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 Für Ärztinnen und Ärzte in Weiterbildung Für Medizinstudierende Patientenratgeber
Erweiterte Suche
Anmelden
nach oben
Esophagus
Erschienen in:

18.03.2021 | Original Article

Two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for treating locally advanced esophageal cancer: short-term outcomes of a multicenter randomized phase II trial

verfasst von: Osamu Shiraishi, Tomoki Makino, Makoto Yamasaki, Koji Tanaka, Kotaro Yamashita, Tomo Ishida, Keijiro Sugimura, Hiroshi Miyata, Masaaki Motoori, Kazumasa Fujitani, Atsushi Takeno, Motohiro Hirao, Yutaka Kimura, Taroh Satoh, Masahiko Yano, Yuichiro Doki, Takushi Yasuda

Erschienen in: Esophagus | Ausgabe 4/2021

Einloggen, um Zugang zu erhalten

Abstract

Objective

To compare short-term outcomes between two- vs. three courses of neoadjuvant chemotherapy (NAC) to clarify the optimal treatment for esophageal squamous cell cancer (ESCC) in a multicenter, randomized, phase II trial.

Background

An optimal number of NAC cycles remains to be established for locally advanced ESCC.

Methods

Patients with locally advanced ESCC were randomly assigned to either two (N = 91) or three (N = 89) courses of DCF (70 mg/m2 intravenous docetaxel and 70 mg/m2 intravenous cisplatin on day 1, and a continuous 700 mg/m2 fluorouracil infusion for 5 days) every 3 weeks followed by surgery. We compared the two groups for perioperative parameters, adverse events, and the response to NAC.

Results

The two- and three-course groups showed similar completion rates and overall NAC dose reductions. Although the two-course group showed significantly lower overall grades 3–4 leukopenia and anemia compared to the three-course group, the two groups had similar overall toxicity rates. Postoperative complications were not significantly different between the two groups, except arrhythmia (13 vs. 0%, P = 0.0007). Only two postoperative in-hospital deaths occurred in the three-course group, due to sepsis following severe pneumonia. Compared to the two-course group, the three-course group was associated with a significantly better clinical response (42.9 vs. 65.2%, P = 0.0027) and a relatively higher rate of pathological complete response (9.1 vs. 15.3%, P = 0.212).

Conclusion

Both two- and three-course DCF regimens in the NAC setting seemed to be equally feasible in locally advanced ESCC patients. Additional DCF courses led to a better NAC response without increasing the incidence of adverse events or postoperative morbidity.

