Skip to main content
Hauptrubriken
CME Facharzt-Training Webinare Zeitschriften Bücher e.Medpedia Podcast
Service
Jobbörse Info & Hilfe
Fachgebiete
Anästhesiologie Allgemeinmedizin Arbeitsmedizin Augenheilkunde Chirurgie Dermatologie Gynäkologie und Geburtshilfe HNO Innere Medizin Kardiologie Neurologie Onkologie und Hämatologie Orthopädie und Unfallchirurgie Pädiatrie Pathologie Psychiatrie Radiologie Rechtsmedizin Urologie Zahnmedizin
Themen
Typ-2-Diabetes und Adipositas Klimawandel und Gesundheit Neues aus dem Markt Praxis und Beruf Seltene Erkrankungen GOÄ & EBM Panorama
Sammlungen
Kasuistiken Algorithmen & Infografiken Blickdiagnosen Arthropedia FlapFinder (für Dermatochirurgen) Videos Kongressberichterstattung Medizin für Apothekerinnen und Apotheker Fachpsychotherapie Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende Patientenratgeber
Erweiterte Suche
Anmelden
nach oben
Annals of Surgical Oncology
Erschienen in:

07.10.2022 | Pancreatic Tumors

A Prospective Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel for Borderline Resectable Pancreatic Cancer with Arterial Involvement

verfasst von: Naoki Ikenaga, MD, PhD, Yoshihiro Miyasaka, MD, PhD, Takao Ohtsuka, MD, PhD, Kohei Nakata, MD, PhD, Tomohiko Adachi, MD, PhD, Susumu Eguchi, MD, PhD, Kazuyoshi Nishihara, MD, PhD, Masafumi Inomata, MD, PhD, Hiroshi Kurahara, MD, PhD, Toru Hisaka, MD, PhD, Hideo Baba, MD, PhD, Hiroaki Nagano, MD, PhD, Toshiharu Ueki, MD, PhD, Hirokazu Noshiro, MD, PhD, Shoji Tokunaga, MD, PhD, Kousei Ishigami, MD, PhD, Masafumi Nakamura, MD, PhD, for the Kyushu Study Group of Treatment for Pancreatobiliary Cancer

Erschienen in: Annals of Surgical Oncology | Ausgabe 1/2023

Einloggen, um Zugang zu erhalten

Abstract

Background

Only two clinical trials have shown the effects of neoadjuvant treatment for borderline resectable pancreatic cancer with arterial involvement (BRPC-A). Here, we aimed to analyze the efficacy and safety of neoadjuvant gemcitabine plus nab-paclitaxel (GnP) for BRPC-A.

Patients and Methods

A prospective, single-arm, multicenter phase II trial was conducted. Patients who were radiologically and histologically diagnosed with BRPC-A were enrolled. A central review was conducted to confirm the presence of BRPC-A. Patients received two to four cycles of GnP before surgery. The primary endpoint of the study was the R0 resection rate. Overall survival (OS) was evaluated in an ancillary study.

Results

Thirty-five patients were enrolled, of whom 33 were subjected to central review and 28 were confirmed to have BRPC-A. All eligible patients with BRPC-A received neoadjuvant GnP. Nineteen patients underwent pancreatic resections. Postoperative complications of Clavien–Dindo IIIa or lower were observed in 11 patients. No treatment-related mortalities were observed. R0 resection was achieved in 17 patients (89%); the R0 resection rate was 61% in eligible patients. One patient underwent curative resection after termination of the treatment protocol, resulting in an overall R0 resection rate of 64%. The median overall survival (OS) and 2-year OS rate were 24.9 months [95% confidence interval (CI) 19.0 months to not estimatable] and 53.6%, respectively. OS in patients with BRPC-A who achieved overall R0 resection was significantly longer than that in the other patients (p = 0.0255).

