2016-01-20 21:13:35 UTC

New Regimen for Locally Advanced Rectal Cancer as Effective but Less Toxic Than Chemoradiation

Highlighted study from the 2016 Gastrointestinal Cancers Symposium, which AGA is co-sponsoring.

Contact: Rachel Shubert

Alise Fisher

Bethesda, MD (Jan. 15, 2016) — Findings from a Polish phase III study point to an additional treatment option for patients with advanced rectal cancer. Patients who received short-course (five-day) radiation followed by consolidation chemotherapy before surgery achieved similar outcomes as those treated with five-week chemoradiation. The study will be presented at the upcoming 2016 Gastrointestinal Cancers Symposium in San Francisco.

“There is a great need for improvement of pre-operative strategies for patients with locally advanced rectal cancer,” said study co-author Lucjan Wyrwicz, MD, PhD, head of Medical Oncology Unit in Department of Gastrointestinal Cancer at the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Warsaw, Poland. “The new regimen has similar efficacy but causes fewer side effects and is more convenient for patients. It is also less costly compared to standard chemoradiation, so it may be especially valuable in limited-resource settings.”

Chemoradiation therapy is often used in rectal cancer before surgery to reduce tumor size and lower the chance that the cancer will recur. Chemoradiation is the standard of care in the U.S. and some European countries. The radiation treatment lasts more than five weeks, with concurrent use of chemotherapy in the first and fifth week. The experimental regimen explored in this study consists of five days of radiation therapy and six days (three two-day cycles) of chemotherapy delivered over a period of seven weeks.

The study enrolled 515 patients with locally advanced rectal cancer (stage cT3 or cT4). The patients were assigned to chemoradiation or the experimental (short-course radiation) regimen. Patients in the chemoradiation group received fluourouracil (5-FU), leucovorin, and oxaliplatin chemotherapy with the radiation, whereas those in the experimental group received the same agents in the so-called FOLFOX4 regimen after the short course radiation. It should be noted that the addition of oxaliplatin to 5-FU and radiation is not considered standard therapy and is known to be more toxic than 5-FU with radiation. Both groups of patients underwent surgery about 12 weeks after starting radiation therapy.

A similar proportion of patients in either group were able to undergo radical surgery after radiation therapy. The rates of acute toxicity were lower in the experimental group compared to the chemoradiation group (74% vs. 83%). The major toxicities associated with radiotherapy include inflammation of the rectum, diarrhea, inflammation of the bladder, and local skin radiation response.

At three years, the disease-free survival was not statistically different between the two groups (53 percent in the experimental group vs. 52 percent in the chemoradiation care group). The initial report indicates improvement in the rates of overall survival (73 percent in the experimental group vs. 63.5 percent in the chemoradiation group).

"If this survival benefit is confirmed with longer follow-up, it might ultimately result in change to the clinical practice in patients with locally advanced rectal cancer similarly to the studied group of patients" added Dr. Wyrwicz.

According to the authors, short-course radiotherapy may be a particularly helpful option for patients with advanced rectal cancer with metastases in the liver or lungs who are potential candidates to have all sites of disease resected. A shorter duration of radiotherapy allows such patients to start chemotherapy to control metastases much earlier.

"This method is implemented in the treatment strategy of our patients in the Maria Sklodowska-Curie Memorial Cancer Center and seems to be feasible and effective also in this rare subgroup of patients," stated Dr. Wyrwicz. 

This study was conducted by the Polish Colorectal Study Group led by Prof. Krzysztof Bujko and received funding from Polish Ministry of Science and Higher Education.

View the full abstract.

2016 Gastrointestinal Cancers Symposium News Planning Team
William Grady, MD, AGA Institute; Smitha Krishnamurthi, MD, American Society of Clinical Oncology (ASCO); Karyn Goodman, MD, MS, American Society for Radiation Oncology (ASTRO); and Jennifer Tseng, MD, MPH, Society of Surgical Oncology (SSO). 
View the disclosures for the News Planning Team


About the AGA Institute 

The American Gastroenterological Association is the trusted voice of the GI community. Founded in 1897, the AGA has grown to more than 16,000 members from around the globe who are involved in all aspects of the science, practice and advancement of gastroenterology. The AGA Institute administers the practice, research and educational programs of the organization.www.gastro.org

Like AGA on Facebook. 
Join AGA on LinkedIn.
Follow us on Twitter @AmerGastroAssn
Check out our videos on YouTube.

More on Colorectal Cancer

Principles of GI for the NP and PA

Aug. 10, 2018

Hear from the experts as they provide you with critical updates on treating and managing patients with a variety of GI disorders.

2018 AGA Postgraduate Course

June 2, 2018

Secure your spot for this clinically focused, multi-topic course that offers immediately applicable information. Held in conjunction with DDW®. Save $75 when you register by April 18.

Ready for the “Jimmy Kimmel effect”?

March 21, 2018

AGA leader Dr. Christina Ha performed Jimmy Kimmel’s first colonoscopy. Here’s the clip.