Journal of Geriatric Oncology - Volume 7/6 - Supplement 1

S82

A B S T R A C T S

Conclusion:

There is a significant difference in disease

free survival and time to recurrence between elderly patients

who undergo a limited resection compared to a lobectomy,

but no statistical difference in 5-year survival between the

groups. The benefit of limited resection in preserving lung

function and reducing post-operative recovery has been

counterbalanced by risk of recurrence. Salvage surgery can

still cure about half of the patients with recurrence.

References

[1] Ginsberg RJ, Rubinstein LV. Randomized trial of lobectomy

versus limited resection for T1 N0 non-small cell lung

cancer. Lung Cancer Study Group.

Ann Thorac Surg

. 1995

Sep;60(3):615-22

[2] Mery CM, Pappas AN, Bueno R, Colson YL, Linden P,

Sugarbaker DJ, Jaklitsch MT Similar long-term survival

of elderly patients with non-small cell lung cancer

treated with lobectomy or wedge resection within the

surveillance, epidemiology, and end results database.

Chest. 2005;128(1):237.

Disclosure of interest:

None declared

Keywords:

Elderly, local recurrence, lung cancer, recurrence,

salvage surgery

P078

EPITOP-01: ELDERLY CANCER PATIENTS, SAFETY AND

QUALITY OF LIFE UNDER IMMUNOTHERAPIES: A PHASE IV

TRIAL

R. Sabatier

, C. Zemmour

, S. Durand

, F. Goldwasser

F. Rousseau

* and Société Francophone d’Oncocogériatrie

Medical Oncology,

Biostatistics,

Pharmacy, Institut Paoli

Calmettes, Marseille,

Medical Oncology, Hopital Cochin, Assistance

Publique Hôpitaux de Paris, Paris, France

Introduction:

Immunotherapies such as PD1/PD-L1 or

CTLA-4 inhibitors have been hugely developed in the last

years in many cancers. Most of published prospective data

related to immunotherapy have been focused on young

patients with only 5 to 10% of patients above 75 years. We

propose here to develop the first clinical study focused on the

impact of immunotherapies in the elderly population.

Objectives:

Our co-primary objectives will be to assess

the safety and quality of life under treatment. Secondary

objectives will be evaluations of geriatric data modifications

under treatment, efficacy, and correlation between toxicity and

efficacy. Another secondary objective will be the comparison

between patients and clinicians symptom reporting. We will

also conduct an ancillary pharmacokinetics analysis to explore

PDL1 inhibitors antibodies residual concentration impact.

Methods:

This phase 4, multi-centre, single arm, open-

label study will evaluate the safety and efficacy of immune

checkpoint inhibitors-based therapies in elderly patients with

advanced or metastatic solid tumours. To answer to primary

objectives, 300 patients are awaited. Subjects who consent to

participate will be enrolled if they meet the all the following

criteria: proven diagnosis of solid tumour, treatment with an

immune checkpoint inhibitor, age equal or over 70 years old,

and patients not included in another clinical trial assessing

immunotherapy efficacy. All patients receiving at least one

dose of treatment will be evaluable for safety, quality of

life, geriatric assessments, and efficacy data. Safety will

be evaluated using CTCAE V4 criteria for both clinical and

biological toxicities. Quality of life will be evaluated using the

EORTC QLQ-ELD14 questionnaire. Comprehensive geriatric

evaluations (including G8, ADL, IADL, GDS15, MNA, MMSE,

modified Charlson’s score, Fried frailty criteria, maximal grip

strength, and one-legged stance test) will be performed at

inclusion. Additional optimized geriatric assessments (ADL,

IADL, GDS15, maximal grip strength, and one-legged stance)

will be done every 2 months until treatment discontinuation.

Efficacy (Progression –free survival and overall survival) will

be assessed using clinical and radiological (RECIST 1.1) criteria

every 2 months. CTCAE v4 questionnaires will be completed

by clinicians before every treatment cycle. Patients will also

complete a language adapted questionnaire (Basch E, Lancet

Oncol 2006). For all symptoms, both patients and clinicians

answers will be compared. Finally, residual PDL1 inhibitor

antibodies concentration before the second and fourth

treatment administration will be assessed. These results

will be compared to sarcopenia evaluation (using CT-scan)

and glomerular filtration rate measurement (using blood

creatinine and Cystatin C).

Fig. 1 (abstract P077) – Disease-free survival.

Fig. 2 (abstract P077) – Overall survival by type of surgery.