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

Abstract Objective: To compare the clinical efficacy of adjuvant chemotherapy alone 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 ≥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 ≥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 ≥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.