Abraxane and gemcitabine evaluated in first-line patients with metastatic pancreatic cancer.
A second-line treatment for first-line metastatic pancreatic cancer showed beneficial results in a recent trial.
Celgene Corporation presented analysis during the 2016 ASCO Gastrointestinal Cancers Symposium of outcomes for second-line treatments following Abraxane (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) and gemcitabine (AG).
The phase 3 study compared AG versus gemcitabine monotherapy in first-line patients with metastatic pancreatic cancer who received a second-line treatment during the study observational extension period.
The trial included 347 patients (40%) who received second-line therapy in the extension. Of those 347 patients, 77% received 5-FU based therapies or capecitabine combinations.
The analysis of overall survival (OS) showed the median OS of patients (n=170) administered AG followed by second-line therapy was 12.8 months, compared with 9.9 months in patients (n=177) who only gemcitabine alone.
Of the patients who received second-line therapies, a majority (n=132) received 5FU or capecitabine-containing regimens, which had a median OS of 13.5 months. Patients administered FOLFIRINOX (fluorouracil [5-FU], leucovorin, irinotecan, oxaliplatin) following AG (n=18) showed median OS of 15.7 months, which was the longest in the study.
“As the body of research and approved options increase in pancreatic cancer, there is now evidence that second-line treatment is feasible and beneficial for certain patients with metastatic disease,” said lead investigator, David Goldstein, MD. “We are seeing an exciting evolution in the treatment of this disease and for patients and physicians, it is now time to consider a total treatment plan when choosing an initial therapy.”
A retrospective cohort study compared the time to treatment discontinuation and database persistence used as a proxy for OS between AG and FOLFIRINOX in the first-line setting.
The results showed time to treatment discontinuation and database persistence for patients with first-line metastatic pancreatic cancer (n=202) were similar (8.6) between the AG (n=122) and FOLFIRINOX (n=80) treatment arms.
Researchers found baseline characteristics were generally similar between groups, with the exception of patient age, which had a median of 67 years for AG versus 61.4 years for FOLFIRINOX.
However, FOLFIRINOX had higher adverse events compared with AG (95% vs 84%). The most common adverse events that caused discontinuation were anemia (8% for FOLFIRINOX and 2% for AG), neutropenia (6% for each), and dehydration (5% vs 3%).