First-line panitumumab plus docetaxel and cisplatin in advanced gastric and gastro-oesophageal junction adenocarcinoma: results of a phase II trial
| Autor: | Rosa López, Y. Vidal Insua, Claudia Alejandra Duque Romero, Mónica Jorge, M. Salgado, M. Covela, J. Méndez, M Carmona, G. Quintero Aldana, Margarita Reboredo, A. Fernández Montes, Sonia Candamio, L. Vázquez Tuñas |
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| Rok vydání: | 2019 |
| Předmět: |
Adult
Male 0301 basic medicine Cancer Research medicine.medical_specialty Colorectal cancer medicine.medical_treatment Docetaxel Adenocarcinoma Gastroenterology 03 medical and health sciences 0302 clinical medicine Stomach Neoplasms Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Clinical endpoint Humans Panitumumab Prospective Studies Adverse effect Aged Aged 80 and over Chemotherapy business.industry General Medicine Middle Aged medicine.disease 030104 developmental biology Oncology 030220 oncology & carcinogenesis Female Esophagogastric Junction Cisplatin business Progressive disease medicine.drug |
| Zdroj: | Clinical and Translational Oncology. 22:495-502 |
| ISSN: | 1699-3055 1699-048X |
| DOI: | 10.1007/s12094-019-02151-6 |
| Popis: | Panitumumab is extensively used for RAS-WT metastatic colorectal cancer. This study assessed the efficacy and safety of panitumumab plus first-line chemotherapy [docetaxel (DOC) and cisplatin (CIS)] in treatment-naive advanced gastric or gastro-oesophageal junction (GEJ) adenocarcinoma (ADC) patients. Phase II, open-label, single-arm study includes treatment-naive advanced gastric or GEJ-ADC patients from ten Spanish centres. Patients received panitumumab (6 mg/kg) plus DOC and CIS (50 mg/m2 both) every 2 weeks until disease progression, unacceptable toxicity, or patient withdrawal. Primary endpoint: objective response rate (ORR); main secondary endpoints: disease control rate (DCR), duration of response (DoR), time to progressive disease (TTP), progression-free-survival (PFS), overall survival (OS), and safety. Forty-four patients were included; median age: 67.8 (range 43.3–82.7) years, 68.2% male. The ORR was 27.3% (95% CI 15.0, 42.8); median PFS and OS: 5.0 (95% CI 3.6, 6.9) and 7.2 (5.5, 9.0) months, respectively. Median TTP, DCR and DoR: 5.3 (range 3.8–7.0) months, 70.5% (95% CI 54.8, 83.2%), and 4.8 (1.8, NE) months. Median panitumumab treatment duration: 11.9 (range 0.1–34.9) weeks; 25.0% patients had a dose reduction and 40.9% discontinued treatment. Grade 3–4 adverse events (AEs): 68.2%/22.2% patients. Most common AEs: asthenia (75.0%) and mucosal inflammation (54.5%). Serious AEs were experienced by 54.6% patients; 9.1%, 13.6%, and 15.9% related to panitumumab, DOC, and CIS, respectively. Three (6.8%) patients died due to AEs not related to study treatment. The addition of panitumumab to standard chemotherapy as the first-line treatment in advanced gastric or GEJ-ADC does not appear to improve the efficacy outcomes. |
| Databáze: | OpenAIRE |
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