Conclusions

Neoadjuvant GnP is a safe and effective strategy for BRPC-A, providing a chance for curative resection and improved survival.
Anhänge
Nur mit Berechtigung zugänglich
Literatur
1.
Siegel RL, Miller KD, Fuchs HE, et al. Cancer statistics, 2021. CA Cancer J Clin. 2021;71:7–33.CrossRef
2.
Katz MH, Pisters PW, Evans DB, et al. Borderline resectable pancreatic cancer: the importance of this emerging stage of disease. J Am Coll Surg. 2008;206:833–46.CrossRef
3.
Japan Pancreas Society. General Rules for the Study of Pancreatic Cancer. 7th edn. Tokyo: Kanehara; 2016.
4.
Kato H, Usui M, Isaji S, et al. Clinical features and treatment outcome of borderline resectable pancreatic head/body cancer: a multi-institutional survey by the Japanese Society of Pancreatic Surgery. J Hepatobiliary Pancreat Sci. 2013;20:601–10.CrossRef
5.
Murakami Y, Satoi S, Sho M, et al. National Comprehensive Cancer Network resectability status for pancreatic carcinoma predicts overall survival. World J Surg. 2015;39:2306–14.CrossRef
6.
Bockhorn M, Uzunoglu FG, Adham M, et al. Borderline resectable pancreatic cancer: a consensus statement by the International Study Group of Pancreatic Surgery (ISGPS). Surgery. 2014;155:977–88.CrossRef
7.
Mollberg N, Rahbari NN, Koch M, et al. Arterial resection during pancreatectomy for pancreatic cancer: a systematic review and meta-analysis. Ann Surg. 2011;254:882–93.CrossRef
8.
Ravikumar R, Sabin C, Abu Hilal M, et al. Impact of portal vein infiltration and type of venous reconstruction in surgery for borderline resectable pancreatic cancer. Br J Surg. 2017;104:1539–48.CrossRef
9.
Jang JY, Han Y, Lee H, et al. Oncological benefits of neoadjuvant chemoradiation with gemcitabine versus upfront surgery in patients with borderline resectable pancreatic cancer: a prospective, randomized, open-label, multicenter phase 2/3 Trial. Ann Surg. 2018;268:215–22.CrossRef
10.
Kurahara H, Shinchi H, Ohtsuka T, et al. Significance of neoadjuvant therapy for borderline resectable pancreatic cancer: a multicenter retrospective study. Langenbecks Arch Surg. 2019;404:167–74.CrossRef
11.
Lee JH, Kang CM, Bang SM, et al. The role of neoadjuvant chemoradiation therapy in patients with borderline resectable pancreatic cancer with isolated venous vascular involvement. Medicine (Baltimore). 2015;94:e1233.CrossRef
12.
Versteijne E, van Dam JL, Suker M, et al. Neoadjuvant chemoradiotherapy versus upfront surgery for resectable and borderline resectable pancreatic cancer: long-term results of the Dutch randomized PREOPANC trial. J Clin Oncol. 2022;40:1220–30.CrossRef
13.
Fujii T, Yamada S, Murotani K, et al. Inverse probability of treatment weighting analysis of upfront surgery versus neoadjuvant chemoradiotherapy followed by surgery for pancreatic adenocarcinoma with arterial abutment. Medicine (Baltimore). 2015;94:e1647.CrossRef
14.
Murakami Y, Uemura K, Sudo T, et al. Survival impact of neoadjuvant gemcitabine plus S-1 chemotherapy for patients with borderline resectable pancreatic carcinoma with arterial contact. Cancer Chemother Pharmacol. 2017;79:37–47.CrossRef
15.
Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369:1691–703.CrossRef
16.
Ueno H, Ikeda M, Ueno M, et al. Phase I/II study of nab-paclitaxel plus gemcitabine for chemotherapy-naive Japanese patients with metastatic pancreatic cancer. Cancer Chemother Pharmacol 2016;77:595–603.CrossRef
17.
Inoue Y, Saiura A, Oba A, et al. Neoadjuvant gemcitabine and nab-paclitaxel for borderline resectable pancreatic cancers: intention-to-treat analysis compared with upfront surgery. J Hepatobiliary Pancreat Sci. 2021;28:143–55.CrossRef
18.
Miyasaka Y, Ohtsuka T, Kimura R, et al. Neoadjuvant chemotherapy with gemcitabine plus nab-paclitaxel for borderline resectable pancreatic cancer potentially improves survival and facilitates surgery. Ann Surg Oncol. 2019;26:1528–34.CrossRef
19.
Okada KI, Hirono S, Kawai M, et al. Phase I study of nab-paclitaxel plus gemcitabine as neoadjuvant therapy for borderline resectable pancreatic cancer. Anticancer Res. 2017;37:853–8.CrossRef
20.
Miyasaka Y, Ohtsuka T, Eguchi S, et al. Neoadjuvant chemotherapy with gemcitabine plus nab-paclitaxel regimen for borderline resectable pancreatic cancer with arterial involvement: a prospective multicenter single-arm phase II study protocol. Int J Surg Protoc. 2021;25:55–60.CrossRef
21.
Tempero MA, Malafa MP, Al-Hawary M, et al. Pancreatic adenocarcinoma, version 2.2021, NCCN Clinical Practice Guidelines in Oncology. J Natl Compr Canc Netw. 2021;19:439–57.CrossRef
