Статья

Neoadjuvant Chemoradiotherapy Versus Upfront Surgery for Resectable and Borderline Resectable Pancreatic Cancer: Long-Term Results of the Dutch Randomized PREOPANC Trial

Eva VersteijneDepartment of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the NetherlandsJacob L. van DamDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsMustafa SukerDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsQuisette P. JanssenDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsKarin GroothuisClinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL) Nijmegen, the NetherlandsJanine M. Akkermans-VogelaarClinical Research Department, Comprehensive Cancer Organisation the Netherlands (IKNL) Nijmegen, the NetherlandsMarc G. BesselinkDepartment of Surgery, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the NetherlandsBert A. BonsingDepartment of Surgery, Leiden University Medical Center, Leiden, the NetherlandsJeroen BuijsenDepartment of Radiation Oncology (MAASTRO), GROW School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, the NetherlandsOlivier R. BuschUniversity of AmsterdamGeert-Jan M. CreemersDepartment of Medical Oncology, Catharina Hospital, Eindhoven, the NetherlandsRonald M. van DamDepartment of General, Visceral and Transplant Surgery, University Hospital Aachen, Aachen, GermanyFerry A. L. M. EskensDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsSebastiaan FestenDepartment of Surgery, OLVG, Amsterdam, the NetherlandsJan Willem B. de GrootDepartment of Medical Oncology, Isala Oncology Center, Zwolle, the NetherlandsBas Groot KoerkampDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsIgnace H. de HinghDepartment of Surgery, Catharina Hospital, Eindhoven, the NetherlandsMarjolein Y. V. HomsDepartment of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsJeanin E. van HooftDepartment of Gastroenterology and Hepatology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the NetherlandsEmile D. KerverDepartment of Medical Oncology, OLVG, Amsterdam, the NetherlandsSaskia A. C. LuelmoDepartment of Medical Oncology, Leiden University Medical Center, Leiden, the NetherlandsKaren J. NeelisDepartment of Radiation Oncology, Leiden University Medical Center, Leiden, the NetherlandsJoost NuyttensDepartment of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the NetherlandsGabriel M. R. M. PaardekooperDepartment of Radiation Oncology, Isala Oncology Center, Zwolle, the NetherlandsGijs A. PatijnDepartment of Surgery, Isala Oncology Center, Zwolle, the NetherlandsMaurice J. C. van der SangenDepartment of Radiation Oncology, Catharina Hospital, Eindhoven, the NetherlandsJudith de Vos-GeelenDepartment of Internal Medicine, Division of Medical Oncology, GROW—School for Oncology and Developmental Biology, Maastricht UMC+, Maastricht, the NetherlandsJohanna W. WilminkDepartment of Medical Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the NetherlandsAeilko H. ZwindermanDepartment of Clinical Epidemiology, Biostatistics and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, the NetherlandsCornelis J. PuntDepartment of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Centre, Utrecht University, the NetherlandsGeertjan van TienhovenDepartment of Radiation Oncology, Cancer Center Amsterdam, Amsterdam UMC, University of Amsterdam, Amsterdam, the NetherlandsCasper H. J. van EijckDepartment of Surgery, Erasmus MC Cancer Institute, Rotterdam, the Netherlandsfor the Dutch Pancreatic Cancer Group

2022en

ABI

Аннотация

PURPOSE The benefit of neoadjuvant chemoradiotherapy in resectable and borderline resectable pancreatic cancer remains controversial. Initial results of the PREOPANC trial failed to demonstrate a statistically significant overall survival (OS) benefit. The long-term results are reported. METHODS In this multicenter, phase III trial, patients with resectable and borderline resectable pancreatic cancer were randomly assigned (1:1) to neoadjuvant chemoradiotherapy or upfront surgery in 16 Dutch centers. Neoadjuvant chemoradiotherapy consisted of three cycles of gemcitabine combined with 36 Gy radiotherapy in 15 fractions during the second cycle. After restaging, patients underwent surgery followed by four cycles of adjuvant gemcitabine. Patients in the upfront surgery group underwent surgery followed by six cycles of adjuvant gemcitabine. The primary outcome was OS by intention-to-treat. No safety data were collected beyond the initial report of the trial. RESULTS Between April 24, 2013, and July 25, 2017, 246 eligible patients were randomly assigned to neoadjuvant chemoradiotherapy (n = 119) and upfront surgery (n = 127). At a median follow-up of 59 months, the OS was better in the neoadjuvant chemoradiotherapy group than in the upfront surgery group (hazard ratio, 0.73; 95% CI, 0.56 to 0.96; P = .025). Although the difference in median survival was only 1.4 months (15.7 months v 14.3 months), the 5-year OS rate was 20.5% (95% CI, 14.2 to 29.8) with neoadjuvant chemoradiotherapy and 6.5% (95% CI, 3.1 to 13.7) with upfront surgery. The effect of neoadjuvant chemoradiotherapy was consistent across the prespecified subgroups, including resectable and borderline resectable pancreatic cancer. CONCLUSION Neoadjuvant gemcitabine-based chemoradiotherapy followed by surgery and adjuvant gemcitabine improves OS compared with upfront surgery and adjuvant gemcitabine in resectable and borderline resectable pancreatic cancer.

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Идентификаторы

DOI: 10.1200/jco.21.02233

Цитирования и источники

Цитирований: 2Использованных источников: 0

Показатели — AkademScholar