927P - Adjuvant sequential radiotherapy and chemotherapy in high-risk endometrial cancer: preliminary analysis of a phase II clinical trial in one institu...

Date 27 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anticancer Agents
Endometrial Cancer
Surgical Oncology
Therapy
Biological Therapy
Radiation Oncology
Presenter Huaying Wang
Citation Annals of Oncology (2014) 25 (suppl_4): iv305-iv326. 10.1093/annonc/mdu338
Authors H. Wang1, Y. Ren2, X. Huang2, B. Shan2, X. Huang1, X. Wu1
  • 1Department Of Gynecologic Oncology, Fudan Uninversity Shanghai Cancer Center, 200032 - Shanghai/CN
  • 2Department Of Gynecologic Oncology, Fudan University Shanghai Cancer Center, 200032 - Shanghai/CN

Abstract

Aim

The management of high-risk endometrial cancer (HREC) and the sequence of chemotherapy and radiotherapy remain controversial. A prospective phase-II clinical trial was conducted to evaluate the sequence and toxicity of adjuvant chemoradiotherapy and chemotherapy in patients with HREC.

Methods

Eligibility included endometrioid endometrial cancer with histologic grade 3 and greater than 50% myometrial invasion, or stromal invasion of the cervix, or pelvic lymph node metastases, or para-aortic lymph node metastases, or extrauterine disease confined to the pelvis; non-endometrioid endometrial cancer regardless of stage; with no gross residual disease and distant metastases. This study was designed to administer pelvic radiation (45 Gy/ 25 fractions), along with cisplatin (50 mg/m2) on Days 1 and 28. Vaginal afterloading brachytherapy (5 Gy/d, 6 fractions) was given for patients with stromal cervical invasion. External para-aortic intensity-modulated radiation was allowed for patients with confirmed para-aortic lymph nodes metastases. Four courses of paclitaxel (135 mg/m2) and carboplatin (AUC = 5), or cisplatin (50 mg/m2) and cyclophosphamide (600 mg/m2) and epirubicin (60 mg/m2) were allowed at 3-week intervals after RT completion.

Results

Number of Events Estimated 3-year rate (%) Estimated 5-year rate (%)
Recurrence in the field of radiation 4 5 5
Local-regional failure 7 10 13
Distant metastases failure 17 20 20
Progression-free survival 24 74 72
Overall survival 12 87 83

One hundred and three patients were enrolled between January 2007 and January 2011. Eighty-eight patients (85.4%) completed the planned treatment. Treatment discontinuation was the result of toxicity (4/103, 3.9%), disease progression (4/103, 3.9%), and patients refusal (3/103, 2.9%). Four patients died before completing therapy. There were no treatment-related deaths. Median follow-up was 35 months (range 3-80 months). Twenty-four (23.3%) patients recurred, in which 4 cases recurred in the field of radiation, and 12 cases died of endometrial cancer. The estimated 3-year and 5-year progression-free survival and overall survival were listed in table1.

Conclusions

This treatment protocol demonstrated an excellent treatment completion rate and expected toxicity. Subsequent phase-III trials are warranted.

Disclosure

All authors have declared no conflicts of interest.