Clinical Trial Registration

University Hospital Medical Information Network Clinical Trials Registry of Japan (Identification Number UMIN 000015788).
Literatur
1.
Colvin H, Mizushima T, Eguchi H, Takiguchi S, Doki Y, Mori M. Gastroenterological surgery in Japan: the past, the present and the future. Ann Gastroenterol Surg. 2017;1(1):5–10.CrossRef
2.
Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics 2011. CA Cancer J Clin. 2011;61(2):69–90.CrossRef
3.
Hofstetter W, Swisher SG, Correa AM, Hess K, Putnam JB Jr, Ajani JA, Dolormente M, Francisco R, Komaki RR, Lara A, et al. Treatment outcomes of resected esophageal cancer. Ann Surg. 2002;236(3):376–84 (discussion 384–375).CrossRef
4.
van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, et al. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012;366(22):2074–84.CrossRef
5.
Sjoquist KM, Burmeister BH, Smithers BM, Zalcberg JR, Simes RJ, Barbour A, Gebski V. Australasian gastro-intestinal trials G: survival after neoadjuvant chemotherapy or chemoradiotherapy for resectable oesophageal carcinoma: an updated meta-analysis. Lancet Oncol. 2011;12(7):681–92.CrossRef
6.
Ando N, Kato H, Igaki H, Shinoda M, Ozawa S, Shimizu H, Nakamura T, Yabusaki H, Aoyama N, Kurita A, et al. A randomized trial comparing postoperative adjuvant chemotherapy with cisplatin and 5-fluorouracil versus preoperative chemotherapy for localized advanced squamous cell carcinoma of the thoracic esophagus (JCOG9907). Ann Surg Oncol. 2012;19(1):68–74.CrossRef
7.
Yamasaki M, Yasuda T, Yano M, Hirao M, Kobayashi K, Fujitani K, Tamura S, Kimura Y, Miyata H, Motoori M, et al. Multicenter randomized phase II study of cisplatin and fluorouracil plus docetaxel (DCF) compared with cisplatin and fluorouracil plus adriamycin (ACF) as preoperative chemotherapy for resectable esophageal squamous cell carcinoma (OGSG1003). Ann Oncol. 2017;28(1):116–20.CrossRef
8.
Shiraishi O, Yamasaki M, Makino T, Motoori M, Miyata H, Shinkai M, Kimura Y, Hirao M, Fujitani K, Tamura S, Kobayashi K, Yano M, Doki Y, Yasuda T. Feasibility of preoperative chemotherapy with docetaxel, cisplatin, and 5-fluorouracil versus adriamycin, cisplatin, and 5-fluorouracil for resectable advanced esophageal cancer. Oncology. 2017;92(2):101–8.CrossRef
9.
Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, et al. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006;355(1):11–20.CrossRef
10.
Yoshikawa T, Morita S, Tanabe K, Nishikawa K, Ito Y, Matsui T, Fujitani K, Kimura Y, Fujita J, Aoyama T, et al. Survival results of a randomised two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of S-1 plus cisplatin (SC) and paclitaxel plus cisplatin (PC) followed by D2 gastrectomy for resectable advanced gastric cancer. Eur J Cancer. 2016;62:103–11.CrossRef
11.
Nakamura K, Kato K, Igaki H, Ito Y, Mizusawa J, Ando N, Udagawa H, Tsubosa Y, Daiko H, Hironaka S, et al. Three-arm phase III trial comparing cisplatin plus 5-FU (CF) versus docetaxel, cisplatin plus 5-FU (DCF) versus radiotherapy with CF (CF-RT) as preoperative therapy for locally advanced esophageal cancer (JCOG1109, NExT study). Jpn J Clin Oncol. 2013;43(7):752–5.CrossRef
12.
Hagi T, Makino T, Yamasaki M, Tanaka K, Nishida N, Sakai D, Motoori M, Kimura Y, Satoh T, Mori M, et al. Dysphagia score as a predictor of adverse events due to triplet chemotherapy and oncological outcomes in 434 consecutive patients with esophageal cancer. Ann Surg Oncol. 2019;26(13):4754–64.CrossRef
13.
Yanagimoto Y, Takiguchi S, Miyazaki Y, Makino T, Takahashi T, Kurokawa Y, Yamasaki M, Miyata H, Nakajima K, Hosoda H, et al. Improvement of cisplatin-related renal dysfunction by synthetic ghrelin: a prospective randomised phase II trial. Br J Cancer. 2016;114(12):1318–25.CrossRef
14.
Sobin LHGM, Wittekind C. TNM classification of malignant tumors. 7th ed. Oxford: Wiley-Blackwell; 2010.
15.
Makino T, Yamasaki M, Miyazaki Y, Takahashi T, Kurokawa Y, Nakajima K, Takiguchi S, Mori M, Doki Y. Short- and long-term outcomes of larynx-preserving surgery for cervical esophageal cancer: analysis of 100 consecutive cases. Ann Surg Oncol. 2016;23(Suppl 5):858–65.CrossRef
16.
