Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy following FOLFIRINOX in Patients with Unresectable Pancreatic Cancer: A Single-Institution, Retrospective Analysis

Abstract

<b><i>Introduction:</i></b> Patients with advanced pancreatic cancer have a poor prognosis. FOLFIRINOX (FFX) and gemcitabine plus nab-paclitaxel (GnP) have been established as first-line treatment, but they have not been confirmed as second-line treatment after FFX. The aim of this study was to evaluate the safety and efficacy of GnP as second-line therapy after FFX in patients with unresectable pancreatic cancer. <b><i>Methods:</i></b> Twenty-five patients with unresectable pancreatic cancer were enrolled. The patients were treated with GnP after FFX between September 2015 and September 2019. Tumor response, progression-free survival (PFS), overall survival (OS), and incidence of adverse events were evaluated. <b><i>Results:</i></b> The response rate, disease control rate, median PFS, and median OS were 12%, 96%, 5.3 months, and 15.6 months, respectively. The common grade 3 or 4 adverse events were neutropenia (76%) and anemia (16%). <b><i>Conclusions:</i></b> GnP after FOLFIRINOX is expected to be one of the second-line recommendations for patients with unresectable pancreatic cancer.

Prognostic analysis and outcomes of metastatic pancreatic cancer patients receiving nab‐paclitaxel plus gemcitabine as second or later‐line treatment

“…In this retrospective study, clinical outcomes of metastatic pancreatic cancer patients who received AG as second or further line of treatment were evaluated. In line with other published results, 29–34 AG was well tolerated in a cohort of pre‐treated patients, showed clinical activity with an ORR of 22.5%, a DCR of 45.6%, and resulted in median PFS and OS of 3.9 and 6.8 months, respectively. In particular, in the subgroup of patients who received AG as a second‐line therapy ( n = 111, 66.9%), median PFS and OS were 4.2 and 7.4 months, respectively.…”

“…29,30 Small retrospective series also evaluated AG in patients progressing from first line FOLFIRINOX with median PFS in the range of 3.8-5.6 months and median OS in the range of 8.8-15.6 months. [31][32][33] Our retrospective data with the AG regimen as second-line treatment are in line with previous experiences in both the gemcitabine-and FOLFIRINOXpretreated populations; however, activity in gemcitabinepretreated patients currently bears little interest as the vast majority of mPC patients receives AG as their first-line treatment. 7 A small, retrospective, Canadian series suggested a potential advantage for AG as compared to gemcitabine monotherapy in the post-FOLFIRINOX setting 42 ; this trend was recently confirmed in a large (n = 427), retrospective analysis, comparing AG (n = 219) versus gemcitabine alone (n = 208) in metastatic pancreatic cancer patients progressing from first-line FOLFIRINOX.…”

“…19,20 However, a second phase III trial (PANCREOX) employing a different regimen (mFOLFOX6) has not shown an advantage for the addition of oxaliplatin, while recent meta-analyses (also including the NAPOLI-1 trial) have suggested a potential advantage for irinotecan-containing regimens. [21][22][23][24] In patients who have been exposed to FOLFIRINOX in first line, gemcitabine monotherapy and AG are supported by retrospective evidence or single-arm phase II studies [25][26][27][28][29][30][31][32][33] ; although no formal, randomized, comparison between gemcitabine monotherapy and AG exists in the post-FOLFIRINOX second-line setting, retrospective analyses suggest a potential advantage for the AG combination. 34 Regardless of the regimen employed, a thorough analysis of prognostic/predictive factors that could assist in tailoring second-line treatment to the subgroup of patients likely to benefit the most is currently lacking.…”

Treatment Outcomes and Prognostic Factors of Gemcitabine Plus Nab-Paclitaxel as Second-Line Chemotherapy after Modified FOLFIRINOX in Unresectable Pancreatic Cancer

“…As gemcitabine-based therapy is recommended as second-line treatment after first-line mFFX [9], GnP is often selected for patients in good general condition, while gemcitabine monotherapy is selected for those in poor general condition. Median OS and PFS of second-line GnP have been reported to be 5.4-15.6 months and 2.8-5.8 months, respectively [10][11][12][13][14][15][16][17][18] (Table 7). The outcomes of this study were comparable to previous reports.…”

“…Since GnP has been reported to outperform gemcitabine monotherapy as first-line chemotherapy, GnP is often selected as second-line chemotherapy after FFX for patients in good general condition [3]. Most reports on GnP as second-line chemotherapy after FFX include small numbers of cases, and the prognostic factors of second-line GnP remain unclear [10][11][12][13][14][15][16][17][18]. Compared to FFX, a modified FOLFIRINOX (mFFX) regimen has fewer adverse events (AEs) and comparable efficacy, and mFFX has been widely used [19].…”