Treatment of Fluorouracil-Refractory Patients With Liver Metastases From Colorectal Cancer by Using Yttrium-90 Resin Microspheres Plus Concomitant Systemic Irinotecan Chemotherapy

2009 ◽  
Vol 27 (25) ◽  
pp. 4089-4095 ◽  
Author(s):  
Guy A. van Hazel ◽  
Nick Pavlakis ◽  
David Goldstein ◽  
Ian N. Olver ◽  
Michael J. Tapner ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Abdominal Pain ◽  
Liver Metastases ◽  
Survival Rates ◽  
Hepatic Metastases ◽  
Progression Free Survival ◽  
Maximum Tolerated Dose ◽  
Elevated Alkaline Phosphatase ◽  
Vein Thrombosis ◽  
Yttrium 90

Purpose Liver metastases are the principal cause of death in patients with advanced colorectal cancer (CRC). Irinotecan is a chemotherapeutic agent used in the treatment of CRC and has demonstrated synergistic potential when used with radiation. Radioembolization with yttrium-90 microspheres has demonstrated increased response and survival rates when given with fluorouracil chemotherapy. This study's goal was to evaluate the maximum-tolerated dose of concomitant irinotecan and radioembolization in fluorouracil-refractory patients with CRC hepatic metastases. Patients and Methods Twenty-five irinotecan-naïve patients who had experienced relapse after previous chemotherapy were enrolled onto three dose-escalating groups. Irinotecan was administered at 50, 75, or 100 mg/m2 on days 1 and 8 of a 3-week cycle for the first two cycles, and full irinotecan doses (ie, 100 mg/m2) were administered during cycles 3 to 9. Radioembolization was administered during the first chemotherapy cycle. Results Most patients experienced acute, self-limiting abdominal pain and nausea. Mild lethargy and anorexia were common. Grades 3 to 4 events were seen in three of six patients at 50 mg/m2 (obstructive jaundice, thrombocytopenia, diarrhea), in five of 13 patients at 75 mg/m2 (neutropenia, leukopenia, thrombocytopenia, elevated alkaline phosphatase, abdominal pain, ascites, fatigue) and in four of six patients at 100 mg/m2 (diarrhea, deep vein thrombosis, constipation, leukopenia). Eleven (48%) of 23 patients had a partial response, and nine patients (39%) had stable disease. The median progression-free survival was 6.0 months; the median survival was 12.2 months. Conclusion Concomitant use of radioembolization plus irinotecan did not reach a maximum-tolerated dose. The recommended dose of irinotecan in this setting is 100 mg/m2 on days 1 and 8 of a 3-week cycle.

Radioembolization of Liver Metastases From Colorectal Cancer Using Yttrium-90 Microspheres With Concomitant Systemic Oxaliplatin, Fluorouracil, and Leucovorin Chemotherapy

2007 ◽  
Vol 25 (9) ◽  
pp. 1099-1106 ◽  
Author(s):  
Ricky A. Sharma ◽  
Guy A. Van Hazel ◽  
Bruno Morgan ◽  
David P. Berry ◽  
Keith Blanshard ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Progression Free Survival ◽  
Maximum Tolerated Dose ◽  
Gastric Ulcers ◽  
Splenic Volume ◽  
Free Survival ◽  
Resin Microspheres ◽  
Grade 3 ◽  
Yttrium 90

Purpose Liver metastases represent the principal cause of death in patients with advanced colorectal cancer (CRC). Injection of resin microspheres (SIR Spheres)—containing the β-emitter, yttrium-90—into the arterial supply of the liver can cause radioembolization of metastases. This treatment has not been tested with the radiosensitizing chemotherapy, oxaliplatin, which appears synergistic in the treatment of CRC when combined with fluorouracil and leucovorin (FOLFOX). Patients and Methods A phase I study of SIR-Spheres therapy with modified FOLFOX4 systemic chemotherapy was conducted in patients with inoperable liver metastases from CRC who had not previously received chemotherapy for metastatic disease. Oxaliplatin (30 to 85 mg/m2) was administered for the first three cycles with full FOLFOX4 doses from cycle 4 until cycle 12. The primary end point was toxicity. Results Twenty patients were enrolled onto the study. Five patients experienced National Cancer Institute (NCI; Bethesda, MD) grade 3 abdominal pain, two of whom had microsphere-induced gastric ulcers. The dose-limiting toxicity was grade 3 or 4 neutropenia, which was recorded in 12 patients. One episode of transient grade 3 hepatotoxicity was recorded. Mean splenic volume increased by 92% following 6 months of protocol therapy. Partial responses were demonstrated in 18 patients and stable disease in two patients. Two patients underwent partial hepatic resection following protocol therapy. Median progression-free survival was 9.3 months, and median time to progression in the liver was 12.3 months. Conclusion The maximum-tolerated dose was 60 mg/m2 of oxaliplatin for the first three cycles, with full FOLFOX4 doses thereafter. This chemoradiation regime merits evaluation in phase II-III trials.

