Curtin J P, Hoskins W J, Venkatraman E S, Almadrones L, Podratz K C, Long H, Teneriello M, Averette H A, Sevin B U
Department of Surgery, Memorial Sloan-Kettering Cancer Center, New York, New York 10021, USA.
Gynecol Oncol. 1996 Apr;61(1):3-10. doi: 10.1006/gyno.1996.0087.
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.
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.
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.
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.
比较辅助化疗单独使用与化疗联合全盆腔放疗（RT）对复发风险高的宫颈癌患者行根治性子宫切除术加盆腔淋巴结清扫术（RH-PLND）后的复发率、复发模式及生存率的影响。
前瞻性多中心随机III期试验。符合条件的患者为接受RH-PLND的IB-IIA期宫颈癌患者。危险因素包括宫颈深层浸润、肿瘤≥4 cm、宫旁组织受累、非鳞状组织学类型和/或盆腔淋巴结转移。化疗由顺铂和博来霉素组成，单独使用或与全盆腔放疗联合使用。生存率通过Kaplan-Meier估计法确定。
1987年至1994年共纳入89例患者。75例为IB期癌症患者，14例为IIA期患者。25例患者有≥3个危险因素。44例患者接受单纯化疗，45例患者接受化疗加放疗。19例患者复发，16例患者死亡。44例接受单纯化疗的患者中有9例（20%）复发，而45例接受化疗加放疗的患者中有10例（22%）复发（P=无统计学意义）。两个治疗组的复发模式在统计学上相似，即使在有≥3个危险因素的患者亚组中也是如此。两种治疗方案耐受性均良好。
在这项有限的试验中，对于早期宫颈癌RH-PLND后复发风险高的患者，CT+RT并未被证明是一种更优的辅助治疗方法。放疗的加入并未影响复发率和复发模式（局部、区域或远处）。
