دورية أكاديمية
VITAL phase 2 study: Upfront 5-fluorouracil, mitomycin-C, panitumumab and radiotherapy treatment in nonmetastatic squamous cell carcinomas of the anal canal (GEMCAD 09-02)
| العنوان: | VITAL phase 2 study: Upfront 5-fluorouracil, mitomycin-C, panitumumab and radiotherapy treatment in nonmetastatic squamous cell carcinomas of the anal canal (GEMCAD 09-02) |
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| المؤلفون: | Feliu, Jaime, Garcia-Carbonero, Rocio, Capdevila, Jaume, Guasch, Inmaculada, Alonso-Orduna, Vicente, Lopez, Carlos, Garcia-Alfonso, Pilar, Castanon, Carmen, Sevilla, Isabel, Cerezo, Laura, Conill, Carles, Quintana-Angel, Begona, Sanchez, Maria E., Ghanem, Ismael, Martin-Richard, Marta, Lopez-Gomez, Miriam, Leon, Ana, Caro, Monica, Fernandez, Teresa, Maurel, Joan |
| المساهمون: | UAM. Departamento de Medicina, Instituto de Investigación Sanitaria Hospital Universitario de La Paz (IdiPAZ) |
| بيانات النشر: | John Wiley & Sons Ltd. |
| سنة النشر: | 2020 |
| المجموعة: | Universidad Autónoma de Madrid (UAM): Biblos-e Archivo |
| مصطلحات موضوعية: | chemotherapy, radiotherapy, rectal cancer, target therapy, Medicina |
| الوصف: | Aim: VITAL, a phase II single-arm study, aimed to evaluate efficacy and safety of panitumumab addition to 5-fluorouracil (5-FU), mitomycin-C (MMC) and radiotherapy (RT) in patients with localized squamous cell carcinoma of the anal canal (SCCAC). Methods: Adult, treatment-naïve SCCAC patients (Stage T2-T4, any N, M0) and ECOG-PS ≤2, received panitumumab (6 mg/kg, day 1 and Q2W; 8 weeks), 5-FU (1000 mg/m2/d, days 1-4 and 29-32), MMC (10 mg/m2, days 1 and 29) and RT 45 Gy (1.8 Gy/fraction) to the primary tumor and mesorectal, iliac and inguinal lymph nodes, plus 10-15 Gy boost dose to the primary tumor and affected lymph nodes. The primary objective was disease free survival rate (DFS) at 3-years (expected 3-year DFS rate: 73.7 ± 12%). Results: Fifty-eight patients (31 women; median age: 59 years; ECOG-PS 0-1:98%; TNM II [29%] (T2 or T3/N0/M0)/IIIA (T1-T3/N1/M0 or T4/N0/M0) [21%]/IIIB (T4/N1/M0 or any T/N2 or N3/M0) [47%]/nonevaluable [4%]) were included. The median follow-up was 45 months. The 3-year DFS rate was 61.1% (95% CI: 47.1, 72.4). The 3-year overall survival rate was 78.4% (95% CI: 65.1, 87.1). Eighteen patients (31.0%) required a colostomy within 2 years posttreatment. Grade 3-4 toxicities were experienced by 53 (91%) patients. Most common grade 3-4 treatment-related events were radiation skin injury (40%) and neutropenia (24%). No toxic deaths occurred. Improved efficacy in colostomy-free survival and complete response rate was observed in human papilloma virus positive patients. Conclusions: Panitumumab addition to MMC-5FU regimen in SCCAC patients increases toxicity and does not improve patients’ outcomes. RT plus MMC-5FU remains the standard of care for localized SCCAC patients. ; This work was supported by Amgen S.A. |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2045-7634 |
| العلاقة: | Cancer Medicine; https://doi.org/10.1002Test/ cam4.2722; Cancer Medicine 9 (2020):1008-1016; http://hdl.handle.net/10486/692398Test; 1008; 1016 |
| DOI: | 10.1002/cam4.2722 |
| الإتاحة: | https://doi.org/10.1002/cam4.2722Test http://hdl.handle.net/10486/692398Test |
| حقوق: | © 2019 The Authors ; Reconocimiento ; openAccess |
| رقم الانضمام: | edsbas.AD661B34 |
| قاعدة البيانات: | BASE |
Full Text Finder | تدمد: | 20457634 |
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| DOI: | 10.1002/cam4.2722 |