Peter Gibbs1, Volker Heinemann2, Navesh K Sharma3, Julien Taieb4, Jens Ricke5, Marc Peeters6, Michael Findlay7, Bridget Robinson8, Christopher Jackson9, Andrew Strickland10, Val Gebski11, Mark Van Buskirk12, Huaqing Zhao12, Guy van Hazel13. 1. Department of Oncology, Western Hospital, Footscray, VIC, Australia. Electronic address: peter.gibbs@mh.org.au. 2. Comprehensive Cancer Center, Ludwig Maximilian University of Munich, Munich, Germany. 3. University of Maryland Medical Center, Baltimore, MD. 4. Department of Gastroenterology and Gastrointestinal Oncology, Paris Descartes University, Georges Pompidou European Hospital, Paris, France. 5. Department of Radiology, Ludwig Maximilian University of Munich, Munich, Germany. 6. Department of Oncology, Antwerp University Hospital, Antwerp, Belgium. 7. Auckland City Hospital and Cancer Trials, Auckland, New Zealand. 8. Oncology Service, Christchurch Hospital, Christchurch, New Zealand. 9. University of Otago, Dunedin, New Zealand. 10. Medical Oncology Hospital, Monash Medical Centre, Clayton, VIC, Australia. 11. National Health and Medical Research Council Clinical Trials Centre, Camperdown, NSW, Australia. 12. Data Reduction LLC, Chester, NJ. 13. School of Medicine and Pharmacology, University of Western Australia, West Perth, WA, Australia.
Abstract
BACKGROUND: The primary tumor side is emerging as a major prognostic factor for patients with metastatic colorectal cancer (mCRC). We examined the survival data from 2 randomized studies to determine whether the outcomes differ between patients with mCRC with right-sided primary (RSP) tumors and those with left-sided primary (LSP) tumors afterselective internal radiation therapy (SIRT) plus mFOLFOX6 (folinic acid [leucovorin], 5-fluorouracil, oxaliplatin) chemotherapy, versus chemotherapy alone. PATIENTS AND METHODS: Separate and combined analyses were performed on the data from the SIRFLOX and FOXFIRE global trials, which compared chemotherapy plus SIRT with chemotherapy alone for patients with mCRC liver metastases. The primary tumor side data were prospectively collected. The principal outcome measure was overall survival (OS) stratified by treatment and primary tumor side. RESULTS: In the combined analysis of all 739 patients enrolled, SIRT had no effect on OS (median OS, 24.3 vs. 24.6 months; hazard ratio [HR], 1.021; P = .810). For the 179 patients (24.2%) with a RSP tumor, OS was improved with the addition of SIRT (median, 22.0 vs. 17.1 months HR, 0.641; P = .008). The addition of SIRT was not associated with a significant difference in OS among the 540 patients with a LSP tumor (median, 24.6 vs. 26.6 months; HR, 1.120; P = .264). A test of treatment interaction by primary tumor side was statistically significant for RSP and SIRT (P = .002). CONCLUSION: The addition of SIRT for patients with RSP tumors, but not for those with LSP tumors, was associated with a statistically and clinically significant OS gain.
RCT Entities:
BACKGROUND: The primary tumor side is emerging as a major prognostic factor for patients with metastatic colorectal cancer (mCRC). We examined the survival data from 2 randomized studies to determine whether the outcomes differ between patients with mCRC with right-sided primary (RSP) tumors and those with left-sided primary (LSP) tumors after selective internal radiation therapy (SIRT) plus mFOLFOX6 (folinic acid [leucovorin], 5-fluorouracil, oxaliplatin) chemotherapy, versus chemotherapy alone. PATIENTS AND METHODS: Separate and combined analyses were performed on the data from the SIRFLOX and FOXFIRE global trials, which compared chemotherapy plus SIRT with chemotherapy alone for patients with mCRC liver metastases. The primary tumor side data were prospectively collected. The principal outcome measure was overall survival (OS) stratified by treatment and primary tumor side. RESULTS: In the combined analysis of all 739 patients enrolled, SIRT had no effect on OS (median OS, 24.3 vs. 24.6 months; hazard ratio [HR], 1.021; P = .810). For the 179 patients (24.2%) with a RSP tumor, OS was improved with the addition of SIRT (median, 22.0 vs. 17.1 months HR, 0.641; P = .008). The addition of SIRT was not associated with a significant difference in OS among the 540 patients with a LSP tumor (median, 24.6 vs. 26.6 months; HR, 1.120; P = .264). A test of treatment interaction by primary tumor side was statistically significant for RSP and SIRT (P = .002). CONCLUSION: The addition of SIRT for patients with RSP tumors, but not for those with LSP tumors, was associated with a statistically and clinically significant OS gain.
Authors: Mary F Mulcahy; Armeen Mahvash; Marc Pracht; Amir H Montazeri; Steve Bandula; Robert C G Martin; Ken Herrmann; Ewan Brown; Darryl Zuckerman; Gregory Wilson; Tae-You Kim; Andrew Weaver; Paul Ross; William P Harris; Janet Graham; Jamie Mills; Alfonso Yubero Esteban; Matthew S Johnson; Constantinos T Sofocleous; Siddharth A Padia; Robert J Lewandowski; Etienne Garin; Philip Sinclair; Riad Salem Journal: J Clin Oncol Date: 2021-09-20 Impact factor: 44.544
Authors: Max Masthoff; Philipp Schindler; Fabian Harders; Walter Heindel; Christian Wilms; Hartmut H Schmidt; Andreas Pascher; Lars Stegger; Kambiz Rahbar; Moritz Wildgruber; Michael Köhler Journal: Ann Transl Med Date: 2020-09
Authors: Jack Martin; Angelica Petrillo; Elizabeth C Smyth; Nadeem Shaida; Samir Khwaja; H K Cheow; Adam Duckworth; Paula Heister; Raaj Praseedom; Asif Jah; Anita Balakrishnan; Simon Harper; Siong Liau; Vasilis Kosmoliaptsis; Emmanuel Huguet Journal: World J Clin Oncol Date: 2020-10-24
Authors: Michael Köhler; Moritz Wildgruber; Max Masthoff; Philipp Schindler; Fabian Harders; Walter Heindel; Christian Wilms; Hartmut H Schmidt; Andreas Pascher; Lars Stegger; Kambiz Rahbar Journal: J Cancer Res Clin Oncol Date: 2020-11-06 Impact factor: 4.553