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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