Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): A randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Background: Cetuximab plus chemotherapy is a first-line treatment option in metastatic KRAS and NRAS wild-type colorectal cancer (CRC) patients. No data are currently available on continuing anti-epidermal growth factor receptor (EGFR) therapy beyond progression. Patients and methods: We did this open-label, 1:1 randomized phase II trial at 25 hospitals in Italy to evaluate the efficacy of cetuximab plus 5-fluorouracil, folinic acid and oxaliplatin (FOLFOX) as second-line treatment of KRAS exon 2 wild-type metastatic CRC patients treated in first line with 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) plus cetuximab. Patients received FOLFOX plus cetuximab (arm A) or FOLFOX (arm B). Primary end point was progressionfree survival (PFS). Tumour tissues were assessed by next-generation sequencing (NGS). This report is the final analysis. Results: Between 1 February 2010 and 28 September 2014, 153 patients were randomized (74 in arm A and 79 in arm B). Median PFS was 6.4 [95% confidence interval (CI) 4.7-8.0] versus 4.5 months (95% CI 3.3-5.7); [hazard ratio (HR), 0.81; 95% CI 0.58-1.12; P = 0.19], respectively. NGS was performed in 117/153 (76.5%) cases; 66/117 patients (34 in arm A and 32 in arm B) had KRAS, NRAS, BRAF and PIK3CA wild-type tumours. For these patients, PFS was longer in the FOLFOX plus cetuximab arm [median 6.9 (95% CI 5.5-8.2) versus 5.3 months (95% CI 3.7-6.9); HR, 0.56 (95% CI 0.33-0.94); P = 0.025]. There was a trend in better overall survival: median 23.7 [(95% CI 19.4-28.0) versus 19.8 months (95% CI 14.9-24.7); HR, 0.57 (95% CI 0.32-1.02); P = 0.056]. Conclusions: Continuing cetuximab treatment in combination with chemotherapy is of potential therapeutic efficacy in molecularly selected patients and should be validated in randomized phase III trials

Atti del I Convegno. Laboratorio dose unitaria Galenica clinica e gestione del rischio: modelli ed esperienze

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Atti del I Convegno. Laboratorio dose unitaria Galenica clinica e gestione del rischio: modelli ed esperienze

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Chronostratigraphy of the Izarorene section in the Melilla Basin (Northeastern Morocco)

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The morbidly adherent placenta: when and what association of signs can improve MRI diagnosis? Our experience.

PURPOSE: We aimed to verify whether combination of specific signs improves magnetic resonance imaging (MRI) accuracy in morbidly adherent placenta (MAP). METHODS: MRI findings for MAP were retrospectively evaluated in 27 women. Histopathology was the reference standard, showing MAP in eight of 27 cases. Specificity, sensitivity, positive predictive value, and negative predictive value were calculated for all MRI signs. Two skilled radiologists analyzed MRI findings, resolving discrepancies by consensus, using three alternative diagnostic criteria during three consecutive sections. First criterion: at least one of reported MRI signs indicates MAP and the absence of any sign is normal; second criterion: at least one statistically significant sign indicates MAP and no sign or nonsignificant sign is normal; third criterion: at least two statistically significant signs indicate MAP and no sign, nonsignificant sign, or only one significant sign is normal. RESULTS: Using the first criterion yielded an unacceptable rate of false positive results (78.9%). Using the second criterion there were less false positive results (31.5%), and diagnostic accuracy of the second criterion was significantly higher than the first; the third criterion correctly classified 100% of cases. CONCLUSION: Only specific MRI signs can correctly predict MAP at histopathology, particularly when multiple (at least two) specific signs are observed together