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A phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) in advanced biliary tract carcinoma.

Kobayashi K, Tsuji A, Morita S, Horimi T, Shirasaka T, Kanematsu T - BMC Cancer (2006)

Bottom Line: There was no significant difference regarding the anti tumor effects against both malignant neoplasms.Figure 2 Shows the BDca a longer MST and TTF than did GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.The estimated MST and median TTF were 225 and 107 days, respectively.The BDca had a longer MST and TTF than GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.

View Article: PubMed Central - HTML - PubMed

Affiliation: Internal medicine, Clinical Oncology Group, Kochi Municipal Central Hospital, Kochi, Japan. bakehasky@eagle.ocn.ne.jp

ABSTRACT

Background: Unresectable biliary tract carcinoma is known to demonstrate a poor prognosis. We conducted a single arm phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) for advanced biliary tract malignancies basically on an outpatient basis.

Methods: Between February 1996 and September 2003, 42 patients were enrolled in this trial. LFP THERAPY: By using a total implanted CV-catheter system, 5-FU (160 mg/m2/day) was continuously infused over 24 hours for 7 consecutive days and CDDP (6 mg/m2/day) was infused for 30 minutes twice a week as one cycle. The administration schedule consisted of 4 cycles as one course. RESIST criteria (Response evaluation criteria for solid tumors) and NCI-CTC (National Cancer Institute-Common Toxicity Criteria) (ver.3.0) were used for evaluation of this therapy. The median survival time (MST) and median time to treatment failure (TTF) were calculated by the Kaplan-Meier method.

Results: Patients characteristics were: mean age 66.5(47-79): male 24 (54%): BDca (bile duct carcinoma) 27 GBca (Gallbladder carcinoma) 15: locally advanced 26, postoperative recurrence 16. The most common toxicity was anemia (26.2%). Neither any treatment related death nor grade 4 toxicity occurred. The median number of courses of LFP Therapy which patients could receive was two (1-14). All the patients are evaluable for effects with an over all response rates of 42.9% (95% confidence interval C.I.: 27.7-59.0) (0 CR, 18 PR, 13 NC, 11 PD). There was no significant difference regarding the anti tumor effects against both malignant neoplasms. Figure 2 Shows the BDca a longer MST and TTF than did GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.The estimated MST and median TTF were 225 and 107 days, respectively. The BDca had a longer MST and TTF than GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.

Conclusion: LFP therapy appears to be useful modality for the clinical management of advanced biliary tract malignancy.

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Related in: MedlinePlus

Schedule for treatment and infusional method. A schematic drawing of the chemotherapy schedule (a), and the Central Venous catheter system consists of PAS port (b), implantation technique (c) and portable infusion pump (d).
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Figure 1: Schedule for treatment and infusional method. A schematic drawing of the chemotherapy schedule (a), and the Central Venous catheter system consists of PAS port (b), implantation technique (c) and portable infusion pump (d).

Mentions: The treatment plan involved the administration of 5-FU (160 mg/m2/day) was continuously infused over 24 hours using a disposable infusion pump (7-day Infuser; Baxter™) and CDDP (3–6 mg/m2/day) diluted with normal serine was infused for half an hour. Hydration was not needed. These doses were determined based on our experience of the previous LFP therapy for hepatocellular carcinoma [15]. The administration schedule consisted of 5-FU for 7 consecutive days and CDDP twice a week (day 1 and day 4) for each of four weeks as one treatment course. The treatment schedule and CV catheter system was depicted on figure 1. Unless an exacerbation of the symptoms was observed, multiple courses of treatment were administered. When more than a grade 3 adverse effect was observed, a CDDP infusion was omitted and observed. If this omission was ineffective, 5-FU was also omitted. In case of hemoglobin < 8.0 g/dl, platelet count < 50,000/μl neutrophil count < 1,000/μl, blood transfusion of concentrated red blood cells (RBCs) or platelets, or granulocyte-stimulating factor (G-CSF) was applied.


A phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) in advanced biliary tract carcinoma.

