Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest

Falcone, Alfredo; Ricci, Sergio; Brunetti, I.; Pfanner, E.; Allegrini, Giacomo; Barbara, C.; Crinò, Lucio; Benedetti, Giovanni; Evangelista, W.; Fanchini, Laura; Cortesi, Enrico; Picone, V.; Vitello, S.; Chiara, Silvana; Granetto, Cristina; Porcile, Gianfranco; Fioretto, Luisa; Orlandini, Cinzia; Andreuccetti, M.; Masi, Gianluca

doi:10.1200/jco.2006.09.0928

Cited by 1,083 publications

(734 citation statements)

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“…The median overall survival of surgical patients was 36.8 months, with a 4-year survival rate of 37%. The (Falcone et al, 2007). A multicentre phase II study investigated the use of irinotecan with 5-FU/FA (FOLFIRI) as neoadjuvant chemotherapy in selected patients with unresectable liver metastases (Ho et al, 2005).…”

Section: Discussionmentioning

confidence: 99%

Final analysis of colorectal cancer patients treated with irinotecan and 5-fluorouracil plus folinic acid neoadjuvant chemotherapy for unresectable liver metastases

et al. 2007

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We have previously reported that neoadjuvant therapy with modified FOLFIRI enabled nearly a third of patients with metastatic colorectal cancer (mCRC) to undergo surgical resection of liver metastases. Here, we present data from the long-term follow-up of these patients. Forty patients received modified FOLFIRI: irinotecan 180 mg m À2 , day 1; folinic acid, 200 mg m À2 ; and 5-fluorouracil: as a 400 mg m À2 bolus, days 1 and 2, and a 48-h continuous infusion 1200 mg m À2 , from day 1. Treatment was repeated every 2 weeks, with response assessed every six cycles. Resected patients received six further cycles of chemotherapy postoperatively. Nineteen (47.5%) of 40 patients achieved an objective response; 13 (33%) underwent resection. After a median follow-up of 56 months, median survival for all patients was 31.5 months: for non-resected patients, median survival was 24 months and was not reached for resected patients. Median time to progression was 14.3 and 5.2 months for all and non-resected patients, respectively. Median disease-free (DF) survival in resected patients was 52.5 months. At 2 years, all patients were alive (8 DF), and at last follow-up, eight were alive (6 DF). Surgical resection of liver metastases after neoadjuvant treatment with modified FOLFIRI in CRC patients achieved favourable survival times.

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Section: Discussionmentioning

confidence: 99%

Final analysis of colorectal cancer patients treated with irinotecan and 5-fluorouracil plus folinic acid neoadjuvant chemotherapy for unresectable liver metastases

et al. 2007

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“…17 With the increasingly efficient chemotherapy regimens, median survivals currently reach 16-22 months. 12,18 In our study group, median overall survival was 37 months after local treatment of the intra-hepatic recurrences. Our study reports overall 3-year and 5-year survival rates of 55% and 35% after local treatment of recurrent colorectal liver metastases, which is comparable to the outcome in our series of first hepatectomies that we published previously.…”

Section: Discussionmentioning

confidence: 99%

Local Treatment for Recurrent Colorectal Hepatic Metastases after Partial Hepatectomy

Pool

Lalmahomed

Wilt

et al. 2009

Journal of Gastrointestinal Surgery

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Objective The objective of the study was to identify patients who may benefit from local treatment in recurrent colorectal liver metastases. Materials and methods A total of 51 consecutive patients were treated for hepatic recurrence(s) after an initial partial hepatic resection. Surgery was considered as the primary treatment option for eligible patients. Patients with a small liver remnant after major hepatectomy were treated with radiofrequency ablation (RFA) or stereotactic body radiation therapy (SRx). SRx was given as an outpatient, emerging local treatment option for patients with intra-hepatic recurrences not eligible for surgery or RFA. Partial liver resection was performed in 36 patients (70%), RFA in ten patients (20%), and SRx in five patients (10%). Results Median hospital stay was 7 (range, 3-62) days with a morbidity of 16% without in-hospital death. None of the patients received adjuvant chemotherapy. There was no difference in recurrence or survival between the three treatment modalities. Overall 5-year survival was 35% with an estimated median survival of 37 months. Patients with a disease-free interval between first hepatectomy and hepatic recurrence less than 6 months did not survive 3 years. Conclusions Resection, RFA, and SRx can be performed safely in patients with recurrent colorectal liver metastases and offer a survival that seems comparable to primary liver resections of colorectal liver metastases.

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“…In people with positive nodes, after adjusting for different factors such as tumour number [8, 16–18], size [16–18], distribution [16, 17], and surgical resection margin [18], survival rates after liver resection are similar to those in patients with unresectable colorectal metastasis who underwent hepatic infusion chemotherapy [19, 20]. Median survival after systemic chemotherapy with leukovorin, 5-fluorouracil, oxaliplatin, and irinotecan has been recently reported to be around 20 months [21, 22] with an estimated 3-year survival of about 10% [22]. In light of this, hepatic node involvement detected pre-operatively or during surgery is generally considered a contra indication for liver resection for liver secondaries from colorectal primary [23, 24].…”

Section: Introductionmentioning

confidence: 99%

Management of the Hepatic Lymph Nodes during Resection of Liver Metastases from Colorectal Cancer: A Systematic Review

2008

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Background. Hepatic lymph node involvement is generally considered a contraindication for liver resection performed for colorectal liver metastases. However, some advocate hepatic lymphadenectomy in the presence of macroscopic involvement and others routine lymphadenectomy. The aim of this review is to assess the role of lymphadenectomy in resection of liver metastases from colorectal cancer. Methods. Medline, Embase and Central databases were searched using a formal search strategy. Trials with survival data with a minimum follow-up of 1 year were considered for inclusion. Meta-analysis was performed using Revman. Results. A total of 4230 references were identified. Ten reports of nine studies including 926 patients qualified for the review. The prevalence of nodal metastases after routine lymphadenectomy was 16.3%. The overall 3-year and 5-year survival rates in node-positive patients were 9/151 (11.3%) and 2/137 (1.5%), respectively, compared to 3-year and 5-year survival rates of 424/787 (53.9%) and 246/767 (32.1%) in node-negative patients. The odds ratios for 3-year and 5-year survivals in node positive disease compared to node-negative disease were 0.12 (95% CI 0.06 to 0.24) and 0.08 (95% CI 0.03 to 0.22). There was no randomized controlled trial which assessed the survival benefit of routine or “selective” lymphadenectomy. Conclusion. Currently, there is no evidence of survival benefit for routine or selective lymphadenectomy. Survival rates are low in patients with positive lymph nodes draining the liver irrespective of whether they are detected by routine lymphadenectomy or by macroscopic involvement. Further trials in this patient group are required.

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Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest

Cited by 1,083 publications

References 28 publications

Final analysis of colorectal cancer patients treated with irinotecan and 5-fluorouracil plus folinic acid neoadjuvant chemotherapy for unresectable liver metastases

Final analysis of colorectal cancer patients treated with irinotecan and 5-fluorouracil plus folinic acid neoadjuvant chemotherapy for unresectable liver metastases

Local Treatment for Recurrent Colorectal Hepatic Metastases after Partial Hepatectomy

Management of the Hepatic Lymph Nodes during Resection of Liver Metastases from Colorectal Cancer: A Systematic Review

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