This multicenter, observational, prospective study will identify a powerful and easy predictive/prognostic marker to use with participants under bevacizumab.
Study Type
OBSERVATIONAL
Enrollment
111
Bevacizumab will be administered as per local clinical practice and local labeling.
Paclitaxel will be administered as per local clinical practice and local labeling.
Percentage of Participants With Clinical Benefit
Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. Results for clinical benefit were reported for 2 groups based on Circulating Tumor Cells (CTC) Levels. The Sensitive group had CTC levels \<5 (\<5 CTCs in one of the two determinations) and Resistant group had CTC ≥5 (≥ 5 CTCs in the two determinations).
Time frame: During follow-up (up to 18 months)
Percentage of Participants With Overall Response as Assessed Using RECIST v1.1
Overall response = Complete Response (CR) + Partial Response (PR). Overall response was evaluated for the Sensitive group (CTC \<5) and Resistant group (CTC ≥5).
Time frame: From Baseline up to end of study (up to 18 months)
Progression Free Survival (PFS) as Assessed Using RECIST v1.1
PFS was evaluated for the Sensitive group (CTC \<5) and Resistant group (CTC ≥5).
Time frame: From Baseline up to end of study (up to 18 months)
Overall Survival
OS was evaluated for the Sensitive group (CTC \<5) and Resistant group (CTC ≥5).
Time frame: From Baseline up to end of study (up to 18 months)
Percentage of Participants With Adverse Events of Toxicity Grading 3 and/or 4
Adverse events (AEs) will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (v 4.0). Any AEs that are not specifically listed in the NCI CTCAE follow the logic - Grade 3) Severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living; Grade 4: Life-threatening consequences or urgent intervention indicated.
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Hospital Universitario Son Espases; Servicio de Oncologia
Palma de Mallorca, Balearic Islands, Spain
Hospital Provincial de Castellon; Servicio de Oncologia
Castellon, Castellon, Spain
Hospital Universitario Reina Sofia; Servicio de Oncologia
Córdoba, Cordoba, Spain
Hospital de Donostia.; Servicio de Oncología Radioterápica
San Sebastián, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Oncologia
A Coruña, LA Coruña, Spain
Hospital Universitario Materno Infantil de Gran Canaria; Servicio de Oncologia
Las Palmas de Gran Canaria, LAS Palmas, Spain
Hospital de Navarra; Servicio de Oncologia
Navarra, Navarre, Spain
Hospital Quiron Barcelona; Servicio de Oncologia
Barcelona, Spain
Hospital Universitario Virgen de las Nieves; Servicio de Oncologia
Granada, Spain
Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico; Servicio de Oncologia
Jaén, Spain
...and 15 more locations
Time frame: From Baseline up to end of study (up to 18 months)
Optimal Cut-off for Clinical Benefit
Clinical benefit was assessed using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (v1.1). Clinical benefit is defined as partial or complete response as well as tumor stabilization for up to 24 weeks. The optimal cut-off for clinical benefit was calculated from a Receiver Operating Curve (ROC) based on CTC level and used to define the prognostic factors that could better predict clinical outcomes.
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
Percentage of Participants With Overall Response (OR) as Assessed Using RECIST v1. in Prognostic Groups
Overall response = CR + PR. An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1), 7 days prior to Day 1 Cycle 3 (Cycle length = 28 days)
PFS as Assessed Using RECIST v1. in Prognostic Groups
An optimal cut-off point for the CTC count of 0.5 after 2 cycles of treatment was used to define the prognostic groups.
Time frame: From Baseline up to end of study (up to 18 months)
Mean CTC Count Levels
CTC and CEA levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Mean Carcinoembryonic Antigen (CEA) Levels
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])
Mean Biomarker Cancer Antigen 15.3 (CA 15.3) Level
CTC and CA 15.3 levels were compared to determine any correlation between the two. Both CTC count at baseline and at cycle 2 were considered.
Time frame: Baseline (within 21 days prior to Day 1 Cycle 1 [Cycle length = 28 days])