Main Session
Sep 28
SS 02 - GI 1: The OPERATIC Side of Rectal Cancer - Organ Preservation, Evaluating Recurrences, and the Immune Checkpoints

107 - Quality of Life and 5-Year Long-Term Organ Preservation in Early Rectal Adenocarcinoma Final Results from the OPERA Trial

02:30pm - 02:40pm PT
Room 307/308

Presenter(s)

Nicolas Barbet, MD - ORLAM, villeurbanne, RHONE ALPES

S. ben Dhia1, J. Doyen2, T. Pace-Loscos1, C. Rao3, D. Baron Jr4, J. P. Gerard1, N. Barbet5, and A. sun Mynt6; 1Antoine lacassagne center, nice, France, 2Department of Radiation Therapy, Antoine Lacassagne Cancer Center and University of Nice-Sophia, Nice, France, 3North Cumbria Integrated Care NHS Foundation Trust, london, United Kingdom, 4Antoine Lacassagne Cancer Center, Nice, France, 5ORLAM Lyon-Villeurbanne-Mâcon, Mâcon, France, 6Clatterbridge Cancer center, clatterbridge, United Kingdom

Purpose/Objective(s): The OPERA trial evaluated the impact of a contact X-ray brachytherapy (CXB) boost on organ preservation (OP) rates and quality of life (QoL) in patients with early rectal adenocarcinoma. The trial aimed to assess the 3-year OP rates, bowel function, and QoL following chemoradiotherapy (CRT) with either external beam radiotherapy boost (EBRT) or CXB boost.

Materials/Methods: OPERA was a multicenter, phase III randomized trial involving 141 patients with cT2-T3b low-mid rectal cancer. Patients received external beam radiotherapy (EBRT) with concurrent capecitabine, with randomization to receive either EBRT boost (9 Gy/5 fractions) or CXB boost (90 Gy/3 fractions). QoL was assessed using the EORTC QLQ-C30 and QLQ-CR29, and bowel function was evaluated with the LARS score. The primary endpoint was OP at 3 years, with follow-up extending to 5 years.

Results: At 3 years, CXB significantly increased the OP rate from 59% to 81% (p=0.003). At 5 years, the difference in OP remained significant (56% vs 79%, p=0.004). For patients with tumors < 3 cm, the 5-year OP rate was 93% in the CXB group versus 54% in the EBRT group. QoL assessments showed no significant differences between the groups, with no impact on global QoL, social functioning, or cognitive functioning. LARS scores =30 were seen in 12% (A) and 18% (B) at 5 years, with no significant difference. Mild rectal bleeding due to radiation telangiectasia was more frequent in the CXB group at 1 year (63% vs. 12%, p<0.0001), but resolved by 3 years.

Conclusion: The OPERA trial demonstrated that CXB boost significantly improves long-term OP in early rectal cancer with comparable QoL outcomes between EBRT and CXB groups. While CXB led to higher incidence of mild rectal bleeding initially, this resolved over time. These results emphasize the importance of maintaining close patient surveillance in the first 5 years.