Abstract 3506
Background
At present, distant metastasis remains the main cause of failure for locally advanced rectal cancer (LARC), efficient short-course radiotherapy (SCRT) combined with neoadjuvant chemotherapy is an attempt of optimizing pre-operative treatment.
Methods
We did this randomized, phase III study in multiple centers in China. Patients with middle or lower rectal adenocarcinomas, staged cT3-4 and/or N1-2 by MRI, were randomly assigned to receive 5Gy × 5 and 4 courses of CAPOX (experimental group) or 50 Gy in 25 fractions concurrently with capecitabine (control group). TME in both groups was performed 6-8 weeks later, then two or six courses of CAPOX as postoperative chemotherapy was prescribed in experimental or control group, respectively. The purpose of this interim analysis was focusing on the compararison of primary enrolled 100 patients.
Results
Initially enrolled 100 patients, 51 in experimental group and 49 in control group were analyzed, with MRF+ 27.5% vs. 30.6%, MRI based T3-4 92.2% vs. 98.0%, N1-2 74.5% vs. 77.6%, and EMVI scores3-4 52.9% vs. 65.3% in each group. The completion rates of neoadjuvant treatment were 98.0% vs. 100% (p = 0.325), with incidences of grade III-IV toxicity 17.6% vs. 4.1% (p = 0.076) in each group, respectively. 80 patients completed surgery and 7 patients (all in experimental group) chose “watch-and-wait” policy due to clinical complete remission (cCR) after neoadjuvant treatment. 92.9% and 89.5% of patients in experimental and control group had R0 resection (p = 0.593), while 26.2% and 5.3% of them achieved ypT0N0 (p = 0.011), respectively. The completion rates of adjuvant chemotherapy were 76.2% vs. 65.8% (p = 0.305) in each group, respectively. On the whole, the patients who had received 6 cycles of chemotherapy accounted for 62.7% vs. 49.0% (p = 0.000) in experimental and control group, and there were 76.5% and 49.0% of patients who could complete all planned treatments in each group, respectively.
Conclusions
The interim analysis revealed the acute toxicity and surgical complication were acceptable and comparable in both groups, however, the people in experimental group showed better treatment completion.
Clinical trial identification
NCT02533271.
Legal entity responsible for the study
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College.
Funding
Collaborative Innovation Center for Cancer Medicine [No. XT2015-03].
Editorial Acknowledgement
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
1159 - Molecular characterization and search for founding effects in Canarian families with Hereditary Breast and Ovarian Cancer Syndrome
Presenter: Elisenda Llabres Valenti
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
3725 - Effect of the polymorphism rs2066844 of the NOD2 gene on colon cancer incidence in a high cardiovascular risk population. Modulation by gender
Presenter: Judith Begona Ramirez Sabio
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
3708 - Effect of the polymorphisms rs1476413, rs1801131, rs4846052 and rs6541003 of the MTHFR gene on prostate cancer in a high cardiovascular risk population
Presenter: Judith Begona Ramirez Sabio
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
5057 - Association of a genetic variant in cyclin-dependent kinase Inhibitor 2A gene with the increased risk of breast cancer
Presenter: Soodabeh Shahid Sales
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
5970 - Investigating the role of HAT protein TIP60 in regulating functional dynamics of nuclear receptor PXR
Presenter: KARISHMA BAKSHI
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
1360 - The role of downregulated SIRT3 expression in patients with hepatocellular carcinoma
Presenter: Hanhee Jo
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
1634 - Prediction and Intervention of Colorectal Cancer Risk with Artificial Intelligent System
Presenter: Yang Ge
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
4921 - Measuring the Efficiency of Cancer Care in Europe
Presenter: Rikard Althin
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
1235 - Circulating cell-free DNA isolated from plasma of mesenteric veins predicts prognosis in stage II colorectal cancer patients
Presenter: Chih-Yung Yang
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract
5169 - _lonality of uterine carcinosarcoma as a factor of clinical prognosis.
Presenter: Natalia Levitskaya
Session: Poster display session: Basic science, Endocrine tumours, Gastrointestinal tumours - colorectal & non-colorectal, Head and neck cancer (excluding thyroid), Melanoma and other skin tumours, Neuroendocrine tumours, Thyroid cancer, Tumour biology & pathology
Resources:
Abstract