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A B S T R A C T S
S55
P033
ARE OLDER PATIENTS PROPERLY REPRESENTED IN
CLINICAL TRIALS? ANALYSIS OF THE SCREENING FAILURES
REASONS IN ELDERLY NON-SMALL CELL LUNG CANCER
PATIENTS (NSCLC) STAGE IV ASSESSED FOR BEVACIZUMAB
THERAPY (GIDO1201 TRIAL)
R. Gironés
1,
*, F. Aparisi
2
, M. de Julián
3
, A. Sánchez-Hernández
3
,
A. Blasco
4
, S. Blasco
5
, O. Juan
6
, on behalf of GIDO and GIDO:
Grup d´investigació i divulgació en oncologia
1
Medical Oncology Unit, Hospital Lluis Alcanyis, Xàtiva,
2
Medical
Oncology Unit, Hospital Virgen de Los Lirios, Alcoi,
3
Medical
Oncology Unit, Hospital Provincial, Castellón,
4
Medical Oncology
Unit, Hospital General, Valencia,
5
Medical Oncology Unit, Hospital
de Sagunto, Sagunto,
6
Medical Oncology Unit, Hospital Universitari
i Politècnic, Valencia, Spain
Introduction:
GIDO 1201 is a phase II trial conducted in 10
centres in Spain that explores the toxicity of a bevacizumab
added to carboplatin-paclitaxel chemotherapy in elderly
patients with NSCLC. Its recruitment was lower than expected.
Objectives:
In order to know the reasons why elderly
patients with NSCLC are unsuitable for this chemotherapy
regimen we collected all screening failures of our phase II trial
GIDO 1201
Methods:
The main eligibility criteria were: age
70
years, ECOG performance status (PS) 0-1, cytologically or
histologically confirmed nonsquamous stage IV NSCLC;
no absolute contraindication to receive bevacizumab, no
mutation of EGFR or rearrangement of ALK. A basal geriatric
assessment was performed and patients with score <5
in activities of daily living (ADL), < 9-12 in the Mini Mental
Status exam (Folstein) or accomplishing one frailty Balducci
criteria [1] (age
85 years old, dependence in 1 or more ADL
3, comorbidities
1 or geriatric syndrome) were excluded.
Results:
Between August 2013 and June 2015, 277 patients
were screened at 10 centres. 26 (20 male, 6 female, median
age: 76 years) eligible patients were enrolled. 3 centres did not
find patients who fulfilled inclusion criteria.
From 250 excluded, median age was 76 years (70-92). 203
were male (82%) and 47 (18%) female.
A main exclusion criterion was no adenocarcinoma
histology (77 pts (31%) squamous, 41 (16%) small-cell lung
cancer, 8 (2.8%) others). For those with adenocarcinoma
histology (126 pts, 50%) were excluded because of: 54 (43%)
PS
2; 22 (17,5%) EGFR mutation; 1 ALK translocation; 21
therapeutic anticoagulation due to previous comorbidity (18
pts) or thromboembolic events related to the NSCLC (3 pts);
3 refused to participate in the trial; 5 haemoptysis; 9 large
vessels infiltration; 4 elder than 85 years; 7 other reasons.
Many patients had PS
2 due to uncontrolled brain
metastases (14 pts)
Conclusion:
In the Spanish population older than 70
years squamous histology comprises 31% of the cases,
and is the main exclusion criteria for the treatment with
bevacizumab. Additionally, nearly 28% patients with
adenocarcinoma presented contraindication to the treatment
with bevacizumab. However, the main reason why patients
with adenocarcinoma were not treated with platinum-based
combination therapy is PS
2 (43%).
References
:
[1] Balducci L. Evidence-based management of cancer in the
elderly. Cancer Control 2000;7(4):368-76.
Disclosure of interest:
None declared
Keywords:
Bevacizumab, elderly phase II studies, non-small
cell lung cancer, screening failures
P034
SHORT-TERM CHANGES IN MOOD AS MEASURED BY
COMPREHENSIVE GERIATRIC ASSESSMENT (CGA) SCORES
FOLLOWING TREATMENT OF PRIMARY BREAST CANCER IN
OLDER WOMEN
R. M. Parks
1,
*, P. Howard
2
, K. Cox
2
, K.-L. Cheung
1
1
School of Medicine,
2
School of Health Sciences, University of
Nottingham, Nottingham, United Kingdom
Introduction:
Treatment decision making in the older
women with primary breast cancer can be challenging.
Evidence is growing for the use of a comprehensive geriatric
assessment (CGA) tool to help identify patients who may be
appropriate for surgery or non-surgery.
Objectives:
To identify whether there are any differences
between CGA performed at 6 weeks compared to 6 months
post-diagnosis in patients with primary operable breast
cancer.
Methods:
A prospective, two-centre, pilot study was
conducted evaluating a previously validated, cancer-specific
CGA tool in older women with primary (stage I/II) breast
cancer. CGA was conducted within 6 weeks and again at
6 months post-diagnosis. The decision of primary treatment
followed consultation with the clinical team and was not
guided by CGA. Total CGA scores included assessment of:
activities of daily living, independent activities of daily living,
performance status, comorbidity, mood, social activity and
social support.
Results:
At the time of analysis, 60 patients had completed
CGA at both 6 weeks and 6 months post-diagnosis. 42 of these
underwent surgery and 18 non-surgery (primary endocrine
therapy). Average age was 80 years (range 68-92).
There was no significant difference between total scores
for CGA (maximum score 263 points); higher scores indicating
better outcomes) between those who had surgery compared
to non-surgery, at 6 weeks or 6 months after diagnosis.
There was a significant (p=0.009) improvement in total
CGA score between the two time points for the patients who
underwent non-surgery; at 6 weeks non-surgery patients had
an average total CGA score of 191/263, compared with 209/263
at 6 months. This was not apparent for the surgical patients.
Analysis of the individual components of total CGA score
(listed above) for non-surgery patients showed a significant
(p=0.045) improvement in mood score alone; at 6 weeks
non-surgery patients had an average mood score of 77/102,
compared to 85/102 at 6 months.
Conclusion:
In this small pilot study, a short-term (at 6
months) improvement in mood has been observed in patients
undergoing non-surgery (primary endocrine therapy). This