Phase II Trial Shows Potential for Second-Line Therapies for Neuroendocrine Carcinomas

Neuroendocrine carcinomas (NECs) are uncommon and aggressive cancers with limited treatment options after the failure of platinum-based therapies. A recently concluded phase II trial investigated the efficacy and safety of two second-line treatments – FOLFIRI and CAPTEM – offering new insights into managing NECs.

The trial evaluated the activity and safety of FOLFIRI and CAPTEM in 53 patients with metastatic NECs who were randomized to receive one of the treatments. The results of the trial suggest that FOLFIRI and CAPTEM can be used interchangeably as second-line treatments for NEC patients, depending on individual patient profiles and comorbidities. This interchangeability provides clinicians with flexibility in managing this difficult-to-treat cancer.

The investigators ended the survey early, but the study still offered valuable insights: 

  • Both drugs showed comparable efficacy, with median overall survival rates of 28.4% for FOLFIRI and 32.4% for CAPTEM at 12 months.
  • The safety profiles of both treatment approaches were manageable, with notable side effects including Grade 3-4 neutropenia and anemia in those receiving FOLFIRI, and thrombocytopenia and nausea/vomiting in those study participants receiving CAPTEM.
  • The investigators identified three microRNAs—miR-1246, miR-1290, and miR-320c—as independent prognostic predictors, potentially paving the way for personalized treatment strategies that may ultimately improve patient outcomes.

While the trial did not reach its primary endpoint, it underscores the potential of FOLFIRI and CAPTEM in improving the quality of life for NEC patients in the second-line setting. Further research is needed to refine these findings and develop more effective treatment protocols.

The Italian Ministry of Health’s Ricerca Corrente program supported the clinical trial.