Comparison of Frontline FOLFIRINOX with Fluorouracil-Based and Gemcitabine-Based Chemotherapies in Metastatic Ampullary Adenocarcinoma: A Multicenter Study by the Turkish Oncology Group (TOG)

<b>Background:</b> Adenocarcinoma arising from the ampulla of Vater is an extremely rare neoplasm, and there are limited data regarding frontline therapy for metastatic disease. We investigated the outcomes of first-line treatment with FOLFIRINOX by comparing it with other treatments in patients with advanced ampullary adenocarcinoma. <b>Methods:</b> We included 123 patients with advanced ampullary adenocarcinoma who were treated with frontline FOLFIRINOX (<i>n</i> = 32), fluorouracil (FU)-based chemotherapy (<i>n</i> = 20), and gemcitabine-based chemotherapy (<i>n</i> = 65) between August 2007 and January 2024 in this retrospective study. The median progression-free survival (mPFS) and overall survival (mOS) according to treatment and clinicopathological features were calculated using the Kaplan-Meier method. <b>Results:</b> The median age of the patients was 62 years (range, 36-78), and 75,6% of the patients had an ECOG performance status of 0-1. The mOS were 13 months (95% CI, 10.6-14.4), 11 months (95% CI, 10.6-14.4), and 12 months (95% CI, 10.6-14.4), respectively [<i>p</i> = 0.865]. There were no significant differences in OS among the chemotherapeutic agents according to histological subtypes. However, FOLFIRINOX and FU-based treatments appeared more effective in the intestinal subtype, while gemcitabine-based therapies were less effective. In the pancreaticobiliary subtype, FU-based therapies yielded a shorter outcome compared to FOLFIRINOX and gemcitabine-based therapies. Grade 3 or 4 hematologic toxicities were higher in patients treated with FOLFIRINOX. <b>Conclusions:</b> In advanced ampullary adenocarcinoma, despite higher toxicity, frontline FOLFIRINOX showed a trend toward an OS benefit in the intestinal subtype while providing a similar outcome in the pancreaticobiliary subtype.

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Journal
Journal of Clinical Medicine
Published
2025-08-20
DOI
https://doi.org/10.3390/jcm14165868
Primary Topic
Pancreatic and Hepatic Oncology Research
Type
article
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article

Comparison of Frontline FOLFIRINOX with Fluorouracil-Based and Gemcitabine-Based Chemotherapies in Metastatic Ampullary Adenocarcinoma: A Multicenter Study by the Turkish Oncology Group (TOG)

Şendağ Yaslıkaya, İbrahim Vedat Bayoğlu, Talat Aykut, Seray Saray et al.
Journal of Clinical Medicine
Pancreatic and Hepatic Oncology Research
article

Comparison of Frontline FOLFIRINOX with Fluorouracil-Based and Gemcitabine-Based Chemotherapies in Metastatic Ampullary Adenocarcinoma: A Multicenter Study by the Turkish Oncology Group (TOG)

Şendağ Yaslıkaya, İbrahim Vedat Bayoğlu, Talat Aykut, Seray Saray, Safa Can Efil, Hatice Bölek, Atike Pınar Erdoğan, Taha Koray Şahin, Ömer Acar, muhammed Fatih Sağıroğlu, Gökmen Aktaş, Berkan Karabuğa, Mehmet Alı Nahıt Şendur, Mustafa Seyyar, Murat Araz, Ertuğrul Bayram, Ulku Yalcintas, Yüksel Ürün, Melike Özçelik, İlkay Tuğba Ünek, Tülay Kuş, Ali̇ Kalem, Savaş Gökçek, Omer Dizdar, Şuayib Yalçın, Tuğçe Kübra Güneş, Nadiye Sever
article en

Abstract

<b>Background:</b> Adenocarcinoma arising from the ampulla of Vater is an extremely rare neoplasm, and there are limited data regarding frontline therapy for metastatic disease. We investigated the outcomes of first-line treatment with FOLFIRINOX by comparing it with other treatments in patients with advanced ampullary adenocarcinoma. <b>Methods:</b> We included 123 patients with advanced ampullary adenocarcinoma who were treated with frontline FOLFIRINOX (<i>n</i> = 32), fluorouracil (FU)-based chemotherapy (<i>n</i> = 20), and gemcitabine-based chemotherapy (<i>n</i> = 65) between August 2007 and January 2024 in this retrospective study. The median progression-free survival (mPFS) and overall survival (mOS) according to treatment and clinicopathological features were calculated using the Kaplan-Meier method. <b>Results:</b> The median age of the patients was 62 years (range, 36-78), and 75,6% of the patients had an ECOG performance status of 0-1. The mOS were 13 months (95% CI, 10.6-14.4), 11 months (95% CI, 10.6-14.4), and 12 months (95% CI, 10.6-14.4), respectively [<i>p</i> = 0.865]. There were no significant differences in OS among the chemotherapeutic agents according to histological subtypes. However, FOLFIRINOX and FU-based treatments appeared more effective in the intestinal subtype, while gemcitabine-based therapies were less effective. In the pancreaticobiliary subtype, FU-based therapies yielded a shorter outcome compared to FOLFIRINOX and gemcitabine-based therapies. Grade 3 or 4 hematologic toxicities were higher in patients treated with FOLFIRINOX. <b>Conclusions:</b> In advanced ampullary adenocarcinoma, despite higher toxicity, frontline FOLFIRINOX showed a trend toward an OS benefit in the intestinal subtype while providing a similar outcome in the pancreaticobiliary subtype.

Journal of Clinical MedicineVol. 14(16)
Ankara University (TR), Manisa Celal Bayar University (TR), Dokuz Eylül University (TR), Ankara Atatürk Eğitim ve Araştırma Hastanesi (TR), Necmettin Erbakan University (TR), Ankara Onkoloji Eğitim ve Araştırma Hastanesi (TR), Ümraniye Eğitim ve Araştırma Hastanesi (TR), Medical Park Gaziantep Hospital (TR), Cukurova University (TR), Gaziantep University (TR), Atatürk University (TR), Hacettepe University (TR), Marmara University (TR)
Openalex Percentile: Top 70%
Pancreatic and Hepatic Oncology Research
DOIOpen Access PDFOpenAlex
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