PARAGON II – A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer

Jones, Rowan Pritchard; Malik, Hassan; Fenwick, Stephen; Terlizzo, Monica; O’Grady, Elizabeth; Stremitzer, Stefan; Gruenberger, Thomas; Rees, Myrddin; Plant, G.; Figueras, Joan; Albiol, M.; Adam, René; Awad, Sameh; Poston, Graeme J.

doi:10.1016/j.ejso.2016.07.142

Cited by 37 publications

(18 citation statements)

References 32 publications

(31 reference statements)

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“…In a Phase 3 trial on 74 patients, 5 DEB loaded with irinotecan (DEBIRI) plus intravenous 5-fluoro-uracil (5FU) was compared to intravenous 5FU plus irinotecan (Folfiri) in patients with unresectable LMCRC after failure of at least two lines of treatment. Overall survival (OS), progression-free survival (PFS), and response rate significantly improved in the DEBIRI arm.…”

Section: Introductionmentioning

confidence: 99%

Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study

et al. 2020

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Background Chemo-embolisation with drug-eluting beads loaded with irinotecan (DEBIRI) increased survival as compared with intravenous irinotecan in chemorefractory patients with liver-dominant metastases from colorectal cancer (LMCRC). First-line DEBIRI with systemic chemotherapy may increase survival and secondary resection. Methods In the FFCD-1201 single-arm Phase 2 study, patients with untreated, non-resectable LMCRC received DEBIRI plus mFOLFOX6. Four courses of DEBIRI were performed alternating right and left lobe or two sessions with both lobes treated during the same session. Results Fifty-seven patients were enrolled. Grade 3–5 toxicities were more frequent when both lobes were treated during the same session (90.5% versus 52.8%). Nine-month PFS rate was 53.6% (95% CI, 41.8–65.1%). The objective response rate (RECIST 1.1) was 73.2%, and the secondary R0 surgery was 33%. With a median follow-up of 38.3 months, median OS was 37.4 months (95% CI, 25.7–45.8), and median PFS 10.8 months (95% CI, 8.2–12.3). Conclusions Front-line DEBIRI + mFOLFOX6 should not be recommended as the hypothesised 9-month PFS was not met. However, high response rate, deep responses, and prolonged OS encourage further evaluation in strategies integrating biologic agent, in particular in patients with secondary surgery as the main goal. Clinical trial registration NCT01839877.

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Section: Introductionmentioning

confidence: 99%

Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study

et al. 2020

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“…The prospective PARAGON II study evaluated beads in a single delivery to sub segment of the liver containing the tumour prior to resection in patients with easily resectable CRLMs. Pathological response rates demonstrated 76% of lesions showing major/complete pathological response, which is similar to six systemic cycles of FOLFOX/FOLFIRI [21][22][23][24]. Delivery of local chemotherapy agent is thought to reduce systemic chemotoxic affect and could be combined alongside systemic agents in the future to maximise treatment for BCRLM and may deliver a chemotherapy combination similar to the FOLFOXIRI trial [25] (without severe chemotoxic load).…”

Section: Chemotherapymentioning

confidence: 64%

An Overview of the Current Management of Bilobar Colorectal Liver Metastases

Griggs

Pathak

Poston

2017

Indian J Surg Oncol

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“…A review on their efficacy of these locoregional methods showed that HAI, RE, and ADET had similar tumor response in patients affected by unresectable CRLM, and only small differences in overall survival[ 18 ]. Other studies reported ADET efficacy also as neo-adjuvant therapy for CRC-LM, obtaining significant surgical down-staging with irinotecan eluting beads[ 4 , 21 ].…”

Section: Discussionmentioning

confidence: 99%

“…A recent report shows the efficacy of ADET with irinotecan loaded beads also as neoadjuvant therapy, leading to complete resectability (R0), and resulting in tumor response and survival comparable to those of chemotherapy[ 4 ].…”

Section: Introductionmentioning

confidence: 99%

Polyethylene glycol microspheres loaded with irinotecan for arterially directed embolic therapy of metastatic liver cancer

Fiorentini

Carandina

Sarti

et al. 2017

WJGO

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AIMTo study tumor response, and tolerability of arterially directed embolic therapy (ADET) with polyethylene glycol embolics loaded with irinotecan for the treatment of colorectal cancer liver metastases (CRC-LM). Secondary objectives were to monitor quality of life, time to progression and survival of patients.METHODSPatients were included in the study if they were affected by CRC-LM, refractory to systemic chemotherapy, treated with ADET using polyethylene glycol embolics, and had liver involvement < 50%. Tumor response, performance status (PS), tumor marker antigens, and quality of life (QoL) were monitored at 1, 3 and 6 mo after ADET. QoL was assessed with the Palliative Performance Scale (PPS).RESULTSWe treated 50 consecutive CRC-LM patients with ADET using polyethylene glycol embolics. Their tumor response one month after ADET was: 28% of complete response (CR), 48% of partial response (PR), 8% stable disease (SD), and 16% of progression. Tumor response 3 mo after ADET was CR 24%, PR 38%, SD 19% and progression disease (PD) 19%. Tumor response 6 mo after ADET was CR 18%, PR 44%, SD 21% and PD 18%. QoL was 90% PPS at each time point. Median time to progression for patients who progressed was 2.5 mo (range 0.8-6). Median follow-up was 14 mo (0.8-25 range). ADETs were performed with no complications. Observed side effects (mild or moderate intensity) were: Pain in 32% of patients, increase of transaminase levels in 20% and fever in 14%, whereas 30% of patients did not complain any adverse event.CONCLUSIONThe treatment of unresectable CRC-LM with ADET using polyethylene glycol microspheres loaded with irinotecan was effective in tumor response and resulted in mild toxicity, and good QoL.

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PARAGON II – A single arm multicentre phase II study of neoadjuvant therapy using irinotecan bead in patients with resectable liver metastases from colorectal cancer

Abstract: Resection after neoadjuvant DEBIRI for CRLM is feasible and safe. Single treatment with DEBIRI resulted in tumour pathologic response and median overall survival comparable to that seen after systemic neoadjuvant chemotherapy. Registered at clinicaltrials.gov (NCT00844233).

Cited by 37 publications

References 32 publications

Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study

Intra-arterial hepatic beads loaded with irinotecan (DEBIRI) with mFOLFOX6 in unresectable liver metastases from colorectal cancer: a Phase 2 study

An Overview of the Current Management of Bilobar Colorectal Liver Metastases

Polyethylene glycol microspheres loaded with irinotecan for arterially directed embolic therapy of metastatic liver cancer

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