- 作者：Luciana Caravatta ; Gilbert D.A. Padula ; Gabriella Macchia ; Gabriella Ferr ; ina ; Pierluigi Bonomo ; Francesco Deodato ; Mariangela Massaccesi ; Samantha Mignogna ; Rosa Tambaro ; Marco Rossi ; Mariano Flocco ; Andrea Scapati ; Giovanni Scambia ; Fabio Pacelli ; Vincenzo Valentini ; Numa Cellini ; Alessio G. Morganti
- 关键词：Pelvic cancer ; Radiotherapy ; Palliative care ; Pain ; Quality of life
- 刊名：International Journal of Radiation Oncology*Biology*Physics
- 出版年：2012
- 出版时间：1 August, 2012
- 年：2012
- 卷：83
- 期：5
- 页码：e627-e631
- 全文大小：159 K
Purpose
To define the maximum tolerated dose of a conformal short-course accelerated radiotherapy in patients with symptomatic advanced pelvic cancer.Methods and Materials
A phase I trial in 3 dose-escalation steps was designed: 14 Gy (3.5-Gy fractions), 16 Gy (4-Gy fractions), and 18 Gy (4.5-Gy fractions). The eligibility criteria included locally advanced and/or metastatic pelvic cancer and Eastern Cooperative Oncology Group performance status of ¡Ü3. Treatment was delivered in 2 days with twice-daily fractionation and at least an 8-hour interval. Patients were treated in cohorts of 6-12 to define the maximum tolerated dose. The dose-limiting toxicity was defined as any acute toxicity of grade 3 or greater, using the Radiation Therapy Oncology Group scale. Pain was recorded using a visual analog scale. The effect on quality of life was evaluated according to Cancer Linear Analog Scale (CLAS).
Results
Of the 27 enrolled patients, 11 were male and 16 were female, with a median age of 72?years (range 47-86). The primary tumor sites were gynecologic (48 % ), colorectal (33.5 % ), and genitourinary (18.5 % ). The most frequent baseline symptoms were bleeding (48 % ) and pain (33 % ). Only grade 1-2 acute toxicities were recorded. No patients experienced dose-limiting toxicity. With a median follow-up time of 6 months (range 3-28), no late toxicities were observed. The overall (complete plus partial) symptom remission was 88.9 % (95 % confidence interval 66.0 % -97.8 % ). Five patients (41.7 % ) had complete pain relief, and six (50 % ) showed >30 % visual analog scale reduction. The overall response rate for pain was 91.67 % (95 % confidence interval 52.4 % -99.9 % ).
Conclusions
Conformal short course radiotherapy in twice-daily fractions for 2 consecutive days was well tolerated up to a total dose of 18 Gy. A phase II study is ongoing to confirm the efficacy on symptom control and quality of life indexes.