Neoadjuvant Treatment With Single-Agent Cetuximab Followed by 5-FU, Cetuximab, and Pelvic Radiotherapy: A Phase II Study in Locally Advanced Rectal Cancer

Bertolini, Federica; Chiara, Silvana; Bengala, Carmelo; Antognoni, Paolo; Dealis, Cristina; Zironi, S.; Malavasi, N.; Scolaro, Tindaro; Depenni, Roberta; Jovic, Gordana; Sonaglio, C.; Rossi, Aldo; Luppi, Gabriele; Conte, Pierfranco

doi:10.1016/j.ijrobp.2008.04.065

Cited by 77 publications

(41 citation statements)

References 29 publications

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“…21 The addition of a second chemotherapeutic agent to neoadjuvant capecitabine-based CRT with cetuximab has not demonstrated a marked improvement to the rates of pCR or tumor downstaging in LARC, 24 which remain similar to those reported from studies of neoadjuvant capecitabine-based CRT, 12,13,25 or capecitabine-based CRT with irinotecan or oxaliplatin. 26,27 In the present study an assessment of radiological tumor response according to RECIST criteria was made.…”

Section: Neoadjuvant Cetuximab Plus Crt On Tumor Response In Larcmentioning

confidence: 70%

“…11 Furthermore when capecitabine was administered concomitantly with radiotherapy to LARC patients in phase II studies, low toxicity profiles, tumor downstaging and pCR rates ranging from 4-31% were reported. 21,22 In the present study the addition of cetuximab to capecitabine-based CRT was investigated in the neoadjuvant treatment of resectable LARC patients. …”

Section: Introductionmentioning

confidence: 99%

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A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer

Velenik

Ocvirk

Oblak

et al. 2010

European Journal of Surgical Oncology (EJSO)

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Please cite this article as: Velenik V, Ocvirk J, Oblak I, Anderluh F. A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer, 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. M A N U S C R I P T A C C E P T E D ARTICLE IN PRESS

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Section: Neoadjuvant Cetuximab Plus Crt On Tumor Response In Larcmentioning

confidence: 70%

Section: Introductionmentioning

confidence: 99%

A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer

Velenik

Ocvirk

Oblak

et al. 2010

European Journal of Surgical Oncology (EJSO)

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“…Attempts to increase the outcome of combined neoadjuvant chemo-radiotherapy have lead to numerous phase 2 studies with tumour targeted drugs. The results of the Italian study, which combined cetuximab and 5-fl uorouracil with radiotherapy, have shown an acceptable toxicity, but surprisingly a low percentage of pathological responses (11). Two American studies had evaluated the effects of bevacizumab in combination with capecitabine or 5-fl uorouracil.…”

Section: Discussionmentioning

confidence: 99%

Influence of neoadjuvant treatment of rectal carcinoma on operability and incidence of distant metastases

Prausová

Kubáčková²,

Dušek³

et al. 2013

BLL

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Abstract:In the Czech Republic, rectal carcinoma does not only represent a medical problem, but also a socioeconomic one. At our department, we treated totally 266 patients with rectal carcinoma in the years 1998 through 2006. Among our patients, neoadjuvant treatment led to a reduction in size of the tumour in 37.6 %, in 50.8 % the size did not change. In T3 tumours, the reduction in size was observed in 36.7 % of the patients and did not change in 56 %; in T4 tumours, the reduction in size was observed in 60% of the patients. In 88 % of the patients who underwent the operation, no residual tumour was found, in 9 % of patients, a residual tumour was detected. In 19 % of the patients, a local recurrence of the tumour was detected. A statistically signifi cant relationship was proved between the appearance of the metastatic disease and the presence of angioinvasion and the size of the primary tumour according to the Duke's classifi cation (Tab. 1, Fig. 4, Ref. 20 In the Czech Republic, the incidence rate of rectal carcinoma has recently reached 20.7 per 100 000 population and mortality rate has reached 10.1 per 100 000 population (data from the year 2007). The incidence increases steeply from 50 years of age. The Czech Republic is ranked among the countries with the highest incidence of this disease. According to the latest Czech population data from the year 2007, the proportions of the stages of rectal carcinoma is as follows: stage I. 22.9 %, stage II 20.4 %, stage III 24.1 %, stage IV 21.7 % and 10.9 % of newly diagnosed cases are unstaged mostly due to objective reasons, like a very advanced disease, early death, patient's refusal of anti-tumour therapy, generally poor health status of a patent, etc.. Surgical approach is the basis of therapy for the clinical stages II and III. In contrary to the early stage I, enough evidence from clinical studies has been collected over the last decade to support a treatment strategy combining chemotherapy and radiotherapy for the stages II and III. These studies were inspired by the frequent appearance of local relapses but also distant metastases in patients treated solely surgically. The results of these studies had clearly shown that a combined therapeutic approach leads to a signifi cantly lower incidence of relapses (1-4).The goal of our retrospective analysis is to ascertain the effect of neoadjuvant treatment on the reduction of size of the primary tumour, achieving operability and affecting the incidence of early generalization of the disease. Patients and methodsIn the period 1998-2006, we treated at our department totally 266 patients diagnosed with rectal carcinoma. 102 of the patients were females, with the median age of 64 years (ranging 29-89 years); 164 were males with the median age of 60 years (ranging 26-84 years) (Fig. 1). 6 % of the tumours were of the stage T2, 82 % stage T3 and 11 % stage T4; in 1 % of the patients the tumour stage was undeterminable. The proportion of the clinical stages I, II, III, and IV were 5.6 %, 72.2 %, 14.7 %, and 2.3 % respe...

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“…In an Italian Phase II study cetuximab and 5FU (225 mg/m 2 /day as continuous infusion) with RT (50.4 Gy in 25-28 fractions) were administered to 40 patients, with pCR in 3 patients (8%) [17]. In a Belgian Phase I/II study, Machiels et al [18] tested the safety and efficacy of combining preoperative RT with capecitabine (650 and 825 mg/m 2 twice daily, continuously for the duration of RT (45 Gy in 25 fractions) and cetuximab.…”

Section: Cetuximabmentioning

confidence: 99%

The contribution of targeted therapy to the neoadjuvant chemoradiation of rectal cancer

Torino

Sarmiento

Gasparini

2013

Critical Reviews in Oncology/Hematology

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Neoadjuvant Treatment With Single-Agent Cetuximab Followed by 5-FU, Cetuximab, and Pelvic Radiotherapy: A Phase II Study in Locally Advanced Rectal Cancer

Cited by 77 publications

References 29 publications

A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer

A phase II study of cetuximab, capecitabine and radiotherapy in neoadjuvant treatment of patients with locally advanced resectable rectal cancer

Influence of neoadjuvant treatment of rectal carcinoma on operability and incidence of distant metastases

The contribution of targeted therapy to the neoadjuvant chemoradiation of rectal cancer

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