|The following article features coverage from the ASCO Gastrointestinal Cancers Symposium 2022. Click here to read more of Cancer Therapy Advisor’s conference coverage.|
There was no significant difference in response rate or survival with first-line treatment of digestive system neuroendocrine carcinoma treated with etoposide plus cisplatin (EP) or irinotecan plus cisplatin (IP), according to phase 3 trial results presented at the ASCO Gastrointestinal Cancers Symposium 2022.
Both platinum-based chemotherapy regimens are standard of care for digestive system neuroendocrine carcinoma. “This phase 3 study aimed to identify [the] more effective regimen between EP and IP in terms of overall survival,” Chigusa Morizane, MD, PhD, of the National Cancer Center Hospital in Japan, and lead author of the study, said.
The phase 3 trial randomly assigned 170 patients with previously untreated recurrent or unresectable neuroendocrine carcinoma arising from the gastrointestinal tract, hepatobiliary region, or pancreas to receive EP or IP. The primary endpoint was overall survival (OS) and the secondary endpoints included response rate, progression-free survival (PFS), and safety.
At baseline, the median age was 65 and 69% of patients were male. The most common primary site of disease was the stomach and pancreas, and 73% of patients had metastases.
OS was similar between the groups, with a median of 12.5 months with EP compared with 10.9 months with IP (hazard ratio [HR], 1.043; 90.0798% CI, 0.794-1.370; P =.7968). OS was similar between the treatment arms for prespecified subgroups, including for primary site and pathology.
There was also no significant difference in PFS between the regimens, with a median of 5.6 and 5.1 months with EP or IP, respectively (HR, 1.060; 95% CI, 0.777-1.445; P =.7161).
The overall response rates were 54.5% with EP and 52.5% with IP and the proportion of patients who achieved complete or partial response or stable disease were similar.
There were some differences in the rate of grade 3 to 4 adverse events (AEs) between the groups. Neutropenia, leukocytopenia, and febrile neutropenia were more common with EP at 91.5%, 61.0%, and 26.8%, respectively, compared with 53.7%, 30.5%, and 12.2% with IP.
Dr Morizane noted that the trial was amended after the first cycle of treatment to include prophylactic granulocyte colony stimulating factor, which reduced febrile neutropenia from 27.9% during the first cycle to 9.5% during subsequent cycles.
These results indicate that “both EP and IP remain standard first-line chemotherapy,” Dr Morizane concluded.
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
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Morizane C, Machida N, Honma Y, et al. Randomized phase III study of etoposide plus cisplatin versus irinotecan plus cisplatin in advanced neuroendocrine carcinoma of the digestive system: A Japan Clinical Oncology Group study (JCOG1213). Presented at ASCO GI 2022; January 20-22, 2022. Abstract 501.