scholarly journals Primary Tumor Location Is a Prognostic Factor for Intrahepatic Progression-Free Survival in Patients with Colorectal Liver Metastases Undergoing Portal Vein Embolization as Preparation for Major Hepatic Surgery

Cancers ◽  
2020 ◽  
Vol 12 (6) ◽  
pp. 1638
Author(s):  
Lea Hitpass ◽  
Daniel Heise ◽  
Maximilian Schulze-Hagen ◽  
Federico Pedersoli ◽  
Florian Ulmer ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Confidence Interval ◽  
Portal Vein ◽  
Liver Metastases ◽  
Portal Vein Embolization ◽  
Hepatic Metastases ◽  
Progression Free Survival ◽  
Tumor Location ◽  
Free Survival ◽  
Right Hemihepatectomy

The aim of this study was to identify prognostic factors affecting intrahepatic progression-free survival (ihPFS) and overall survival (OS) in patients with colorectal cancer liver metastases (CRCLM) undergoing portal vein embolization (PVE) and subsequent (extended) right hemihepatectomy. A total of 59 patients (mean age: 60.8 ± 9.3 years) with CRCLM who underwent PVE in preparation for right hemihepatectomy were included. IhPFS and OS after PVE were calculated using the Kaplan–Meier method. Cox regression analyses were conducted to investigate the association between the following factors and survival: patient age, laterality of the colorectal cancer (right- versus left-sided), tumor location (colon versus rectal cancer), time of occurrence of hepatic metastases (synchronous versus metachronous), baseline number and size of hepatic metastases, presence or absence of metastases in the future liver remnant (FLR) before PVE, preoperative carcinoembryogenic antigen (CEA) levels, time between PVE and surgery, history of neoadjuvant or adjuvant chemotherapy, and the presence or absence of extrahepatic disease before PVE. Median follow up was 18 months. The median ihPFS was 8.2 months (95% confidence interval: 6.2–10.2 months), and median OS was 34.1 months (95% confidence interval: 27.3–40.9 months). Laterality of the primary colorectal cancer was the only statistically significant predictor of ihPFS after PVE (hazard ratio (HR) = 2.242; 95% confidence interval: 1.125, 4.465; p = 0.022), with patients with right-sided colorectal cancer having significantly shorter median ihPFS than patients with left-sided cancer (4.0 ± 1.9 months versus 10.2 ± 1.5 months; log rank test: p = 0.018). Other factors, in particular also the presence or absence of additional metastases in the FLR, were not associated with intrahepatic progression-free survival. The presence of extrahepatic disease was associated with worse OS (HR = 3.050, 95% confidence interval: 1.247, 7.459; p = 0.015).

scholarly journals Tumor Vascularity Does Not Predict Response to Yttrium-90 Radioembolization for Hepatic Metastases from Colorectal Cancer

2017 ◽  
Vol 02 (01) ◽  
pp. 003-012
Author(s):  
Alipi Naydenov ◽  
William Harris ◽  
Guy Johnson ◽  
Daniel Hippe ◽  
Siddharth Padia
Keyword(s):  
Colorectal Cancer ◽  
Median Overall Survival ◽  
Tumor Response ◽  
Hepatic Metastases ◽  
Progression Free Survival ◽  
Tumor Vascularity ◽  
Free Survival ◽  
Hypervascular Tumors ◽  
Imaging Response ◽  
Yttrium 90

