Background There have been no head to head clinical trials to compare the main alternatives available to first line metastatic pancreatic cancer (mPC).
Purpose To assess the relative effectiveness of treatments that have demonstrably increased overall survival in mPC
Materials and methods A search was performed in PubMed and selected Phase III trials with overall survival data in first-line mPC and drugs approved by the FDA or EMEA.
Similarity among trials was assessed according patient selection criteria, study population and control group results. The effectiveness outcome selected was overall survival. A therapeutic equivalence interval was established: 0.75 to 1.33 using hazard ratio (HR) obtained for sample calculation of erlotinib/gemcitabine study.
Therapeutic equivalence of treatments was determined according to a previous guideline for positioning of equivalent therapeutic alternative. Grades 3 or 4 neutropenia data were used to assess relative safety.
Bucher’s method was used to adjust the therapeutic comparison and the application developed by the Canadian Agency for Drugs and Technologies in Health (CADTH) to compare treatment indirectly (ITC).
Results Three trials were selected: FOLFIRINOX, Albumin-bound paclitaxel (Nab) paclitaxel/gemcitabine and erlotinib/gemcitabine treatments compared with gemcitabine alone.
They were similar for patient-selection criteria, study population and control group results.
The results are summarised in the table:
OS: overall survival HR: hazard ratio
Conclusions FOLFIRINOX was more effective than erlotinib/gemcitabine.
Erlotinib/gemcitabine and Nab-paclitaxel/gemcitabine are not therapeutically equivalent to FOLFIRINOX.
FOLFIRINOX resulted in less grade 3/4 neutropenia than Nab-paclitaxel/gemcitabine.
No conflict of interest.
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