Safe Use of FOLFOX in Two Patients With Metastatic Colorectal Carcinoma and Severe Hepatic Dysfunction

Roderburg, Christoph; O, Nicole do; Fuchs, Roland J.; Bubenzer, J; Spannbauer, M; Luedde, Tom; Tischendorf, Jens J. W.

doi:10.3816/ccc.2011.n.011

Cited by 8 publications

(5 citation statements)

References 15 publications

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“…The toxicities were well tolerated in all 4 studies. In the present study, the median PFS was 7.5 months, and the median OS was 8.5 months, which was superior to those reported in previous studies with FOLFOX [5,6,7,8,9,10]. …”

Section: Discussionsupporting

confidence: 71%

“…Furthermore, Walia et al [6] treated 6 cases with FOLFOX, and 71 days of OS (range 23-283 days) were noted. Roderburg et al [8] reported on 2 patients treated with FOLFOX. One PR and 1 long-term (10- month) SD were reported.…”

Section: Discussionmentioning

confidence: 99%

“…Therefore, no standard therapeutic protocol for patients with mCRC and hyperbilirubinemia has been developed. Additionally, few cases have been reported regarding the treatment of patients with mCRC and hyperbilirubinemia [5,6,7,8,9,10]. …”

Section: Introductionmentioning

confidence: 99%

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Patients with Metastatic Colorectal Cancer and Hyperbilirubinemia Treated with FOLFIRI plus Bevacizumab as First-Line Treatment

Huang

Yeh²,

Ma³

et al. 2016

Chemotherapy

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Metastatic colorectal cancer (mCRC) combined with hyperbilirubinemia is typically considered a contraindication to irinotecan-based therapy, a proven first-line treatment of mCRC. Herein, we present 6 consecutive patients with mCRC combined with hyperbilirubinemia who underwent UGT1A1 genotyping before receiving FOLFIRI plus bevacizumab. Dose escalation of irinotecan was performed according to the results of UGT1A1 genotyping in all patients. Improvement in the serum total bilirubin level to a normal range was noted in all 6 patients. Disease control was 100%. The median progression-free survival was 7.5 months and the median overall survival was 8.5 months. FOLFIRI plus bevacizumab as a first-line chemotherapy may achieve effective disease control and be safe in patients with mCRC and hyperbilirubinemia based on UGT1A1 genotyping. More prospective clinical studies are necessary to evaluate the clinical benefits and safety of this treatment approach.

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Section: Discussionsupporting

confidence: 71%

Section: Discussionmentioning

confidence: 99%

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Patients with Metastatic Colorectal Cancer and Hyperbilirubinemia Treated with FOLFIRI plus Bevacizumab as First-Line Treatment

Huang

Yeh²,

Ma³

et al. 2016

Chemotherapy

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“…Alternatively, in this group, gemcitabine monotherapy has been endorsed, which could also be a treatment possibility in patients with serum bilirubin level >1.5×, the upper limit of normal (ULN). On the basis of a phase II trial, patients with serum bilirubin >1.5× ULN have also been offered FOLFOX [26,27].…”

Section: First-line Treatmentsmentioning

confidence: 99%

Advanced Pancreatic Ductal Adenocarcinoma: Moving Forward

Franck

Müller

Rosania

et al. 2020

Cancers

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Globally, the death rate of pancreatic ductal adenocarcinoma (PDAC) has doubled over 30 years and is likely to further increase, making PDAC a leading cause of cancer-related death in the coming years. PDAC is typically diagnosed at an advanced stage, and modified FOLFIRINOX or nab-paclitaxel and gemcitabine are the mainstay of systemic therapy. For elderly patients with good performance status, low-dose treatment can preserve quality of life without compromising cancer control or survival. Maintenance therapy should be considered in PDAC patients achieving disease control with systemic therapy. In particular, olaparib has demonstrated a progression-free survival benefit of 3.6 months in a subgroup of PDAC patients with germline BRCA1/2 mutations (ca. 10% of all PDAC). Pancreatic enzyme replacement therapy is often omitted in the treatment of patients with PDAC, with possibly deleterious consequences. Small intestinal bacterial overgrowth is highly prevalent in patients with PDAC and should be considered in the diagnostic algorithm of PDAC patients with bloating and diarrhea. Rivaroxaban has been associated with a reduced risk of thrombosis without an increase in major bleeding events, and its use should be considered in every patient with advanced PDAC undergoing systemic therapy.

