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Thanh G.N. Ton



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    EP1.12 - Small Cell Lung Cancer/NET (ID 202)

    • Event: WCLC 2019
    • Type: E-Poster Viewing in the Exhibit Hall
    • Track: Small Cell Lung Cancer/NET
    • Presentations: 1
    • Now Available
    • Moderators:
    • Coordinates: 9/08/2019, 08:00 - 18:00, Exhibit Hall
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      EP1.12-06 - New Treatment Option for ES-SCLC: Patient Characteristics and Use of an Atezolizumab Regimen in the Real-World Setting (Now Available) (ID 2651)

      08:00 - 18:00  |  Presenting Author(s): Thanh G.N. Ton

      • Abstract
      • Slides

      Background

      Results from the Phase III IMpower133 study (NCT02763579) were previously made public. Based on improvements in overall survival in patients with extensive-stage small cell lung cancer (ES-SCLC) who received atezolizumab plus carboplatin and etoposide (IMpower133 regimen) vs chemotherapy administered in the 1L setting, the NCCN added this regimen to its guidelines (category 1, preferred) on October 10, 2018. Accordingly, some providers began implementing this regimen in their clinical practice, creating a unique opportunity to characterise its early and broad use in a real-world setting.

      Method

      Patients with ES-SCLC who started treatment within 90 days of initial diagnosis and had a confirmed administration of atezolizumab with carboplatin or cisplatin and etoposide (atezo regimen) on or after September 25, 2018, were included from the de-identified Flatiron Health electronic health records–derived database, representing > 280 US cancer clinics (≈ 800 sites of care). Treatment data were analysed through April 30, 2019. Broad use was defined as treatment with the atezo regimen outside of several main clinical trial restrictions (ECOG PS ≥ 2, abnormal laboratory values, cisplatin use or as 2L treatment). Frequencies and percentages are reported. Monthly uptake was defined as the percentage of ES-SCLC patients starting 1L therapy each month who were treated with the atezo regimen.

      Result

      Uptake of the atezo regimen increased from 10% in October 2018 to 46% in February 2019 (before FDA approval on March 18, 2019) and 66% in April 2019 (after FDA approval); 143 patients were identified, 92% of whom had ES-SCLC at initial diagnosis (Table). The atezo regimen was used broadly among 46% of patients (18% with ECOG PS ≥ 2, 18% with an abnormal laboratory value, 1% on cisplatin, 17% as 2L ES-SCLC treatment). The median time from ES-SCLC diagnosis to start of the atezo regimen was 16 days for 1L patients and 78 days for 2L patients. Patients treated with the atezo regimen in the 1L were administered atezolizumab at a median of 8 days after start of chemotherapy; those treated in the 2L were typically administered atezolizumab immediately at the start of the line.

      Conclusion

      This real-world analysis demonstrates the broad use of the atezo regimen, with nearly half of patients treated outside of several main IMpower133 trial restrictions. Further, a rapid uptake of the regimen even before FDA approval underscores its impact on changing clinical practice and the high unmet need of this patient population.

      Table. Characteristics of Patients Treated With the Atezolizumab Plus Carboplatin/Cisplatin and Etoposide Regimen in Routine Clinical Care

      Patients, n

      143

      Treated prior to FDA approval (March 18, 2019), n (%)

      101 (71)

      Median age at ES-SCLC diagnosis (IQR), years

      67 (61, 73)

      Aged ≥ 65 years at ES-SCLC diagnosis, n (%)

      90 (63)

      Female, n (%)

      71 (50)

      White, n (%)

      100 (70)

      Smoking history, n (%)

      137 (96)

      Stage at initial diagnosis, n (%)

      LS

      7 (5)

      ES

      132 (92)

      Unknown

      4 (3)

      ECOG PS, n (%)a

      0 or 1

      76 (53)

      2+

      26 (18)

      Unknown

      41 (29)

      Radiation therapy, n (%)b

      14 (10)

      LS setting, n

      7

      ES setting, n

      7

      Regimen, n (%)

      Atezolizumab, carboplatin, etoposide

      141 (99)

      Atezolizumab, cisplatin, etoposide

      2 (1)

      Line of therapy of atezo regimen in ES setting, n (%)

      1L

      119 (83)

      2L

      24 (17)

      Median time from ES-SCLC diagnosis to start of line of therapy containing atezo regimen (IQR), days

      1L

      16 (11, 26)

      2L

      78 (59, 98)

      Median time from ES-SCLC diagnosis to first administration of atezo within line (IQR), days

      1L

      24 (14, 27)

      2L

      78 (59, 98)

      Abnormal baseline laboratory value, n (%)c

      26 (18)

      1L, first line; 2L, second line; atezo, atezolizumab; ECOG, Eastern Cooperative Oncology Group; FDA, US Food and Drug Administration; IQR, interquartile range; LS, limited stage; PS, performance status.

      a ECOG PS value closest to within −30 to +7 days of treatment start.

      b Includes radiation therapy to chest following initial diagnosis of SCLC, including concurrent radiation therapy with systemic chemotherapy, chemotherapy followed by radiation therapy, up-front palliative radiation therapy to the chest or for superior vena cava syndrome.

      c Abnormal values defined as those not meeting the following definitions: absolute lymphocyte count ≥ 500/μL, lymphocyte count ≥ 500/μL, absolute neutrophil count ≥ 1500 cells/μL, platelet count ≥ 100,000/μL, hemoglobin ≥ 9.0 g/dL, aspartate aminotransferase ≤ 5 × upper limit of normal (ULN), alanine aminotransferase ≤ 5 × ULN, alkaline phosphatase ≤ 5 × ULN, serum bilirubin ≤ 1.25 × ULN, serum creatinine ≤ 1.5 × ULN, serum calcium ≤ 12 mg/dL.

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