A French Real-life Study: EvaluatioN of durvALumab Utilization and Effectiveness for First Line Extensive Stage Small Cell Lung Cancer.

For patients who start durvalumab at a later cycle than first cycle PE, the index date will be the first infusion of PE.

If the treatment is stopped during the first phase of 4 to 6 cycles (induction) with a new re- start of durvalumab and PE, the treatment will be considered as temporary stop. If the treatment is stopped during the durvalumab maintenance with a re-start of durvalumab in monotherapy, the treatment will be also considered as temporary stop.

Durvalumab will be considered definitely discontinued when the maintenance phase with durvalumab in monotherapy is stopped and results in a new administration of PE (+/-durvalumab) (subsequent treatment line).

For patients still receiving durvalumab at the end of follow-up or when they are lost to follow-up, TTD will be right-censored at the last recorded day of ongoing durvalumab treatment.

rwOS is defined as the time from index date (date of first infusion of durvalumab and/ or platinum-etoposide) to date of death due to any cause. rwOS will be censored on the last date patient is known to be alive.

rwOS rate at 1, 2 and 3 years (rwOS1y, rwOS2y, rwOS3y) and median real-world overall survival (mrwOS) will be assessed.

rwPFS is defined as the time from index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the date of disease progression as assessed by physicians or the date of death, whichever occurs first. rwPFS will be censored on the date of last follow-up.

The rwPFS date will be based on the investigator's judgement. The real-world progression may be based on radiological evaluation or clinical judgement, or other measure to compensate absence of RECIST criteria.

rwPFS rate at 6, 12, 18, 24 and 36 months (rwPFS6m, rwPFS12m, rwPF18m, rwPFS24m, rwPFS36m) and median rwPFS (mrwPFS) will be assessed.

The tumour response will be assessed by investigator as Complete response (CR), Partial response (PR), Stable disease (SD), Progressive disease (PD). The patient individual best response is defined as the best response recorded from the start of treatment until disease progression.

The proportion of patients with a CR as best response, with a PR as best response, with SD as best response and with PD as best response will be assessed.

ORR is defined as proportion of patients with at least one complete response (CR) or partial response (PR) at least one visit (Paz Ares et al, 2019).

DCR is defined as the proportion of patients with at least one complete response (CR), partial response (PR) or stable disease.

rwPFS2 is defined as the time from index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the second record of disease progression determined by physicians' assessment, or death. rwPFS2 will be right-censored at the date of last follow-up.

Age

Proportion of patients with previous history of cancer, Proportion of patients with history of paraneoplastic syndromes, Proportion of patients with history of auto-immune disease (including past, stabilized or active disease, disease duration), Proportion of patient treated with antibiotics, corticosteroids or other immunosuppressive therapy in the last 4 weeks before treatment initiation.

Treatment history at durvalumab + platinum-etoposide initiation will be described in terms of:

Proportion of patients with previous SCLC anti-cancer therapy (for limited and extensive stage),

Proportion of patients with previous auto-immune disease associated treatment, Proportion of patients with previous non cancer therapies of interest (immunosuppressive therapy, nephrotoxic and anti-inflammatory drugs, antibiotherapy, corticosteroid therapy, supportive treatments).

Safety profile of durvalumab + platinum-etoposide will be described in terms of:

• Incidence rate of grade ≥3 durvalumab -related according to Common Terminology Criteria for Adverse Events (CTCAE),
• Incidence rate of durvalumab -related immune-related AEs (imAE),
• Incidence rate of SAEs, AESIs, AEs resulting in treatment modification,
• Incidence rate of AEs resulting in treatment discontinuation,

Gender

BMI

Smoking status

• Duration between initial SCLC diagnosis and ES-SCLC for patients with first diagnosis at limited stage,
• Duration between initial ES-SCLC diagnosis and treatment initiation,

• Disease stage at tumour diagnosis (limited or extensive stage; number of metastatic sites) and at baseline,

• Actual number and localization of metastases at baseline including brain metastases (symptomatic or asymptomatic, treated or not), bone metastases (extension), and liver metastases,

• Performance status at baseline (before durvalumab initiation),

Comorbidities.

Time from discontinuation of the last treatment received for limited stage to start of first treatment for extensive stage

• Description of concomitant treatments including nephrotoxic and steroids-immunosuppressive drugs used to manage durvalumab related adverse events.

The impact of different sequential therapeutical strategies (including local and systemic treatments) on patient outcomes will be described in terms of:

• Treatment pathways description (sequences description, duration of sequences),

The association between clinical and biomolecular disease characteristics and cancer progression or response to treatment will be investigated.

Time between chemotherapy and durvalumab initiation is defined as the time from date of first infusion of platinum etoposide to the date of first infusion of durvalumab.

• Proportion of patients receiving durvalumab-etoposide-cisplatin,
• . Proportion of patients receiving durvalumab-etoposide-carboplatin,
• Proportion of patients receiving the combination durvalumab plus PE at first infusion (first cycle),
• Proportion of patients receiving PE at first infusion and durvalumab at a later cycle (if later, initiation cycle),

• Proportion of patients treated with 4 cycles/ 6 cycles before maintenance period,
• Proportion of patients with doses modifications during treatment, description of the changes,
• Proportion of patients with delayed cycles and reason for delay.

• Number of cycles with durvalumab in combination with PE (induction period),
• Number of cycles with durvalumab in monotherapy (maintenance period),

Mean and median duration of first line treatment from the date of first infusion of durvalumab and /or PE to the date of last infusion of durvalumab.

TFST is defined as the time from the index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the date of subsequent therapy or the date of death. For patients still receiving durvalumab at the end of follow-up, TFST will be right-censored at the last recorded day of ongoing durvalumab treatment.

TSST is defined as the time from the index date (date of first infusion of durvalumab and/ or platinum-etoposide) to the date of second subsequent therapy or date of death. For patients still receiving durvalumab at the end of follow-up, TSST will be right-censored at the last recorded day of ongoing durvalumab treatment.

• Proportion of patients with mediastinal irradiation while on durvalumab treatment,
• Proportion of patients with prophylactic cranial irradiation while on durvalumab treatment,
• Proportion of patients with other irradiation while on durvalumab treatment,
• Proportion of patients with surgery while on durvalumab treatment,
• Proportion of patients with GCS-F while on durvalumab treatment,
• Proportion of patients with EPO while on durvalumab treatment,
• Proportion of patients with phosphonate while on durvalumab treatment,

• Pattern of tumor progression, rwPFS2, TFST, TSST).

• Treatment effectiveness (ORR, DCR, mrwOS, mrwPFS, mrwPFS2, TFST, TSST).

• Description of dosage for durvalumab plus PE at initiation
• Description of reasons for platinum salt choice (better tolerance, better efficacy, hospital protocol, patient status, age, other),

Number of cycles with platinum-etoposide,

• Time between each cycle,

• Time between each cycle,

• Proportion of patients with delayed cycles and reason for delay.

Time between the end of induction period and the first local treatment (mediastinal irradiation or prophylactic cranial irradiation).