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  • br A total of patients provided informed

    2019-11-05


    A total of 48 patients provided informed consent and were enrolled in the study (ITT population). The majority (44/48, 91.7%) of these pa-tients received OTL38 and were included in the Safety population. Data from 29/48 (60.4%) patients were included in the mITT Diphenylterazine (DTZ) and were used in the efficacy analysis. Of the 19 patients that were ex-cluded from the mITT population, 7 did not have at least one FRa
    Tumor histology
    4 L.M. Randall et al. / Gynecologic Oncology xxx (xxxx) xxx
    Table 2
    Sensitivity and PPV of OTL38 in detecting FRa + ovarian cancer lesions.
    Number of Estimate (lower Estimate (lower
    (with patient as random (without patient as a
    effect) random effect)
    Sensitivityc
    Note: Includes lesions with positive result for both ovarian cancer and FRa + or negative for both tests.
    TP: Lesions that fluoresced and tested positive for FRa and ovarian cancer.
    FP: Lesions that fluoresced but did not test positive for both FRa and ovarian cancer.
    FN: Lesions that did not fluoresce but tested positive for both FRa and ovarian cancer.
    TN: Lesions that did not fluoresce and did not test positive for both FRa and ovarian cancer.
    a Estimated using Proc Glimmix in SAS® for binomial distribution with patient as a random effect. b Estimated using Proc Glimmix in SAS® for binomial distribution.
    c Sensitivity of OTL38 for the detection of FRa + ovarian cancer lesions.
    d Positive Predictive Value (PPV) of OTL38 for the detection of FRa + ovarian cancer lesions.
    estimate for PPV was 94.93% with a 95% lower boundaryCI = 86.13. The “goodness of fit” test indicated that the GLMM model was the better fitting model due to a non-zero correlation (confirmation of intrapatient correlation of image-guided detection of lesions).
    Additional patient level analyses revealed that 14 of the 29 (48.3%, 95% CI 0.29–0.67) mITT patients had at least one additional pathology-confirmed FRa + ovarian cancer lesion that was detected by OTL38 alone. Miliary disease was identified in 20 FRa + ovarian cancer lesions. In 17 of these 20 cases, 2 or more lesions were identified by OTL38 alone as compared to normal light. In 8 of these 20 (40%) cases, 4 or more le-sions were identified by OTL38 alone, and were not detected by normal white light. In addition, 29 falsely positive lesions were detected in 11
    Table 3
    Sensitivity and PPV of OTL38 in the detection of any ovarian cancer lesion (FRa positive or negative).
    Number of Estimate (lower Estimate (lower
    (with patient as random (without patient as a
    effect) random effect)
    Sensitivityc
    PPVd
    Note: Includes all lesions with pathology results.
    TP: Lesions that fluoresced and tested positive for ovarian cancer.
    FP: Lesions that fluoresced but tested negative for ovarian cancer.
    FN: Lesions that did not fluoresce but tested positive for ovarian cancer.
    TN: Lesions that did not fluoresce and tested negative for ovarian cancer.
    a Estimated using Proc Glimmix in SAS® for binomial distribution with patient as a random effect. b Estimated using Proc Glimmix in SAS® for binomial distribution.
    c Sensitivity of OTL38 for the detection of ovarian cancer lesions.
    d Positive Predictive Value (PPV) of OTL38 for the detection of ovarian cancer lesions.
    patients by each of the 4 investigators. False positives were detected in various anatomic sites, but lymph nodes were the most common lo-cation (Table 4).
    3.2. Safety population
    All patients in the Safety population had at least 1 treatment-emergent adverse event (TEAE) reported during the study. The most common TEAE was procedural pain. Procedural pain was reported in 40 of 44 (90.9%) patients within 1 to 2 days following surgery; none of which were considered related to study drug or imaging device. The majority of TEAEs were of moderate severity (26/44 patients; 59.1%). There were 6 (13.6%) patients who had mild TEAEs and 12 (27.3%) pa-tients who had severe TEAEs. Of the severe TEAEs the most common were infections and infestations (6/44; 13.6%) and blood and lymphatic system disorders (5/44; 11.4%). The most common SAEs were infections (7/44 patients; 15.9%) and included postoperative wound infection (2/ 44 patients; 4.5%) and sepsis (2/44 patients; 4.5%), which occurred on Days 9/10 and Day 7, respectively. None of the SAEs were considered re-lated to study drug or to imaging device. All of the SAEs resolved during the study.