Comparison of Two Neoadjuvant Chemoradiotherapy Regimens for Locally Advanced Rectal Cancer: Results of the Phase III Trial ACCORD 12/0405-Prodige 2

Gérard, Jean-Pierre; Azria, D.; Gourgou-Bourgade, Sophie; Martel-Laffay, I.; Hennequin, Christophe; Etienne, Pierre-Luc; Vendrely, V.; François, Ετιεννε; Bouché, Olivier; Mirabel, X.; Denis, Bernard; Mineur, Laurent; Berdah, Jean-François; Mahé, M.-A.; Bécouarn, Y.; Dupuis, Olivier; Lledo, Gérard; Montoto-Grillot, C.; Conroy, Thierry

doi:10.1200/jco.2009.25.8376

Cited by 689 publications

(426 citation statements)

References 22 publications

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“…At the moment, a final conclusion cannot be drawn until the definitive results of the ongoing CAO/AIO/ARO-04 trial are available. However, results similar to those in the present study were reported by Gérard et al [12] after analyzing the results of the ACCORD 12/0405-Prodige 2 trial. In this study, additional oxaliplatin was not found to be more effective than 5-FU alone for preoperative RCT in rectal cancer patients.…”

Section: Discussionsupporting

confidence: 54%

“…Proven indications exist for the use of intensified chemotherapy as a standard regimen for advanced stage local tumors and expanding tumor growth [12,14,39,40]. The use of an induction chemotherapy followed by standard RCT with 5-FU monotherapy might be more effective concerning tumor response without increasing acute toxicity during RCT [41,42].…”

Section: Discussionmentioning

confidence: 99%

“…After chemotherapy treatment modalities are intensified, the risk of high-grade acute toxicity during therapy increases [8 -11]. Gérard et al [12] observed a nonsignificant positive trend after 5-FUϩoxaliplatin treatment, as compared with 5-FU (capecitabine) alone, in preoperative RCT for rectal cancer patients in the ACCORD 12/0405-Prodige 2 trial. This trend was based on the pathological complete response rates (19% versus 14%, p ϭ .11) and the high-grade acute organ toxicity rates significantly increased (15% versus 3%) when the treatment was intensified with additional oxaliplatin.…”

Section: Introductionmentioning

confidence: 99%

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Gender-Specific Acute Organ Toxicity during Intensified Preoperative Radiochemotherapy for Rectal Cancer

et al. 2011

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Learning Objectives After completing this course, the reader will be able to: Describe present strategies of treatment of locally advanced rectal cancer and ongoing clinical trials, including neoadjuvant radiochemotherapy with 50.4 Gy and concomitant 5-FU +/− oxaliplatin.Define the basic clinical parameters, with special emphasis on gender and BMI, correlating with radiochemotherapy-associated side effects in rectal cancer patients and differences in severity of toxicity. CME This article is available for continuing medical education credit at CME.TheOncologist.com Patients with locally advanced rectal cancer (cUICC stages II/III) are typically treated with preoperative 5-fluorouracil–based (5-FU–based) radiochemotherapy (RCT). However, trials are currently being conducted to improve the complete remission rates and the systemic control by combining 5-FU with oxaliplatin. The primary objective was to identify the subgroups of rectal cancer patients who were at risk for high-grade toxicity. All 196 patients who were included in the present study were treated with 50.4 Gy and chemotherapy that included either 5-FU (n = 115) or 5-FU+oxaliplatin (n = 81). The preoperative RCT was followed by a total mesorectal excision and adjuvant chemotherapy. Acute toxicity was monitored weekly and a toxicity grade ≥3 (Common Toxicity Criteria) for a skin reaction, cystitis, proctitis, or enteritis was defined as high-grade acute organ toxicity. After RCT with 5-FU+oxaliplatin, complete tumor remission was achieved in 13.6% of the patients and in 11.3% after RCT with 5-FU alone. Complete irradiation dosages of 50.4 Gy were given to 99% (5-FU) and 95% (5-FU+oxaliplatin) of the patients. Concomitant chemotherapy was fully administered in 95% of the patients treated with 5-FU compared with the 84% of patients treated with 5-FU+oxaliplatin. A significantly higher proportion of acute organ toxicity was found in the patients who were treated with 5-FU+oxaliplatin compared with those who were treated with 5-FU. Additionally, women with a low body mass index were at the highest risk for acute organ toxicity. These results suggest that there are basic clinical parameters, such as gender and body mass index, that may be potential markers for generating individual risk profiles of RCT-induced toxicity.

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Section: Discussionsupporting

confidence: 54%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Gender-Specific Acute Organ Toxicity during Intensified Preoperative Radiochemotherapy for Rectal Cancer

et al. 2011

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“…The importance of adding oxaliplatin into the neoadjuvant treatment is supported by the study ACCORD 12/405, which compared concomitant chemo-radiotherapy comprising capecitabine against to the same treatment supplemented with oxaliplatin. The results did not prove any signifi cant advantage of the combined chemotherapy and recommended capecitabine as "merits investigation" for T3 and T4 tumours (10). Attempts to increase the outcome of combined neoadjuvant chemo-radiotherapy have lead to numerous phase 2 studies with tumour targeted drugs.…”

Section: Discussionmentioning

confidence: 94%

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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“…В целом показатели токсичности были приемлемыми и соответ-ствовали данным крупных зарубежных рандомизиро-ванных исследований, где также использовали оксали-платин в сочетании с фторпиримидинами [14,15]. При сравнении межгрупповых показателей токсичности наи-более предпочтительным вариантом неоадъювантного лечения выглядит ЛТ на фоне приема капецитабина или оксалиплатина+капецитабина.…”

Section: Discussionunclassified

Neoadjuvant therapy for locally advanced rectal cancer

Бердов¹,

Erygin²,

Nevolskikh³

et al. 2018

Onkol. Z. im. P.A. Gercena

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Comparison of Two Neoadjuvant Chemoradiotherapy Regimens for Locally Advanced Rectal Cancer: Results of the Phase III Trial ACCORD 12/0405-Prodige 2

Abstract: The benefit of oxaliplatin was not demonstrated and this drug should not be used with concurrent irradiation. Cap 50 merits investigation for T3-4 rectal cancers.

Cited by 689 publications

References 22 publications

Gender-Specific Acute Organ Toxicity during Intensified Preoperative Radiochemotherapy for Rectal Cancer

Gender-Specific Acute Organ Toxicity during Intensified Preoperative Radiochemotherapy for Rectal Cancer

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

Neoadjuvant therapy for locally advanced rectal cancer

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