Kobayashi K, Tsuji A, Morita S, Horimi T, Shirasaka T, Kanematsu T - BMC Cancer (2006)

Schedule for treatment and infusional method. A schematic drawing of the chemotherapy schedule (a), and the Central Venous catheter system consists of PAS port (b), implantation technique (c) and portable infusion pump (d).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC1483897&req=5

Figure 1: Schedule for treatment and infusional method. A schematic drawing of the chemotherapy schedule (a), and the Central Venous catheter system consists of PAS port (b), implantation technique (c) and portable infusion pump (d).
Mentions: The treatment plan involved the administration of 5-FU (160 mg/m2/day) was continuously infused over 24 hours using a disposable infusion pump (7-day Infuser; Baxter™) and CDDP (3–6 mg/m2/day) diluted with normal serine was infused for half an hour. Hydration was not needed. These doses were determined based on our experience of the previous LFP therapy for hepatocellular carcinoma [15]. The administration schedule consisted of 5-FU for 7 consecutive days and CDDP twice a week (day 1 and day 4) for each of four weeks as one treatment course. The treatment schedule and CV catheter system was depicted on figure 1. Unless an exacerbation of the symptoms was observed, multiple courses of treatment were administered. When more than a grade 3 adverse effect was observed, a CDDP infusion was omitted and observed. If this omission was ineffective, 5-FU was also omitted. In case of hemoglobin < 8.0 g/dl, platelet count < 50,000/μl neutrophil count < 1,000/μl, blood transfusion of concentrated red blood cells (RBCs) or platelets, or granulocyte-stimulating factor (G-CSF) was applied.

Bottom Line: There was no significant difference regarding the anti tumor effects against both malignant neoplasms.Figure 2 Shows the BDca a longer MST and TTF than did GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.The estimated MST and median TTF were 225 and 107 days, respectively.The BDca had a longer MST and TTF than GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.

View Article: PubMed Central - HTML - PubMed

Affiliation: Internal medicine, Clinical Oncology Group, Kochi Municipal Central Hospital, Kochi, Japan. bakehasky@eagle.ocn.ne.jp

ABSTRACT

Background: Unresectable biliary tract carcinoma is known to demonstrate a poor prognosis. We conducted a single arm phase II study of LFP therapy (5-FU (5-fluorourasil) continuous infusion (CVI) and Low-dose consecutive (Cisplatin) CDDP) for advanced biliary tract malignancies basically on an outpatient basis.

Methods: Between February 1996 and September 2003, 42 patients were enrolled in this trial. LFP THERAPY: By using a total implanted CV-catheter system, 5-FU (160 mg/m2/day) was continuously infused over 24 hours for 7 consecutive days and CDDP (6 mg/m2/day) was infused for 30 minutes twice a week as one cycle. The administration schedule consisted of 4 cycles as one course. RESIST criteria (Response evaluation criteria for solid tumors) and NCI-CTC (National Cancer Institute-Common Toxicity Criteria) (ver.3.0) were used for evaluation of this therapy. The median survival time (MST) and median time to treatment failure (TTF) were calculated by the Kaplan-Meier method.

Results: Patients characteristics were: mean age 66.5(47-79): male 24 (54%): BDca (bile duct carcinoma) 27 GBca (Gallbladder carcinoma) 15: locally advanced 26, postoperative recurrence 16. The most common toxicity was anemia (26.2%). Neither any treatment related death nor grade 4 toxicity occurred. The median number of courses of LFP Therapy which patients could receive was two (1-14). All the patients are evaluable for effects with an over all response rates of 42.9% (95% confidence interval C.I.: 27.7-59.0) (0 CR, 18 PR, 13 NC, 11 PD). There was no significant difference regarding the anti tumor effects against both malignant neoplasms. Figure 2 Shows the BDca a longer MST and TTF than did GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.The estimated MST and median TTF were 225 and 107 days, respectively. The BDca had a longer MST and TTF than GBca (234 vs 150, 117 vs 85, respectively), but neither difference was statistically significant.

Conclusion: LFP therapy appears to be useful modality for the clinical management of advanced biliary tract malignancy.

Show MeSH
Related in: MedlinePlus