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Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial.

ABSTRACT: In the cetuximab after progression in KRAS wild-type colorectal cancer patients (CAPRI) trial patients with metastatic colorectal cancer (mCRC) received 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) and cetuximab in first line followed by 5-Fluorouracil, folinic acid, oxaliplatin (FOLFOX) with or without cetuximab until progression. Limited data are available on the efficacy and safety of anti-epidermal growth factor receptor (anti-EGFR) agents on elderly patients with mCRC. In the current study we evaluated the efficacy and safety of FOLFIRI plus cetuximab in age-defined subgroups.A post-hoc analysis was performed in CAPRI trial patients; outcomes (progression-free survival (PFS), overall response rate (ORR), safety) were analysed by age-groups and stratified according to molecular characterisation. 3 age cut-offs were used to define the elderly population (?65; ?70 and ?75?years).340 patients with mCRC were treated in first line with FOLFIRI plus cetuximab. Among those, 154 patients were >65?years, 86 >70?years and 35 >75?years. Next-generation sequencing (NGS) was performed in 182 patients. Among them, 87 patients were >65?years, 46 >70 and 17 >75. 104 of 182 patients were wild type (WT) for KRAS, NRAS, BRAF, PIK3CA genes. In the quadruple WT group, 51 patients were ?65?years; 29 were ?70; 9 were ?75. Median PFS was similar within the age-subgroups in the intention-to-treat population, NGS cohort and quadruple WT patients, respectively. Likewise, ORR was not significantly different among age-subgroups in the 3 populations. Safety profile was acceptable and similarly reported among all age-groups, with the exception of grade ?3 diarrhoea (55% vs 25%, p=0.04) and neutropaenia (75% vs 37%, p=0.03) in patients ?75?years and grade ?3 fatigue (31% vs 20%, p=0.01) in patients <75?years.Tolerability of cetuximab plus FOLFIRI was acceptable in elderly patients. Similar ORR and PFS were observed according to age-groups. No differences in adverse events were reported among the defined subgroups with the exception of higher incidence of grade ?3 diarrhoea and neutropaenia in patients ?75?years and grade ?3 fatigue in patients <75?years.2009-014041-81.

SUBMITTER: Martinelli E

PROVIDER: S-EPMC5548975 | biostudies-literature | 2016

REPOSITORIES: biostudies-literature

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Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial.

Martinelli E E Cardone C C Troiani T T Normanno N N Pisconti S S Sforza V V Bordonaro A R AR Rachiglio A M AM Lambiase M M Latiano T P TP Modoni G G Cordio S S Giuliani F F Biglietto M M Montesarchio V V Barone C C Tonini G G Cinieri S S Febbraro A A Rizzi D D De Vita F F Orditura M M Colucci G G Maiello E E Ciardiello F F Iaffaioli Vincenzo V Nasti Guglielmo G Nappi Anna A Botti Gerardo G Tatangelo F F Chicchinelli Nicoletta N Montrone Mirko M Sebastio Annamaria A Guarino Tiziana T Simone Gianni G Graziano Paolo P Chiarazzo Cinzia C Maggio GabrieleDi G Longhitano Laura L Manusia Mario M Cartenì Giacomo G Nappi Oscar O Micheli Pietro P Leo Luigi L Rossi Sabrina S Cassano Alessandra A Tommaselli Eugenio E Giordano Guido G Sponziello Francesco F Marino Antonella A Rinaldi Antonio A Romito Sante S Muda Andrea Onetti AO Lorusso Vito V Leo Silvana S Barni Sandro S Grimaldi Giuseppe G Aieta Michele M

ESMO open 20160101 6

<h4>Background</h4>In the cetuximab after progression in KRAS wild-type colorectal cancer patients (CAPRI) trial patients with metastatic colorectal cancer (mCRC) received 5-fluorouracil, folinic acid and irinotecan (FOLFIRI) and cetuximab in first line followed by 5-Fluorouracil, folinic acid, oxaliplatin (FOLFOX) with or without cetuximab until progression. Limited data are available on the efficacy and safety of anti-epidermal growth factor receptor (anti-EGFR) agents on elderly patients with ...[more]

PMID: 28848656

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Project description:BackgroundColorectal cancer is the third most common malignant disease and the second leading cause of death worldwide. Previous studies showed improved bioavailability and cytotoxicity of ginsenoside-modified nanostructured lipid carrier containing curcumin (G-NLC) in human colon cancer cell lines. This study aimed to evaluate the safety and tolerability with long-term survival rates in patients with colorectal cancer with unresectable metastases after treatment with first-line bevacizumab/FOLFIRI (folinic acid, bolus/continuous fluorouracil, and irinotecan) in combination with a dietary supplement of G-NLC.MethodsThis study was a prospective, observational, single-group analysis. The enrolled patients had colorectal cancer with unresectable metastases and were administered bevacizumab and FOLFIRI in combination with daily oral G-NLC as first-line treatment. Overall survival, progression-free survival, tumor response, and adverse events were evaluated.ResultsA total of 44 patients were enrolled between 2015 and 2019. The median age was 65 (range 45-81) years and the sex ratio was 31:13 (male:female). The primary tumor locations were the colon (31 patients) and rectum (13 patients). The metastatic sites included, liver only (n = 20), lung only (n = 6), both liver and lung (n = 12), and others (n = 6). The median duration of curcumin supply was 7.9 (range 0.9-16.6) months. The most common grade 3 or higher adverse events were neutropenia (n = 15, 34.1%), followed by nausea (n = 4, 9.1%) and vomiting (n = 4, 9.1%). Within the median follow-up period of 22.8 months, the median overall survival was 30.7 months, and the median progression-free survival was 12.8 months. None of the patients achieved complete response (CR); however, 9 patients showed partial response (PR), and 3 patients underwent conversion surgery.ConclusionsBevacizumab/FOLFIRI with G-NLC as first-line chemotherapy in patients with colorectal cancer with unresectable metastases presented comparable long-term survival outcomes with acceptable toxicity outcomes. Additional randomized controlled studies are needed to establish definitive conclusions regarding this new regimen for metastatic colorectal cancer.

Dataset Information

Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial.

Publications

Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial.

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