Long-term results of the Lyons R90-01 randomized trial of preoperative radiotherapy with delayed surgery and its effect on sphincter-saving surgery in rectal cancer

Gléhen, Olivier; Chapet, O.; Adham, Mustapha; Nemoz, J. C.; Gérard, Jean-Pierre

doi:10.1002/bjs.4162

Cited by 100 publications

(44 citation statements)

References 30 publications

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“…Sphincter preservation was achieved in 79% of patients with a long interval (4 -6 weeks) following radiotherapy, compared with 69% of patients where the interval was only short (2 weeks). A further report (Glehen et al, 2003) documents that, with a median followup of 6.3 years, no differences were found in the degree of local control, overall survival, morbidity, anal function or surgical complications between the two groups. The addition of chemotherapy to radiotherapy can be used to shrink the primary tumour further and facilitate sphincter-sparing options.…”

Section: Discussionmentioning

confidence: 93%

A phase I/II study of oxaliplatin when added to 5-fluorouracil and leucovorin and pelvic radiation in locally advanced rectal cancer: a Colorectal Clinical Oncology Group (CCOG) study

et al. 2005

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The purpose of this study was to evaluate the maximum tolerated dose (MTD) and recommended dose of oxaliplatin given synchronously with 5-fluorouracil (5FU), leucovorin (LV) and preoperative pelvic radiation for primary unresectable, locally advanced, rectal cancer. Preoperative pelvic radiotherapy using a three-or four-field technique and megavoltage photons comprised 45 Gy given in 25 fractions, 1.8 Gy per fraction, and delivered with escalating doses of oxaliplatin in combination with low-dose LV and 5FU. Chemotherapy was given synchronously with radiotherapy in weeks 1 and 5. Escalating doses of oxaliplatin (85, 130 and 150 mg m À2 ) were given on days 2 and 30, followed by low-dose LV (20 mg m À2 ) and 5FU (350 mg m À2 ), both given on days 1 -5 and 29 -33. Surgery was performed 6 -10 weeks later. The MTD was determined as the dose causing more than a third of patients to have a dose-limiting toxicity (DLT). Once the MTD was reached, a further 14 patients were treated at the dose level below the MTD. In all, 32 patients received oxaliplatin at the three dose levels, median age 60 years (range 31 -79), 24 males and eight females. . In all, 28 out of 32 patients completed all treatments as planned; three had radiotherapy interrupted and three a chemotherapy dose reduction. Four patients did not proceed to surgery due to the presence of metastatic disease (two), unfitness (one) or patient refusal (one). Also, 28 patients underwent surgical resection. Histopathology demonstrated histopathological complete response (pCR) 2 out of 27 (7%), Tmic 3 out of 27 (11%), pCR þ Tmic 5 out of 27 (19%), pT0 -2 6 out of 27 (22%) and histologically confirmed clear circumferential resection margins in 22 out of 27 (81%). Dose-limiting toxicity with oxaliplatin is 150 mg m À2 given days 2 and 30 when added to the described 5FU LV and 45 Gy radiation preoperatively. The acceptable toxicity and compliance at 130 mg m À2 recommend testing this dose in future phase II studies. The tumour downstaging and complete resection rates are encouragingly high for this very locally advanced group.

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Section: Discussionmentioning

confidence: 93%

A phase I/II study of oxaliplatin when added to 5-fluorouracil and leucovorin and pelvic radiation in locally advanced rectal cancer: a Colorectal Clinical Oncology Group (CCOG) study

et al. 2005

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“…In the Lyon R90-01 randomized trial [11], employing 39 Gy in 13 fractions, a long interval between preoperative radiotherapy and surgery was associated with a significantly better clinical tumor response (53.1 % in the short interval group v 71.7 % in the long interval group, p00.007) and pathologic down staging (10.3 % in the short interval group v 26 % in the long interval group, p00.005). Dutch trial [3] employed short-tem radiotherapy and found no significant difference in tumor classification between irradiated and non-irradiated groups.…”

Section: Discussionmentioning

confidence: 99%

Preoperative Radiotherapy in Carcinoma Rectum

Ramakrishnaiah

Thomas

Elangovan

et al. 2012

Indian J Surg Oncol

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The present study was undertaken to address the various concerns that has limited the use of preoperative radiotherapy in rectal cancer in our institution. All patients diagnosed as having carcinoma rectum between August 2005 and July 2007 were included in the study. Group 1 patients consisted of those presenting with T2, T3 and T4 who received preoperative radiation of 25 Gy. Group 2 consisted of those with T4 tumours, who received Long course radiotherapy. Complication of radiation like dermatitis, enteritis and proctitis were noted. Before surgery CT scan and TRUS were repeated. In the postoperative period a record of abdominal, perineal wound complications and other complications were noted. The results were compared with a similar group of patients who did not receive preoperative radiotherapy. There were 21 patients (12males) with a mean age of 48.4 years (Range 18-70) in the radiotherapy group. Sixteen patients received short course (25 Gy) and five patients received long course of preoperative radiotherapy. Fourteen patients underwent definitive surgery in the form of abdominoperineal resection (APR) or anterior resection (AR). In the non-RT group there were 17 patients (8 males) with a mean age of 50.2 year. Fourteen patients underwent definitive surgery like APR (11) and AR (3). In the RT group CT scan and TRUS failed show any significant downsizing or down staging of tumour. In the RT group, incidence of acute skin toxicity was 23.8 % (5/21), all were seen in those who received long course of radiotherapy (Group 2). Grade 2 or 3 lower G I symptoms occurred in 3 (18.6 %) patients of Group 1 and 1(20 %) patient of group 2. There was higher incidence of perineal wound complication in the RT group (19.0 % vs 5.9 %). Preoperative long course of radiotherapy may be associated with high rates of dermatitis and perineal wound infection. Short course may be associated with lower G I toxicity.

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“…This study elegantly demonstrated that a longer interval increases the pCR rate. 23,24 In the Dutch Surgical Colorectal audit evaluable patients who underwent preoperative CRT for rectal cancer between 2009 and 2011 were evaluated to determine the influence of the interval between radiotherapy and surgery, which was calculated from the start of radiotherapy. 5 In this study an interval of 15-16 weeks after the start of CRT resulted in the highest pCR rate (18·0 per cent; P = 0·013), with an independent association (hazard ratio 1·63, 95 per cent confidence interval 1·20 to 2·23).…”

Section: For Debatementioning

confidence: 99%