GOLFIG Chemo-Immunotherapy in Metastatic Colorectal Cancer Patients. A Critical Review on a Long-Lasting Follow-Up

Michele Caraglia; Pierpaolo Correale; Rocco Giannicola; Nicoletta Staropoli; Cirino Botta; Pierpaolo Pastina; Antonello Nesci; Nadia Caporlingua; Edoardo Francini; Laura Ridolfi; Enrico Mini; Giandomenico Roviello; Domenico Ciliberto; Rita Maria Agostino; Alessandra Strangio; Domenico Azzarello; Valerio Nardone; Antonella Falzea; Salvatore Cappabianca; Marco Bocchetti; Graziella D'Arrigo; Giovanni Tripepi; Pierfrancesco Tassone; Raffaele Addeo; Antonio Giordano; Luigi Pirtoli; Guido Francini; Pierosandro Tagliaferri

doi:10.3389/fonc.2019.01102

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GOLFIG Chemo-Immunotherapy in Metastatic Colorectal Cancer Patients. A Critical Review on a Long-Lasting Follow-Up

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GOLFIG Chemo-Immunotherapy in Metastatic Colorectal Cancer Patients. A Critical Review on a Long-Lasting Follow-Up

Michele Caraglia, Pierpaolo Correale, Rocco Giannicola, Nicoletta Staropoli, Cirino Botta, Pierpaolo Pastina, Antonello Nesci, Nadia Caporlingua, Edoardo Francini, Laura Ridolfi, …

Frontiers in oncology, Vol.9, p.1102

11/08/2019

DOI: 10.3389/fonc.2019.01102

PMID: 31781481

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Abstract

Background: GOLFIG is a chemo-immunotherapy regimen established in preclinical models that combines gemcitabine + FOLFOX (fluoropyrimidine backbone coupled to oxaliplatin) poly-chemotherapy with low-dose s. c. recombinant interleukin-2 (rIL-2) and granulocyte-macrophage colony stimulating factor (GM-CSF). Promising antitumor effects in metastatic colorectal cancer (mCRC) patients were obtained in previous phase II and III trials. Here we report the results of 15 years of follow-up. Methods: This is a multi-institutional retrospective analysis including 179 mCRC patients receiving GOLFIG regimen between June 2002 and June 2018. Sixty-two of them received the treatment as frontline (enrolled in the GOLFIG-2 phase III trial) and 117 as second/third line (49 enrolled in the GOLFIG-1 phase II trial and 68 as compassionate use). One hundred twelve patients showed a primary left side and 67 a primary right side; K/N-ras mutational status was available in 74 cases, and an activating mutation was detected in 33. Kaplan-Meier and Cox regression analyses were carried out to relate PFS and OS with different parameters. Results: Overall, we recorded a mean PFS and OS of 15.28 (95% CI: 10.36-20.20) and 24.6 (95% CI: 19.07-30.14) months, respectively, with 14 patients surviving free of progression for 10 years. This regimen, in our updated survey of the GOLFIG-2 trial, confirmed superiority over FOLFOX in terms of PFS (hazard ratio (HR) = 0.58, p = 0.006) with a trend to a longer OS (HR = 0.69, P = 0.06) in the first line. Our analysis also confirmed significant antitumor activity in pre-treated patients, reporting a mean PFS and OS of 12.55 (95% CI: 7.19-17.9) and 20.28 (95% CI: 14.4-26.13) months, respectively. Immune-related adverse events (irAEs) were recorded in 24% of the cases and were related to a longer survival (HR = 0.36; P = 0.0001). Finally, patients' outcome was not correlated to sex, sidedness, and MT-K/N-ras. Conclusions: The GOLFIG regimen is a reliable underestimated therapeutic option in pre-treated mCRC patients and offers a strong rationale to design further trials.

Life Sciences & Biomedicine

Oncology

Science & Technology

Details

Title: Subtitle: GOLFIG Chemo-Immunotherapy in Metastatic Colorectal Cancer Patients. A Critical Review on a Long-Lasting Follow-Up
Creators: Michele Caraglia - University of Campania "Luigi Vanvitelli"
Pierpaolo Correale - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Rocco Giannicola - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Nicoletta Staropoli - Magna Graecia University
Cirino Botta - Magna Graecia University
Pierpaolo Pastina - University of Siena
Antonello Nesci - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Nadia Caporlingua - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Edoardo Francini - University of Siena
Laura Ridolfi - Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Enrico Mini - University of Florence
Giandomenico Roviello - University of Florence
Domenico Ciliberto - Magna Graecia University
Rita Maria Agostino - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Alessandra Strangio - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Domenico Azzarello - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Valerio Nardone - University of Siena
Antonella Falzea - Azienda ospedaliera "Bianchi-Melacrino-Morelli"
Salvatore Cappabianca - University of Campania "Luigi Vanvitelli"
Marco Bocchetti - University of Campania "Luigi Vanvitelli"
Graziella D'Arrigo - Istituto di Fisiologia Clinica
Giovanni Tripepi - Istituto di Fisiologia Clinica
Pierfrancesco Tassone - Magna Graecia University
Raffaele Addeo - Nuovo Ospedale San Giovanni di Dio
Antonio Giordano - University of Siena
Luigi Pirtoli - Temple University
Guido Francini - University of Siena
Pierosandro Tagliaferri - Magna Graecia University
Resource Type: Journal article
Publication Details: Frontiers in oncology, Vol.9, p.1102
DOI: 10.3389/fonc.2019.01102
PMID: 31781481
ISSN: 2234-943X
eISSN: 2234-943X
Publisher: Frontiers Media Sa
Number of pages: 10
Grant note: 2009EHW394 / Italian Ministry of Education and Research (MIUR); Ministry of Education, Universities and Research (MIUR) Associazione Culturale Federico II and Associazione Riuniti Calabria Oncologia (ARCO)
Language: English
Date published: 11/08/2019
Academic Unit: Internal Medicine
Record Identifier: 9985221145302771

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