Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study

Klautke, Günther; Küchenmeister, Ute; Foitzik, Thomas; Ludwig, Kaja; Prall, Friedrich; Klar, E.; Fietkau, Rainer

doi:10.1038/sj.bjc.6603053

Cited by 66 publications

(38 citation statements)

References 32 publications

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“…We found a considerable rate of pCR and microfoci (14 out of 34 resected patients; 41%), which appears to be almost doubled in comparison to 5-FU-based chemoradiotherapy regimen provided that standardised histopathological work-up is in place. This finding is consistent with data published by Klautke et al (2006) using a CapIri-RT regimen with somewhat higher doses of capecitabin (750 mg m À2 bid) and irinotecan (6 Â weekly 40 mg m À2 ). A total of seven out of 26 evaluable patients in this phase I/II trial had pCR or microfoci.…”

Section: Discussionsupporting

confidence: 92%

“…The rate of grade 3 -4 diarrhoea reported in the CapIri-RT trials is about 15 -30% (Hofheinz et al, 2005;Gollins et al, 2006;Klautke et al, 2006). Using capecitabine and oxaliplatin combinations, grade 3 -4 diarrhoea is reported to range between 18% (n ¼ 85; CORE-trial; Rutten et al, 2006) and 30% (n ¼ 40; RadiOxCape-study; Machiels et al, 2005).…”

Section: Discussionmentioning

confidence: 99%

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A phase II study of capecitabine and irinotecan in combination with concurrent pelvic radiotherapy (CapIri-RT) as neoadjuvant treatment of locally advanced rectal cancer

et al. 2007

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We sought to evaluate the efficacy and safety data of a combination regimen using weekly irinotecan in combination with capecitabine and concurrent radiotherapy (CapIri-RT) as neoadjuvant treatment in rectal cancer in a phase-II trial. Patients with rectal cancer clinical stages T3/4 Nx or N þ were recruited to receive irinotecan (50 mg m À2 weekly) and capecitabine (500 mg m À2 bid days 1 -38) with a concurrent RT dose of 50.4 Gy. Surgery was scheduled 4 -6 weeks after the completion of chemoradiation. A total of 36 patients (median age 62 years; m/f: 27:9) including three patients with local recurrence were enclosed onto the trial. The median distance of the tumour from the anal verge was 5 cm. The main toxicity observed was (NCI-CTC grades 1/2/3/4 (n)): Anaemia 23/9/À/À; leucocytopenia 12/7/7/2, diarrhoea 13/15/4/À, nausea/vomiting 9/10/2/À, and increased activity of transaminases 3/3/1/À. One patient had a reversible episode of ventricular fibrillation during chemoradiation, most probably caused by capecitabine. The relative dose intensity was (median/mean (%)): irinotecan 95/91, capecitabine 100/92). Thirty-four patients underwent surgery (anterior resection n ¼ 25; abdomino-perineal resection n ¼ 6; Hartmann's procedure n ¼ 3). R0-resection was accomplished in all patients. Two patients died in the postoperative course from septic complications. Pathological complete remission was observed in five out of 34 resected patients (15%), and nine patients showed microfoci of residual tumour (26%). After a median follow-up of 28 months one patient had developed a local recurrence, and five patients distant metastases. Three-year overall survival for all patients with surgery (excluding three patients treated for local relapse or with primary metastatic disease) was 80%. In summary, preoperative chemoradiation with CapIri-RT exhibits promising efficacy whereas showing managable toxicity. The local recurrence and distant failure rates observed after a median 28 months are low compared with standard 5-fluorouracil based therapy. Advances in surgical technique, including total mesorectal excision and thorough pathohistological work-up of the resected specimen have significantly improved the prognosis of patients with localised rectal cancer during the past two decades. Nevertheless, preoperative radiotherapy further improves local recurrence rates (Kapiteijn et al, 2001). The German CAO/AIO/ARO-94 trial, which compared pre-and postoperative chemoradiation in resectable rectal cancer, established the neoadjuvant approach as a new standard of care given it's superiority with respect to local failure rates and toxicity (Sauer et al, 2004). Moreover, the MRC CR07 trial, which compared short-course preoperative radiotherapy (5 Â 5 Gy) in resectable rectal cancer with selective postoperative chemoradiation in patients with compromised circumferential resection margins, showed a significant reduction in local recurrence and improved disease-free survival in favour of the short-course preoperative radiotherapy . Finally, bot...