AbstractThe purpose of this study was to determine whether the degree of tumor vascularity based on imaging has an impact on tumor response and survival in patients with metastatic colorectal cancer (mCRC) to the liver undergoing yttrium-90 radioembolization. A retrospective study of 75 mCRC patients from a single-institution undergoing radioembolization was performed over a 7-year period. Tumors were categorized as hypo- or hypervascular based on digital subtraction angiography (DSA) and C-arm CT during mapping angiography. Tumor response and survival were compared between each group, after undergoing radioembolization. Hypervascular tumors were present in 37 of 75 (49%) patients according to DSA. Of 37 patients who underwent C-arm CT during the procedure, 22 (59%) had tumors classified as hypervascular. There were no significant differences in tumor response rates when vascularity was stratified by DSA or C-arm CT. Median progression-free survival (PFS) was 111 versus 128 days (p = 0.41) between DSA hypervascular and hypovascular cases, and median overall survival (OS) was 439 versus 342 days (p = 0.96). When stratified by C-arm CT, median PFS was 313 versus 244 days (p = 0.83) and median OS was 489 versus 342 days (p = 0.74) for hypervascular and hypovascular cases, respectively. Tumor vascularity based on DSA or C-arm CT does not predict imaging response or survival after radioembolization and should not be used as a criterion for selecting candidates for radioembolization for hepatic mCRC.

scholarly journals Tumor Vascularity Does Not Predict Response to Yttrium-90 Radioembolization for Hepatic Metastases from Colorectal Cancer

2018 ◽  
Vol 02 (01) ◽  
pp. 003-012
Author(s):  
Alipi Naydenov ◽  
William Harris ◽  
Guy Johnson ◽  
Daniel Hippe ◽  
Siddharth Padia
Keyword(s):  
Colorectal Cancer ◽  
Median Overall Survival ◽  
Tumor Response ◽  
Hepatic Metastases ◽  
Progression Free Survival ◽  
Tumor Vascularity ◽  
Free Survival ◽  
Hypervascular Tumors ◽  
Imaging Response ◽  
Yttrium 90

AbstractThe purpose of this study was to determine whether the degree of tumor vascularity based on imaging has an impact on tumor response and survival in patients with metastatic colorectal cancer (mCRC) to the liver undergoing yttrium-90 radioembolization. A retrospective study of 75 mCRC patients from a single-institution undergoing radioembolization was performed over a 7-year period. Tumors were categorized as hypo- or hypervascular based on digital subtraction angiography (DSA) and C-arm CT during mapping angiography. Tumor response and survival were compared between each group, after undergoing radioembolization. Hypervascular tumors were present in 37 of 75 (49%) patients according to DSA. Of 37 patients who underwent C-arm CT during the procedure, 22 (59%) had tumors classified as hypervascular. There were no significant differences in tumor response rates when vascularity was stratified by DSA or C-arm CT. Median progression-free survival (PFS) was 111 versus 128 days (p = 0.41) between DSA hypervascular and hypovascular cases, and median overall survival (OS) was 439 versus 342 days (p = 0.96). When stratified by C-arm CT, median PFS was 313 versus 244 days (p = 0.83) and median OS was 489 versus 342 days (p = 0.74) for hypervascular and hypovascular cases, respectively. Tumor vascularity based on DSA or C-arm CT does not predict imaging response or survival after radioembolization and should not be used as a criterion for selecting candidates for radioembolization for hepatic mCRC.

Dose escalation of capecitabine in combination with biweekly cetuximab and hepatic arterial infusion (HAI) of oxaliplatin in patients with liver metastases of colorectal cancer: Preliminary clinical results

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e15080-e15080
Author(s):  
A. Viudez ◽  
R. Zárate ◽  
M. Garrido ◽  
J. Rodríguez ◽  
A. Chopitea ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Performance Status ◽  
Hepatic Metastases ◽  
Hepatic Arterial Infusion ◽  
Clinical Results ◽  
Maximum Tolerated Dose ◽  
Ecog Performance Status ◽  
Grade 3

