Phase I/II trial of external irradiation plus medium-dose brachytherapy given concurrently to liposomal doxorubicin and cisplatin for advanced uterine cervix carcinoma

Strahlentherapie und Onkologie : Organ der Deutschen Röntgengesellschaft ... [et al]
Haralambos VarverisMaria Vlachaki

Abstract

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. 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/m2/week was increased in 5-mg/m2 increments to two levels. The standard dose of CDDP was 20-25 mg/m2/week. Concurrent chemoradiation (CCRT) sequelae and the DLTs (grade 3 myelotoxicity and grade 3 proctitis in five patients treated at the 17 mg/m2/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...Continue Reading

Citations

Feb 21, 2008·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·J KodamaY Hiramatsu
Jan 25, 2013·Therapeutic Delivery·Seth M Miller, Andrew Z Wang
Mar 31, 2009·Strahlentherapie und Onkologie : Organ der Deutschen Röntgengesellschaft ... [et al]·Viorica NagyNicolae Ghilezan
Sep 17, 2009·Strahlentherapie und Onkologie : Organ der Deutschen Röntgengesellschaft ... [et al]·Mihály PatyánikArpád Mayer

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