Lancet: New rectal cancer treatment yields promising outcomes
For patients with high-risk, potentially operable rectal cancer, therapy with preoperative chemotherapy prior to standard chemoradiation and surgical resection is a reasonable treatment with acceptable safety and promising long-term outcomes, based on a study published in the March issue of the Lancet Oncology.
Yu Jo Chua, MBBS, and colleagues from the department of medicine at Royal Marsden Hospital in Sutton, England, and the medical oncology unit of the Canberra Hospital in Canberra, Australia, defined high-risk patients as those that are “at high risk of disease recurrence despite standard chemoradiotherapy and optimum surgery.”
In their multi-site phase two study, the authors assessed the safety, as well as the long-term benefits of preoperative chemotherapy with capecitabine (Xeloda, Roche) and oxaliplatin (Eloxatin, Sanofi-Aventis) before total surgical resection and chemoradiotherapy, thought to be the gold standard of treatment for this patient population.
The researchers recruited 77 patients with high-risk rectal cancer and without metastatic disease as defined by high-resolution MRI between November 2001 and August 2005. In January 2004, the researchers changed the requirements to exclude patients with a recent history of clinically significant cardiac problems following nine treatment-related cardiotoxic events in eight of the 77 patients.
After the change in protocol, the study consisted of 105 patients, with one cardiac event occurring after the change in eligibility criteria, the authors wrote.
The participants were administered preoperative capecitabine and oxaliplatin twice daily for 14 days every three weeks for 12 weeks, followed by surgical resection and 12 weeks of chemoradiotherapy with capecitabine, twice daily for 14 days every three weeks. The follow-up period was an average of 55 months, and the authors determined the primary endpoint to be a pathologically complete response rate.
The authors noted that the radiological response rates after preoperative chemotherapy and chemoradiotherapy was 74 percent and 89 percent, respectively.
Of the 97 patients who underwent surgical resection, 95 individuals underwent total mesorectal excision and 93 had microscopically clear resection margins, wrote the authors.
Chua and colleagues reported that 21 participants saw a complete pathological response (20 percent) and the three-year progression-free and overall survival rates were 68 percent.
For the study’s findings on the treatment of rectal cancer by way of combination chemotherapy, the authors wrote that “future development of this multidisciplinary treatment strategy in randomized trials is warranted."
Yu Jo Chua, MBBS, and colleagues from the department of medicine at Royal Marsden Hospital in Sutton, England, and the medical oncology unit of the Canberra Hospital in Canberra, Australia, defined high-risk patients as those that are “at high risk of disease recurrence despite standard chemoradiotherapy and optimum surgery.”
In their multi-site phase two study, the authors assessed the safety, as well as the long-term benefits of preoperative chemotherapy with capecitabine (Xeloda, Roche) and oxaliplatin (Eloxatin, Sanofi-Aventis) before total surgical resection and chemoradiotherapy, thought to be the gold standard of treatment for this patient population.
The researchers recruited 77 patients with high-risk rectal cancer and without metastatic disease as defined by high-resolution MRI between November 2001 and August 2005. In January 2004, the researchers changed the requirements to exclude patients with a recent history of clinically significant cardiac problems following nine treatment-related cardiotoxic events in eight of the 77 patients.
After the change in protocol, the study consisted of 105 patients, with one cardiac event occurring after the change in eligibility criteria, the authors wrote.
The participants were administered preoperative capecitabine and oxaliplatin twice daily for 14 days every three weeks for 12 weeks, followed by surgical resection and 12 weeks of chemoradiotherapy with capecitabine, twice daily for 14 days every three weeks. The follow-up period was an average of 55 months, and the authors determined the primary endpoint to be a pathologically complete response rate.
The authors noted that the radiological response rates after preoperative chemotherapy and chemoradiotherapy was 74 percent and 89 percent, respectively.
Of the 97 patients who underwent surgical resection, 95 individuals underwent total mesorectal excision and 93 had microscopically clear resection margins, wrote the authors.
Chua and colleagues reported that 21 participants saw a complete pathological response (20 percent) and the three-year progression-free and overall survival rates were 68 percent.
For the study’s findings on the treatment of rectal cancer by way of combination chemotherapy, the authors wrote that “future development of this multidisciplinary treatment strategy in randomized trials is warranted."