Abstract 3895
Background
The standard treatment for cT3-4 N0-1 rectal cancer is preoperative chemo-radiation therapy (CT/RT). The combination of capecitabine plus long course radiotherapy (RT) is standard therapy in locally advanced rectal cancer. Pathologic Complete remission (pCR) can be considered as surrogate end point of efficacy of treatment in terms of disease free survival (DFS). Clinical complete remission (cCR) is an important endpoint for “wait and see” strategy. In the PACIFIC trial in non-small cell lung cancer the patients were treated with durvalumab maintenance after CT/RT with advantage in progression free survival. “Abscopal effect” is proposed as mediator of systemic effects after localized RT. Preclinical data points heavily toward a strong synergy between RT and immune treatments. Recent reports already illustrate that such a systemic effect of RT is possible when enhanced by targeted immune treatments.
Trial design
This is a prospective phase II, open label, single arm, multi-centre study to evaluate, in patients with operable rectal cancer, activity of an innovative sequence: standard concomitant CT/RT therapy with 825 mg/m2 twice daily capecitabine every day and 5040 cGy radiotherapy for 5 days per week for 5 weeks followed by 1500 mg Q4W durvalumab for 3 administration. After 9-10 weeks from neoadjuvant therapy will be performed re-staging with CT and MRI scan. Surgery will be performed at week 10-12 from the end of CT/RT. Primary Objective: pCR rate, defined as a TRG 3-4 according to DWORAK criteria. Secondary Objectives: Safety of treatment with durvalumab; cCR rate after durvalumab treatment before surgery and DFS. cCR will be evaluated with clinical, endoscopic and radiological assessment to look for evidence of residual disease. DFS will be evaluated during a follow up of 5 years. Exploratory Objective: Biological translational analysis of tumor biomarkers will be performed on the endoscopy biopsy done at the diagnosis and on the biopsy performed after the CT/RT prior to treatment with durvavalumab. We have planned to enlist 60 patients in 7 centers with an enrollment period of 12 months, already underway.
Clinical trial identification
2018-004758-39.
Editorial acknowledgement
Legal entity responsible for the study
Tamberi Stefano.
Funding
AstraZeneca.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
4317 - Prognostic factors analysis of 343 patients with adenocarcinoma of esophagogastric junction
Presenter: Yixun Lu
Session: Poster Display session 2
Resources:
Abstract
4099 - Effects of preoperative preparation time on efficacy of neoadjuvant chemotherapy (SOX) in patients with advanced gastric cancer
Presenter: Xinxin Wang
Session: Poster Display session 2
Resources:
Abstract
3769 - The prognostic value of higher absolute lymphocyte counts for patients with surgically resected non-advanced gastric cancer
Presenter: Se Jun Park
Session: Poster Display session 2
Resources:
Abstract
1718 - Trastuzumab and pertuzumab added to neoadjuvant chemoradiotherapy in resectable HER2+ esophageal adenocarcinoma patients: an update on survival and predictive biomarkers in the TRAP study
Presenter: Charlotte Stroes
Session: Poster Display session 2
Resources:
Abstract
5403 - Interim analysis of a phase II trial of perioperative chemotherapy plus avelumab in esophagogastric and gastric adenocarcinoma
Presenter: Thierry Alcindor
Session: Poster Display session 2
Resources:
Abstract
591 - Evaluation of the introduction of primary G-CSF prophylaxis to the FLOT chemotherapy regimen.
Presenter: Kelly-Marie Crampton
Session: Poster Display session 2
Resources:
Abstract
1402 - Subgroup analyses of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with 2 and 4 courses of cisplatin/S-1 (CS) and docetaxel/cisplatin/S-1 (DCS) as neoadjuvant chemotherapy for locally advanced gastric cancer
Presenter: Tsutomu Hayashi
Session: Poster Display session 2
Resources:
Abstract
3743 - HER2 Copy Number as Predictor of Disease-Free Survival in HER2-Positive Resectable Gastric Cancer
Presenter: Zimin Liu
Session: Poster Display session 2
Resources:
Abstract
2032 - Effect of neoadjuvant chemotherapy on the Programmed Death-1 pathway in esophageal and gastric cancer
Presenter: Maria Svensson
Session: Poster Display session 2
Resources:
Abstract
4304 - A user-friendly nomogram to predict relapse-free survival (RFS) in western patients with resected gastric cancer (GC)
Presenter: Massimiliano Salati
Session: Poster Display session 2
Resources:
Abstract