Cetuximab Maintenance Therapy in Patients with Unresectable Wild-Type RAS and BRAF Metastatic Colorectal Cancer: A Single-Institute Prospective Study
| Autor: | Xinli Wang, Mengxin Lin, Qing Liu, Hao Chen, Baoyu Yang, Jinhuo Lai, Dongta Zhong, Tao Jiang, Jianwei Zheng, Peifeng Hou, Bin Du, Xiaoyan Lin, Han Wang |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Proto-Oncogene Proteins B-raf Oncology medicine.medical_specialty Adolescent Colorectal cancer Leucovorin Cetuximab Irinotecan Maintenance Chemotherapy Young Adult Maintenance therapy Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Mucositis Humans Pharmacology (medical) Prospective Studies Neoplasm Metastasis Aged business.industry Hazard ratio General Medicine Middle Aged medicine.disease Progression-Free Survival digestive system diseases Fluorouracil FOLFIRI Female Colorectal Neoplasms business medicine.drug |
| Zdroj: | Advances in Therapy. 37:2829-2840 |
| ISSN: | 1865-8652 0741-238X |
| DOI: | 10.1007/s12325-020-01360-8 |
| Popis: | Cetuximab plus FOLFIRI (leucovorin, fluorouracil, and irinotecan) is the preferred first-line therapy for RAS and BRAF wild-type (RBWT) metastatic colorectal cancer (mCRC). To counter chemotherapy-induced side effects, use of maintenance therapy is suggested. Therefore, we evaluated the efficacy and safety of cetuximab maintenance therapy in patients after effective completion of first-line induction therapy. This prospective study enrolled untreated patients with mCRC RBWT who received first-line cetuximab plus FOLFIRI therapy. Following this, patients with treatment response either entered observation (stop treatment) or maintenance treatment 1 (cetuximab plus irinotecan) groups. After 6–12 cycles of maintenance treatment 1, patients entered maintenance treatment 2 (cetuximab only). If a patient progressed on maintenance 2, cetuximab plus FOLFIRI was reintroduced. The primary end point was failure-free survival (FFS), whereas the secondary end points included disease control rate (DCR), objective remission rate (ORR), and progression-free survival (PFS). Safety events were also evaluated. Among 79 enrolled patients, 72 completed first-line treatment effectively (DCR 91.1%, ORR 63.9%) and 44 entered maintenance 1 [median PFS 1 (mPFS, maintenance 1) 6.1 months, 95% confidence interval (CI) 6.0–6.2; DCR 56.8%; ORR 22.7%]. Of them, 21 entered maintenance treatment 2 (mPFS2 8.7 months, 95% CI 3.3–14.1; DCR 28.6%; ORR 4.8%). Median FFS (mFFS) was significantly longer in the maintenance 1 group compared with the observation group [12.7 vs. 3.0 months; hazard ratio (HR) 0.202, 95% CI 0.111–0.369; P |
| Databáze: | OpenAIRE |
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