Phase I trial of erlotinib combined with cisplatin and radiotherapyfor patients with locallyAdvanced Cervical Squamous Cell Cancer
Rodrigues, Angelica Nogueira; Carmo, Cla£dio C. do; Viegas, Clia; Erlich, Felipe; CamisÆo, Cl udia; FontÆo, Karina; Lima, Roberta; Herchenhorn, Daniel; Martins, Renato G; Moralez, Giulliana M; Small, Isabele A; Ferreira, Carlos Gil.
Clin Cancer Res
; 14: 6324-6329, 30 sept. 2008. tab
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| TXTC | ID: txt-23715
Purpose:
This phase I trial was aimed to determine the maximum tolerated dose and related toxicity of erlotinib( E) when administered concurrently with standard chemoradiation (CRT) forcervical cancer. ExperimentalDesign:
In a modified Fibonacci design, the study aimed to study three cohortsof at least three patients receiving escalating doses of erlotinib( 50/100/150 mg) combined withcisplatin (40 mg/m2, weekly, 5 cycles) and radiotherapy (external beam 4,500 cGy in 25 fractions, followed by 4 fractions/600 cGy/weekly of brachytherapy) in squamous cell cervicalcarcinoma patients, stage IIB to IIIB.Results:
Fifteenpatients were enrolled, 3 at dose level (DL) 50mg,4 atDL100mg, and 8 at DL 150 mg. Patients presented median age 47 (36-59), stage IIB (46.2%) and IIIB (53.8%). Overall,E+CRTwas well-tolerated.Three patients did not complete the planned schedule. One patient at DL 100 mg withdrew informed consent due to grade 2 rash; at DL 150 mg, 1patient presentedRaynauds Syndrome and had C interrupted, and another patient presented grade 4 hepatotoxicity.The latter was interpreted as dose limiting toxicity and a new cohort of 150 mg was started. No further grade 4 toxicity occurred. Grade 3 toxicity occurred in 6 cases diarrhea in3 patients, rash in 2 patients, and leukopenia in 1patient. E+CRTdid not lead to limiting in-field toxicity.Conclusions:
E+CRT is feasible to locally advanced squamous cell cervical cancer and is well tolerated.Themaximumtolerated dose has been defined as150mg.To the best of our knowledge, this is the first report of a combination of erlotinib, cisplatin, and pelvic radiotherapy.(AU)
Biblioteca responsable:
BR440.1
Ubicación: BR440.1
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