22.
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009;45:228–47.CrossRef
23.
Evans DB, Rich TA, Byrd DR, et al. Preoperative chemoradiation and pancreaticoduodenectomy for adenocarcinoma of the pancreas. Arch Surg. 1992;127:1335–9.CrossRef
24.
Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004;240:205–13.CrossRef
25.
EQ-5D-5L User Guide. Basic information on how to use the EQ-5D-5L instrument. Version 3.0, Updated September 2019. Accessed 10 March 2021. Volume 2021.
26.
Tang K, Lu W, Qin W, et al. Neoadjuvant therapy for patients with borderline resectable pancreatic cancer: a systematic review and meta-analysis of response and resection percentages. Pancreatology. 2016;16:28–37.CrossRef
27.
MB A. American Joint Committee on Cancer, American Cancer Society. AJCC Cancer Staging Manual. Chicago, IL: American Joint Committee on Cancer, Springer. 2017.
28.
Katz MH, Shi Q, Ahmad SA, et al. Preoperative modified FOLFIRINOX treatment followed by capecitabine-based chemoradiation for borderline resectable pancreatic cancer: Alliance for Clinical Trials in Oncology Trial A021101. JAMA Surg. 2016;151:e161137.CrossRef
29.
Takahashi S, Ohno I, Ikeda M, et al. Neoadjuvant S-1 with concurrent radiotherapy followed by surgery for borderline resectable pancreatic cancer: a phase II open-label multicenter prospective trial (JASPAC05). Ann Surg. 2020.
30.
Takeda Y, Nakamori S, Eguchi H, et al. Neoadjuvant gemcitabine-based accelerated hyperfractionation chemoradiotherapy for patients with borderline resectable pancreatic adenocarcinoma. Jpn J Clin Oncol. 2014;44:1172–80.CrossRef
31.
Nagakawa Y, Hosokawa Y, Nakayama H, et al. A phase II trial of neoadjuvant chemoradiotherapy with intensity-modulated radiotherapy combined with gemcitabine and S-1 for borderline-resectable pancreatic cancer with arterial involvement. Cancer Chemother Pharmacol. 2017;79:951–7.CrossRef
32.
Kondo N, Uemura K, Sudo T, et al. A phase II study of gemcitabine/nab-paclitaxel/S-1 combination neoadjuvant chemotherapy for patients with borderline resectable pancreatic cancer with arterial contact. Eur J Cancer. 2021;159:215–23.CrossRef
33.
Chiorean EG, Cheung WY, Giordano G, et al. Real-world comparative effectiveness of nab-paclitaxel plus gemcitabine versus FOLFIRINOX in advanced pancreatic cancer: a systematic review. Ther Adv Med Oncol. 2019;11:1758835919850367.CrossRef
34.
Ahmad SA, Duong M, Sohal DPS, et al. Surgical outcome results from SWOG S1505: a randomized clinical trial of mFOLFIRINOX versus gemcitabine/nab-paclitaxel for perioperative treatment of resectable pancreatic ductal adenocarcinoma. Ann Surg. 2020;272:481–6.CrossRef
35.
Wei AC, Ou FS, Shi Q, et al. Perioperative gemcitabine + erlotinib plus pancreaticoduodenectomy for resectable pancreatic adenocarcinoma: ACOSOG Z5041 (Alliance) phase II trial. Ann Surg Oncol. 2019;26:4489–97.CrossRef
36.
Sohal DPS, Duong M, Ahmad SA, et al. Efficacy of Perioperative chemotherapy for resectable pancreatic adenocarcinoma: a phase 2 randomized clinical trial. JAMA Oncol. 2021;7:421–7.CrossRef
37.
Macarulla T, Hendifar AE, Li CP, et al. Landscape of health-related quality of life in patients with early-stage pancreatic cancer receiving adjuvant or neoadjuvant chemotherapy: a systematic literature review. Pancreas. 2020;49:393–407.CrossRef
38.
Serrano PE, Herman JM, Griffith KA, et al. Quality of life in a prospective, multicenter phase 2 trial of neoadjuvant full-dose gemcitabine, oxaliplatin, and radiation in patients with resectable or borderline resectable pancreatic adenocarcinoma. Int J Radiat Oncol Biol Phys. 2014;90:270–7.CrossRef
Metadaten
Titel
A Prospective Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Gemcitabine Plus Nab-Paclitaxel for Borderline Resectable Pancreatic Cancer with Arterial Involvement
verfasst von
Naoki Ikenaga, MD, PhD
Yoshihiro Miyasaka, MD, PhD
Takao Ohtsuka, MD, PhD
Kohei Nakata, MD, PhD
Tomohiko Adachi, MD, PhD
Susumu Eguchi, MD, PhD
Kazuyoshi Nishihara, MD, PhD
Masafumi Inomata, MD, PhD
Hiroshi Kurahara, MD, PhD
Toru Hisaka, MD, PhD
Hideo Baba, MD, PhD
Hiroaki Nagano, MD, PhD
Toshiharu Ueki, MD, PhD
Hirokazu Noshiro, MD, PhD
Shoji Tokunaga, MD, PhD
Kousei Ishigami, MD, PhD
Masafumi Nakamura, MD, PhD
for the Kyushu Study Group of Treatment for Pancreatobiliary Cancer
Publikationsdatum
07.10.2022
Verlag
Springer International Publishing
Erschienen in
Annals of Surgical Oncology / Ausgabe 1/2023
Print ISSN: 1068-9265
Elektronische ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-022-12566-1

