Phase II Evaluation of Treatment of Complete Resection of Hepatic Metastases From Colorectal Cancer and Adjuvant Hepatic Arterial Infusion of Floxuridine

1999 ◽  
Vol 22 (3) ◽  
pp. 291-293 ◽  
Author(s):  
Jordan Berlin ◽  
Hollis W. Merrick ◽  
Thomas J. Smith ◽  
Harvey Lerner
Keyword(s):  
Colorectal Cancer ◽  
Phase Ii ◽  
Hepatic Metastases ◽  
Hepatic Arterial Infusion ◽  
Complete Resection ◽  
Arterial Infusion

Phase I/II study of irinotecan, UFT, and leucovorin with hepatic arterial infusion in colorectal cancer patients with unresectable liver metastases: Preliminary results

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 14549-14549
Author(s):  
T. Yamaguchi ◽  
H. Matsumoto ◽  
K. Takahashi ◽  
M. Yasutome ◽  
T. Mori
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Liver Metastases ◽  
Phase Ii ◽  
Phase I Study ◽  
Phase Ii Study ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion ◽  
Unresectable Liver Metastases ◽  
Colorectal Cancer Patients

14549 Background: To determine the maximum-tolerated dose (MTD) and to evaluate the efficacy and tolerability of combination chemotherapy of irinotecan (CPT-11), UFT and leucovorin (LV) with hepatic arterial infusion (HAI) in colorectal cancer patients with unresectable liver metastases. Methods: Patients who had unresectable liver metastases from colorectal cancer were treated concurrently with intravenous CPT-11 on day1 of each 14-day treatment cycle with dose escalation, with orally UFT and LV on day 1–7 of each cycle, and with HAI of 5-FU on day 8–14 of each cycle. The primary objective of this phase I study was to determine the MTD of biweekly intravenous CPT-11 and UFT/LV with HAI of 5-FU. In the phase II study, the primary endpoint was to determine the response rate. Results: In the phase I study, the recommended dose of CPT-11 for phase II study was 140 mg/m2 combined with UFT 300 mg/m2/day, LV 75 mg/body/day and 5-FU 2,000 mg/body/week. Sixteen patients were enrolled onto the phase II study. The six patients treated at the recommended dose during the phase I study also included in the phase II analysis (n = 22). Median number of liver metastases was 12 (range, 3 to 35). Median size of maximum diameter was 6.3 cm (range, 2.0 to 12.0 cm). The most common adverse event was neutropenia. The complete and partial response rate totaled 81.8%. Median survival time has not been reached yet. Eleven patients (50.0%) were ultimately able to undergo liver resection. Conclusions: The combination chemotherapy of CPT-11 and UFT/LV with HAI was safe, well tolerate and effective in current population of the patients with unresectable liver metastases from colorectal cancer. Updated toxicity and response data will be available in the spring of 2007. No significant financial relationships to disclose.

Phase II Study of UFT with Leucovorin Plus Hepatic Arterial Infusion with Irinotecan, 5-Fluorouracil and Leucovorin for Non-Resectable Liver Metastases of Colorectal Cancer

Chemotherapy ◽  
2008 ◽  
Vol 55 (2) ◽  
pp. 76-82 ◽  
Author(s):  
Efraim Idelevich ◽  
Franklin Greif ◽  
Eli Mavor ◽  
Rafael Miller ◽  
Hanoch Kashtan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion

Hepatic Arterial Infusion of Chemotherapy after Resection of Hepatic Metastases from Colorectal Cancer

1999 ◽  
Vol 341 (27) ◽  
pp. 2039-2048 ◽  
Author(s):  
Nancy Kemeny ◽  
Ying Huang ◽  
Alfred M. Cohen ◽  
Weiji Shi ◽  
John A. Conti ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Hepatic Metastases ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion

Quality of life in colorectal cancer patients with hepatic arterial infusion (HAI) pumps

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19602-19602
Author(s):  
V. C. Sun ◽  
R. Nelson ◽  
B. Wagman ◽  
M. Carroll ◽  
B. Lee ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Colorectal Cancer ◽  
Cancer Patients ◽  
Assessment Tool ◽  
Hepatic Metastases ◽  
Hepatic Arterial Infusion ◽  
Arterial Infusion ◽  
Colorectal Cancer Patients ◽  
The Impact

19602 Background: More than half of patients diagnosed with colorectal cancer will develop hepatic metastases. Most patients with hepatic metastases will recur within two years after resection. Hepatic arterial infusion (HAI) pumps deliver regional treatment. However, very few studies quantitatively explore the patient's experience of living with an HAI pump and how this experience impacts HAI-related quality of life (QOL). This study explored the impact of HAI pump treatment on patient's overall QOL within the specific domains of physical, psychological, social, and functional well-being. Methods: Twenty-five colorectal cancer patients treated with HAI pumps completed an HAI pump- specific QOL assessment tool at one data collection time point. The QOL assessment tool items were derived from the investigator's previous QOL research with this patient population [Blair et al., 2002, Annals of Surgical Oncology]. Demographic, disease and QOL data were summarized using descriptive statistics. Results: Of the 25 patients accrued, 32% were receiving treatments through their HAI pump and 68% were not. There were no significant difference in QOL between treatment status, gender, and age (<65 or = 65). Currently treated pump patients experienced more appetite changes (p=0.03), sleep changes (p=0.08), and more restrictions in traveling (p=0.08). Male patients had more concerns with lifting heavy items (p=0.05), while female patients had more concerns with isolation (p=0.17) and changes in the type of clothing worn (p=0.16). Younger patients had more concerns with vigorous activity (p=0.01), bending (p=0.08), and were more self-conscious of their appearance with the pump (p=0.01). Conclusions: Overall, in this study, colorectal cancer patients with HAI pumps reported good QOL and were satisfied with their overall treatment experience. Although there was no comparative statistical analysis performed in this study, several QOL concerns remain worrisome for patients. Defining these specific QOL concerns in HAI patients will enhance clinical understanding of their unique experience with this treatment modality and impact patient management. This will enable further development of educational tools and research to test interventions to support HAI patients and sustain their QOL. No significant financial relationships to disclose.

