In a Chinese phase II study (NEOCAP) reported in The Lancet Oncology, Yu et al found that neoadjuvant camrelizumab plus apatinib produced promising complete response rates in patients with locally advanced microsatellite instability–high or mismatch repair–deficient colorectal cancer.
Study Details
In the study, 53 patients enrolled at Sun Yat-sen University Cancer Center and the Provincial Hospital of Traditional Chinese Medicine, Guangzhou, between September 2020 and December 2022 received camrelizumab at 200 mg on day 1 and apatinib at 250 mg on days 1 to 14 every 3 weeks for 3 months in those undergoing surgery and for 6 months in those not undergoing surgery. Patients with a clinical complete response alone did not undergo surgery and were followed in a watch-and-wait approach. The primary outcome measure of the study was the proportion of patients with a pathologic or clinical complete response.
Key Findings
Median follow-up was 16.4 months. Among 52 evaluable patients, 28 (54%, 95% confidence interval [CI] = 35%–68%) had a clinical complete response, with 24 being managed with a watch-and-wait approach. Among the 28 patients with clinical complete response, 4 underwent surgery and had a pathologic complete response. A total of 23 patients (44%) underwent surgery for the primary tumor, with 14 (61%, 95% CI = 39%–80%) having a pathologic complete response. Overall, 38 patients (73%, 95% CI = 59%–84%) had a complete response.
Among 53 patients who received treatment, the most common adverse events of any grade were hemangioma (47%), increased aminotransferase (47%), rash (45%), hypertension (36%), and stomatitis (26%). Grade ≥ 3 adverse events occurred in 20 patients (38%), most commonly increased aminotransferase (11%), bowel obstruction (8%), and hypertension (8%). Drug-related serious adverse events occurred in 11% of patients. One patient died from treatment-related (immune-related) hepatitis.
The investigators concluded, “Neoadjuvant camrelizumab plus apatinib show promising antitumor activity in patients with locally advanced mismatch repair–deficient or microsatellite instability–high colorectal cancer. Immune-related adverse events should be monitored with the utmost vigilance. Organ preservation seems promising not only in patients with rectal cancer, but also in those with colon cancer who have a clinical complete response. Longer follow-up is needed to assess the oncological outcomes of the watch-and-wait approach.”
Pei-Rong Ding, MD, of the Department of Colorectal Surgery, Cancer Center, Sun Yat-sen University, Guangzhou, is the corresponding author for The Lancet Oncology article.
Disclosure: The study was funded by the National Natural Science Foundation of China, Guangdong Basic and Applied Basic Research Foundation, and the Cancer Innovative Research Program of Sun Yat-sen University Cancer Center. For full disclosures of the study authors, visit thelancet.com.
