Phase I clinical trial of chemoimmunotherapy in combination with radiotherapy in stage IIIB cervical cancer patients.
To determine the feasibility and toxicity of a chemoimmunotherapy regimen in combination with radiotherapy in stage IIIB cervical cancer patients, cisplatin 10-20 mg/m(2) intravenous (iv) weekly, 5-fluorouracil (5FU) 500 mg/m(2) (24-h infusion) weekly, interferon alpha-2a 3 MU subcutaneously 3 days a week, and 13-cis-retinoic acid 0.5 mg/kg/day orally were given in concurrence with 8-week period of radiotherapy and continued for another 4 weeks after finishing radiotherapy. The dose of cisplatin was escalated from 10 mg/m2 in the first group of three patients (level 1) to 15 mg/m(2) in the second group of three patients (level 2) and to 20 mg/m(2) in the third group of two patients (level 3) if the former groups could tolerate the drugs well. Patients in levels 1 and 2 had tolerable toxicities. Two patients in level 3 experienced grade 4 leukopenia, so chemoimmunotherapy was discontinued after 2 and 3 cycles orderly. After recovery from toxicities, they continued with radiotherapy. In conclusion, cisplatin 15 mg/m2, 5-FU 500 mg/m(2) weekly, interferon alpha-2a 3 MU subcutaneously 3 days a week, and 13-cis-retinoic acid 0.5 mg/kg/day orally in combination with radiotherapy in stage IIIB cervical cancer patients is tolerable. Leukopenia is the dose-limiting toxicity.
Wilailak
S
S
Department of Obstetrics and Gynaecology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. rasw1@mahidol.ac.th
Dangprasert
S
S
Srisupundit
S
S
D000284:Administration, Oral; D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D007167:Immunotherapy; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000008:administration & dosage; D015474:Isotretinoin / Q000008:administration & dosage; D008875:Middle Aged; D009367:Neoplasm Staging; D018714:Radiotherapy, Adjuvant; D011994:Recombinant Proteins; D016896:Treatment Outcome; D002583:Uterine Cervical Neoplasms / Q000473:pathology / Q000628:therapy*
D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D015474:Isotretinoin; D002945:Cisplatin; D005472:Fluorouracil