Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Long-term survival results of a randomized phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC).

Ruers, Theo J.M.; Coevorden, Frits van; Pierie, Jean-Pierre E. N.; Rinkes, Inne Borel; Punt, Cornelis J.A.; Ledermann, Jonathan A.; Poston, Graeme J.; Bechstein, W. O.; Lentz, M.A.; Collette, Laurence; Nordlinger, Bernard

doi:10.1200/jco.2015.33.15_suppl.3501

Cited by 58 publications

(27 citation statements)

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“…We assume that drug efficacy against microscopic disease and indolent disease biology combined to influence for the better RFS and OS in our study population 24. While the randomized phase II CLOCC trial documents an OS benefit from adding RFA upfront to systemic therapy 11, our study shows that response is prognostically important, rather than the use of systemic therapy itself. In addition to response, number (≥2) of lines of pre-RFA systemic therapy, number (≥4) and size (≥3 cm) of CLM were also independent predictors of early and/or multiple site recurrence and poor outcome in our study cohort.…”

Section: Discussionmentioning

confidence: 89%

“…The randomized phase II CLOCC trial supports this concept and documents improved 5-year OS from adding RFA upfront to chemotherapy in patients with up to 9 liver-limited CLM 10,11. However, >80% of patients' experience disease recurrence distant from RFA-treated CLM within 12 months, and virtually no RFA-treated patient achieves 5-year recurrence-free survival (RFS) 12.…”

Section: Introductionmentioning

confidence: 93%

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Impact of Systemic Therapy and Recurrence Pattern on Survival Outcome after Radiofrequency Ablation for Colorectal Liver Metastases

et al. 2016

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Background: Most patients undergoing radiofrequency ablation (RFA) of colorectal liver metastasases (CLM) develop disease recurrence, but little is known about the effect of recurrence patterns and/or systemic therapy on outcome. In this study, we examined the recurrence patterns and survival after systemic therapy plus RFA in patients with unresectable CLM without extrahepatic disease. The aims were to analyze the effect of recurrence patterns on survival and to assess the relative benefit contributed by systemic therapy and local ablation to disease control and patient outcome.Methods: From January 2002 to December 2012, 113 patients underwent RFA of liver-limited CLM after systemic therapy. Univariate and multivariate analyses for associations between clinical and/or treatment-related variables, recurrence-free survival (RFS), recurrence patterns, and overall survival (OS) were carried out.Results: Of 113 patients, 105 (92.8%) had disease recurrence (median RFS: 6.1 months). Lower post-recurrence OS was observed after early (≤6 months) than after late recurrence (8.5 versus 24.0 months, p < 0.001). Recurrence sites were RFA-sites only (4.8%), liver-only (57.1%), lung-only (10.5%), or multiple (27.6%); the corresponding post-recurrence OS was 21, 19, 39, and 7 months (p < 0.001), respectively. Response to pre-RFA systemic therapy was the strongest predictor for OS (hazard ratio [HR] 5.28), RFS (HR 3.30), early (odds ratio [OR] 6.34) and multiple-site recurrence (OR 3.83) (p < 0.01), respectively; only responders achieved 5-year OS and RFS (29% and 12% versus 0% and 0% for non-responders, p < 0.001, respectively).Conclusions: Survival after RFA for liver-limited CLM is strongly linked to the timing and pattern of non-local disease recurrence. Local ablation efficacy is necessary but not sufficient to obtain long-term disease control. Effective pre-RFA systemic therapy does favourably affect the incidence, timing and patterns of recurrence and long-term survival and appears essential for the tailoring of RFA application to maximize patient benefit.

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Section: Discussionmentioning

confidence: 89%

Section: Introductionmentioning

confidence: 93%

Impact of Systemic Therapy and Recurrence Pattern on Survival Outcome after Radiofrequency Ablation for Colorectal Liver Metastases

et al. 2016

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“…Recently the randomized CLOCC (Chemotherapy + Local Ablation Versus Chemotherapy) study reported that RFA + chemotherapy offered better long‐term survival for unresectable CRLM than chemotherapy alone (8‐year OS rate 35·9 versus 8·9 per cent respectively), demonstrating the potential of RFA as a radical treatment strategy for CRLM. The combination of hepatectomy and RFA has the potential to increase the rate of radical treatment in patients with multinodular tumours.…”

Section: Discussionmentioning

confidence: 99%

Long-term outcomes of radiofrequency ablation combined with hepatectomy compared with hepatectomy alone for colorectal liver metastases

Imai

Allard

Benítez

et al. 2017

British Journal of Surgery

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“…In an effort to control disease, palliate symptoms, and extend survival, several types of treatment approaches have been pursued in patients with primary liver tumors or hepatic metastases [1–18]. The Hepatic CHEMOSAT ® Delivery System (Delcath Systems Inc., New York, NY, USA) is an innovative medical device for the treatment of patients with unresectable primary liver tumors or unresectable hepatic metastases from solid organ malignancies, in which a high dose of the chemotherapeutic agent melphalan is delivered directly to the liver while limiting systemic exposure.…”

Section: Introductionmentioning

confidence: 99%

Chemosaturation Percutaneous Hepatic Perfusion: A Systematic Review

et al. 2016

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The Hepatic CHEMOSAT® Delivery System is an innovative medical device for the treatment of patients with unresectable primary liver tumors or unresectable hepatic metastases from solid organ malignancies. This system is used to perform chemosaturation percutaneous hepatic perfusion (CS-PHP), a procedure in which a high dose of the chemotherapeutic agent melphalan is delivered directly to the liver while limiting systemic exposure. In a clinical trial program, CS-PHP with melphalan significantly improved hepatic progression-free survival in patients with unresectable hepatic metastases from ocular or cutaneous melanoma. Clinically meaningful hepatic responses were also observed in patients with hepatocellular carcinoma or neuroendocrine tumors. Furthermore, the results of published studies and case reports demonstrated that CS-PHP with melphalan resulted in favorable tumor response rates in a range of tumor histologies (ocular or cutaneous melanoma, colorectal cancer, and hepatobiliary tumors). Analyses of the safety profile of CS-PHP revealed that the most common adverse effects were hematologic events (thrombocytopenia, anemia, and neutropenia), which were clinically manageable. Taken together, these findings indicate that CS-PHP is a promising locoregional therapy for patients with primary and secondary liver tumors and has a acceptable safety profile. Funding: Delcath Systems Inc., New York, NY, USA.

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Radiofrequency ablation (RFA) combined with chemotherapy for unresectable colorectal liver metastases (CRC LM): Long-term survival results of a randomized phase II study of the EORTC-NCRI CCSG-ALM Intergroup 40004 (CLOCC).

Cited by 58 publications

References 0 publications

Impact of Systemic Therapy and Recurrence Pattern on Survival Outcome after Radiofrequency Ablation for Colorectal Liver Metastases

Impact of Systemic Therapy and Recurrence Pattern on Survival Outcome after Radiofrequency Ablation for Colorectal Liver Metastases

Long-term outcomes of radiofrequency ablation combined with hepatectomy compared with hepatectomy alone for colorectal liver metastases

Chemosaturation Percutaneous Hepatic Perfusion: A Systematic Review

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