التفاصيل البيبلوغرافية
| العنوان: |
Phase II randomised trial of autologous tumour lysate dendritic cell plus best supportive care compared with best supportive care in pre-treated advanced colorectal cancer patients. |
| المؤلفون: |
Caballero-Baños, Miguel1 miguelcaballerobanos@gmail.com, Benitez-Ribas, Daniel2, Tabera, Jaime3, Varea, Sara4, Vilana, Ramon5, Bianchi, Luis5, Ayuso, Juan Ramón6, Pagés, Mario6, Carrera, Gemma7, Cuatrecasas, Miriam8, Martin-Richard, Marta9, Cid, Joan10, Lozano, Miguel10, Castells, Antoni2, García-Albéniz, Xabier11, Maurel, Joan12, Vilella, Ramon1 |
| المصدر: |
European Journal of Cancer. Sep2016, Vol. 64, p167-174. 8p. |
| مصطلحات موضوعية: |
*METASTASIS, *CANCER treatment, *ANTINEOPLASTIC agents, *CONFIDENCE intervals, *COLON tumors, *DENDRITIC cells, *LACTATE dehydrogenase, *CANCER vaccines, *RANDOMIZED controlled trials, *TREATMENT effectiveness, *DESCRIPTIVE statistics, *PROGNOSIS, *TUMOR treatment, RECTUM tumors |
| مستخلص: |
Background Autologous tumour lysate dendritic cell vaccine (ADC) has T-cell stimulatory capacity and, therefore, potential antitumour activity. We designed a phase II randomised trial of ADC + best supportive care (BSC) (experimental arm [EA]) compared with BSC (control arm [CA]), in pre-treated metastatic colorectal cancer (mCRC) patients. Patients and methods Patients with progressive mCRC, at least to two chemotherapy regimens and Eastern Cooperative Oncology Group performance status (ECOG PS) 0–2, were randomised to EA versus CA. Stratification criteria: ECOG PS (0–1 versus 2) and lactate dehydrogenase (ULN). EA was administered subcutaneously till progressive disease. Primary end-point was progression-free survival (PFS) at 4 months. Results Fifty-two patients were included (28 EA/24 CA). An interim analysis recommended early termination for futility. No objective radiological response was observed in EA. Median PFS in EA was 2.7 months (95% confidence interval [CI], 2.3–3.2 months) versus 2.3 months (95% CI, 2.1–2.5 months) in CA (p = 0.628). Median overall survival (OS) was 6.2 months (95% CI, 4.4–7.9 months) in EA versus 4.7 months (95% CI, 2.3–7 months) in CA (p = 0.41). No ADC-related adverse events were reported. Immunization induces tumour-specific T-cell response in 21 of 25 (84%) patients. Responder patients have an OS of 7.3 months (95% CI, 5.2–9.4 months) versus 3.8 months (95% CI, 0.6–6.9 months) in non-responders; p = 0.026). Conclusion Our randomised clinical trial comparing ADC + BSC versus BSC in mCRC demonstrates that ADC generates a tumour-specific immune response but not benefit on PFS and OS. Our results do not support the use of ADC alone, in a phase III trial. [ABSTRACT FROM AUTHOR] |
| قاعدة البيانات: |
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