e15080 Background: To determine the maximum-tolerated dose (MTD) and the doses-limiting-toxicities (DLT) of concurrent capecitabine and cetuximab plus HAI of oxaliplatin (LOHP) in patients with hepatic metastases from colorectal cancer (CCR). Methods: Successive cohorts of 3–6 patients (pts) were treated with HAI LOHP (100 mg/m2), biweekly cetuximab (500 mg/m2) and escalation doses of capecitabine (825 mg/m2 BID d1–7:DL1; 1000 mg/m2 BID d1- 7:DL2; 1250 mg/m2 BID d1–7:DL3; 1500 mg/m2 BID d1–7:DL4) recycled every 14 days. Dose-limiting-toxicities (DLT) were defined as any grade 3–4 events, excepting grade 3–4 skin rash. LOHP and cetuximab PK/PD data were prospectively collected. Results: 19 patients (median age: 60; range: 34–74; 52.9% men, 47.1% females) and ECOG performance status of 1 (range 0–2) were treated at 4 DLs (dose level) as follows: DL: 3 pts, DL2: 6 pts, DL 3: 7 pts and DL 4: 3 pts. All pts were evaluable for toxicity. With a median of follow-up of 21.23 months, ORR was 78.9%, all of them partial response, with 4 pts SD (21.1%). Initially, only 4 pts were considered potentially resectable. Among the remaining 15 pts, 4 (20.6%) could be resected after treatment. Disease progression occurred in 15 pts (78.9%; 3 pts in liver only; 4 pts with extrahepatic metastases; 8 cases with both, hepatic and extrahepatic disease). The TTP was 9.6 months. OS has not been reached. 4 pts have died during the follow-up. Grade ¾ toxicities including Hand-foot Syndrome in 3 pts (1 pt at DL1, other at DL3 and other at DL4), diarrhoea in 3 pts ( one at DL3 and 2 at DL4), anaemia in 2 pts (DL2 and DL4), asthenia in 2 pts (DL2 and DL4) and mucositis in 1 pts (DL3). DLT and MTD were established in DL4 (two pts with diarrhoea grade IV with one of them with grade III HFS) Conclusions: Combination therapy with HAI LOHP plus concurrent capecitabine and cetuximab, can be safely administered to patients with liver metastases from CCR. The MTD and DLT was established in 1500 mg/m2 BID d1 to d7 of capecitabine. The Doses-recommended (DR) has not been obtained yet. oxaliplatin PK/PD is best defined through a bicompartimental model. Mature results of PK/PD analysis will be presented at 2009 ASCO Symposium. No significant financial relationships to disclose.

Intra-individual genetic heterogeneity among liver metastases in metastatic colorectal cancer.

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 555-555 ◽  
Author(s):  
Anita Sveen ◽  
Inger Marie Loes ◽  
Sharmini Alagaratnam ◽  
Gro Nilsen ◽  
Maren Høland ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Resection ◽  
Liver Metastases ◽  
Genetic Heterogeneity ◽  
Survival Rates ◽  
Snp Array ◽  
Progression Free Survival ◽  
Partial Liver Resection ◽  
High Level ◽  
A Prospective Study

555 Background: Almost 50% of patients with colorectal cancer (CRC) develop liver metastases, often as multiple simultaneous metastatic deposits. Up to 25% of the patients are eligible for partial liver resection, but 70% will relapse after surgery and there are currently no good criteria to select patients who will benefit from the treatment. Genetic heterogeneity among metastatic deposits has great potential impact on disease progression, but has not been well described. Methods: Totally 134 liver metastatic deposits were collected from 45 patients undergoing partial liver resection for metastatic CRC according to a prospective study protocol. All deposits were analyzed for high-resolution DNA copy number variation using the Affymetrix SNP Array 6.0. A novel bioinformatic approach was used to measure intra-individual genetic heterogeneity among the metastatic deposits. Results: The patients showed a large variation in the level of intra-individual metastatic heterogeneity, and heterogeneity was independent of the number of liver metastases analyzed per patient. Heterogeneity was a strong and independent prognostic factor in multivariate analysis with known clinicopathological prognostic factors. Patients with a high level of heterogeneity (above the median) had a three-year overall survival rate of 18%, compared with 66% for patients with a low level (hazard ratio, HR = 3.7, P = 0.007). The corresponding survival rates for progression-free survival were 6% and 24% (HR = 2.6, P = 0.01). Conclusions: A high level of intra-individual genetic heterogeneity among liver metastatic deposits is associated with poor survival after partial liver resection in patients with metastatic CRC.

Phase I/II Study of Hepatic Arterial Therapy With Floxuridine and Dexamethasone in Combination With Intravenous Irinotecan As Adjuvant Treatment After Resection of Hepatic Metastases From Colorectal Cancer

2003 ◽  
Vol 21 (17) ◽  
pp. 3303-3309 ◽  
Author(s):  
N. Kemeny ◽  
W. Jarnagin ◽  
M. Gonen ◽  
J. Stockman ◽  
L. Blumgart ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Liver Metastases ◽  
Hepatic Metastases ◽  
Hepatic Arterial Infusion ◽  
Maximum Tolerated Dose ◽  
Systemic Control ◽  
Pump Flow Rate ◽  
Comparable Activity

