Conference Paper
Critical Analysis of Electromagnetic Hyperthermia Randomized Trials: Dubious Effect and Multiple Biases
Table 9
Analysis of available randomized clinical trials on TRT of cervix cancer.
| | | Harima et al., 2001 [24] | Vasanthan et al., 2005 [15] | van der Zee et al., 2000 [21] |
| | Country | Japan | India, Republic of Korea, China, Ukraine | The Netherlands | | Centers | 1 | 5 | 11 (2 subtrials) | | Enrollment period | 1994–1999 (5 y) | 1998–2002 (4 y) | 1990–1996 (6 y) |
| | | TRT arm | RT arm | TRT arm | RT arm | TRT arm | RT arm |
| | Patients characteristics |
| | Prior treatment | Not pretreated | Not pretreated | Not pretreated | | Age | 64.9 | 61.6 | 50 | 45 | 51 | 50 |
| | Number of patients |
| | Total | 40 | 110 | 114 | | By groups | 20 | 20 | 55 | 55 | 58 | 56 |
| | FIGO stage |
| | IIb | | | 29 (52.7%) | 27 (49.1%) | 11 (19.0%) | 11 (19.6%) | | IIIa | | | 6 (10.9%) | 3 (5.5%) | 0 (0.0%) | 1 (1.8%) | | IIIb | 20 (100%) | 20 (100%) | 19 (34.5%) | 23 (41.8%) | 40 (69.0%) | 40 (71.4%) | | Iva | | | 1 (1.8%) | 2 (3.6%) | 7 (12.1%) | 4 (7.1%) |
| | Tumor characteristics |
| | Size | 5.9 | 6.1 | [4.6] | [4.9] | [7.1] | [7.0] | | Volume | [107] | [118] | 49.5 | 60.3 | [187] | [179] | | Histology | | | | | | | | Squamous cell carcinoma | 17 (85.0%) | 18 (90.0%) | 52 (94.5%) | 51 (92.7%) | 51 (87.9%) | 46 (82.1%) | | Adenocarcinoma | 3 (15.0%) | 2 (10.0%) | 1 (1.8%) | 3 (5.5%) | 4 (6.9%) | 7 (12.5%) | | Other | | | 2 (3.6%) | 1 (1.8%) | 3 (5.2%) | 3 (5.4%) |
| | Hyperthermia | |
Number of sessions |
| | 0 | | | >0% | | 7 (12.1%) | | | 1–3 | | | | | 11 (19.0%) | | | 3 | 20 (100%) | | | | | | | 3–7 | | | <100% | | | | | 4–6 | | | | | 40 (69.0%) | |
| | Technology |
| | HT-system | Thermotron RF8 | | Thermotron RF8 | | BSD-2000 TEM 4-waveguide | | | Technology | Capacitive | | Capacitive | | APAS, TEM, 4-WG | | | Outside heating | 100% | | 100% | | 100% | | | Intracavitary heating | | | 49% | | | | | Frequency | 8 MHz | | 8 MHz | | 10–120 MHz | |
| | HT treatment parameters |
| | Power | 800–1500 W | | 450–? W | | N/A | | | RT-coupling | 30′ after RT | | just after RT | | 1–4 hr after RT | | | Heating period | 20′ | | [20′] | | <30′ | | | HT-period | 60′ | | 60′ | | 60′ | | | HT sessions | 3 | | 5 | | 5 | | | Frequency | 1/week | | 1/week | | 1/week | |
| | Thermal control |
| | Thermosensors | Intratumoral | | Intratumoral and intraluminar | | Intraluminar | | | Measuring points | 4 point | | 2 point (IL + IT) | | 1 point | | | Measurement | 100% | | ~2.5 times per course | | Only part of sessions | | | 41.8 | | 42.1 | | N/A [40.0] [37] | | | 40.6 | | 41.6 | | N/A [39.5] [37] | | | 39.6 | | 41 | | N/A | |
| | Radiotherapy |
| | Coverage | 100% | N/A [90%?] | 98% | 96% | | Total dose (TD) | 82.2 Gy | ≈84 Gy | 68 Gy | 67 Gy | | to tumor mass (TMD) | 60.6 Gy | ≈72 Gy | N/A (<68 Gy) | N/A (<67 Gy) |
| | External-beam radiotherapy (EBRT) |
| | Technology | 6 MV | 6–18 MV (>70%), 60Co (<30%), | Linear accelerators | | Single dose | 1.8 Gy | 2 Gy | 1.8–2.0 Gy | | Total dose | 52.2 Gy | ≈62 Gy | 46–50.4 Gy | | to whole pelvis | 30.6 Gy | ≈50 Gy | N/A (<46–50.4 Gy) | | to pelvis wall | 21.6 Gy | ≈12 Gy | N/A |
| | Brachytherapy (BT) |
| | High-dose rate (HDR) | 100% | 49% | 33% | | Low-dose rate (LDR) | | 51% | 46% | | Coverage | 100% | N/A |
79% (for others EBRT boost was used) | | Single dose | 7.5 Gy | | | | | | Total dose | 30 Gy | 22 Gy | 17 Gy (LDR), 20–30 Gy (HDR) | | BT% TD/TMD | 37%/50% | 26%/30% | 25%–44% |
| | Clinical results |
| | CLR | 80% | 50% | 80% | 83% | 57% | | LDFS 3 y | 80% | 49% | 69% | 61% | 41% | | OS 3 y | 58% | 48% | 73% | 51% | 27% |
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