Makino T, Yamasaki M, Miyazaki Y, Wada N, Takahashi T, Kurokawa Y, Nakajima K, Takiguchi S, Mori M, Doki Y. Utility of initial induction chemotherapy with 5-fluorouracil, cisplatin, and docetaxel (DCF) for T4 esophageal cancer: a propensity score-matched analysis. Dis Esophagus. 2018;31(4). https://​doi.​org/​10.​1093/​dote/​dox130.
17.
Makino T, Yamasaki M, Tanaka K, Masuike Y, Tatsumi M, Motoori M, Kimura Y, Hatazawa J, Mori M, Doki Y. Metabolic tumor volume change predicts long-term survival and histological response to preoperative chemotherapy in locally advanced esophageal cancer. Ann Surg. 2019;270(6):1090–5.CrossRef
18.
Makino T, Yamasaki M, Tanaka K, Tatsumi M, Takiguchi S, Hatazawa J, Mori M, Doki Y. Importance of positron emission tomography for assessing the response of primary and metastatic lesions to induction treatments in T4 esophageal cancer. Surgery. 2017;162(4):836–45.CrossRef
19.
Makino T, Miyata H, Yamasaki M, Fujiwara Y, Takiguchi S, Nakajima K, Higuchi I, Hatazawa J, Mori M, Doki Y. Utility of response evaluation to neo-adjuvant chemotherapy by (18)F-fluorodeoxyglucose-positron emission tomography in locally advanced esophageal squamous cell carcinoma. Surgery. 2010;148(5):908–18.CrossRef
20.
Makino T, Yamasaki M, Miyata H, Tanaka K, Takahashi T, Kurokawa Y, Nakajima K, Takiguchi S, Mori M, Doki Y. Solitary lymph node recurrence of esophageal squamous cell carcinoma: surgical failure or systemic disease? Ann Surg Oncol. 2016;23(6):2087–93.CrossRef
21.
22.
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(2):205–13.CrossRef
23.
Yamashita K, Makino T, Miyata H, Miyazaki Y, Takahashi T, Kurokawa Y, Yamasaki M, Nakajima K, Takiguchi S, Mori M, et al. Postoperative infectious complications are associated with adverse oncologic outcomes in esophageal cancer patients undergoing preoperative chemotherapy. Ann Surg Oncol. 2016;23(6):2106–14.CrossRef
24.
Hashimoto T, Makino T, Yamasaki M, Tanaka K, Miyazaki Y, Takahashi T, Kurokawa Y, Motoori M, Kimura Y, Nakajima K, et al. The pattern of residual tumor after neoadjuvant chemotherapy for locally advanced esophageal cancer and its clinical significance. Ann Surg. 2020;271(5):875–84.CrossRef
25.
Makino T, Yamasaki M, Miyata H, Yoshioka S, Takiguchi S, Fujiwara Y, Nakajima K, Nishida T, Mori M, Doki Y. p53 Mutation status predicts pathological response to chemoradiotherapy in locally advanced esophageal cancer. Ann Surg Oncol. 2010;17(3):804–11.CrossRef
26.
27.
28.
Yamasaki M, Miyata H, Tanaka K, Shiraishi O, Motoori M, Peng YF, Yasuda T, Yano M, Shiozaki H, Mori M, et al. Multicenter phase I/II study of docetaxel, cisplatin and fluorouracil combination chemotherapy in patients with advanced or recurrent squamous cell carcinoma of the esophagus. Oncology. 2011;80(5–6):307–13.CrossRef
29.
Yamamoto K, Makino T, Sato E, Noma T, Urakawa S, Takeoka T, Yamashita K, Saito T, Tanaka K, Takahashi T, et al. Tumor-infiltrating M2 macrophage in pretreatment biopsy sample predicts response to chemotherapy and survival in esophageal cancer. Cancer Sci. 2020;111(4):1103–12.CrossRef
30.
Motoori M, Yano M, Miyata H, Sugimura K, Saito T, Omori T, Fujiwara Y, Miyoshi N, Akita H, Gotoh K, et al. Randomized study of the effect of synbiotics during neoadjuvant chemotherapy on adverse events in esophageal cancer patients. Clin Nutr. 2017;36(1):93–9.CrossRef
31.
Hirao M, Ando N, Tsujinaka T, Udagawa H, Yano M, Yamana H, Nagai K, Mizusawa J, Nakamura K, Japan Esophageal Oncology Group/Japan Clinical Oncology Group. Influence of preoperative chemotherapy for advanced thoracic oesophageal squamous cell carcinoma on perioperative complications. Br J Surg. 2011;98(12):1735–41.CrossRef
Metadaten
Titel
Two versus three courses of preoperative cisplatin and fluorouracil plus docetaxel for treating locally advanced esophageal cancer: short-term outcomes of a multicenter randomized phase II trial
verfasst von
Osamu Shiraishi
Tomoki Makino
Makoto Yamasaki
Koji Tanaka
Kotaro Yamashita
Tomo Ishida
Keijiro Sugimura
Hiroshi Miyata
Masaaki Motoori
Kazumasa Fujitani
Atsushi Takeno
Motohiro Hirao
Yutaka Kimura
Taroh Satoh
Masahiko Yano
Yuichiro Doki
Takushi Yasuda
Publikationsdatum
18.03.2021
Verlag
Springer Singapore
Erschienen in
Esophagus / Ausgabe 4/2021
Print ISSN: 1612-9059
Elektronische ISSN: 1612-9067
DOI
https://doi.org/10.1007/s10388-021-00831-3

