The results from a comparative phase III clinical study reported by Polish investigators at the 2016 Gastrointestinal Cancers Symposium in San Francisco have identified an additional treatment option for patients with advanced rectal cancer.
The study demonstrated that patients who received short-course (five-day) radiation followed by chemotherapy before surgery can achieve similar outcomes as those treated with the more traditional five-week chemo-radiation treatment regimen.
Chemo-radiation therapy is often used in the “neoadjuvant” setting before surgery with the goal of decreasing the size of the cancer. Chemo-radiation is the standard of care in the United States and most European countries for locally advanced rectal cancer. The standard radiation treatment lasts more than five weeks, with concurrent use of chemotherapy.
The experimental treatment regimen explored in this study consisted 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 and patients were treated with standard chemo-radiation or the investigational short-course 5-day radiation. Patients in both groups received the so-called FOLFOX4 chemotherapy regimen. Both groups of patients underwent surgery about 12 weeks after starting radiation therapy.
The results of the study revealed that a similar proportion of patients in either group were able to undergo radical surgery after radiation therapy. The short-term side effects were fewer with the short-course radiation. The number of patients surviving without cancer recurrence was similar in both groups, however, the short-course radiation patients had improved overall survival 3 years from treatment (73% vs. 63.5%).
This new short-course radiation regimen causes fewer side effects, is more convenient, is less costly, and may confer a survival benefit compared to standard chemo-radiation.
Reference: Bujko K, Sklodowska M, et al. Neoadjuvant chemoradiation for fixed cT3 or cT4 rectal cancer: Results of a Polish II multicentre phase III study. J Clin Oncol 34, 2016 (suppl 4S; abstract 489).