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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

1023 - Tumor Regression Grading After Preoperative Hyperfractionated Radiotherapy/ Chemoradiotherapy for Locally Advanced Rectal Cancers: A Phase III Clinical Study

Date

21 Oct 2018

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

Presenters

ADAM IDASIAK

Citation

Annals of Oncology (2018) 29 (suppl_8): viii150-viii204. 10.1093/annonc/mdy281

Authors

A. IDASIAK1, K. Galwas-Kliber1, K. Behrendt1, I. Wziętek2, M. Zeman3, E. Stobiecka4, E. Chmielik4, T. Dworzecki2, R. Suwiński1

Author affiliations

  • 1 Radiotherapy And Chemotherapy Clinic And Teaching Hospital, Maria Sklodowska Curie MSC Memorial Cancer Institute in Gliwice, 44-101 - Gliwice/PL
  • 2 Radiotherapy Department, Maria Sklodowska Curie MSC Memorial Cancer Institute in Gliwice, 44-101 - Gliwice/PL
  • 3 Department Of Surgery, Maria Sklodowska Curie MSC Memorial Cancer Institute in Gliwice, 44-101 - Gliwice/PL
  • 4 Department Of Pathology, Maria Sklodowska Curie MSC Memorial Cancer Institute in Gliwice, 44-101 - Gliwice/PL
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Resources

Abstract 1023

Background

We investigated tumor regression grading (TRG) as a prognostic marker for disease-free survival (DFS) in patients with advanced rectal cancer treated within phase III randomized study. The study was prospective trial of preoperative hyperfractionated radiotherapy (HART) compared with concomitant hyperfractionated radiotherapy with co-administration of chemotherapy based on 5FU (HART-CT) in patients with T2/N+ or T3/any N resectable mid-low primary rectal cancer.

Methods

The 136 patients were randomly assigned to HART (n = 69) and HART-CT (n = 67). The pelvis was irradiated twice a day (28 fractions of 1.5 Gy), with a minimal interfraction interval of 8 hrs to total dose 42 Gy over 18 days (HART) or mentioned scheme with concurrent chemotherapy: 5FU-325mg/m2 (bolus) on days 1-3 and days 16-18 (HART-CT). Surgery was performed 5-6 weeks after HART/HART-CT. The TRG was recorded using 4-point scale: TRG0 (pCR) denoted no cancer cells; TRG1 - cancer cells less than 10% of a tumor mass; TRG2 cancer cells in 10-50% or TRG3 - cancer cells in more than 50% of tumor mass. Multivariable analysis was performed using Cox regression models adjusted for treatment arm, resection status and pathologic stage. Cox proportional hazard model was used in survival analysis.

Results

The crude rate of patients with any serious adverse events during the follow-up was 12% vs. 17% for HART and HART-CT. Anterior resection was performed in 52% vs. 62% for HART and HART-CT respectively (p = 0.06). Of the 136 patients evaluable for pathologic response there were 3(4%) vs. 9(13%), 16(23%) vs. 24(36%), 40(58%) vs. 30(45%), and 10 (15%) vs. 4(6%) patients with TRG 0, 1, 2 and 3, respectively in HART vs. HART-CT, the difference was statistically significant p = 0.002. The actuarial 2-year cumulative loco-regional relapse free survival control rates (LRC) for HART vs. HART-CT were 86% vs. 91% and actuarial DFS control rates were 70% vs. 76%, respectively.

Conclusions

Significant differences in the tumor regression grading (TRG) were found. Both LRC and DFS of rectal cancer patients treated with HART vs. HART-CT had favorable outcomes in those allocated to HART-CT. Also the sphincter preservation rate tended to favor HART-CT.

Clinical trial identification

NCT01814969.

Legal entity responsible for the study

Maria Skłodowska-Curie Memorial Cancer Center and Institute of Oncology, Gliwice Branch, 44-100 Gliwice, Poland.

Funding

Has not received any funding.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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