Weitere Artikel der Ausgabe 4/2021

Metachronous carcinogenesis of superficial esophagus squamous cell carcinoma after endoscopic submucosal dissection: incidence and risk stratification during long-term observation

  • Original Article

Modeling the risk of radiation pneumonitis in esophageal squamous cell carcinoma treated with definitive chemoradiotherapy

  • Original Article

Early intervention of the perioperative multidisciplinary team approach decreases the adverse events during neoadjuvant chemotherapy for esophageal cancer patients

  • Original Article

Therapeutic effect of laparoscopic fundoplication for patients with GERD from the viewpoint of Lyon Consensus

  • Original Article

Does thoracoscopic esophagectomy really reduce post-operative pneumonia in all cases?

  • Review Article

Obesity reduces the requirement for subsequent esophageal stricture dilation in adults with eosinophilic esophagitis

  • Original Article

Kompaktes Leitlinien-Wissen Innere Medizin (Link öffnet in neuem Fenster)

Mit medbee Pocketcards schnell und sicher entscheiden.
Leitlinien-Wissen kostenlos und immer griffbereit auf ihrem Desktop, Handy oder Tablet.

Kostenlos registrieren

Neu im Fachgebiet Innere Medizin

Verbände und Cremes gegen Dekubitus: „Wir wissen nicht, was sie bringen!“

Die Datenlage zur Wirksamkeit von Verbänden oder topischen Mitteln zur Prävention von Druckgeschwüren sei schlecht, so die Verfasser einer aktuellen Cochrane-Studie. Letztlich bleibe es unsicher, ob solche Maßnahmen den Betroffenen nutzen oder schaden.

Schützt das tägliche Glas Milch vor Darmkrebs?

Die Milch machts – sie bietet Frauen nach Daten einer großen Ernährungsanalyse den besten Darmkrebsschutz aller Lebensmittel, was am hohen Kalziumgehalt liegen dürfte. Am anderen Ende des Spektrums steht der Alkoholkonsum: Das Glas Wein am Abend ist eher ungünstig.

Vorsicht mit Glukokortikoiden bei Glomerulopathie

Auch niedrig dosierte Glukokortikoide zur Behandlung einer primären Glomerulopathie lassen offenbar die Infektionsgefahr steigen. In einer US-Studie hing das Risiko vor allem mit der kombinierten Anwendung von Immunsuppressiva zusammen.

KI-gestütztes Mammografiescreening überzeugt im Praxistest

Mit dem Einsatz künstlicher Intelligenz lässt sich die Detektionsrate im Mammografiescreening offenbar deutlich steigern. Mehr unnötige Zusatzuntersuchungen sind laut der Studie aus Deutschland nicht zu befürchten.

EKG Essentials: EKG befunden mit System (Link öffnet in neuem Fenster)

In diesem CME-Kurs können Sie Ihr Wissen zur EKG-Befundung anhand von zwölf Video-Tutorials auffrischen und 10 CME-Punkte sammeln.
Praxisnah, relevant und mit vielen Tipps & Tricks vom Profi.

Jetzt 10 CME-Punkte sammeln

Update Innere Medizin

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

Newsletter bestellen
Bildnachweise