First-line gemcitabine plus nab-paclitaxel versus FOLFIRINOX for metastatic pancreatic cancer in a real-world population

Abstract

Aim: To compare the overall survival (OS) among patients who received first-line modified gemcitabine plus nab-paclitaxel (G/nab-P) or 5-fluorouracil, leucovorin, irinotecan and oxaliplatin (mFOLFIRINOX) for metastatic pancreatic cancer. Methods: A single-center, retrospective, real-world study was conducted. Results: The median OS was 9.4 months versus 7.5 months in the mFOLFIRINOX and modified G/Nab-P groups, respectively (p = 0.16). An exploratory subgroup analysis excluding patients who received one infusion and had an Eastern Cooperative Oncology Group performance score of 2 demonstrated similar OS of 11.3 months and 8.9 months, respectively. Median progression-free survival and time-to-treatment failure were not significantly different. Higher rates of adverse events were noted with mFOLFIRINOX. Conclusion: mFOLFIRINOX did not significantly prolong OS compared with modified G/nab-P and was associated with increased toxicities.

The Trends and Outcomes of Initial Palliative Chemotherapy in Patients with Pancreatic Cancer in Korea Based on National Health Insurance Service Data

“…Most importantly, the NHIS database contains no information on cancer stage, tumor location, performance status, or adverse events (toxicity). Therefore, although the results of this study showed that FFX was better than any other regimen in terms of survival, it was not possible to compare toxicity, and previous studies have shown various problems due to the toxicity of FFX [ 5 , 9 , 24 , 26 , 35 ]; therefore, it is difficult to conclude that FFX is the best option. Second, because we used an operational definition to identify patients who received initial palliative chemotherapy for PC and to classify the chemotherapy regimen, the inclusion of patients may not have been uniform, and the regimen classification may not have been accurate.…”

“…On the other hand, most meta-analyses [ 16 , 17 , 18 , 19 ] and some other studies [ 5 , 20 , 21 , 22 , 23 , 24 , 25 , 26 ] have not found a significant difference between the two groups. However, most studies included small numbers of PC patients [ 20 , 21 , 23 , 24 ].…”

“…On the other hand, most meta-analyses [ 16 , 17 , 18 , 19 ] and some other studies [ 5 , 20 , 21 , 22 , 23 , 24 , 25 , 26 ] have not found a significant difference between the two groups. However, most studies included small numbers of PC patients [ 20 , 21 , 23 , 24 ]. The main reason for this discordance is likely the absence of prospective studies thus far; all studies were retrospective, raising the possibility of numerous biases.…”

Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: A multicenter retorospective ovservational study (NAPOLEON-2)

“…In the real-world application of regimens that have proven e cacy and safety in clinical trials, e cacy [16] and treatment intensity are often reduced for safety reasons [17]. This is because clinical trials usually involve patients who are relatively young, in good general health, free from serious complications, and different from those in clinical practice [18].…”

Nanoliposomal irinotecan with fluorouracil and folinic acid in patients with unresectable or recurrent pancreatic cancer: A multicenter retrospective observational study (NAPOLEON-2)

“…In the real-world application of regimens that have proven e cacy and safety in clinical trials, e cacy [18] and treatment intensity are often reduced for safety reasons [19]. This is because clinical trials usually involve patients who are relatively young, in good general health, free from serious complications, and different from those in clinical practice [20].…”