Purpose: Patients who undergo resection of liver metastases from colorectal cancer have an average 2-year survival of 65%. With hepatic arterial infusion (HAI) plus systemic fluorouracil and leucovorin, 2-year survival increased to 86%. For further improvement in both local and systemic control, combinations of new systemic drugs with HAI are being explored. The purpose of this study was to determine the maximum-tolerated dose (MTD) of systemic irinotecan (CPT-11) and HAI floxuridine (FUDR) plus dexamethasone (DEX) as combination adjuvant therapy after liver resection. Patients and Methods: Ninety-six patients who underwent complete resection of liver metastases from colorectal cancer were treated with six monthly cycles of HAI FUDR plus DEX for 14 days of each 4-week cycle plus escalating doses of systemic CPT-11. The primary end points of the phase I/II study were the MTD and efficacy of this regimen. Results: The MTD for combined systemic CPT-11 and HAI FUDR was CPT-11 at 200 mg/m2 every other week and FUDR at 0.12 mg/kg × pump volume ÷ pump flow rate. The dose-limiting toxicities were diarrhea and neutropenia. With a median follow-up time of 26 months, the 2-year survival rate is 89%. All of the 27 patients who were treated at the MTD are alive. Conclusion: In patients who undergo resection of liver metastases from colorectal cancer, adding systemic CPT-11 to HAI therapy in an adjuvant regimen is feasible. This regimen seems to have comparable activity to fluorouracil and leucovorin, but further studies are needed to assess whether it improves local control or decreases extrahepatic recurrences.

scholarly journals Liver Resection for Hepatic Metastases from Soft Tissue Sarcoma: A Nationwide Study

2018 ◽  
Vol 36 (6) ◽  
pp. 479-486 ◽  
Author(s):  
Frederike A.B. Grimme ◽  
Maarten F.J. Seesing ◽  
Richard van Hillegersberg ◽  
Frits van Coevorden ◽  
Koert P. de Jong ◽  
...  
Keyword(s):  
Liver Resection ◽  
Liver Metastases ◽  
Primary Tumour ◽  
Survival Rates ◽  
Hepatic Metastases ◽  
Progression Free Survival ◽  
Included Study ◽  
Good Survival ◽  
R0 Resection ◽  
Term Survival

Background: This study aims to evaluate the feasibility and safety of resection of sarcoma liver metastases, and to identify possible prognostic factors for long-term survival. Methods: All patients who underwent resection of liver metastases of sarcoma in the Netherlands from 1998 to 2014 were included. Study data was retrospectively collected from patient files. Survival rates were calculated using Kaplan-Meier survival analysis. Results: Some 38 patients treated in 16 hospitals were included (15 male, 23 female). The median age was 57 years (37–80 years). The most common histological subtype was leiomyosarcoma (63%). The predominant site of primary tumour was the abdomen (59%). R0 resection was achieved in 16 patients. Mortality was 3 and 16% of included patients had 1 or more complications. The median follow-up period was 18 months (range 1–161). After liver resection, 1-, 3-, and 5-year survival were 88, 54, and 42% respectively. Median overall survival was 46 months (1–161 months). One- and three-year progression-free survival (PFS) after liver resection were 54 and 19% respectively. Median PFS was 16 months (1–61 months). Conclusions: Liver surgery for sarcoma metastases is safe and leads to a relatively good survival. The choice for surgical treatment should always be discussed in a multidisciplinary sarcoma and liver team.

Radioembolization of unresectable hepatic metastases using yttrium-90 microspheres in heavily pretreated colorectal cancer.

2011 ◽  
Vol 29 (4_suppl) ◽  
pp. 559-559
Author(s):  
M. E. Hill ◽  
M. F. Mulcahy ◽  
R. Lewandowski ◽  
A. Rademaker ◽  
R. Salem
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Metastatic Colorectal Cancer ◽  
Metastatic Disease ◽  
Hepatic Metastases ◽  
Extrahepatic Disease ◽  
Disease Stabilization ◽  
Heavily Pretreated ◽  
One Year ◽  
Yttrium 90

