Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer

Rödel, Claus; Liersch, Torsten; Hermann, Robert Michael; Arnold, Dirk; Reese, Thomas J.; Hipp, Matthias; Fürst, Alois; Schwella, N.; Bieker, Michael; Hellmich, Gunter; Ewald, H.; Haier, Jörg; Lordick, Florian; Flentje, Michael; Sülberg, Heiko; Hohenberger, Werner; Sauer, Rolf

doi:10.1200/jco.2006.08.3675

Cited by 202 publications

(102 citation statements)

References 28 publications

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“…More importantly, we were able to replicate, and thus confirm the findings from Roedel et al (2003Roedel et al ( , 2007 in a multicentre setting in Switzerland.…”

Section: Discussionsupporting

confidence: 70%

“…This rate is slightly higher than that reported by Roedel et al (2003Roedel et al ( , 2007 and suggests that the additional cycle of XELOX increased the toxicity of preoperative CRT. All other toxicities were in the range of other trials with the exception of grade 3 or 4 lymphocytopaenia.…”

Section: Discussioncontrasting

confidence: 59%

“…A different treatment strategy, in an attempt to increase the quantity of systemic treatment, was studied by Roedel et al (2007). After preoperative capecitabine/oxaliplatin radiotherapy, 60% of patients received all four cycles of adjuvant capecitabine/ oxaliplatin underlining the feasibility of delivering adequate doses of postoperative combination chemotherapy in rectal cancer patients.…”

Section: Discussionmentioning

confidence: 99%

“…These include continuous capecitabine (7 days per week) with oxaliplatin given on days 1 and 29 (Glynne-Jones et al, 2006c), continuous capecitabine (5 days per week) with weekly doses of oxaliplatin (Machiels et al, 2005;Rutten et al, 2006) and discontinuous capecitabine (days 1 -14 and 22 -35) with oxaliplatin on days 1, 8, 22 and 29 (Roedel et al, 2003(Roedel et al, , 2007. The aim of the present multicentre phase II study was to evaluate the efficacy, tolerability and feasibility of preoperative capecitabine plus oxaliplatin in combination with radiotherapy as described by Roedel et al (2003Roedel et al ( , 2007, and to investigate the contribution of an additional single cycle of neoadjuvant capecitabine and oxaliplatin (XELOX regimen) (Díaz-Rubio et al, 2002;Cassidy et al, 2004) before the start of radiotherapy.…”

mentioning

confidence: 99%

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Phase II study of capecitabine and oxaliplatin given prior to and concurrently with preoperative pelvic radiotherapy in patients with locally advanced rectal cancer

et al. 2008

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This multicentre phase II study evaluated the efficacy and safety of preoperative capecitabine plus oxaliplatin and radiotherapy (RT) in patients with locally advanced rectal cancer (T3/T4 rectal adenocarcinoma with or without nodal involvement). Treatment consisted of one cycle of XELOX (capecitabine 1000 mg m À2 bid on days 1 -14 and oxaliplatin 130 mg m À2 on day 1), followed by RT (1.8 Gy fractions 5 days per week for 5 weeks) plus CAPOX (capecitabine 825 mg m À2 bid on days 22 -35 and 43 -56, and oxaliplatin 50 mg m À2 on days 22, 29, 43 and 50). Surgery was recommended 5 weeks after completion of chemoradiotherapy. The primary end point was pathological complete tumour response (pCR). Sixty patients were enrolled. In the intent-to-treat population, the pCR rate was 23% (95% CI: 13 -36%). 58 patients underwent surgery; R0 resection was achieved in 57 (98%) patients, including all 5 patients with T4 tumours. Sphincter preservation was achieved in 49 (84%) patients. Tumour and/or nodal downstaging was observed in 39 (65%) patients. The most common grade 3/4 adverse events were diarrhoea (20%) and lymphocytopaenia (43%). Preoperative capecitabine, oxaliplatin and RT achieved encouraging rates of pCR, R0 resection, sphincter preservation and tumour downstaging in patients with locally advanced rectal cancer.

