Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer

Leonard, Pauline; Seymour, Matthew; James, Roger D; Hochhauser, Daniel; Ledermann, Jonathan A.

doi:10.1038/sj.bjc.6600641

Cited by 23 publications

(9 citation statements)

References 17 publications

(24 reference statements)

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“…Several studies have shown that the modified de Gramont schedule is an active and well-tolerated regimen in combination with oxaliplatin or irinotecan [5,6,21,34]. Our study was a cost-minimization analysis considering effectiveness to be similar between the two regimens.…”

Section: Discussionmentioning

confidence: 99%

“…We compared this a simplified de Gramont regimen that combines calcium folinate (400 mg/ m 2 as a 2-h infusion, day 1), 5-FU bolus (400 mg/m 2 , day 1), and 5-FU continuous infusion (2400 mg/m 2 as a 46-h infusion, day 1) [5,6,21,34]. In all cases the 5-FU continuous infusion was given using a portable disposable pump.…”

Section: Treatment Regimensmentioning

confidence: 99%

“…Recently a simplified de Gramont regimen has demonstrated superimposable efficacy and safety [5,6,21,34]. The present study compared the costs related to the two de Gramont schedules (standard vs. simplified) given in first-line chemotherapy in patients with advanced colorectal cancer.…”

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confidence: 99%

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Economic impact of simplified de Gramont regimen in first-line therapy in metastatic colorectal cancer

et al. 2006

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The cost of chemotherapy has dramatically increased in advanced colorectal cancer patients, and the schedule of fluorouracil administration appears to be a determining factor. This retrospective study compared direct medical costs related to two different de Gramont schedules (standard vs. simplified) given in first-line chemotherapy with oxaliplatin or irinotecan. This cost-minimization analysis was performed from the French Health System perspective. Consecutive unselected patients treated in first-line therapy by LV5FU2 de Gramont with oxaliplatin (Folfox regimen) or with irinotecan (Folfiri regimen) were enrolled. Hospital and outpatient resources related to chemotherapy and adverse events were collected from 1999 to 2004 in 87 patients. Overall cost was reduced in the simplified regimen. The major factor which explained cost saving was the lower need for admissions for chemotherapy. Amount of cost saving depended on the method for assessing hospital stay. In patients treated by the Folfox regimen the per diem and DRG methods found cost savings of Euro 1,997 and Euro 5,982 according to studied schedules; in patients treated by Folfiri regimen cost savings of Euro 4,773 and Euro 7,274 were observed, respectively. In addition, travel costs were also reduced by simplified regimens. The robustness of our results was showed by one-way sensitivity analyses. These findings demonstrate that the simplified de Gramont schedule reduces costs of current first-line chemotherapy in advanced colorectal cancer. Interestingly, our study showed several differences in costs between two costing approaches of hospital stay: average per diem and DRG costs. These results suggested that standard regimen may be considered a profitable strategy from the hospital perspective. The opposition between health system perspective and hospital perspective is worth examining and may affect daily practices. In conclusion, our study shows that the simplified de Gramont schedule in combination with oxaliplatin or irinotecan is an attractive option from the French Health System perspective. This safe and less costly regimen must compared to alternative options such as oral fluoropyrimidines.

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Section: Discussionmentioning

confidence: 99%

Section: Treatment Regimensmentioning

confidence: 99%

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Economic impact of simplified de Gramont regimen in first-line therapy in metastatic colorectal cancer

et al. 2006

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“…The MdG regimen is used to treat patients with incurable colorectal cancer and provides dose intensive exposure to 5‐Fluorouracil (5‐FU) every two weeks (Leonard et al. 2002).…”

Section: Infusion Regime In the Study Sitementioning

confidence: 99%

“…2002). The cytotoxic agent 5‐FU has been the mainstay of chemotherapy for colorectal cancer for more than 20 years (Leonard et al. 2002) and both the National Institute for Health and Clinical Evidence (2005) and the Scottish Intercollegiate Guidelines Network (2003) recommend ‘5‐FU containing’ regimens as first line treatment in colorectal cancer.…”

