A phase II randomised trial of induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer: the Taiwan Cooperative Oncology Group T2212 study

Yung-Yeh Su; Yen-Feng Chiu; Chung-Pin Li; Shih-Hung Yang; Johnson Lin; Shyh-Jer Lin; Ping-Ying Chang; Nai-Jung Chiang; Yan-Shen Shan; Hui-Ju Ch'ang; Li-Tzong Chen

doi:10.1038/s41416-021-01649-7

A phase II randomised trial of induction chemotherapy followed by concurrent chemoradiotherapy in locally advanced pancreatic cancer: the Taiwan Cooperative Oncology Group T2212 study

Br J Cancer. 2022 Apr;126(7):1018-1026. doi: 10.1038/s41416-021-01649-7. Epub 2021 Dec 17.

Authors

Yung-Yeh Su^#^{1

2

3}, Yen-Feng Chiu^#⁴, Chung-Pin Li^{5

6

7}, Shih-Hung Yang⁸, Johnson Lin⁹, Shyh-Jer Lin¹⁰, Ping-Ying Chang¹¹, Nai-Jung Chiang^{2

3}, Yan-Shen Shan^{12

13}, Hui-Ju Ch'ang^{14

15

16}, Li-Tzong Chen^{17

18

19}

Affiliations

¹ Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
² National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan.
³ Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
⁴ Institute of Population Health Sciences, National Health Research Institutes, Miaoli, Taiwan.
⁵ Division of Clinical Skills Training, Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan.
⁶ Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.
⁷ National Yang Ming Chiao Tung University School of Medicine, Taipei, Taiwan.
⁸ Department of Oncology, National Taiwan University Hospital and Graduate Institute of Oncology, National Taiwan University, College of Medicine, Taipei, Taiwan.
⁹ Department of Hematology, Mackay Memorial Hospital, Taipei, Taiwan.
¹⁰ Department of Hematology, Veteran General Hospital, Kaohsiung, Taiwan.
¹¹ Division of Hematology/Oncology, Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.
¹² Institute of Clinical Medicine, College of Medicine, National Cheng Kung University, Tainan, Taiwan. [email protected].
¹³ Department of Surgery, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. [email protected].
¹⁴ National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan. [email protected].
¹⁵ Department of Radiation Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. [email protected].
¹⁶ Taipei Cancer Center, Taipei Medical University Hospital, Taipei Medical University, Taipei, Taiwan. [email protected].
¹⁷ National Institute of Cancer Research, National Health Research Institutes, Tainan, Taiwan. [email protected].
¹⁸ Department of Oncology, National Cheng Kung University Hospital, College of Medicine, National Cheng Kung University, Tainan, Taiwan. [email protected].
¹⁹ Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung Medical University, Kaohsiung, Taiwan. [email protected].

^# Contributed equally.

Abstract

Background: The objective of this study was to evaluate the efficacy and safety of induction chemotherapy (ICT), GOFL (gemcitabine, oxaliplatin plus fluorouracil (5-FU)/leucovorin) versus modified FOLFIRINOX (irinotecan, oxaliplatin plus 5-FU/leucovorin), followed by concurrent chemoradiotherapy (CCRT) in locally advanced pancreatic adenocarcinoma (LAPC).

Methods: Chemo-naive patients with measurable LAPC were eligible and randomly assigned to receive biweekly ICT with either mFOLFIRINOX or GOFL for 3 months. Patients without systemic progression would have 5-FU- or gemcitabine-based CCRT (5040 cGy/28 fractions) and were then subjected to surgery or continuation of chemotherapy until treatment failure. The primary endpoint was 9-month progression-free survival (PFS) rate.

Results: Between July 2013 and January 2019, 55 patients were enrolled. After ICT, 21 (77.8%) of 27 patients who received mFOLFIRINOX and 17 (60.7%) of 28 patients who received GOFL completed CCRT. Of them, one and five had per-protocol R0/R1 resection. On intent-to-treat analysis, the 9-month PFS rate, median PFS and overall survival in mFOLFIRINOX and GOFL arms were 30.5% versus 35.9%, 6.6 (95% confidence interval: 5.9-12.5) versus 7.6 months (3.9-12.3) and 19.6 (13.4-22.9) versus 17.9 months (13.4-23.9), respectively. Grade 3-4 neutropenia and diarrhoea during induction mFOLFIRINOX and GOFL were 37.0% versus 21.4% and 14.8% versus 3.6%, respectively.

Conclusion: Induction GOFL and mFOLFIRINOX followed by CCRT provided similar clinical outcomes in LAPC patients.

Gov identifier: NCT01867892.

Publication types

Clinical Trial, Phase II
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adenocarcinoma* / pathology
Adenocarcinoma* / therapy
Antineoplastic Combined Chemotherapy Protocols / adverse effects
Chemoradiotherapy* / adverse effects
Fluorouracil
Humans
Induction Chemotherapy* / adverse effects
Leucovorin
Pancreatic Neoplasms* / pathology
Pancreatic Neoplasms* / therapy
Taiwan

Substances

Leucovorin
Fluorouracil

Associated data

ClinicalTrials.gov/NCT01867892