title: Chemoradiation with paclitaxel and carboplatin in high-risk cervical cancer patients after radical hysterectomy: a Korean Gynecologic Oncology Group study.
abstract: OBJECTIVE
  To evaluate the efficacy and toxicity of concurrent chemoradiation with paclitaxel and carboplatin in patients with high-risk cervical cancer.
  
  
  METHODS
  Patients after radical hysterectomy for cervical cancer, with at least 1 high-risk characteristic, were administered paclitaxel 135 mg/m(2), carboplatin area under the curve = 5 every 3 weeks for 3 cycles concomitant with radiation therapy as adjuvant treatment.
  
  
  RESULTS
  This prospective study enrolled 71 consecutive patients. Sixty-six patients (93%) completed the planned treatment. The majority of grade 3/4 neutropenia or nonhematologic toxicities were usually self-limited. Diarrhea grades 3/4 were observed in 4 patients (5.6%). One patient developed anaphylactic shock after infusion of paclitaxel. With a median follow-up of 57 months, recurrences occurred in 16 patients. Multivariable analysis indicated that common iliac lymph node involvement is an independent risk factor for disease recurrence (odds ratio 13.48; 95% confidence interval 2.93-62.03). In the intent-to-treat population (n=71), the estimated 5-year disease-free survival and overall survival rates were 77.3% and 80.3% respectively. In the per-protocol population (n=62), disease-free survival was 78.9% and overall survival was 83.9%.
  
  
  CONCLUSIONS
  Concurrent chemoradiation with paclitaxel/carboplatin is well tolerated and seems to be effective for patients who undergo radical hysterectomy. Therefore, a prospective, randomized controlled study should be designed to evaluate efficacy of this approach for patients with high-risk cervical cancer.
authors: Department of Obstetrics and Gynecology, SMG-SNU Boramae Medical Center, Seoul, Korea.
authors: Taek Sang
authors: TS
authors: Lee
authors: Soon Beom
authors: SB
authors: Kang
authors: Young Tak
authors: YT
authors: Kim
authors: Byung Joo
authors: BJ
authors: Park
authors: Yong Man
authors: YM
authors: Kim
authors: Jong Min
authors: JM
authors: Lee
authors: Seok Mo
authors: SM
authors: Kim
authors: Young Tae
authors: YT
authors: Kim
authors: Jae Hoon
authors: JH
authors: Kim
authors: Kyung Tai
authors: KT
authors: Kim
mesh_terms: D000230:Adenocarcinoma / Q000401:mortality / Q000473:pathology / Q000628:therapy; D000328:Adult; D000368:Aged; D000704:Analysis of Variance; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D019540:Area Under Curve; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018196:Carcinoma, Adenosquamous / Q000401:mortality / Q000473:pathology / Q000628:therapy; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy; D059248:Chemoradiotherapy / Q000009:adverse effects / Q000379:methods*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007044:Hysterectomy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011182:Postoperative Care / Q000379:methods; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D056910:Republic of Korea; D015996:Survival Rate; D002583:Uterine Cervical Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*
chemical_list: D016190:Carboplatin; D017239:Paclitaxel