Concomitant boost plus large-field preoperative chemoradiation in locally advanced uterine cervix carcinoma: Phase II clinical trial final results (LARA-CC-1)

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• 作者：Gabriella Macchia^a ; ^{gmacchia@rm.unicatt.it} ; Alessio G. Morganti^a ; ^b ; Francesco Deodato^a ; Savino Cilla^c ; Alessandro Lucidi^d ; Mariangela Massaccesi^a ; Giovanni Scambia^e ; Vincenzo Valentini^b ; Numa Cellini^b ; Gabriella Ferrandina^d
• 关键词：Locally advanced cervical cancer ; Frozen section analysis ; Preoperative chemoradiation ; Concomitant boost radiotherapy
• 刊名：Gynecologic Oncology
• 出版年：2012
• 期刊代码：295_00908258
• 类别：med
• 出版时间：June, 2012
• 卷：125
• 期：3
• 页码：594-599
• 文件大小：285 K

摘要

Objective

To report the Phase II study final results in terms of pathological complete response (pCR) and complications in locally advanced cervical carcinoma (LACC) patients treated with chemoradiation (CT/RT) regimen based on accelerated fractionation, nodal extended fields and adjuvant radical surgery.

Methods

The sample size was quantified according to published data which shows that CT/RT followed by radical surgery in LACC patients provides a pCR rate above 45%. The 2-stage design by Simon was used to test the null hypothesis that the true pCR would improve by above 20%. The chemoradiation regimen was considered active if > 24/43 pCRs were recorded. 40 Gy/2 Gy fraction in 4 weeks was delivered to nodal volume extending up to L3 vertebra, concurrently with chemotherapy. 45 Gy in 20 fractions with a concomitant boost strategy was delivered to the macroscopic disease only.

Results

47 patients were enrolled. Median follow-up was 26 months (3-52 months). Pathological response was assessed in 44/47 patients: 17/44 (38.6%) showed a pCR to treatment, and 9/44 cases (20.5%) showed microscopic disease. Pelvic nodal metastases were documented in 9/44 cases (20.5%). 87.5%of recurrences were extra pelvic. Five patients (11%) developed acute severe gastrointestinal toxicity. The actuarial cumulative 2-year incidence of G 鈮?#xA0;2 late cutaneous, gastrointestinal, and genitourinary toxicity was 10.3%, 8.3%and 24.9%, respectively. The 3-year DFS was 77.1%, while the 3-year OS was 80.5%.

Conclusions

Our results confirm the high tolerability and efficacy of this accelerated regimen. However, based on the study design, 45 Gy as a concomitant boost CT/RT delivered by a 3D technique does not seem sufficient to increase pCR rate.