Systemic capecitabine and oxaliplatin administered with hepatic arterial infusion (HAI) of floxuridine (FUDR) following complete resection of colorectal metastases (M-CRC) confined to the liver

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4057-4057 ◽  
Author(s):  
S. Alberts ◽  
M. R. Mahoney ◽  
J. H. Donohue ◽  
M. S. Roh ◽  
E. M. Green ◽  
...  
Keyword(s):  
Median Overall Survival ◽  
Hepatic Metastases ◽  
Hepatic Arterial Infusion ◽  
Dual Therapy ◽  
Complete Resection ◽  
Colorectal Metastases ◽  
Time To Progression ◽  
Arterial Infusion ◽  
Improve Outcome

4057 Background: The prognosis for patients with hepatic metastases from M-CRC can be poor. However, surgery followed by HAI FUDR plus systemic (SYS) 5-FU improves 5-yr survival. Dual therapy OXAL+CAPE has demonstrated activity in advanced CRC. We report final results of an analysis of SYS OXAL+CAPE, alternating with HAI FUDR. The primary endpoint is 2-yr survival (2YS), with 36 of 45 patients surviving 2 yrs as evidence of promising efficacy. Methods: Patients with M-CRC liver lesions amenable to resection ± ablation were eligible. Prior adjuvant chemotherapy for completely resected primary was allowed. HAI+SYS therapy was initiated 21–56 days post-metastasectomy. Four alternating courses of HAI consisted of 0.2 mg/m2/d FUDR and dexamethasone, d1–14 wks 1&2. SYS included 130 mg/m2 OXAL d1, with CAPE at 1,000 mg/m2 po BID, d1–14, wks 4&5. Two additional 3-wk courses of SYS were given. CAPE was reduced to 850 mg/m2/BID after interim review of toxicity. Results: 54 of 73 eligible patients initiated HAI FUDR + SYS. 52% had a solitary met and 24% presented with bilobar mets. Patients completed median of 6 cycles (range 1–6). Reasons for discontinuation included: refusal/toxicity (10), completed per protocol (32), recurrence (4), and medical/other (3). No HAI+SYS related deaths occurred. Median follow-up on the 42 survivors is 28 months (range 7–51). 6 deaths occurred within 2 yrs. 48% (26/54) have recurred; 42% (11/26) with liver involvement. Median time-to-progression is 30 months. The estimated 2YS rate is 88% (95% CI 80–98%) and median overall survival is 46 months (95% CI 41.3-NA). Conclusions: The combination of HAI FUDR and SYS therapy appears to improve outcome following resection of hepatic CRC-M. A 2YS of 88% exceeds our preplanned level of success, supporting the use of this combination in the ongoing NSABP trial C-09. Supported by NIH Grant CA25224–18, Sanofi-Synthelabo, and Roche Laboratories, Inc. No significant financial relationships to disclose.

Irinotecan Hepatic Arterial Infusion Chemotherapy for Hepatic Metastases from Colorectal Cancer: Results of a Phase I Clinical Study

2001 ◽  
Vol 87 (6) ◽  
pp. 388-390 ◽  
Author(s):  
Giammaria Fiorentini ◽  
Silvia Ricci Lucchi ◽  
Petros Giovanis ◽  
Maurizio Cantore ◽  
Stefano Guadagni ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Liver Metastases ◽  
Phase Ii ◽  
Active Drug ◽  
Hepatic Arterial Infusion ◽  
Hepatic Arterial Infusion Chemotherapy ◽  
Arterial Infusion ◽  
Arterial Infusion Chemotherapy ◽  
Infusion Chemotherapy ◽  
Phase Ii Studies

Background Hepatic arterial infusion chemotherapy is a promising approach in liver metastases from colorectal cancer, but chemical hepatitis, biliary sclerosis, arterial thrombosis and right upper quadrant pain are limiting factors. Irinotecan (CPT-11) is an active drug in colorectal cancer. We planned a short hepatic arterial infusion of CPT-11 to describe the toxicity, to determine the dose-limiting toxicity, and to define the doses of CPT-11 to be recommended for phase II studies. Patients and Methods Fourteen patients with a median liver substitution of 30% (10-60%) were enrolled. All patients received hepatic arterial infusion chemotherapy with CPT-11 on an outpatient basis every 3 weeks as a short, 30-min infusion. Results At 240 mg/m2, 2 of 4 patients experienced grade 4 diarrhea and neutropenia, and 3 of them also reported grade 4 abdominal pain of the right upper quadrant. The maximum tolerated dose was reached at 240 mg/m2. The recommended doses of CPT-11 for phase II studies is 200 mg/m2, given every 3 weeks. Conclusions CPT-11 presents a low hepatic toxic profile and could be considered a new active drug, suitable for hepatic arterial infusion in liver metastases from colorectal cancer.

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