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Section: Discussionsupporting

confidence: 92%

Section: Discussionmentioning

confidence: 99%

A phase II study of capecitabine and irinotecan in combination with concurrent pelvic radiotherapy (CapIri-RT) as neoadjuvant treatment of locally advanced rectal cancer

et al. 2007

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“…Sauer oxaliplatin. The pathological complete response is usually more than 20% (27)(28)(29)(30), but the toxicity of the treatment is higher.…”

Section: Anastomotic Leakmentioning

confidence: 99%

Neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic resection in locally advanced tumors of middle and low rectum – Toxicity and complications of the treatment

Soumarová¹,

Škrovina²,

Bartoš³

et al. 2010

European Journal of Surgical Oncology (EJSO)

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Please cite this article as: Soumarova R, Skrovina M, Bartos J, Gruna J, Wendrinski A, Czudek S, Kycina R, Parvez J. Neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic resection in locally advanced tumors of middle and low rectum-toxicity and complications of the treatment, European Journal of Surgical Oncology (2009Oncology ( ), doi: 10.1016Oncology ( /j.ejso.2009 This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. The aim of this prospective study is to elucidate feasibility of protocol of neodjuvant concomitant radio chemotherapy with capecitabine and long course radiotherapy with subsequent laparoscopic rectal resection. We assessed treatment toxicity, downstaging rate, pathological response to the neoadjuvant treatment, surgery complications, rate of conversions and sphincter-preserving surgical procedures, and intraoperative and early postoperative complications too. Methods:We acquired data of 78 patients from 1 January 2005 to 31 December 2007 with a locally advanced rectal cancer in our study. All patients were indicated for the neoadjuvant concomitant chemoradiotherapy due to locally advanced tumor (T3 or T4) or lymph nodes involvement suspicion (N+). Both radiotherapy (to pelvic region) and chemotherapy (capecitabine) were administered. Rectal tumors were localized within 12cm from the anocutaneous verge. The average follow-up time was 23.9 months. Results:All patients completed their treatment according to the planned regimen and dose. The surgery was performed laparoscopicaly within 4-8 weeks following the concomitant chemoradiotherapy -in 17% cases was converted into conventional surgery. Downstaging was achieved in 69% of patients, pathological complete response in 10 %, histologically negative lymph nodes were documented in 58% of patients. Grade 3 toxicity of the concomitant chemoradiotherapy was present in 3%; grade 2 in 29% of patients, particularly skin and gastrointestinal form. Intraoperative and early postoperative complications of the surgery were 18%. Reoperation was needed in 5% cases. M A N U S C R I P T A C C E P T E D ARTICLE IN PRESS Conclusions:We demonstrated safety and low toxicity of the concomitant chemoradiotherapy with capecitabine.

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“…The results of the trial of Klautke et al (2006). 'Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study' create concerns regarding the toxicity of their scheme.…”

Section: Sirmentioning

confidence: 99%

High mortality from neo-adjuvant chemo-radiotherapy for rectal cancer needs to be evaluated against the alternative of adjuvant therapy

Papagrigoriadis

2006

Br J Cancer

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Concurrent chemoradiation with capecitabine and weekly irinotecan as preoperative treatment for rectal cancer: results from a phase I/II study

Cited by 66 publications

References 32 publications

A phase II study of capecitabine and irinotecan in combination with concurrent pelvic radiotherapy (CapIri-RT) as neoadjuvant treatment of locally advanced rectal cancer

A phase II study of capecitabine and irinotecan in combination with concurrent pelvic radiotherapy (CapIri-RT) as neoadjuvant treatment of locally advanced rectal cancer

Neoadjuvant chemoradiotherapy with capecitabine followed by laparoscopic resection in locally advanced tumors of middle and low rectum – Toxicity and complications of the treatment

High mortality from neo-adjuvant chemo-radiotherapy for rectal cancer needs to be evaluated against the alternative of adjuvant therapy

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