Section: Infusion Regime In the Study Sitementioning

confidence: 99%

Cytotoxic chemotherapy for incurable colorectal cancer: living with a PICC‐line

Molloy¹,

Smith²,

Aitchison³

2008

Journal of Clinical Nursing

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Title.Cytotoxic chemotherapy for incurable colorectal cancer: living with a PICC-line Objectives.1. To determine which aspects of living with a peripherally inserted central catheter (PICC) line cause Modified de Gramont (MdG) patients most difficulty.2. To explore MdG patients' views of the PICC-line experience.3. To determine if patients view PICC-lines as a benefit or a burden when receiving ambulatory MdG chemotherapy. Design.A two-stage, descriptive study. Phase 1 comprised semi-structured interviews. Phase 2 surveyed the MdG population. Phase 1 interview data informed the Phase 2 questionnaire. Setting.West of Scotland Cancer Care Centre. Sample.Phase 1, a convenience sample of 10 MdG patients; Phase 2, 62 consecutive patients. Findings and results.A response rate of 93.9% for Phase 2. The majority of PICC-line patients held favourable views towards having a PICC-line and adapted well with minimal disruption to daily life.Concerns evident regarding coping at home with a PICC-line, chemotherapy spillage, dealing with complex information and the responsibility of patients/carers regarding PICC-line management. Patients preferred ambulatory chemotherapy to in-patient treatment. Conclusions.PICC-lines should be considered for more chemotherapy patients but that service development necessary to ensure individual needs addressed. Relevance to Clinical Practice.• Contributes to the PICC-line literature by providing a national patient perspective on a range of daily living activities• PICC-line patients prefer out-patient ambulatory chemotherapy rather than in-patient treatment • the longer a patient has a PICC-line, the more able they are to manage activities such as dressing.• Highlights concerns remain over chemotherapy spillage, partner/carer responsibility for PICC-line maintenance and the proper balance between required information and what the patient wants to know.

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Vaccination of colorectal cancer patients with TroVax given alongside chemotherapy (5-fluorouracil, leukovorin and irinotecan) is safe and induces potent immune responses

Harrop

Drury

Shingler

et al. 2007

Cancer Immunol Immunother

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Modified vaccinia Ankara (MVA) encoding the tumor antigen 5T4 (TroVax) has been evaluated in an open label phase II study in metastatic colorectal cancer patients. The primary objective was to assess the safety and immunogenicity of TroVax injected before, during and after treatment with 5-fluorouracil, leukovorin and irinotecan. TroVax was administered to 19 patients with metastatic colorectal cancer. Twelve patients had blood samples taken following each of the six injections and were considered to be evaluable for assessment of immunological responses. Both antibody and cellular responses specific for the tumor antigen 5T4 and the viral vector MVA were monitored throughout the study. Administration of TroVax alongside chemotherapy was safe and well tolerated with no SAEs attributed to the vaccine and no enhancement of chemo-related toxicity. Of the 12 patients who were evaluable for assessment of immune responses, ten mounted 5T4-specific antibody responses with titers ranging from 10 to > 5,000. IFNgamma ELISPOT responses specific for 5T4 were detected in 11 patients with frequencies exceeding one in 1,000 PBMCs in five patients. Eight patients presented with elevated circulating CEA concentrations, six of whom showed decreases in excess of 50% during chemotherapy and four had CEA levels which remained stable for > 1 month following completion of chemotherapy. Of the 19 intention to treat (ITT) patients, one had a CR, six had PRs and five had SD. Potent 5T4-specific cellular and/or humoral immune responses were induced in all 12 evaluable patients and were detectable in most patients during the period in which chemotherapy was administered. These data demonstrate that TroVax can be layered on top of chemotherapy regimens without any evidence of enhanced toxicity or reduced immunological or therapeutic efficacy.

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Phase II study of irinotecan with bolus and high dose infusional 5-FU and folinic acid (modified de Gramont) for first or second line treatment of advanced or metastatic colorectal cancer

Cited by 23 publications

References 17 publications

Economic impact of simplified de Gramont regimen in first-line therapy in metastatic colorectal cancer

Economic impact of simplified de Gramont regimen in first-line therapy in metastatic colorectal cancer

Cytotoxic chemotherapy for incurable colorectal cancer: living with a PICC‐line

Vaccination of colorectal cancer patients with TroVax given alongside chemotherapy (5-fluorouracil, leukovorin and irinotecan) is safe and induces potent immune responses

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