Preoperative radiation and irinotecan in combination with 5 fluorouracil (5-FU) and low-dose leucovorin (LV) in locally advanced rectal cancer (LARC)

Sebag‐Montefiore, David; Falk, S.; Glynne‐Jones, Robert; Maughan, Tim; Meadows, Helen

doi:10.1200/jco.2005.23.16_suppl.3576

Cited by 12 publications

(13 citation statements)

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“…The proportion of patients obtaining a pathological complete response (19%) was similar to that reported for some other irinotecan-based protocols (11 -25%) (Mitchell et al, 2004;Klautke et al, 2005;Sebag-Montefiore et al, 2005). Considering all irinotecan-based protocols together, the pathological complete Relapse-free survival (%) Figure 2 Relapse-free survival in patients who underwent surgical resection.…”

Section: Discussionsupporting

confidence: 57%

“…Furthermore, the resection rate achieved in this study is higher than that observed in studies using radiotherapy alone (range, 64 -75%) (Emami et al, 1982;Frykholm et al, 2001) or in some studies of CRT regimens (62 -95%) (de la Torre et al, 1999;Frykholm et al, 2001;Klautke et al, 2006;Glynne-Jones et al, 2007), and it is comparable to that cited in other reports of research with irinotecan (90 -100%) (Minsky et al, 1999;Mitchell et al, 2004;Klautke et al, 2005;Sebag-Montefiore et al, 2005). It is worth noting, that this current trial included only patients with T3/T4 cancers-that is patients with more advanced disease than those included in previously published studies.…”

Section: Discussionsupporting

confidence: 53%

“…Considering CRM involvement, 81% of patients in this study who underwent TME surgery were classed as R 0 after surgery (CRM-negative). In studies that report data on the number of CRM-negative cases, results range from 61 -74% with radiotherapy (Emami et al, 1982;Frykholm et al, 2001) to 72 -89% with 5-FUbased protocols (de la Torre et al, 1999;Frykholm et al, 2001;Avallone et al, 2006;Klautke et al, 2006;Glynne-Jones et al, 2007) or 88 -89% when irinotecan is given as part of the CRT regimen (Klautke et al, 2005;Sebag-Montefiore et al, 2005). The addition of irinotecan to CRT regimens does not, therefore, seem to increase the high rate of CRM-negative surgery reported previously, but CRT certainly seems to be more successful than radiotherapy alone.…”

Section: Discussionmentioning

confidence: 91%

“…Irinotecan has been administered as monotherapy combined with radiation, but most of the studies have assessed the CRT regimen of irinotecan plus 5-FU and radiotherapy (Minsky et al, 1999;Klautke et al, 2001Klautke et al, , 2005Klautke et al, , 2006Kalofonos et al, 2003;Mehta et al, 2003;Navarro et al, 2003Navarro et al, , 2007Mitchell et al, 2004;Sebag-Montefiore et al, 2005).…”

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confidence: 99%

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Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study

et al. 2008

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In the UK, 10% of patients diagnosed with rectal cancer have inoperable disease at presentation. This study ascertained whether the resectability rate of inoperable locally advanced rectal cancer was improved by administration of intravenous irinotecan, 5-fluorouracil (5-FU) and pelvic radiotherapy. During phase I of the trial (n ¼ 12), the dose of irinotecan was escalated in three-patient cohorts from 50 mg m À2 to 60 mg m À2 to 70 mg m À2 to identify the maximum tolerated dose (60 mg m À2 ). In phase II, 31 patients with nonresectable disease received 45 Gy radiotherapy and 5-FU infusions (200 mg m À2 per day) for 5 weeks. Irinotecan (60 mg m À2 ) was given on days 1, 8, 15 and 22. After treatment, patients were operated on if possible. Thirty patients completed the protocol, 28 underwent surgery. Before surgery, MRI restaging of 24 patients showed that 19 (79%) had a reduction in tumour stage after treatment (seven complete clinical response and 12 partial). Of 27 patients followed up after surgery, 22 (81%) had clear circumferential resection margins. Disease-free and overall survival estimates at 3 years were 65 and 90%, respectively. The regimen was well tolerated. Irinotecan, 5-FU and radiotherapy results in tumour downgrading, allowing resection of previously inoperable tumour with acceptable toxicity.

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Section: Discussionsupporting

confidence: 57%

Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 91%

mentioning

confidence: 99%

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Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study

et al. 2008

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“…given days 2 and 30 with 5-FU and radiotherapy, with DLTs of grade 3 diarrhoea and neurological toxicity (Sebag-Monefiore et al, 2002). Maintenance chemotherapy postcompletion of chemoradiation should be explored in future studies in those who show sensitivity to treatment as the higher cumulative doses received may increase response rates at distant sites.…”

Section: à2mentioning

confidence: 99%

Oxaliplatin combined with infusional 5-fluorouracil and concomitant radiotherapy in inoperable and metastatic rectal cancer: a phase I trial

et al. 2005

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The aim of this study was to define the recommended dose of oxaliplatin when combined with infusional 5-fluorouracil (5-FU) and concurrent pelvic radiotherapy. Eligible patients had inoperable rectal cancer, or symptomatic primary rectal cancer with metastasis. Oxaliplatin was given on day 1 of weeks 1, 3 and 5 of radiotherapy. Dose level 1 was oxaliplatin 70 mg m À2 with 5-FU 200 mg m À2 day À1 continuous infusion 96 h week À1 . On dose level 2, the oxaliplatin dose was increased to 85 mg m À2 . On dose level 3, the duration of the 5-FU was increased to 168 h per week. Pelvic radiotherapy was 45 Gray (Gy) in 25 fractions over 5 weeks with a boost of 5.4 Gy. Fluorine-18 fluoro deoxyglucose and Fluorine-18 fluoro misonidazole positron emission tomography (FDG-PET and FMISO-PET) were used to assess metabolic tumour response and hypoxia. In all, 16 patients were accrued. Dose-limiting toxicities occurred in one patient at level 2 (grade 3 chest infection), and two patients at level 3 (grade 3 diarrhoea). Dose level 2 was declared the recommended dose level. FDG-PET imaging showed metabolic responses in 11 of the 12 primary tumours assessed. Four of six tumours had detectable hypoxia on FMISO-PET scans. The addition of oxaliplatin to infusional 5-FU chemoradiotherapy was feasible and generally well tolerated. For future trials, oxaliplatin 85 mg m À2 and 5-FU 200 mg m À2 day À1 continuous infusion 96 h week À1 is the recommended dose when combined with 50.4 Gy of pelvic radiotherapy.

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Adjuvant Radiotherapy and Chemoradiotherapy in the Treatment of Rectal Cancer

Cooper¹,

Sebag‐Montefiore²

2006

Challenges in Colorectal Cancer

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Preoperative radiation and irinotecan in combination with 5 fluorouracil (5-FU) and low-dose leucovorin (LV) in locally advanced rectal cancer (LARC)

Cited by 12 publications

References 0 publications

Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study

Irinotecan+5-fluorouracil with concomitant pre-operative radiotherapy in locally advanced non-resectable rectal cancer: a phase I/II study

Oxaliplatin combined with infusional 5-fluorouracil and concomitant radiotherapy in inoperable and metastatic rectal cancer: a phase I trial

Adjuvant Radiotherapy and Chemoradiotherapy in the Treatment of Rectal Cancer

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