Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting

Abstract

BackgroundThe combination chemotherapy regimens of nab-paclitaxel plus gemcitabine (nab-p + G) and FOLFIRINOX (FFX) have each demonstrated improved survival compared with gemcitabine monotherapy in clinical trials for metastatic pancreatic cancer; however, limited comparative data exist.ObjectiveThe objective of this study was to compare patient characteristics and clinical outcomes including time to treatment failure and overall survival in patients with metastatic pancreatic cancer receiving first-line chemotherapy in the community.MethodsWe conducted a retrospective, multi-site, observational cohort study of patients with metastatic pancreatic cancer receiving first-line nab-p + G, FFX, or gemcitabine monotherapy between April 2013 and October 2015, using data from the iKnowMed electronic health record database. Patients on clinical trials or with other cancer diagnoses were excluded. Time to treatment failure and overall survival were assessed by Kaplan–Meier methods.ResultsFour hundred and eighty-six patients met selection criteria, 255 nab-p + G, 159 FFX, and 72 gemcitabine patients. Median age was 61, 68, and 73 years for FFX, nab-p + G, and gemcitabine patients, respectively (p < 0.01 for nab-p + G vs. FFX). Eastern Cooperative Oncology Group performance status of 0–1 was 91% for FFX, 77% for nab-p + G, and 68% for gemcitabine patients (p < 0.01 for nab-p + G vs. FFX). For the nab-p + G vs. FFX cohorts, respectively, time to treatment failure was 3.7 vs. 4.3 months (log-rank p = 0.25); and OS was 9.8 vs. 11.4 months (log-rank p = 0.38). Among patients with Eastern Cooperative Oncology Group performance status 0–1, time to treatment failure was 4.2 vs. 4.3 months (log-rank p = 0.47); and overall survival was 12.1 vs 11.4 months (log-rank p = 0.68).ConclusionsThe nab-p + G patients were older and had worse performance status than FFX patients. Time to treatment failure and overall survival were not observed to be significantly different in first-line nab-p + G and FFX patients. Results were similar after stratifying by performance status.

Survival Benefits of Chemotherapy for Patients with Advanced Pancreatic Cancer in A Clinical Real-World Cohort

“…Interestingly, treatment with gemcitabine in combination with capecitabine resulted in similar survival outcomes as treatment with gemcitabine/nab-paclitaxel and even the more intense 5-FU/oxaliplatin/irinotecan treatment. While this had not been demonstrated for gemcitabine/capecitabine before, these findings are in line with recently published retrospective cohort studies that found no differences in OS or TTF between patients treated with 5-FU/oxaliplatin/irinotecan or gemcitabine/nab-paclitaxel in Korean and North American centers [19,20,21]. All three combination therapies were superior to gemcitabine alone or 5-FU/oxaliplatin as first-line treatments (Figure 1 and Figure 2, Table 2) but their benefit was lost as patients discontinued their treatment and it disappeared around the time most patients were off the respective protocol (Figure 2).…”

Comparative Effectiveness of Gemcitabine plus Nab-Paclitaxel and FOLFIRINOX in the First-Line Setting of Metastatic Pancreatic Cancer: A Systematic Review and Meta-Analysis

“…We found a total of 493 publications in the electronic databases. A total of 16 studies including 3813 patients (2123 and 1690 of whom were treated with GEM-NAB and FOLFIRINOX respectively), were finally selected for inclusion after exclusion of duplicates and other non-pertinent papers [3,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20]. Fourteen were retrospective case series and two were cohort-studies.…”

“…In particular, there is no randomized controlled trial comparing GEM-NAB and FOLFIRINOX in the first-line setting. Secondly, cross-trial comparisons are problematic due to differences in trial designs (inclusion criteria more restrictive for the ACCORD trial) and in patients’ baseline characteristics [6,7]. The ACCORD trial was conducted at academic centers in France and enrolled patients aged ≤75 years with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤1.…”

RX-3117 (fluorocyclopentenyl cytosine): a novel specific antimetabolite for selective cancer treatment

“…Overall median survival for patients with advanced cancer even with treatment is about 10 months. FOLFIRINOX (5-fluorouracil-leucovorin combined with oxaliplatin and irinotecan), is usually given to patients with a good performance status, since it is a relatively toxic regimen [18]. In a retrospective study in several community hospitals patients with a good performance received FOLFIRINOX, while gemcitabine/Abraxane was usually given to patients with a poor PFS; when very poor, gemcitabine was given to a minority as an alternative single agent.…”