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Toxicity and morbility after isolated lower limb perfusion in 242 chemo-hyperthermal treatments for cutaneous melanoma: the experience of the Tuscan Reference Centre.

Pace M, Gattai R, Matteini M, Mascitelli EM, Bechi P - J. Exp. Clin. Cancer Res. (2008)

Bottom Line: Local and systemic side-effects were transient; no permanent neurological limb deficit was registered.These data suggested that the technical implementations reduced the occurrence and the severity of the side effects and complications.The essential requirement for HILP is the quality assurance of the procedures.

View Article: PubMed Central - HTML - PubMed

Affiliation: Dept, of Medical and Surgical Critical Care, University of Florence, Regional Reference Centre of Tuscany for Locoregional Perfusional Therapies in Oncology, Florence, Italy. marcello.pace@unifi.it

ABSTRACT

Background: The aim of this retrospective study was to assess the results concerning the regional and systemic toxicity and complications in 242 chemo-hyperthermal treatments (HILPs) for lower limb melanoma.

Patients and methods: 60 HILPs (G-A) were performed with mild HT plus L-PAM (10 mg/lt) +/- D-actimomycin; 74 HILPs (G-B) with true HT (40-41.8 degrees C) plus L-PAM (10 mg/lt) +/- D-act; 108 HILPs (G-C) with true HT plus L-PAM (10 mg/lt) +/- D-act plus L-PAM (5 mg/lt) additional bolus.

Results: Limb toxicity was very low in G-A and in G-B; increasing toxicity (grade III = 37%) in G-C; no grade IV statistical difference was registered in all three groups, with percentage values among 1.6% and 2.7%. Systemic toxicity showed itself only in the haemopoietic parameters. No differences were registered in G-B vs G-A group. In G-C vs G-B a significative increase of systemic toxicity was seen in grade 3 (p < 0.05). Postoperative complications were acceptable. Local and systemic side-effects were transient; no permanent neurological limb deficit was registered. The postoperative mortality was recorded in 3/182 HILPs (1.6%) of the G-B and G-C groups.

Conclusion: These data suggested that the technical implementations reduced the occurrence and the severity of the side effects and complications. The essential requirement for HILP is the quality assurance of the procedures. Although higher regional and systemic toxicity were observed in the G-C group caused by L-PAM additional bolus, the safeness of the procedures under the true hyperthermal regimen and the time increase of the high L-PAM concentration have assured the treatment reliability along with the increased clinical efficacy expectations of the treatments.

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Related in: MedlinePlus

D.A. – ILP (28.03.07) – Typical temperature profile during lower limb perfusion with L-PAM bolus (10 mg/lt) plus additional bolus (5 mg/lt).
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Figure 1: D.A. – ILP (28.03.07) – Typical temperature profile during lower limb perfusion with L-PAM bolus (10 mg/lt) plus additional bolus (5 mg/lt).

Mentions: When the extracorporeal circulation starts, the administration of L-PAM is performed when the limb temperature has reached 40°C and the active phase starts. D-actinomycin when employed, is administered ten minutes before L-PAM. The chemo-hyperthermal phase is maintained for 60 minutes at the temperature range of 41–41.8°C. The additional bolus (5 mg/lt) is administered 30 minutes after the first L-PAM standard dosage, during the active phase, in order to maintain a high concentration for a longer time. The perfusate flow is maintained at 600–800 ml/min during the transitory thermal phase of the prime heating. Typically, when the limb temperature reaches 40°C, the flow rate may be reduced up to 300–400 ml/min before the drug administering. This action allows to contain the systemic leakage and at the same time checking that the various temperatures remain substantially constant in time. Afterwards, the perfusate flow rate is again risen step by step so that the temperature will rise to 41.5–41.8°C. Figs. 1 and 2 show the temperatures/time and leakage/time typical profiles of the borderline true HILP with double L-PAM bolus.