Weitere Artikel der Ausgabe 1/2023

ASO Visual Abstract: Co-existing Papillary and Anaplastic Thyroid Cancer—Elucidating the Spectrum of Aggressive Behavior

  • ASO Visual Abstract

ASO Visual Abstract: Switching Perfusion Agents for Repeat Cytoreductive Surgery with Hyperthermic Intraperitoneal Chemotherapy, Surgical Dogma or Evidence-Based Practice?

  • ASO Visual Abstract

ASO Visual Abstract: Circulating Tumor DNA, Imaging, and Carcinoembryonic Antigen: Comparison of Surveillance Strategies in Patients Who Underwent Resection pf Colorectal Cancer: A Systematic Review and Meta-Analysis

  • ASO Visual Abstract

ASO Visual Abstract: Comparison of Perioperative Outcomes of Subxiphoid Approach versus Lateral Intercostal Approach Thoracoscopic Thymectomy for Masaoka–Koga I–II Thymoma—a Propensity Score Matching Analysis

  • ASO Visual Abstract

Screening MRI Does Not Increase Cancer Detection or Result in an Earlier Stage at Diagnosis for Patients with High-Risk Breast Lesions: A Propensity Score Analysis

  • Breast Oncology

ASO Author Reflections: Multimodality Treatment of Cutaneous Angiosarcoma

  • ASO Author Reflections

Neu im Fachgebiet Chirurgie

Hochrisiko-Spinaliom am besten mit der Mohs-Chirurgie entfernen

Die Mohs-Chirurgie ist zwar mit mehr Aufwand verbunden als die herkömmliche Exzision; für die Versorgung kutaner Hochrisiko-Plattenepithelkarzinome lohnt sich die zeitintensive Technik aber in jedem Fall. Laut einer aktuellen Studie sinkt im Vergleich das Sterberisiko.

Darmpolyp weg – Peptid-Gel gegen Nachblutungen drauf?

Das Nachblutungsrisiko nach einer endoskopischen Mukosaresektion von flachen kolorektalen und duodenalen Adenomen war in der deutschen PURPLE-Studie mit einem hämostatischen Gel nicht kleiner als ohne Prophylaxe.

Krebs-Op. besser erst nach mehrwöchigem Rauchverzicht?

Aktive Raucher haben nach onkologischen Operationen ein höheres Komplikationsrisiko als Nieraucher, aber auch als Exraucher. Damit der Rauchstopp einen Nutzen hat, darf er aber nicht zu kurz vor der Op. erfolgen, wie eine Metaanalyse nahelegt.

Periprozeduraler Myokardschaden nach NSTEMI prognostisch bedeutsam

Erleiden NSTEMI-Patienten und -Patientinnen infolge einer PCI Myokardschädigungen mit oder ohne Infarkt, erhöht das die Gesamtmortalität und das Risiko für weitere schwere Herzereignisse. Dafür sprechen zumindest Daten aus zwei italienischen Zentren.

Update Chirurgie

Bestellen Sie unseren Fach-Newsletter und bleiben Sie gut informiert.

Newsletter bestellen
Bildnachweise