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“…Several case reports involving 11 separate patients with metastatic colorectal cancer have shown that the administration of FOLFOX4 or mFOLFOX6 is safe and tolerated in patients with severe hepatic dysfunction (35)(36)(37)(38)(39)(40)(41). Total bilirubin levels ranged from 3.5-22.5 mg/dL and treatment with FOLFOX often resulted in dramatic improvements in hyperbilirubinemia as early as 1-2 cycles of therapy without significant toxicities ( Table 2).…”

Section: Folfoxmentioning

confidence: 99%

Chemotherapy in patients with hepatobiliary cancers and abnormal hepatic function

Gong

Cho

Fakih

2017

J. Gastrointest. Oncol.

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Sorafenib and cisplatin plus gemcitabine currently represent first-line treatment standards in advanced hepatocellular carcinoma and biliary cancer, respectively. Conventional cytotoxic agents (monotherapy or combination therapy) have demonstrated activity in the second-line setting or in those in which first-line agents are contraindicated. A strategy for safe yet effective administration of such systemic therapies in patients with advanced hepatobiliary cancer and abnormal liver function needs to be strongly considered. Here, we highlight the safety and tolerability of systemic therapies routinely used for the treatment of advanced hepatobiliary cancer in patients with hepatic dysfunction. Based on data from available clinical studies, we review dosing strategies recommended for chemotherapy and targeted therapy in those with liver dysfunction. Dose modifications for many agents in this population remain empiric due to limited clinical evidence. Future dedicated phase I studies are needed to provide further dosing considerations for combination therapy in those with abnormal liver function in which data is lacking. J Gastrointest Oncol 2017;8(2):314-323 jgo.amegroups.com considered a standard therapy in inoperable HCC, doxorubicin demonstrated significant toxicities (neutropenia and cardiotoxicity) that outweighed its modest benefits in this population (18). Moreover, FOLFOX represents a more preferred first-line option over doxorubicin given the improved progression-free survival (PFS) and overall response rates (ORRs) seen with FOLFOX4 vs. single-agent doxorubicin in a phase III trial involving Asian patients with advanced HCC (19).The majority of patients with HCC and biliary cancer present with advanced disease (20,21). The intrinsic liver dysfunction associated with hepatobiliary cancer often presents a challenge to the administration of the aforementioned systemic therapies in the treatment of advanced disease. In addition, chemotherapy and targeted therapy-induced hepatotoxicity can further complicate the treatment in these patients. The potential toxic effects of chemotherapy (including the majority of agents used in the treatment of advanced hepatobiliary cancer) on the liver have been extensively reviewed (22,23). Instead, this review will focus on dosage considerations for chemotherapy and targeted therapy in patients with abnormal hepatic function. Specifically, we review available clinical data that offer recommendations for dosing strategies, in the setting of liver dysfunction, of systemic therapies used in treating advanced hepatobiliary cancer. Chemotherapy and targeted therapy in patients with liver dysfunctionThere is a growing body of clinical evidence to recommend dosing guidelines based on serum liver biochemical tests involving agents used in the treatment of advanced hepatobiliary cancer in patients with liver dysfunction (Tables 1-3). GemcitabineAn early phase I trial investigated gemcitabine at a starting dose of 800 mg/m 2 30-minute infusion every week for 3 weeks followed ...

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Safe Use of FOLFOX in Two Patients With Metastatic Colorectal Carcinoma and Severe Hepatic Dysfunction

Cited by 8 publications

References 15 publications

Patients with Metastatic Colorectal Cancer and Hyperbilirubinemia Treated with FOLFIRI plus Bevacizumab as First-Line Treatment

Patients with Metastatic Colorectal Cancer and Hyperbilirubinemia Treated with FOLFIRI plus Bevacizumab as First-Line Treatment

Advanced Pancreatic Ductal Adenocarcinoma: Moving Forward

Chemotherapy in patients with hepatobiliary cancers and abnormal hepatic function

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