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  • Tables and Figure Legends br Table

    2019-11-05

    Tables and Figure Legends:
    Table 1 Patient and Disease Characteristics (N=47)
    Table 2a- Anti-estrogen therapies administered in combination with everolimus (N=47) Table 2b Patient Treatment Summary
    Table 3 Summary of Treatment Efficacy (N=47)
    Table 4 Treatment-Related Adverse Events Occurring in ≥ 10% of Patients Table 5 Number of patients with identified genetic mutations Figure 1a Progression-Free Survival (N=47)
    Figure 1b Overall Survival (N=47)
    Figure 2 Efficacy evaluable patients with mutations in the PI3K/AKT/mTOR pathway
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    Table 1 Patient and Disease Characteristics (N=47)
    Characteristic Total (N=47)
    Black or African American 4 (9%)
    American Indian or Alaskan Native 2 (4%)
    Invasive ductal carcinoma 31 (66%)
    Invasive lobular carcinoma 7 (15%)
    Invasive carcinoma, not otherwise specified 9 (19%)
    Histologic Grade, n (%)
    Well differentiated 4 (9%)
    Moderately differentiated 21 (45%)
    Sites of Metastatic Disease, n (%)
    Local or regional Actinomycin D nodes 7 (15%)
    Skin or subcutaneous 4 (9%)
    Number of Metastatic Sites per Patient, n (%)
    Prior Chemotherapy, n (%)
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    Neoadjuvant/Adjuvant only 21 (45%)
    Prior Targeted Agents/Biologics, n (%)
    Neoadjuvant/Adjuvant 5 (11%)
    Prior Hormonal Therapy, n (%)
    Neoadjuvant/Adjuvant only 14 (30%)
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    Table 2a- Anti-estrogen therapies administered in combination with everolimus (N=47)
    Anti-Estrogen Therapy Total (N=47)
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    Table 2b Patient Treatment Summary
    Patient Status Total (N=47)
    Still on Study Treatment 1 (2%)
    Discontinued Treatment 46 (98%)
    Physician Decision 1 (2%)
    Patient Decision 1 (2%)
    **Intercurrent illness: uterine cancer (1pt); gastric cancer (1pt); G3 dyspnea/G5 respiratory failure (1pt)
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    Table 3 Summary of Treatment Efficacy (N=47)
    Response Total (N=47) Evaluable Patients (N=36)
    Best Response
    * Two patients discontinued due to an AE (hypersensitivity reaction, and fatigue), plus 1 patient died (treatment-related sepsis) prior to response assessment, 2 patients discontinued due to intercurrent illness, 1 patient was non-compliant, 1 patient had clinical progression, but did not under RECIST 1.1 response assessment, and 1 patient withdrew from the study. Patients with a baseline scan and ≥1 post-baseline response assessment were included in the efficacy analysis.
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    Table 4 Treatment-Related Adverse Events Occurring in ≥ 10% of Patients
    Inflammation
    One patient had grade 4 toxicity (anemia).
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    Table 5 Number of patients with identified genetic mutations
    Number of patients Gene with mutation (%)
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    Gynecologic Oncology xxx (xxxx) xxx
    Contents lists available at ScienceDirect
    Gynecologic Oncology
    A phase II, multicenter, open-label trial of OTL38 injection for the intra-operative imaging of folate receptor-alpha positive ovarian cancer☆,☆☆
    a University of California Irvine Health, Orange, CA, United States of America
    b Moffitt Cancer Center, Tampa, FL, United States of America
    c Department of Chemistry, Purdue University, W. Lafayette, IN, United States of America
    d Division of Gynecologic Oncology, Mayo Clinic, Rochester, MN, United States of America
    e University of Pennsylvania Health System, Philadelphia, PA, United States of America
    • OTL-38 binds preferentially to ovarian cancer tumors in this phase 2 study.
    • OTL-38-guided surgery was safe and detected additional ovarian cancer implants in half of subjects.