Clinical efficacy of sequential treatments in KRASG12C-mutant metastatic colorectal cancer: findings from a real-life multicenter Italian study (CRC-KR GOIM).


Journal

ESMO open
ISSN: 2059-7029
Titre abrégé: ESMO Open
Pays: England
ID NLM: 101690685

Informations de publication

Date de publication:
10 2022
Historique:
received: 29 06 2022
revised: 16 07 2022
accepted: 19 07 2022
pubmed: 23 8 2022
medline: 25 10 2022
entrez: 22 8 2022
Statut: ppublish

Résumé

The presence of KRASG12C mutation in metastatic colorectal cancer (mCRC) correlates with poor outcome. Although different selective inhibitors are under clinical development, the optimal treatment remains uncertain. Thus, we conducted a retrospective analysis in a large cohort of patients with KRASG12C mCRC treated in 12 Italian oncology units. Patients with unresectable mCRC harboring KRASG12C mutation receiving a first-line chemotherapy doublet or triplet between 2011 and 2021 were included in the study. Evaluation of overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) analysis was carried out. A total of 256/6952 (3.7%) patients with mCRC displayed KRASG12C mutation; of these, 111 met the inclusion criteria. The ORR of first-line therapy was 38.7% (43/111). Median PFS (mPFS) was 9 months [95% confidence interval (CI) 7.5-10.5 months]. After progression, only 62% and 36% of the patients are fit to receive second or third lines of treatment, with limited clinical benefit. Median OS (mOS) was 21 months (95% CI 17.4-24.6 months). In patients receiving first-line triplet chemotherapy, ORR was 56.3% (9/16), mPFS was 13 months (95% CI 10.3-15.7 months) and mOS was 32 months (95% CI 7.7-56.3 months). For irinotecan-based doublets, ORR was 34.5 (10/29), mPFS was 9 months (95% CI 6.4-11.6 months) and mOS was 22 months (95% CI 16.0-28.0 months). With oxaliplatin-based doublets ORR was 36.4% (24/62), mPFS was 7 months (95% CI 4.6-9.4 months) and mOS was 18 months (95% CI, 13.6-22.4 months). Patients with KRASG12C-mutant mCRC had a disappointing response to standard treatments. Within the limitations of a retrospective study, these results suggest that first-line chemotherapy intensification with FOLFOXIRI is a valid option in fit patients.

Sections du résumé

BACKGROUND
The presence of KRASG12C mutation in metastatic colorectal cancer (mCRC) correlates with poor outcome. Although different selective inhibitors are under clinical development, the optimal treatment remains uncertain. Thus, we conducted a retrospective analysis in a large cohort of patients with KRASG12C mCRC treated in 12 Italian oncology units.
PATIENTS AND METHODS
Patients with unresectable mCRC harboring KRASG12C mutation receiving a first-line chemotherapy doublet or triplet between 2011 and 2021 were included in the study. Evaluation of overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) analysis was carried out.
RESULTS
A total of 256/6952 (3.7%) patients with mCRC displayed KRASG12C mutation; of these, 111 met the inclusion criteria. The ORR of first-line therapy was 38.7% (43/111). Median PFS (mPFS) was 9 months [95% confidence interval (CI) 7.5-10.5 months]. After progression, only 62% and 36% of the patients are fit to receive second or third lines of treatment, with limited clinical benefit. Median OS (mOS) was 21 months (95% CI 17.4-24.6 months). In patients receiving first-line triplet chemotherapy, ORR was 56.3% (9/16), mPFS was 13 months (95% CI 10.3-15.7 months) and mOS was 32 months (95% CI 7.7-56.3 months). For irinotecan-based doublets, ORR was 34.5 (10/29), mPFS was 9 months (95% CI 6.4-11.6 months) and mOS was 22 months (95% CI 16.0-28.0 months). With oxaliplatin-based doublets ORR was 36.4% (24/62), mPFS was 7 months (95% CI 4.6-9.4 months) and mOS was 18 months (95% CI, 13.6-22.4 months).
CONCLUSION
Patients with KRASG12C-mutant mCRC had a disappointing response to standard treatments. Within the limitations of a retrospective study, these results suggest that first-line chemotherapy intensification with FOLFOXIRI is a valid option in fit patients.

