ADJUVANT CHEMOTHERAPY VERSUS CHEMOTHERAPY PLUS PELVIC IRRADIATION FORHIGH-RISK CERVICAL-CANCER PATIENTS AFTER RADICAL HYSTERECTOMY AND PELVIC LYMPHADENECTOMY (RH-PLND) - A RANDOMIZED PHASE-III TRIAL

Objective: To compare the clinical efficacy of adjuvant chemotherapy a lone vs chemotherapy plus whole pelvic radiation therapy (RT) on recur rence rates, patterns of recurrence, and survival of patients post-RH- PLND for cervical cancer at high risk for recurrence. Methods: Prospec tive multicenter randomized Phase III trial. Patients with Stage IB-II A cervical cancer undergoing RH-PLND were eligible, Risk factors inclu de deep cervical invasion, tumor greater than or equal to 4 cm, parame trial involvement, nonsquamous histology, and/or pelvic lymph node met astasis, Chemotherapy consisted of cisplatin and bleomycin, alone or i n combination with whole pelvic RT. Survival was determined by Kaplan- Meier estimate. Results: Eighty-nine patients were entered from 1987 t o 1994. Seventy-five patients had a Stage IB cancer and 14 patients ha d Stage IIA. Twenty-five patients had 93 risk factors, Forty-four pati ents received chemotherapy alone vs 45 patients treated with chemother apy and RT. Nineteen patients had recurrences and 16 patients have die d, Nine of 44 (20%) patients receiving chemo alone recurred compared t o 10/45 (22%) patients receiving chemo and RT (P = ns). Patterns of re currence were statistically similar between the two treatment arms, ev en among the subgroup of patients with greater than or equal to 3 risk factors. Both regimens were well tolerated, Conclusion: CT + RT did n ot prove a superior adjuvant therapy for patients at high risk of recu rrence after RH-PLND for early cervical cancer in this limited trial. Recurrence rates and patterns of recurrences (local, regional, or dist ant) were not influenced by the addition of RT. (C) 1996 Academic Pres s, Inc.