PROspective Master-protocol for Evaluation of Systemic THErapeutics in Elderly With Thoracic Malignancies

Objective Response Rate (ORR)

The objective response rate (ORR) is defined as the proportion of patients with complete response (CR) or partial response (PR) as the best response during the study according to RECIST 1.1 criteria based on tumoral assessment performed by thorax-abdominal-pelvic and brain CT scans. The frequency of the tumor assessments will follow the site practices.

Time frame: From the date of first dose of treatment received until the date of the first documented disease progression according to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 or to death from any cause, whichever comes first, assessed up to 2 years

Overall Survival (OS)

Overall survival (OS) is calculated as the time between the date of treatment initiation and date of death, and censored at date of last news for patients alive at the end of the study.

Time frame: From the treatment start date up to the date of death for a 2-year-period maximum

Duration of Response (DOR)

The duration of response is defined as the time between the date of the first response assessed by RECIST 1.1 to the date of progression or death for any cause, whichever comes first, and censored at the date of last tumor evaluation for patients still responding to treatment at the end of the study (after 2 years).

Time frame: From the date of the first response to the date of progression or death, whichever comes first, or for a 2-year-period maximum

Time to Response (TTR)

Time to response is measured from the date of treatment initiation to the date of first response as defined by RECIST 1.1.

Time frame: From the start date of treatment up to the date of first response or for a 2-year-period maximum

Treatment Duration

The duration of treatment is defined as the time between the treatment start date and the date of definitive cessation of treatment, whatever the cause.

Time frame: From the treatment start date and the treatment stop date whatever the cause up to a 2-year-period maximum.

Safety events

All adverse events experienced by the participants, whatever the grades of toxicity, will be collected according to CTCAE v4.0 (common terminology criteria for adverse events).

Time frame: From the enrollment up to the participants study end date or for a 2-year-period maximum

Treatments description

The treatments for NSCLC will be described including the adaptations: discontinuations, treatment interruptions, dose adaptations. The reasons for the changes will be recorded.

Time frame: From the start date of the NSCLC treatment up to the participant study end date or for a 2-year-period maximum

Geriatric interventions: specialized consultations

The specialized geriatric consultations carried out to correct frailties will be collected during the study participation including psychological and/or dietetic consultations.

Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum

Geriatric interventions: specialized exercises

The specialized geriatric exercises carried out to correct frailties will be collected during the study participation including prescription of adapted physical activity and/or cognitive stimulation exercises.

Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum

Geriatric interventions: specialized help at home

The specialized geriatric interventions at home carried out to correct frailties will be collected during the study participation including home visits by a nurse or home help.

Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum

Geriatric interventions: specialized medications

The specialized geriatric medications carried out to correct frailties will be collected during the study participation.

Time frame: From the enrollment up to the participant study end date or for a 2-year-period maximum

European Organisation for Research and Treatment of Cancer Core Function Questionnaire (QLQ-F17)

The QLQ-F17 is a validated cancer-specific questionnaire specific to cancer. It includes 17 items to assess 6 QoL scales: 1 global health scale and 5 functional scales (physical, role,emotional, cognitive, social). This is a shortened version of the QLQ-C30, containing only the functional and overall quality of life sections. This questionnaire was developed by the EORTC in order to optimize the collection of quality-of-life data, and to avoid overloading the patient with a lengthy questionnaire. Symptoms will be assessed via modules. A score is generated for each dimension and standardized on a scale from 0 to 100, so that a high score reflects a high overall health status, a high functional level and a high symptomatic level. According to EORTC recommendations, the score can be calculated if at least 50% of the items in the corresponding dimension have been completed. Otherwise, the score will be considered missing.

Time frame: At enrolment, at 12 weeks, at 6 months and at 12 months.

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-ELDerly 14 (QLQ-ELD14)

The QLQ-ELD14 questionnaire is specific to elderly cancer patients. It contains 14 items measuring 7 dimensions of quality of life : two functional dimensions (maintaining a positive positive vision/motivation, family support) and 5 symptomatic dimensions (mobility, worries about others, worries about the future, disease burden, joint problems). All of the scales and single-item range in score from 0-100. A score is generated for each dimension, so that a high score reflects a high functional level (for the scales concerned), and a high symptomatic level (for the scales concerned).

Time frame: At enrolment, at 12 weeks, at 6 months and at 12 months

European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13)

The QLQ-LC13 is a lung cancer-specific questionnaire containing 13 items to assess symptoms specific to lung cancer and its treatment: dyspnea, cough, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, chest pain, arm or shoulder pain or shoulder pain, pain in other parts, anti-inflammatory drugs, drugs for pain. A score is generated per dimension so that a high score reflects a high symptomatic level. All of the scales and single-item range in score from 0-100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status represents a high quality of life, but a high score for symptom scale/item represents a high level of symptomatology/problems.

Time frame: At enrolment, at 12 weeks, at 6 months and at 12 months

Geriatric characteristics G8 score

The following geriatric characteristics will be collected is available in the participant medical file: G8 score. The total G-8 score lies between 0 and 17. A higher score indicates a better health status.

Time frame: At enrollment and at disease progression for a maximum of 2-year-period.

Geriatric characteristics Geriatric Core DatasEt (G-CODE)

The following geriatric characteristics will be collected is available in the participant medical file: Geriatric Core DatasEt (G-CODE). G-CODE is a core set of geriatric data. It has ten tools/items and a median completion time of 9 min. It includes Katz autonomy scale (ADL), Instrumental Activities of Daily Living (IADL), Charlson score, mini Geriatric Depression Sale (mini-GDS), short cognitive impairment screening exam (mini COG), falls history, Timed Get Up and Go test, social environment. The G-CODE allows for a minimal geriatric description of the older cancer population and standardisation of geriatric data, enabling comparison across trials.

Time frame: At enrollment and at disease progression for a maximum of 2-year-period.