Identifiants

pubmed: 35994791
pii: S2059-7029(22)00195-8
doi: 10.1016/j.esmoop.2022.100567
pmc: PMC9588891
pii:
doi:

Substances chimiques

Oxaliplatin 04ZR38536J
Irinotecan 7673326042
Fluorouracil U3P01618RT

Types de publication

Multicenter Study Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

100567

Informations de copyright

Copyright © 2022 The Author(s). Published by Elsevier Ltd.. All rights reserved.

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Auteurs

D Ciardiello (D)

Oncology Unit, IRCCS Foundation Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

C Chiarazzo (C)

Oncology Unit, IRCCS Foundation Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

V Famiglietti (V)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

A Damato (A)

Medical Oncology Unit, Comprhensive Cancer Center, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy.

C Pinto (C)

Medical Oncology Unit, Comprhensive Cancer Center, AUSL-IRCCS Reggio Emilia, Reggio Emilia, Italy.

M G Zampino (MG)

Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.

G Castellano (G)

Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.

L Gervaso (L)

Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.

A Zaniboni (A)

Medical Oncology Unit, Poliambulanza Foundation, Brescia, Italy.

E Oneda (E)

Medical Oncology Unit, Poliambulanza Foundation, Brescia, Italy.

S Rapisardi (S)

Medical Oncology Unit, ARNAS Garibaldi, Catania, Italy.

R Bordonaro (R)

Medical Oncology Unit, ARNAS Garibaldi, Catania, Italy.

C Zichi (C)

Department of Oncology, University of Turin, A.O. Ordine Mauriziano, Turin, Italy.

F De Vita (F)

Department of Oncology, University of Turin, A.O. Ordine Mauriziano, Turin, Italy.

M Di Maio (M)

Department of Oncology, University of Turin, A.O. Ordine Mauriziano, Turin, Italy.

A Parisi (A)

Department of Life, Health and Environmental Sciences, University of L'Aquila, L'Aquila, Italy; Department of Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.

R Giampieri (R)

Department of Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.

R Berardi (R)

Department of Oncology, Università Politecnica delle Marche, Azienda Ospedaliero-Universitaria Ospedali Riuniti di Ancona, Ancona, Italy.

D Lavacchi (D)

Clinical Oncology Unit, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

L Antonuzzo (L)

Clinical Oncology Unit, Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy.

E Tamburini (E)

Oncology Department and Palliative Care, Cardinale Panico, Tricase City Hospital, Tricase, Italy.

B A Maiorano (BA)

Oncology Unit, IRCCS Foundation Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy; Department of Translational Medicine and Surgery, Catholic University of the Sacred Heart, Rome, Italy.

P Parrella (P)

Oncology Laboratory, Foundation Casa Sollievo della Sofferenza IRCCS, San Giovanni Rotondo, Foggia, Italy.

T P Latiano (TP)

Oncology Unit, IRCCS Foundation Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

N Normanno (N)

Cellular Biology and Biotherapy, Istituto Nazionale Tumori, IRCCS-Fondazione G. Pascale, Naples, Italy.

A De Stefano (A)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori, IRCCS-Fondazione G. Pascale, Naples, Italy.

A Avallone (A)

Experimental Clinical Abdominal Oncology Unit, Istituto Nazionale Tumori, IRCCS-Fondazione G. Pascale, Naples, Italy.

G Martini (G)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

S Napolitano (S)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

T Troiani (T)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

E Martinelli (E)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

F Ciardiello (F)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy. Electronic address: davide.ciardiello@unicampania.it.

F De Vita (F)

Medical Oncology Unit, Department of Precision Medicine, "Luigi Vanvitelli" University of Campania, Naples, Italy.

E Maiello (E)

Oncology Unit, IRCCS Foundation Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.

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