Toxicity and morbility after isolated lower limb perfusion in 242 chemo-hyperthermal treatments for cutaneous melanoma: the experience of the Tuscan Reference Centre.

Pace M, Gattai R, Matteini M, Mascitelli EM, Bechi P - J. Exp. Clin. Cancer Res. (2008)

D.A. – ILP (28.03.07) – Typical temperature profile during lower limb perfusion with L-PAM bolus (10 mg/lt) plus additional bolus (5 mg/lt).
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2602991&req=5

Figure 1: D.A. – ILP (28.03.07) – Typical temperature profile during lower limb perfusion with L-PAM bolus (10 mg/lt) plus additional bolus (5 mg/lt).
Mentions: When the extracorporeal circulation starts, the administration of L-PAM is performed when the limb temperature has reached 40°C and the active phase starts. D-actinomycin when employed, is administered ten minutes before L-PAM. The chemo-hyperthermal phase is maintained for 60 minutes at the temperature range of 41–41.8°C. The additional bolus (5 mg/lt) is administered 30 minutes after the first L-PAM standard dosage, during the active phase, in order to maintain a high concentration for a longer time. The perfusate flow is maintained at 600–800 ml/min during the transitory thermal phase of the prime heating. Typically, when the limb temperature reaches 40°C, the flow rate may be reduced up to 300–400 ml/min before the drug administering. This action allows to contain the systemic leakage and at the same time checking that the various temperatures remain substantially constant in time. Afterwards, the perfusate flow rate is again risen step by step so that the temperature will rise to 41.5–41.8°C. Figs. 1 and 2 show the temperatures/time and leakage/time typical profiles of the borderline true HILP with double L-PAM bolus.

Bottom Line: Local and systemic side-effects were transient; no permanent neurological limb deficit was registered.These data suggested that the technical implementations reduced the occurrence and the severity of the side effects and complications.The essential requirement for HILP is the quality assurance of the procedures.

View Article: PubMed Central - HTML - PubMed

Affiliation: Dept, of Medical and Surgical Critical Care, University of Florence, Regional Reference Centre of Tuscany for Locoregional Perfusional Therapies in Oncology, Florence, Italy. marcello.pace@unifi.it

ABSTRACT

Background: The aim of this retrospective study was to assess the results concerning the regional and systemic toxicity and complications in 242 chemo-hyperthermal treatments (HILPs) for lower limb melanoma.

Patients and methods: 60 HILPs (G-A) were performed with mild HT plus L-PAM (10 mg/lt) +/- D-actimomycin; 74 HILPs (G-B) with true HT (40-41.8 degrees C) plus L-PAM (10 mg/lt) +/- D-act; 108 HILPs (G-C) with true HT plus L-PAM (10 mg/lt) +/- D-act plus L-PAM (5 mg/lt) additional bolus.

Results: Limb toxicity was very low in G-A and in G-B; increasing toxicity (grade III = 37%) in G-C; no grade IV statistical difference was registered in all three groups, with percentage values among 1.6% and 2.7%. Systemic toxicity showed itself only in the haemopoietic parameters. No differences were registered in G-B vs G-A group. In G-C vs G-B a significative increase of systemic toxicity was seen in grade 3 (p < 0.05). Postoperative complications were acceptable. Local and systemic side-effects were transient; no permanent neurological limb deficit was registered. The postoperative mortality was recorded in 3/182 HILPs (1.6%) of the G-B and G-C groups.

Conclusion: These data suggested that the technical implementations reduced the occurrence and the severity of the side effects and complications. The essential requirement for HILP is the quality assurance of the procedures. Although higher regional and systemic toxicity were observed in the G-C group caused by L-PAM additional bolus, the safeness of the procedures under the true hyperthermal regimen and the time increase of the high L-PAM concentration have assured the treatment reliability along with the increased clinical efficacy expectations of the treatments.

Show MeSH
Related in: MedlinePlus