TY - JOUR
TI - Phase I/II trial of external irradiation plus medium-dose brachytherapy
given concurrently to liposomal doxorubicin and cisplatin for advanced
uterine cervix carcinoma
AU - Varveris, H
AU - Kachris, S
AU - Mazonakis, M
AU - Lyraraki, E and
AU - Petineli, E
AU - Varveris, A
AU - Fasoulaki, A
AU - Tzedakis, A and
AU - Kouloulias, V
AU - Zolindaki, A
AU - Vlachaki, M
JO - Strahlentherapie und Onkologie
PY - 2006
VL - 182
TODO - 3
SP - 125-134
PB - Urban & Vogel Medien & Medizin
SN - 0179-7158, 1439-099X
TODO - 10.1007/s00066-006-1440-0
TODO - cervical cancer; radiotherapy; cisplatin; liposomal doxorubicin
TODO - Background and Purpose: Although the standard of care for patients with
Locally advanced uterine cervix carcinoma is cisplatin-(CDDP-) based
chemotherapy and irradiation (RT), the optimal regimen remains to be
elucidated. A phase I/II study was conducted to evaluate the dose
Limiting toxicity (DLT) and the maximum tolerated dose (MTD) of
liposomal doxorubicin (Caelyx) combined with CDDP and RT for cervical
cancer.
Patients and Methods: 24 patients with stage IIB-IVA were enrolled
(Table 1). They all received external RT (up to 50.4 Gy) and two
medium-dose rate (MDR) brachytherapy implants (20 Gy each at point A).
The Caelyx starting dose of 7 mg/m(2)/week was increased in 5-mg/m(2)
increments to two levels. The standard dose of CDDP was 20-25
mg/m(2)/week.
Results: Concurrent chemoradiation (CCRT) sequelae and the DLTs (grade 3
myelotoxicity and grade 3 proctitis in five patients treated at the 17
mg/m(2)/week Caelyx dose level) are shown in Tables 2, 3, 4, and 5.
After a median follow-up time of 17.2 months (range 4-36 months), four
patients had died, 15 showed no evidence of progressive disease, and
five (20.8%, 95% confidence interval [CI]: 12.5-29.1%) were alive
with relapse (Figure 1). There were seven complete (29.1%, 95% CI:
19.8-38.4%) and 17 partial clinical responses (95% CI: 61.1-80.1%).
The median progression-free survival was 10.4 months. Causes of death
were local regional failure with or without paraaortic node relapse
combined with distant metastases (Table 6).
Conclusion: The MTD of Caelyx given concurrently with CDDP and RT was
determined at the 12 mg/m(2)/week dose level. The above CCRT schema is a
well-tolerated regimen, easy to administer in ambulatory patients, and
results appear promising.
ER -