Annual Meeting Proceedings Part 1 - American Society of Clinical ...

404s Health Services Research
6089 General Poster Session (Board #7F), Mon, 1:15 PM-5:15 PM
Use and duration of chemotherapy (CT) in patients (pts) with metastatic breast
cancer (MBC) according to tumor subtype (TS) and line of therapy (tx).
Presenting Author: Davinia Shien Seah, Dana-Farber Cancer Institute, Boston,
MA
Background: Benefits of CT vary widely in MBC pts. We aimed to describe the impact
of breast cancer TS and line of tx on the duration of CT. Methods: In a retrospective
analysis, we identified 205 pts treated with CT for MBC at the Dana-Farber Cancer
Institute between 2005-8. TS were classified as hormone receptor (HR)� (ER�/PR�/
HER2-), triple negative (TN) (ER-/PR-/HER2-) or HER2� (HER2�, any HR). CT
duration was defined as �time from start of one CT line to the start of the next CT.�
Chi-square, Kruskal-Wallis, and Kaplan-Meier methods were used. Results: Median
follow-up was 54 months (m). Most pts had received adjuvant tx, though 23% had
MBC at diagnosis. Almost all HER2� pts had concurrent anti-HER2 tx. CT duration
was longest in 1st line with consecutive stepwise decrease. The proportion of pts
who received CT beyond the 3rd line varied by TS: 52% of HER2� pts received � 4
CT lines, compared with 37% of HR� and 29% of TN pts. Duration in later CT lines
also differed by TS. Median CT duration in HER2� pts was � 4 m in all 6 lines, but
HR� and TN pts had a median CT duration of �4m from the 4th line onwards.
Quartile estimates suggested a substantial fraction of HER2� and HR� pts
receiving �6m of CT in 5th and 6th line; by contrast, CT duration for TN pts were
consistently brief in later CT lines. Conclusions: TS determines the likely duration
and number of lines of CT for MBC. Among HR� and HER2� pts who receive CT
beyond 3rd line, there are substantial rates of prolonged tx suggesting clinical
benefit. For TN pts, the opportunity for additional lines and the CT duration declined
more dramatically. The true role of advanced (� 3rd) CT lines for all MBC in
improving quality of life, survival, and the predictors of such benefit, warrant further
study.
CT characteristics.
HR� TN HER2�
No. of pts, N (%) 102 49 45 22 58 28
No. of CT lines
median, min, xax
Pts receiving nth CT line
N, %
3 1 9 3 1 8 4 1 9
1 102 100 45 100 58 100
2 79 77 36 80 44 76
3 56 55 26 58 40 69
4 38 37 13 29 30 52
5 24 24 8 18 24 40
6
CT duration
Median, 1st, 3rd quartile
9 9 6 13 19 33
1 6.5 2.9 12.0 5.8 2.8 10.7 9.0 4.3 13.1
2 4.4 2.6 7.9 3.3 2.0 6.3 5.1 2.8 11.3
3 3.6 1.9 6.0 2.8 2.1 6.8 6.3 2.9 8.3
4 4.0 2.1 7.3 3.4 1.8 8.1 4.7 2.7 8.9
5 3.5 1.9 6.5 2.6 1.9 3.2 4.0 2.3 7.0
6 3.3 2.1 7.4 2.0 1.8 2.3 4.2 1.9 6.1
6091 General Poster Session (Board #7H), Mon, 1:15 PM-5:15 PM
Recruitment of cancer patients to National Institute for Health research
cancer research network portfolio studies between 2001 and 2011.
Presenting Author: Matthew Cooper, National Institute for Health Research
Cancer Research Network, Leeds, United Kingdom
Background: The National Institute for Health Research Cancer Research
Network (NCRN) was established in 2001 in England, United Kingdom to
improve cancer patient outcomes by improving the coordination, integration
and speed of cancer research. Methods: Baseline recruitment of cancer
patients in England to clinical studies was around 4% of incident
population. Research Networks were established initially in England
(NCRN) and then across the UK, co-terminus with clinical cancer service
networks, and a per capita based funding model used to provide a research
infrastructure to support recruitment to a nationally defined research
portfolio. Results: Within 3 years, as the networks were established,
recruitment of patients to studies doubled from 10,000 to 20,000 cancer
patients per year. Recruitment has continued to increase year on year,
supported initially by underspend that had accrued from earlier years in the
life of NCRN, and more recently from additional resources invested via the
NIHR comprehensive networks. Data for 2010/11 show that over 45,000
cancer patients are now recruited into portfolio studies in England each
year, with over 50,000 across the whole of the UK. Conclusions: Dedicated,
targeted, clinician-led National Health Service investment into supporting
national portfolio studies, has delivered an unprecedented five-fold increase
in recruitment of cancer patients into clinical trials across the
United Kingdom. This required coordinated research infrastructure, close
cooperation with research funders, particularly Cancer Research UK and
the National Cancer Research Institute, and the enthusiasm and hard work
of many clinicians, patients and others working to deliver clinical cancer
care in the National Health Service in the United Kingdom.
