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 Anti-Cancer Agents & Biologic Therapy
Endometrial Cancer
Surgery and/or Radiotherapy of Cancer
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.