Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial

Hofheinz, Ralf–Dieter; Wenz, Frederik; Post, Stefan; Matzdorff, Axel; Laechelt, Stephan; Hartmann, Jörg T.; Müller, Lothar; Link, Hartmut; Moehler, Markus; Kettner, E.; Fritz, Elisabeth; Hieber, U.; Lindemann, Hans Walter; Grunewald, Martina; Kremers, Stephan; Constantin, Carolina; Hipp, Matthias; Hartung, G.; Gencer, Deniz; Kienle, Peter; Burkholder, Iris; Hochhaus, Andreas

doi:10.1016/s1470-2045(12)70116-x

Cited by 453 publications

(345 citation statements)

References 20 publications

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“…Dies wurde in Metaanalysen bestätigt [968,969] [997]. Die Resultate der amerikanischen NSABP R04-Studie, die in einem 2 × 2-faktoriellen Design neben der Frage der neoadjuvanten Radiochemotherapie mit infusionalem 5-Fluorouracil (225 mg/m²/Tag während der RT) vs. Capecitabin (1650 mg/m²/Tag während der RT) auch den Einsatz von Oxaliplatin untersuchte (siehe unten), bestätigten die Deutsche Studie, soweit es chirurgische Resultate, pCR-Raten und die Verträglichkeit der Therapie betrifft [998].…”

Section: Hintergrundunclassified

“…Als Argument für eine adjuvante Chemotherapie nach neoadjuvanter Radiochemotherapie kann gelten, dass die Großzahl der Studien zur multimodalen Behandlung des Rektumkarzinoms die adjuvante Chemotherapie als obligaten Bestandteil inkludierten und somit gut etablierte Behandlungsmodalitäten darstellen [956,973,997] Hintergrund Aufgrund der sich unter der Behandlung verändernden Molekularbiologie des Tumors und der damit verbundenen Resistenzentwicklung sind in späteren Therapielinien verabreichte Behandlungen deutlich weniger wirksam und können daher die in der Erstlinientherapie möglichen Effekte mutmaßlich nicht aufwiegen. Darüber hinaus kommt es im Therapieverlauf zu einer deutlichen Abnahme der behandelbaren Patienten, sodass in der Zweitlinientherapie etwa 70 % und in der Drittlinientherapie meist nicht mehr als 50 % der initial behandelbaren Patienten eine Therapie erhalten können [1038,1039].…”

Section: Level Of Evidenceunclassified

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S3-Leitlinie – Kolorektales Karzinom

Schmiegel

Buchberger

Follmann³

et al. 2017

Z Gastroenterol

148

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Section: Hintergrundunclassified

Section: Level Of Evidenceunclassified

S3-Leitlinie – Kolorektales Karzinom

Schmiegel

Buchberger

Follmann³

et al. 2017

Z Gastroenterol

148

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“…Pre-operative RT is used as either SCPRT of 25 Gy in 5 daily fractions over 1 week, followed by surgery within a week [6,7]. Alternatively LCPCRT is used, typically with 45-50.4 Gy in 1.8 Gy fractions over approximately 5 weeks with a concurrent fluoropyrimidine (either 5-Fluorouracil (FU) or capecitabine), followed by a gap of 8-10 weeks before surgery [4,5,9]. Both LCPCRT and SCPRT approximately halve the risk of pelvic LR and LCPCRT and SCPRT are equivalent in their ability to reduce LR in phase III trials of resectable rectal cancer [10.11].…”

Section: Introductionmentioning

confidence: 99%

Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer

Gollins

Sebag‐Montefiore

2016

Clinical Oncology

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Improved surgical technique plus selective pre-operative radiotherapy, has decreased rectal cancer pelvic local recurrence (LR) from historically 25%, down to approximately 5-10%. However, this improvement has not reduced distant metastatic relapse, the main cause of death and a key issue in rectal cancer management.The current standard is local pelvic treatment (surgery +/-pre-operative radiotherapy) followed by adjuvant chemotherapy (AC), depending on resection histology. For circumferential resection margin (CRM)-threatened cancer on baseline MRI, downstaging long-course pre-operative chemoradiation (LCPCRT) is generally used. However, for non-CRM threatened disease, varying approaches are currently adopted in the UK, including straight to surgery (STS), short-course pre-operative radiotherapy (SCPRT) and LCPCRT.Clinical trials are investigating intensification of concurrent chemoradiation. There is also increasing interest in investigating pre-operative neoadjuvant chemotherapy (NAC) as a way of exposing micro-metastatic disease to full dose systemic chemotherapy as early as possible and potentially reducing metastatic relapse.Phase II trials suggest that this strategy is feasible, with promising histological response and low rates of tumour progression during NAC. Phase III trials are needed to determine the benefit of NAC when added to standard therapy and also to determine if it can be used instead of neoadjuvant radiotherapy based schedules.

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“…A number of trials comparing capecitabine with the continuous infusion of 5FU were performed in the late 2000s 7) , and these showed that the response to capecitabine was not inferior to that achieved by 5FU. Oral anticancer drugs are far superior in terms of both cost and convenience to patients, and today oral 5FU formulations such as capecitabine are used most commonly for treatment.…”

Section: Efforts To Improve Combined Chemotherapymentioning

confidence: 99%

Recent advances in neoadjuvant chemoradiotherapy in locally advanced rectal cancer

Kawai

Ishihara

Nozawa

et al. 2017

J Anus Rectum Colon

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Abstract:Preoperative chemoradiotherapy (CRT) has been actively used in Europe and the United States to treat advanced low rectal cancer, and provides excellent local control. In Japan, however, the standard treatment is lateral lymph node dissection, and to date CRT has not been actively used. In recent years, an increasing number of Japanese institutions have been using preoperative CRT to treat locally advanced rectal cancer. In this review, we describe the latest trends in CRT under five headings: short-course or long-course radiation, efforts to improve combined chemotherapy, the addition of preoperative adjuvant chemotherapy, the watch and wait strategy, and the significance of lateral lymph node dissection in patients receiving CRT.

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Chemoradiotherapy with capecitabine versus fluorouracil for locally advanced rectal cancer: a randomised, multicentre, non-inferiority, phase 3 trial

Cited by 453 publications

References 20 publications

S3-Leitlinie – Kolorektales Karzinom

S3-Leitlinie – Kolorektales Karzinom

Neoadjuvant Treatment Strategies for Locally Advanced Rectal Cancer

Recent advances in neoadjuvant chemoradiotherapy in locally advanced rectal cancer

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