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In the context of Gemcitabine & Pancreatic Ductal Adenocarcinoma (PDAC) / Pancreatic Cancer, for the U.S., gemcitabine injection is FDA‑approved as first‑line treatment for patients with locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) / Pancreatic Cancer and gemcitabine has been a standard‑of‑care backbone for decades in exocrine pancreatic cancer (1).
Gemcitabine is also centrally authorized in the EU for for the treatment of locally advanced or metastatic Pancreatic Ductal Adenocarcinoma (PDAC) / Pancreatic Cancer (2).
A study, utilizing data from the SEER Program of the National Cancer Institute, analyzed the survival outcomes of patients during the gemcitabine era (1998–2004) compared to the pre-gemcitabine era (1988–1997). It focused on 7,151 patients with metastatic disease who did not undergo extirpative surgery, 14,369 patients who had metastases and did not have surgery, 5,042 patients who underwent surgery without metastases, and 5,011 patients who had surgery and metastases. The survival time ratios (TR) were adjusted for factors such as radiotherapy history, grade, nodal status, loco-regional extent of disease, age, race, and gender. Among those who did not have extirpative surgery, there was an improvement in survival for patients with metastatic cancer during the gemcitabine era (TR = 1.20, 95% c.i. 1.15–1.25), but this improvement was not observed in patients without metastatic cancer (TR = 1.05, 95% c.i. 1.00–1.15). For patients who underwent extirpative surgery, the improvement was more pronounced in those with metastatic cancer (TR = 1.61, 95% c.i. 1.45–1.80) compared to those without metastases (TR = 1.23, 95% c.i. 1.15–1.31). These findings align with the idea that the positive results of gemcitabine observed in controlled clinical trials are reflected in the broader population of patients with pancreatic cancer (1).