A Phase I Study using low-dose fractionated whole abdominal radiotherapy as a chemopotentiator to full-dose cisplatin for optimally debulked stage III/IV carcinoma of the endometrium

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• 作者：Dené ; C. Wrenn^a ; Kunal Saigal^b ; Joseph A. Lucci III^a ; Matthew J. Pearson^a ; Fiona Simpkins^a ; Samer Schuman^a ; Leo B. Twiggs^a ; Gail R. Walker^c ; Aaron H. Wolfson^b ; ^{AWolfson@med.miami.edu"" rel=""nofollow}
• 关键词：Endometrial cancer ; Chemopotentiator ; Abdominal radiation ; Cisplatin
• 刊名：Gynecologic Oncology
• 出版年：2011
• 出版时间：July 2011
• 年：2011
• 卷：122
• 期：1
• 页码：59-62
• 全文大小：191 K

文摘

Objective

To evaluate the feasibility of combining low-dose fractionated whole abdominal radiation (LDF-WAR) with weekly full-dose cisplatin (FD-CDDP) for patients with stage III/IV endometrial carcinoma.

Methods

Patients with optimally debulked stage III/IV carcinoma of the endometrium (without extra-abdominal disease) were eligible for the study. Postoperatively, patients received the institutional standard systemic chemotherapy and vaginal brachytherapy. Patients then underwent experimental six weekly cycles of FD-CDDP (40 mg/m², maximum 70 mg IV) followed by LDF-WAR 6–8 hours after initiation of chemotherapy. In a conservative design, 6 patients were accrued to two sequential cohorts of LDF-WAR, at 0.5 Gy/fraction [Fx] (total 3 Gy) and 0.75 Gy/Fx (total 4.5 Gy). Toxicities and laboratory studies were evaluated at each visit.

Results

Twelve patients were enrolled from January 2005 to June 2009 with median follow-up of 13.5 months (range: 5–27 months). Seventy-five percent of enrolled patients had uterine papillary serous histology. Eleven patients at least partially completed therapy (range: 2–6 cycles of FD-CDDP/LDF-WAR) with one additional patient opting out at the higher dose level. Combination therapy overall was well tolerated. Three patients in each cohort experienced grade 3 acute hematologic events with one recorded grade 4 toxicity in the second cohort. Of patients receiving any of the experimental treatment, five have experienced recurrences. Three of these patients were in cohort one and received 0.5 Gy/Fx LDF-WAR.

Conclusion

Combination therapy with LDF-WAR as a novel chemopotentiator to FD-CDDP is a feasible adjuvant regimen in optimally debulked patients with stage III/IV endometrial carcinoma. Further investigation is warranted to determine treatment efficacy.