Korean J Gynecol Oncol Colposc.  1999 Mar;10(1):39-46.

Phase II Study of FAC(5-FU/Interferon- a/CBDCA) as Neoadjuvant Chemotherapy in Patients with Locally Advanced and/or Bulky

• Kim YB
• Kim JW
• Park NH
• Song YS
• Kang SB
• Lee HP
• Kim MH

Abstract

Interferon(IFN) has been noted to augment the cytotoxicity of cisplatin analogues and S-FU, and varying degrees of success were reported when combined with chemotherapy in a number of squamous cell carcinomas. The aims of this study were to assess its therapeutic efficacy and to establish the feasibility and toxicity of biochemical modulation of the interferon-a-2a when combined with 5-FU and carboplatin(CBDCA) in locally advanced(> or =FIGO clinical stage IJb) and/or bulky(largest diameter > or = 3cm) cervical cancer. From January 1995 to December 1996, 20 patients with bulky and/or locally advanced cervical cancer were enrolled in this study and received FAC(5-FU/Interferon-a/CBDCA) combination chemotherapy as a neoadjuvant setting. The FAC regimen was composed of IFN- a -2a 3x10(6) IU/day from day l to day 6, 5-FU 750mg/m2/day from day 2 to day 6, and carboplatin at a dose calculated by Calvert formula with AUC(area under the curve) 6.0 on day 2. Three cycles of neoadjuvant chemotherapy was performed with 3 weeks interval if toxicity permitted it. Patients were examined after every treatment cycle and evaluated for toxicities and responses using standard GOG criteria. Two patients(10.0%) showed complete clinical response and 15 patients(75,0%) had partial response. The other patients had stable(10.0%) or progressive disease(5.0%). Among fifteen patients who have undergone radical hysterectomy, pathological complete response was not noted. Surgery was possible in 15 patients(75.0%) and 10 patients received adjuvant radiotherapy. Lymph node metastases were found in 5 patients(33.3%) and the number of positive nodes was ranged from 1 to 5. The most frequent grade 3 or 4 toxicity was neutropenia(60.0%) followed by alopecia(40.0%), nausea/vomiting(35.0%), thrombocytopenia(15.0%), diarrhea(5.0%), and anemia(5.0%). (continue)

MeSH Terms

Carboplatin
Carcinoma, Squamous Cell
Cisplatin
Drug Therapy*
Drug Therapy, Combination
Fluorouracil
Humans
Hysterectomy
Lymph Nodes
Neoplasm Metastasis
Radiotherapy, Adjuvant
Uterine Cervical Neoplasms
Carboplatin
Cisplatin
Fluorouracil