Bloss J D, Lucci J A, DiSaia P J, Manetta A, Schiano M A, Ramsinghani N, Berman M L
Division of Gynecologic Oncology, Wilford Hall USAF Medical Center, Lackland Air Force Base, Texas 78236, USA.
Gynecol Oncol. 1995 Oct;59(1):105-10. doi: 10.1006/gyno.1995.1275.
This prospective trial was designed to access the efficacy and safety of neoadjuvant chemotherapy followed by radical hysterectomy and/or radiation therapy in women with advanced carcinoma of the uterine cervix.
Thirty women, clinical stages IIb-IVa, were enrolled in this clinical trial. Initial treatment consisted of three cycles of bleomycin, cisplatin, and vincristine administered every 10 days. Depending on the extent of disease after chemotherapy, patients then either underwent radical hysterectomy with bilateral pelvic and periaortic lymphadenectomy or surgical staging. Following review of the surgical findings, tailored radiotherapy was administered.
Only 10 women (34%) had tumor regression from neoadjuvant chemotherapy sufficient to allow radical hysterectomy prior to tailored adjuvant radiotherapy; the remainder received primary radiotherapy after surgical staging. Two-year disease-free survival was 68, 43, and 0% for women with clinical stages II, III, and IV, respectively. Four women experienced acute toxicity from chemotherapy requiring medical intervention and eight women suffered chronic toxicities requiring hospitalization and/or surgery.
The neoadjuvant chemotherapy utilized in this trial was generally ineffective in converting patients from inoperable to operable, had no apparent effect on survival, and was associated with significant toxicity.
本前瞻性试验旨在评估新辅助化疗后行根治性子宫切除术和/或放射治疗对晚期宫颈癌女性患者的疗效和安全性。
30例临床分期为IIb-IVa期的女性患者纳入本临床试验。初始治疗为每10天给予博来霉素、顺铂和长春新碱三个周期的化疗。根据化疗后疾病的范围，患者随后要么接受根治性子宫切除术及双侧盆腔和腹主动脉旁淋巴结清扫术，要么接受手术分期。在对手术结果进行评估后，给予针对性的放射治疗。
仅10例女性患者（34%）新辅助化疗后肿瘤缩小，足以在进行针对性辅助放疗前行根治性子宫切除术；其余患者在手术分期后接受了原发性放射治疗。临床分期为II期、III期和IV期的女性患者的两年无病生存率分别为68%、43%和0%。4例患者出现需要医疗干预的化疗急性毒性反应，8例患者出现需要住院和/或手术治疗的慢性毒性反应。
本试验中使用的新辅助化疗通常无法使患者从不可手术转变为可手术，对生存率无明显影响，且伴有显著毒性。