559 Background: Yttrium-90 (Y90) microsphere liver-directed treatment has previously demonstrated the ability to provide disease stabilization to patients with liver-dominant metastatic colorectal cancer. Methods: We conducted a retrospective analysis of 36 patients with metastatic colorectal cancer who had undergone Y90 liver-directed therapy between November 2001 and March 2009. All patients had previously received 5-fluorouracil, irinotecan, and oxaliplatin and had unresectable hepatic metastases, with or without extrahepatic metastases. Results: Thirty-six patients with a mean age of 58 were included in the analysis. Twenty patients had both hepatic and extrahepatic metastatic disease and 16 had liver-confined metastatic disease at the time of first Y90 treatment. Radiologic response rate with stabilization of liver metastases was 72%. Median survival from time of diagnosis of liver metastases and from time of first Y90 treatment was 31.7 months and 9.4 months, respectively. One patient is still alive. Nine patients received only one Y90 treatment, 20 patients received two treatments, and 7 patients received three treatments. One-year survival from first Y90 treatment was 47%, and 53% of these patients had no extrahepatic metastatic disease prior to therapy, 41% had minimal extrahepatic disease, and 6% had significant extrahepatic disease. Fifty-three percent of patients survived less than one year after the first Y90 treatment. Of these, 36.8% had no evidence of extrahepatic metastatic disease prior to first Y90 therapy, 31.6% had a small volume of extrahepatic disease, and 31.6% had extensive extrahepatic disease. Conclusions: Liver-directed therapy with Y90 was observed to control the growth of unresectable metastatic liver disease in the majority of patients with heavily-pretreated colorectal cancer. A significantly smaller proportion of patients who survived a year or more had extensive extrahepatic mestastatic disease at the time of first Y90 treatment than those who survived less than a year. This suggests a potential survival advantage of Y90 liver-directed treatment in patients with primary liver metastatic disease and minimal extrahepatic disease. [Table: see text]

A prospective phase II study of neoadjuvant FOLFOX6 plus cetuximab in patients with colorectal cancer and unresectable liver metastasis.

2012 ◽  
Vol 30 (15_suppl) ◽  
pp. e14072-e14072
Author(s):  
Jun Ho Ji ◽  
Young Suk Park ◽  
Jeeyun Lee ◽  
Tae Won Kim ◽  
Yong Sang Hong ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Liver Metastases ◽  
Disease Progression ◽  
Hepatic Metastases ◽  
Progression Free Survival ◽  
Response Rates ◽  
R0 Resection ◽  
Resection Rate ◽  
Curative Intent

e14072 Background: Colorectal cancer(CRC) with liver-only metastasis is considered potentially curable when liver metastases are completely resectable, while nonresectable liver metastases(NLM) are still incurable. In the latter cases, neoadjuvant chemotherapy could render curability by achieving resectability. We assessed efficacy of neoadjuvant cetuximab combined with FOLFOX6 in colorectal patients with NLM. Methods: Between July 2008 and Dec 2009, 73 patients were enrolled from 11 centers in Korea. Newly diagnosed K-RAS wild type CRC patients with NLM were treated with FOLFOX6 plus cetuximab(provided by Merck Serono) every 2 weeks. Response was evaluated every 3 cycles by CT scan according to RECIST 1.0. Chemotherapy was continued until disease progression or maximum of 12 cycles. Liver metastasectomy was performed at physician’s discretion in patients with enough tumor shrinkage, followed by chemotherapy of same regimen to complete total 12 cycles. The primary endpoint was overall R0 resection rate. The secondary endpoints were the response rates, progression-free survival(PFS), overall survival and toxicity. Results: In total, 73 patients were enrolled and analyzed. The median follow up duration was 28.6 months (range 11.5 to 38.1). Among 53 (72.6%) patients who showed response, surgery with curative intent was attempted in 36 (49.3%) patients. With intention-to-treat analysis, R0 resection rate(RR) was 19.2% (14/73), RFA plus R0, R1 and R2 RR were 8.2% (6/73), 8.2% (6/73), 13.7% (10/73), respectively. Despite neoadjuvant chemotherapy, 37 (50.7%) patients had unresectable hepatic metastases, however. RFA was successfully performed in combination with surgery (n=7) or alone (n=1) in 8 patients of them. Chemotherapy was discontinued in 26 patients due to disease progression (n=13), death (n=2), consent withdrawal (n=10), or protocol violation (n=1). The most common grade 3 and 4 toxicity was neutropenia (10.7%). Median PFS was 14.1 months (range 1.3 - 30.8) in patients received R0 resection and RFA + R0 resection. Conclusions: Neoadjuvant chemotherapy with FOLFOX6 plus cetuximab showed high response rates and increase resection rate in CRC patients with NLM.

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