiatives.
The vision of the CARE Oncology Faculty is to share opinions and update Canadian specialists with
news and developments from key conferences framed in a Canadian perspective.
The mission of the CARE Oncology Faculty is to enhance medical education with the explicit goal of
improving patient outcomes.
i
Pertuzumab plus Trastuzumab plus Docetaxel for Metastatic Breast Cancer. J Baselga et al. N Engl J Med 2012; 366:109-119.
Final overall survival (OS) analysis from the CLEOPATRA study of first-line (1L) pertuzumab (Ptz), trastuzumab (T), and docetaxel (D) in patients (pts) with HER2-positive metastatic breast cancer
(MBC). Swain SM et al. Abstract 350O_PR. ESMO 2014
iii Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open
label, phase 2 trial. Gianni L et al. Lancet Oncol. 2012 Jan;13(1):25-32.
iv First results from the phase III ALTTO trial (BIG 2-06; NCCTG [Alliance] N063D) comparing one year of anti-HER2 therapy with lapatinib alone (L), trastuzumab alone (T), their sequence (T-L), or their
combination (T+L) in the adjuvant treatment of HER2-positive early breast cancer (EBC). Piccart-Gebhart MJ et al. J Clin Oncol 32:5s, 2014 (suppl; abstr LBA4)
ii
This CARE PUBLICATION provides educational updates on current trends in medicine. Views expressed in this report are those of the faculty. All information is provided for
general informational purposes only, on an “as is” basis, without any representations, warranties or conditions, whether express or implied, statutory or otherwise, including,
without limitation, any representations, warranties or conditions as to quality, accuracy, completeness, currency, reliability, efficacy, or fitness for a particular purpose. This
information is not a substitute for informed medical advice. Support for the distribution of this report was provided by Boehringer Ingelheim (Canada) Ltd./Ltée, Amgen
Canada, Eli Lilly Canada Inc. and Novartis Pharmaceuticals Canada Inc. Copyright © 2014 by CARE. All rights reserved. This publication or any portion thereof, in print, electronic
copy or any other form, cannot be reproduced without the express written consent of CARE. Any information, data, analysis, or results reproduced from another source remains
the property of its authors.

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