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Table 1 Design of clinical studies employing regional hyperthermia with chemotherapy

From: Regional hyperthermia combined with chemotherapy in paediatric, adolescent and young adult patients: current and future perspectives

Reference

Indication

Research design

Schedule of Hyperthermia/Number of sessions

Chemotherapy/Number of courses

Number of patients

Outcome measure

Comment

Romanowski Klinische Pädiatrie 1993 [10]

Different solid tumors with prognostically unfavorable tumor diseases

Feasibility of regional hyperthermia with systemic chemotherapy

Day 1 and 4 simultaneously to the chemotherapy (2–16 RHT sessions per patient; mean 6,5)

16 patients: IE: etoposide 4 x 150 mg/m2 and ifosfamide 4 x 2000 mg/m2

8 patients: ICE: etoposide 4 x 150 mg/m2 and ifosfamide 4 x 2000 mg/m2 or every 2nd cycle carboplatinum 4 x 150 mg/m2

10 patients received various substances including adriamycin

Mean 3 treatment courses

34 (age: mean 11 years: 6 month)

Feasability study

First study in children and adolescents on RHT and Chemotherapy

20 % complete remission

7 patients were in CR up to 64 month

Wessalowski R.

Klinische Pädiatrie 1997 [11]

Locoregional Recurrences of abdominal Germ Cell Tumors

Pilot study

PEI-chemotherapy and RHT compared to a mached cohort

Day 1 and 4 simultaneously to the chemotherapy

(6–30 RHT sessions per patient; mean 12,4)

PEI: cisplatinum 40 mg/m2 on day 1 and 4; etoposide 100 mg/m2 on day 1 to 4 and ifosfamide 2000 mg/m2 on day 1 to 4)

Mean 6 treatment courses

9 RHT (age: mean 10 years; 11 month)

23 matched cohort

RHT subgroup

5-year EFS 0.41 ± 0.33

(5 CR, 2PR, 1SD, 1PD)

matched cohort 5-year EFS 0.16 ± 0.25

 

Wessalowski R.

Cancer. 1998 [12]

Recurrence of an Malignant sacrococcygeal germ cell tumors

Phase I/II study

Day 1 and 4 simultaneously to the chemotherapy

(6–10 RHT sessions per patient; mean 8,8)

PEI: cisplatinum 40 mg/m2 on day 1 and 4; etoposide 100 mg/m2 on day 1 to 4 and ifosfamide 2000 mg/m2 on day 1 to 4)

Mean 4 treatment courses

10 (age: mean 11 years; 3 month)

Phase I/II study

Toxicity

(5 CR, 2PR, 1SD. 1NC, 1PD)

WHO grade 4 neutropenia and thrombocytopenia after all cycles

Granulocytopenic fever after 27 % cycles; WHO grade-3 acute renal toxicity after 5 % cycles; WHO grade 3 mucositis after 11 % cycles

Schneider D.

J Clin Oncol, 2001 [7]

Relapsed or refractory germ cell tumour

Subgroup in a prospective study

no control group

Day 1 and 4 simultaneously to the chemotherapy

PEI: cisplatinum 40 mg/m2 on day 1 and 4; etoposide 100 mg/m2 on day 1 to 4 and ifosfamide 2000 mg/m2 on day 1 to 4)

A subgroup of 8 Patients (age: mean 11 years; 3 month) with RHT out of 22 first-, 14 s-, 5 third-, and 2 fourth-relapse

5 CR, 2 PR

 

Wessalowski R.

Klinische Pädiatrie 2003 [9]

Unresectable malignant tumours

(24 extracranial non-testicular germ cell tumours; 15 soft tissue or chondrosarcomas)

Phase-II study

PEI-chemotherapy and RHT

Day 1 and 4 simultaneously to the chemotherapy

(6–10 RHT sessions per patient; mean 8,5)

PEI: cisplatinum 40 mg/m2 on day 1 and 4; etoposide 100 mg/m2 on day 1 to 4 and ifosfamide 2000 mg/m2 on day 1 to 4)

Three to four treatment courses

24 Germ cell tumours (age: mean 3 years; 7 month)

15 Soft tissue sarcoma (age: mean 7 years; 6 month)

Whole study cohort

median follow-up 27 months

5-year EFS 0.39 +/− 0.11 (20/39 patients)

5-year OS 0.52 +/− 0.11 (25/39 patients)

13 patients received local radiotherapy

Wessalowski R.

The Lancet Oncology, 2013 [8]

Relapsed or refractory germ cell tumour

Prospective study

no control group

Day 1 and 4 simultaneously to the chemotherapy

(6–10 RHT sessions per patient; mean 8,2)

PEI: cisplatinum 40 mg/m2 on day 1 and 4; etoposide 100 mg/m2 on day 1 to 4 and ifosfamide 2000 mg/m2 on day 1 to 4)

Three to four treatment courses

44 (age: median 2 years; 7 months)

response to treatment

16 patients had CR and 14 had PR

median follow-up 82 months

5-year event-free survival was 62 % (95 % CI 45–75)

5-year overall survival was 72 % (95 % CI 55–83).

Local radiotherapy if incompletely resected

WHO grade 3–4 neutropenia and thrombocytopenia after every cycle.

Granulocytopenic fever in 29 (66 %) of 44 patients after 53 (29 %) cycles.

WHO grade-3 acute renal toxic effects in five patients