The Safety and Suitability of DNA Sequencing of Tissue Biopsies Performed on Patients Referred to a Phase I Unit
2024

Safety and Suitability of DNA Sequencing in Cancer Biopsies

Sample size: 731 publication 10 minutes Evidence: moderate

Author Information

Author(s): Angela Esposito, Edoardo Crimini, Carmen Criscitiello, Carmen Belli, Roberta Scafetta, Raimondo Scalia, Grazia Castellano, Elisa Giordano, Jalissa Katrini, Liliana Ascione, Luca Boscolo Bielo, Matteo Repetto, Antonio Marra, Dario Trapani, Gianluca Maria Varano, Daniele Maiettini, Paolo Della Vigna, Franco Orsi, Rocco Elena Guerini, Nicola Fusco, Giuseppe Curigliano

Primary Institution: European Institute of Oncology, IRCCS

Hypothesis

The study aims to assess the safety and adequacy of next-generation sequencing (NGS) for research tissue biopsies in cancer patients.

Conclusion

The study found that biopsies for NGS testing were generally safe, with a low complication rate and a high success rate for obtaining adequate samples.

Supporting Evidence

  • 355 out of 731 patients underwent protocol-mandated biopsies.
  • Histological diagnosis was achieved in 98% of patients.
  • NGS testing was successfully conducted in 88.4% of cases.
  • Only 4.8% of patients experienced mild adverse events.
  • NGS failure rates varied significantly based on the specific tests attempted.

Takeaway

Doctors took tissue samples from cancer patients to test for DNA changes, and most patients were safe with only a few having minor problems.

Methodology

A retrospective review of electronic medical records of patients who underwent biopsies for research purposes from January 2014 to December 2022.

Potential Biases

Potential bias due to the retrospective nature of the study and reliance on medical records.

Limitations

The study did not provide information on the results of analyses for 168 patients, which may affect the overall assessment of NGS adequacy.

Participant Demographics

The median age of participants was 56 years, with 79% female and the most common tumor type being breast cancer.

Statistical Information

P-Value

p=0.004

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.3390/cancers16244252

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