BARCELONA – One-fifth of rectal cancer patients can avoid the need to have their rectum removed by the addition of high-dose, contact irradiation to external beam radiation therapy, data from a 10-year follow-up of a randomized, controlled trial have demonstrated.
As reported at the biennial meeting of the European Society for Therapeutic Radiology and Oncology (ESTRO 29), the findings from the LYON R96-02 trial show clear, long-term benefits for patients with cancer of the lower rectum by the addition of contact irradiation (CXRT) to external beam radiation therapy (EBRT).
“When we add the technique of contact radiation therapy to conventional radiotherapy in the preoperative treatment of patients with rectal cancer, we improve the chances of conserving the sphincter of these patients,” said study investigator Dr. C?cile Ortholan in an interview.
Dr. Ortholan of the department of radiation oncology at the Centre Antoine-Lacassagne in Nice, France, added that “preserving the sphincter is very important for patients in terms of their quality of life.” She noted that the technique is very easy and takes about 3 minutes to perform, requires local anesthesia only, and there were no real side effects. Perhaps most important, however, is that there was a significantly decreased rate of permanent colostomy in the patients who received CXRT-EBRT vs. EBRT alone.
Between 1996 and 2001, a total of 88 patients with a median age of 68 years were enrolled into the LYON R96-02 study. Of these patients, 43 were randomized to receive EBRT, given at a total dose of 39 Gy in 13 fractions, while 45 were randomized to receive a high (85 Gy) CXRT dose in addition to EBRT. Between 1996 and 2001, CXRT was administered on days 1, 8, and 21 in decreasing dose fractions (35 Gy, 30 Gy, and 20 Gy, respectively). Median follow-up was 132 months.
While no patient who had EBRT before surgery was able to keep their rectum, nine (20%) of those who had additional CXRT were able to avoid the muscle’s removal, and a higher percentage given CXRT-EBRT avoided the need for a permanent colostomy. Indeed, the cumulative rate of permanent colostomy at 10 years in this group was 29% vs. 63% for radiotherapy alone (P less than .001).
These benefits came at no extra cost in terms of local disease control, disease-free survival, or overall survival at 10 years. Although the difference was not significant, the local recurrence rate was lower in the CXBT-EBRT-treated patients (10% vs. 15%). The clinical complete response rate was significantly better at 24% with the added radiation vs. 2% with EBRT alone (P = .006).
“My take-home message is that, with the addition of contact radiotherapy, we avoid definitive colostomy for the patient,” said Dr. Ortholan, who plans to study the use of CXRT in combination with chemoradiotherapy in the treatment of patients with small rectal tumors and in very elderly patients, with the hope of avoiding the need for surgery altogether.
“These findings are important because they highlight that it is not only important to cure a patients’ cancer, but it is also important to maintain their long-term quality of life,” commented Dr. Jean Bourhis, chairman of the radiation and oncology department at the Institut Gustave Roussy in Villejuif, France.
Dr. Bourhis, who is the president of ESTRO and cochair of ESTRO 29, added: “If you can preserve the sphincter, then patients’ long-term quality of life is completely different as compared to surgical removal and permanent colostomy.”
Dr. Ortholan had no financial disclosures. Dr. Bourhis was not involved in the study.