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Original Investigation
July 15, 2020

Response and Survival Associated With First-line FOLFIRINOX vs Gemcitabine and nab-Paclitaxel Chemotherapy for Localized Pancreatic Ductal Adenocarcinoma

Author Affiliations
  • 1Department of Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston
  • 2Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston
  • 3Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston
  • 4Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston
JAMA Surg. 2020;155(9):832-839. doi:10.1001/jamasurg.2020.2286
Key Points

Question  What are the radiologic, serologic, and survival outcomes of patients associated with receipt of first-line chemotherapy with FOLFIRINOX (fluorouracil, leucovorin, irinotecan, and oxaliplatin) or gemcitabine plus nab-paclitaxel for localized pancreatic cancer?

Findings  Among 485 patients treated in this case series with first-line FOLFIRINOX or gemcitabine plus nab-paclitaxel, Response Evaluation Criteria in Solid Tumors partial response was more common and pancreatectomy was performed more often after FOLFIRINOX; however, other measures of response to therapy and overall survival were similar. Anatomic downstaging occurred in less than 10% of patients with borderline resectable or locally advanced tumors treated with each regimen.

Meaning  Chemotherapy with FOLFIRINOX may have advantages relative to gemcitabine plus nab-paclitaxel and may be considered preferentially for patients without contraindications and who are anticipated to tolerate it, although known regimen toxicity profiles and patient clinical status should also be considered.

Abstract

Importance  Fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) and gemcitabine plus nanoparticle albumin-bound (nab)–paclitaxel (GA) are first-line chemotherapy regimens for pancreatic cancer. Their relative efficacy in the setting of localized disease is unknown.

Objective  To evaluate radiographic and serologic measures of responses associated with first-line chemotherapy with FOLFIRINOX or GA, and to determine the association between these drug regimens, putative measures of response, and survival.

Design, Setting, and Participants  This case series assessed 485 consecutive patients who were diagnosed as having previously untreated localized pancreatic ductal adenocarcinoma at The University of Texas MD Anderson Cancer Center between January 1, 2010, and December 31, 2017, and who received at least 3 cycles of first-line chemotherapy with FOLFIRINOX or GA. The median (range) follow-up duration was 33 (2-28) months.

Exposures  Administration of FOLFIRINOX (285 patients [59%]) or GA (200 patients [41%]) as first-line chemotherapy.

Main Outcomes and Measures  Resection rate, radiographic metrics (Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1, and change in tumor volume or anatomic staging), a serologic metric (serum cancer antigen 19-9 level), and overall survival after administration of first-line chemotherapy.

Results  In total, 485 patients (266 [55%] male) were included in the analysis. Patients treated with FOLFIRINOX were generally younger (median [range] age at diagnosis: 61 [30-81] vs 71 [36-89] years; P = .001) and had better performance status as indicated by the Eastern Cooperative Oncology Group scale (range 0-4, with lower numbers representing better performance) score of 2 or lower (274 patients [96%] vs 165 patients [82%] P = .001) but more invasive tumors than patients who received GA (91 [32%] vs 90 [45%] resectable tumors; P = .01). After propensity score matching to control for these biases, many objective serologic and radiographic metrics of response associated with administration of FOLFIRINOX or GA—including low rates of local tumor downstaging—did not differ. However, RECIST partial response was more common among patients treated with FOLFIRINOX (27 of 140 patients [19%]) than with GA (8 of 140 patients [6%]; P = .001). Moreover, (chemo)radiation (50% vs 34%; P = .001) was more commonly administered to and pancreatectomy (27% vs 16%; P = .01) was subsequently performed more frequently for patients initially treated with FOLFIRINOX. The overall survival duration of patients treated with either regimen was similar (hazard ratio, 1.48; 95% CI, 0.97-2.26; P = .07).

Conclusions and Relevance  In this cohort of patients with localized pancreatic adenocarcinoma who received FOLFIRINOX or GA as their first line of therapy, FOLFIRINOX was associated with higher rates of RECIST partial response and subsequent pancreatectomy than GA, but the overall survival associated with these regimens was similar.

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