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“…More importantly, we were able to replicate, and thus confirm the findings from Roedel et al (2003Roedel et al ( , 2007 in a multicentre setting in Switzerland.…”

Section: Discussionsupporting

confidence: 70%

Section: Discussioncontrasting

confidence: 59%

Section: Discussionmentioning

confidence: 99%

mentioning

confidence: 99%

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Phase II study of capecitabine and oxaliplatin given prior to and concurrently with preoperative pelvic radiotherapy in patients with locally advanced rectal cancer

et al. 2008

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“…Using the pCRT approach, the rate of local recurrence at 5-year ranges from 6 to 8%, 1,2 and the rate of complete pathological response ranges from 4 to 44% of cases, as reported in single institution series trials, 3,4 in phase II studies [5][6][7] and in randomized trials. 2,8 For patients with good pathologic response to pCRT, the oncological outcome has been reported to be better for 'responders' than for 'nonresponders'.…”

Section: Introductionmentioning

confidence: 94%

Tumor response is predicted by patient genetic profile in rectal cancer patients treated with neo-adjuvant chemo-radiotherapy

et al. 2010

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The aim of the study was the identification of a pharmacogenetic profile predictive of the tumor regression grade (TRG), considered as tumor response parameter, after neo-adjuvant treatment in rectal cancer patients. A total of 238 rectal cancer patients treated in a neo-adjuvant setting by a fluoropyrimidines-based chemo-radiotherapy (RT) were genotyped for 25 genetic polymorphisms in 16 genes relevant for treatment-associated pathways. Two polymorphisms were associated with TRG in a multivariate analysis: hOGG1-1245C4G, which can affect radiosensitivity and MTHFR-677C4T, which is involved in fluoropyrimidines action. Patients bearing at least one variant allele had a lower chance to get TRGp2 (OR ¼ 0.46 95% CI 0.23-0.90, P ¼ 0.024; and OR ¼ 0.48 95% CI 0.24-0.96, P ¼ 0.034; respectively). An association trend was observed for ABCB1-3435C4T, which is responsible for the multi-drug resistance (odds ratio (OR) ¼ 1.96, 95% confidence interval (CI) 0.98-3.95, P ¼ 0.057). Exploratory classification and regression tree (CART) analysis highlighted high-order gene-gene and gene-environment interactions and a genetic signature associated with differential response, with hOGG1-1245C4G as the most predictive factor. Other significant variables were: ABCB1-3435C4T, MTHFR-677C4T, ERCC1-8092C4A, ABCC2-1249G4A, XRCC1-28152G4A, XRCC3-4541A4G and patients gender. On the basis of CART results, patients were categorized into three groups according to tumor response probability: intermediate and high profiles had a higher probability to get TRGp2 as compared with low profiles (OR ¼ 4.12 95% CI 1. Po0.001 and OR ¼ 12.44, Po0.0001, respectively). This study evidences a major role of hOGG1-1245C4G and MTHFR-677C4T polymorphisms in the tumor response of rectal cancer patients treated with chemo-RT in neo-adjuvant setting, and shows the relevance of gene-gene and gene-environment interactions for complex phenotypes as tumor response.

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Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer

et al. 2020

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Multicenter Phase II Trial of Chemoradiation With Oxaliplatin for Rectal Cancer

Abstract: Preoperative XELOX-RT plus four cycles of adjuvant XELOX is an active and feasible treatment. This regimen is proposed for phase III evaluation comparing standard fluorouracil-based treatment with XELOX- based multimodality treatment.

Cited by 202 publications

References 28 publications

Phase II study of capecitabine and oxaliplatin given prior to and concurrently with preoperative pelvic radiotherapy in patients with locally advanced rectal cancer

Phase II study of capecitabine and oxaliplatin given prior to and concurrently with preoperative pelvic radiotherapy in patients with locally advanced rectal cancer

Tumor response is predicted by patient genetic profile in rectal cancer patients treated with neo-adjuvant chemo-radiotherapy

Association of Treatment Adherence With Oncologic Outcomes for Patients With Rectal Cancer

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