An Indian Multicentric, Open Label, Prospective Phase IV Study of Bevacizumab in the Front Line Management of Advanced/Metastatic Epithelial Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer in Real-Life Clinical Practice

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Clinical trial
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Clinical trials

• Clinical trial regulatory scope:
  Post-authorisation interventional clinical trial
• Clinical trial phase:
  Therapeutic use (Phase IV)
• Clinical trial randomisation:
  Non-randomised clinical trial
• Clinical trial types:
  Single-arm trial

Study drug and medical condition

• Medicinal product name:
  AVASTIN
• Study drug International non-proprietary name (INN) or common name:
  BEVACIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01FG01) bevacizumab

  bevacizumab
• Medical condition to be studied:
  Fallopian tube cancer

  Ovarian epithelial cancer metastatic

  Peritoneal carcinoma metastatic

Population studied

• Short description of the study population:
  Patients must meet the following criteria for study entry:; • Female subjects ≥18 years of age; • Subjects willing and able to give informed consent; • Subjects who are prescribed to receive bevacizumab for advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (FIGO Stage lllb, lllc and lV) according to the routine clinical practice.; • Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of bevacizumab.; ; Subjects who meet any of the following criteria will be excluded from study entry:; • There is no specific exclusion criteria for this study and subjects who are considered not eligible to receive bevacizumab for advanced/metastatic epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer (FIGO Stage IIIb, IIIc and IV) according to the local prescribing information will not be enrolled in the study.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Special population of interest:
  Women of childbearing potential using contraception
• Estimated number of subjects:
  100

Study design details

• Study design:
  This is a Phase IV, single-arm, open-label, prospective, interventional, multicenter study.
• Main study objective:
  This multicenter, prospective, interventional study will evaluate the safety and efficacy of Avastin (bevacizumab) when added to standard chemotherapy (carboplatin and paclitaxel) in routine clinical practice in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
• Setting:
  13 center(s) in India
• Interventions:
  The investigational medicinal product (IMP) for this study was Bevacizumab. The non-investigational therapies administered concurrently were Paclitaxel and Carboplatin. During the treatment phase, patients received Bevacizumab in combination with Paclitaxel and Carboplatin chemotherapy followed by Bevacizumab monotherapy.; ; Bevacizumab 15 mg/kg was administered intravenously every 3 weeks for five cycles concurrently with six cycles of standard chemotherapy (Paclitaxel and Carboplatin). Thereafter, patients continued to receive Bevacizumab 15 mg/kg every 3 weeks as a single agent for up to 16 additional cycles or until disease progression or death, whichever occurred earlier. A total of 21 cycles of Bevacizumab were planned in this study.; ; Paclitaxel and Carboplatin were administered according to locally approved prescribing information. All dose modifications, interruptions, and discontinuations were managed as per protocol and local label recommendations, with corresponding documentation in the eCRF. Medication errors or overdoses, along with any related adverse events, were reported according to pharmacovigilance procedures.
• Outcomes:
  • The incidence of AEs and SAEs; • Progression free survival (PFS); • Overall survival (OS); • Overall response rates (Complete response (CR)+ Partial response (PR)); • Clinical benefit response rates (CR+PR+ Stable disease(SD))
• Data analysis plan:
  All efforts will be made to regularly follow up patients to calculate Progression Free survival (PFS) and Overall Survival (OS). Kaplan-Meier procedure will be used to estimate the median PFS and OS for total as well as ECOG PS 0 and ECOG PS 1-2 at baseline. Log rank test will be used to compare the median survival time between subjects with ECOG PS 0 and ECOG PS 1-2 at baseline. The overall response rate (CR + PR) will be summarized using number and percentage along with two-sided 95% Pearson-Clopper confidence interval. Similarly, the Clinical Benefit Response rate (CR + PR + SD) will be summarized using number and percentage along with the two-sided 95% Pearson-Clopper confidence interval. All statistical tests will be done at 5% level of significance. All patients with at least one follow up evaluation available would be evaluated for efficacy.
• Summary results:
  • Treatment with bevacizumab plus standard chemotherapy followed by bevacizumab monotherapy demonstrated favorable overall survival (OS) and durable disease control in Indian patients with advanced/metastatic ovarian, fallopian tube, or primary peritoneal cancer.; • Median OS was not reached, and median PFS was approximately 24 months, consistent with the known efficacy profile of bevacizumab in this indication.; • The safety profile of bevacizumab was manageable and predictable, with most adverse events (AEs) of low to moderate intensity.; • Serious or treatment-limiting toxicities were infrequent, and the incidence of Grade ≥3 and serious AEs was within the expected range for bevacizumab-treated populations.; • PFS outcomes in Indian patients were consistent with those observed in pivotal global trials and real-world studies.; • The toxicity profile mirrored the established global experience, with no new concerns identified in the Indian clinical setting.; • The study provides important local evidence supporting the integration of bevacizumab into front-line therapy for advanced/metastatic ovarian cancer in India.; • The results reinforce the favorable risk-benefit profile of bevacizumab when patients are appropriately selected and toxicities proactively managed.; • In conclusion, this Phase IV study met its regulatory objective, confirming that bevacizumab is both effective and safe in Indian patients with advanced/metastatic ovarian cancer and supports its role as a standard component of front-line therapy in this population.