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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

3704 - A multi-institutional randomized phase II study on the timing of Oxaliplatin plus 5-Fluorouracil (FOLFOX) for patients (pts) with operable stage III rectal cancer: The KIR 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

Topics

Cytotoxic Therapy

Tumour Site

Colon and Rectal Cancer

Presenters

Petr Kavan

Citation

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

Authors

P. Kavan1, I. Barrera1, L. Azoulay1, A. Martin2, C. Vasilevsky1, M. Boutros1, E. Ferland3, G. Batist1, T. Vuong1

Author affiliations

  • 1 Oncology, Jewish General Hospital McGill University, H3T 1E2 - Montreal/CA
  • 2 Oncology, CHU de Quebec Laval, H3 - Montreal/CA
  • 3 Oncology, CHUM, H3 - Montreal/CA
More

Resources

Abstract 3704

Background

Recent randomized studies have shown low compliance to adjuvant chemotherapy in stage III rectal cancer pts who received preoperative combined chemotherapy and external beam radiation (CT/EBRT) with total mesorectal excision (TME surgery). We examined whether giving part of the chemotherapy prior to radiotherapy (delivered by brachytherapy (HDRBT)) and surgery (instead of chemotherapy after RT and surgery, which is the current standard of care) for pts with node positive operable rectal cancer, would result in higher pt compliance to chemotherapy.

Methods

Between 2010-2017, 180 eligible pts were randomly assigned (2:1) to two arms, 6 cycles of FOLFOX prior to radiotherapy and surgery following by 6 cycles of FOLFOX in adjuvant (Arm A, (AA)), or 12 cycles of FOLFOX in adjuvant (Arm B, (AB)). The primary end point was compliance to chemotherapy (pts receiving at least 85% of full-dose CT prescribed at each cycle (x 12 cycles), 1 yr post-diagnosis); secondary end points were disease free survival rate (DFS), pT0N0, local recurrence rate and overall survival (OS), 5 yrs post-surgery.

Results

All pts were randomly assigned to either AA (n = 120; 84 pts were male (M), median age (MA) was 65 years) or AB (n = 60; 35 pts were M, MA was 63.5 years). Compliance on AA was 78% and 51.9% on AB. Levels of G3/G4 toxicity were 30.8% in AA and 28.3% in AB respectively. 174 of 178 pts completed HDRBT as planned (97.7%). In AA, 3 pts progressed locally under CT. 1 pt refused HDRBT after randomization in AB. pT0N0 for AA and AB were 35pts (30.1%) and 15 pts (25%). The 3-year DFS was 80% with AA and 76% with AB (p = 0.6511). The 3-year OS for AA and AB were 94% and 85%, respectively (p = 0.8219).

Conclusions

The safety and improved compliance to neoadjuvant CT is confirmed in this study using HDRBT as a neoadjuvant modality for rectal cancer. There is no statistical difference in pT0N0 rate, local recurrence, and DFS between the two arms in the early result analysis, but favorable oncological outcomes are observed. At the time of this reporting, pelvic nodal recurrence is seldom isolated, asymptomatic and preceded by systemic failure.

Clinical trial identification

NCT01274962.

Legal entity responsible for the study

Jewish General Hospital-McGill.

Funding

Sanofi.

Editorial Acknowledgement

Disclosure

All authors have declared no conflicts of interest.

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