6090 General Poster Session (Board #7G), Mon, 1:15 PM-5:15 PM
Health-related quality of life assessment in EORTC cancer clinical trials.
Presenting Author: Efstathios Zikos, European Organisation for Research
and Treatment of Cancer Headquarters, Brussels, Belgium
Background: Over the last three decades health-related quality of life
(HRQOL) has become an important part of the randomised controlled trials
(RCTs) conducted by the European Organisation for Research and Treatment
of Cancer (EORTC). This review aims to undertake a descriptive
database evaluation of all the HRQOL studies conducted in EORTC since
1980. Methods: The EORTC protocol database (n�785) was reviewed,
restricting the search to between 1980 and 2011 (n�735). We investigated
the number of HRQOL studies conducted in EORTC trials, the RCTs’
status and the use of HRQOL tools since 1980. Results: 157 protocols with
HRQOL assessment were identified involving 70,903 patients. 73 studies
ended as defined in the protocol; 27 studies closed early due to poor
accrual; 17 are at the final analysis of the primary end point stage; 14
studies are still open to recruitment; 11 are closed to patient entry; and 15
new RCTs are pending activation with HRQOL. The majority of phase III
(n�135) and phase II/III (n�9) RCTs have HRQOL as secondary endpoint.
EORTC also conducted a number of large scale field studies (n�11), where
HRQOL was the primary endpoint. During the early period of 1980 to 1989
HRQOL was assessed in 12 EORTC RCTs by using a small number of
HRQOL items, but from 1990 to 2000, HRQOL was assessed in 97 RCTs
using more comprehensive HRQOL tools. Between 2001 and 2011 the
number of RCTs with HRQOL was 48. The EORTC clinical groups with the
most RCTs containing HRQOL were Radiation Oncology (n�22), Genito-
Urinary (n�20), Gynaecological (n�16), Breast Cancer (n�16), Lung
(n�13), Gastrointestinal, (n�13) and Brain (n�10). The EORTC HRQOL
tools were used in 90% of the trials, with other validated tools being used
when required. Conclusions: Our review of EORTC RCTs has shown how
patient perspective has been constantly considered of major importance in
oncology during the last three decades. The inclusion of patient perspective
in drug development shows that a more comprehensive HRQOL assessment
has taken place over time as better instruments have become available. As
the positive value of patient perspective grows to clinicians, regulatory
bodies and industry, we expect that EORTC will continue its support by
including HRQOL endpoints where appropriate.
6092 General Poster Session (Board #8A), Mon, 1:15 PM-5:15 PM
Characterizing fatigue associated with sunitinib (SU) in patients (pts) with
metastatic renal cell carcinoma (mRCC). Presenting Author: David Cella,
Department of Medical Social Sciences, Northwestern University Feinberg
School of Medicine, Chicago, IL
Background: Fatigue is common in cancer pts and associated with use of
tyrosine kinase inhibitors (TKIs) such as SU. Limited data exist on the time
pattern of fatigue with TKI therapy. Methods: Data from treatment-naïve
mRCC pts in SU arms of two clinical trials were analyzed retrospectively.
Study 1; 375 pts were randomized to SU 50 mg/d on a 4 weeks-on-2-weeksoff
schedule (Schedule 4/2), for up to 30 cycles. Study 2; pts were
randomized to SU 50 mg/d Schedule 4/2 (Group 1; n�146) or 37.5 mg/d
continuous daily dosing (CDD; Group 2; n�146). In both trials, fatigue was
measured with the question to pts: “I feel fatigued” over the past week
(5-point rating scale, not at all-very much), and with the provider-rated
Common Terminology Criteria for Adverse Events (CTCAE). In addition to
descriptive profiles, Study 1 used two modeling approaches; repeated
measures model (M1), with time as a categorical predictor; and random
intercept-slope model (M2), with time as a continuous predictor. Study 2
calculated mean absolute values of within-cycle rate of change (from one
assessment to the next) through the first 6 treatment cycles. Results: In
Study 1, representing fatigue across cycles, M1 showed that the initial
increase in patient-reported fatigue was worst during Cycle 1; mean values
at all subsequent cycles were numerically better. For CTCAE fatigue, M1
showed that all but one of the pair-wise comparisons of the cycle means
were not significantly different. M2 showed that the overall trend for
patient-reported fatigue and CTCAE fatigue was not statistically different
from zero. In Study 2, the mean absolute rate of change for fatigue during 6
treatment cycles was greater for Group 1 (4/2) compared to Group 2 (CDD):
0.042 vs. 0.032, respectively; P�0.003, t-test. Conclusions: In Study 1,
pts reported notable fatigue in Cycle 1, which improved or stabilized,
thereafter. In Study 2, Schedule 4/2 was associated with more within-cycle
fluctuation in fatigue. These findings illustrate how SU-associated fatigue
occurs early in therapy and continues with more within-cycle fluctuation
associated with 4/2 dosing. This may help patient-clinician communications
and interventions that support maintaining effective therapy.
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