Is Second Line Chemotherapy in Pancreatic Cancer One Line Too Many? (#312)
Systemic chemotherapy with single agent gemcitabine still remains the standard of care for the treatment of patients with locally advanced and metastatic pancreatic cancer. Despite clinical trials showing that selected patients may benefit from second line chemotherapy there are no large randomized Phase III trials supporting this.
The German CONKO-003 group showed that in a randomized phase III study second line fluorouracil, leucovorin and oxaliplatin (OFF regimen) was superior to FF (fluorouracil and folinic acid) with a median OS of 26 weeks compared to 13 weeks (p< 0.014).
A further phase III study from the same group showed that the median OS with gemcitabine followed by OFF regimen was 9.09 months compared to 7.9 months with best supportive care alone after first line chemotherapy.
Here we present a single centre retrospective case series of 8 patients who underwent second line fluorouracil-based chemotherapy after progression on gemcitabine. Each patient was matched with similar controls who underwent best supportive care only (same sex, within 10 years of age and similar CA19-9 as a surrogate of tumour burden).
Median PFS on first line chemotherapy in control group was 94 days (44-175 days) and in those receiving second line was 180 days (7-788 days). Median overall survival in the control group was 246 days (110-467 days) compared with 363 days (85-852 days) in those that received second line, an improvement of 117 days (4.1 months). This data is comparable to that obtained by the CONKO study group comparing OFF to best supportive care.
The increasing evidence for the activity of multi-agent therapy in the first line setting is increasing the numbers of patients still well enough to receive second line therapy. Our data set utilising a matched contemporaneous sample is encouraging of ongoing exploration of multicentre randomised trials to provide evidence-based recommendations for second line chemotherapy in locally advanced or metastatic pancreatic cancer.