Adjuvant chemotherapy versus chemotherapy plus pelvic irradiation for high-risk cervical cancer patients after radical hysterectomy and pelvic lymphadenectomy (RH-PLND): a randomized phase III trial

Gynecol Oncol. 1996 Apr;61(1):3-10. doi: 10.1006/gyno.1996.0087.

Abstract

Objective: To compare the clinical efficacy of adjuvant chemotherapy a lone vs chemotherapy plus whole pelvic radiation therapy (RT) on recurrence rates, patterns of recurrence, and survival of patients post-RH-PLND for cervical cancer at high risk for recurrence.

Methods: Prospective multicenter randomized Phase III trial. Patients with Stage IB-IIA cervical cancer undergoing RH-PLND were eligible. Risk factors include deep cervical invasion, tumor > or = 4 cm, parametrial involvement, nonsquamous histology, and/or pelvic lymph node metastasis. Chemotherapy consisted of cisplatin and bleomycin, alone or in combination with whole pelvic RT. Survival was determined by Kaplan-Meier estimate.

Results: Eighty-nine patients were entered from 1987 to 1994. Seventy-five patients had a Stage IB cancer and 14 patients had Stage IIA. Twenty-five patients had > or = 3 risk factors. Forty-four patients received chemotherapy alone vs 45 patients treated with chemotherapy and RT. Nineteen patients had recurrences and 16 patients have died. Nine of 44 (20%) patients receiving chemo alone recurred compared to 10/45 (22%) patients receiving chemo and RT (P=ns). Patterns of recurrence were statistically similar between the two treatment arms, even among the subgroup of patients with > or = 3 risk factors. Both regimens were well tolerated.

Conclusion: CT + RT did not prove a superior adjuvant therapy for patients at high risk of recurrence after RH-PLND for early cervical cancer in this limited trial. Recurrence rates and patterns of recurrences (local, regional, or distant) were not influenced by the addition of RT.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bleomycin / administration & dosage
  • Chemotherapy, Adjuvant
  • Cisplatin / administration & dosage
  • Female
  • Humans
  • Hysterectomy*
  • Lymph Node Excision*
  • Middle Aged
  • Pelvis / radiation effects*
  • Pelvis / surgery
  • Prospective Studies
  • Risk Factors
  • Survival Analysis
  • Treatment Outcome
  • Uterine Cervical Neoplasms / drug therapy
  • Uterine Cervical Neoplasms / pathology
  • Uterine Cervical Neoplasms / radiotherapy
  • Uterine Cervical Neoplasms / surgery
  • Uterine Cervical Neoplasms / therapy*

Substances

  • Bleomycin
  • Cisplatin