|The following article features coverage from the European Society for Medical Oncology (ESMO) Congress 2021. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
Neoadjuvant capecitabine plus oxaliplatin (CapeOx) could be an alternative to chemoradiotherapy (CRT) for patients with locally advanced rectal cancer, according to a presentation at the European Society for Medical Oncology (ESMO) Congress 2021.
Phase 3 trial results showed that CapeOx and CRT produced similar pathologic complete response (pCR) rates and safety outcomes, but CapeOx reduced rates of perioperative distant metastasis and preventive ileostomy.
Pei-Rong Ding, MD, of Sun Yat-sen University Cancer Center in Guangzhou, China, presented these results, from the phase 3 CONVERT trial (ClinicalTrials.gov Identifier: NCT02288195), at ESMO 2021.
The trial enrolled 663 patients with locally advanced rectal cancer and uninvolved mesorectal fascia. The patients were randomly assigned to neoadjuvant therapy with 4 cycles of CapeOx (331 patients) or CRT, consisting of capecitabine and radiotherapy given at 50 Gy over 5 weeks (332 patients).
After patients underwent surgery, those in the CapeOx arm received another 4 cycles of CapeOx, and patients in the CRT arm received 6 cycles of CapeOx.
Surgery was performed in 83.2% of patients in the CapeOx arm and 79.1% of those in the CRT arm. Adjuvant chemotherapy was given to 71.9% and 67.3%, respectively.
The pCR rate was similar in both treatment arms — 11.0% with CapeOx and 13.8% with CRT (P =.333). The downstaging rate was also similar — 40.8% and 45.6%, respectively (P =.265).
On the other hand, the rate of perioperative distant metastases was significantly lower with CapeOx than with CRT — 0.7% and 3.1%, respectively (P =.034). The rate of preventative ileostomy was also significantly lower with CapeOx than with CRT — 52.2% and 63.6%, respectively (P =.008).
Grade 3-4 adverse events (AEs) occurred more frequently in the CapeOx arm than in the CRT arm in the neoadjuvant phase — 12.3% and 8.3%, respectively — but not in the adjuvant phase — 5.1% and 9.0%, respectively.
There were 2 patients who died in the CapeOx arm during the neoadjuvant phase. There were no other deaths.
Based on these results, Dr Ding concluded that CapeOx could serve as a potential alternative to CRT in locally advanced rectal cancer with uninvolved mesorectal fascia. However, he said, “long-term follow-up is needed to confirm these results.”
Ding P, Wang X, Li Y, et al. Neoadjuvant chemotherapy with oxaliplatin and capecitabine versus chemoradiation with capecitabine for locally advanced rectal cancer with uninvolved mesorectal fascia (CONVERT): Initial results of a multicenter randomised, open-label, phase III trial. Presented at: European Society of Medical Oncology (ESMO) Congress 2021; September 16-21, 2021. Abstract LBA22.