C. Mathias

Real Hospital Português

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Antônio C. Buzaid

Beneficência Portuguesa de São Paulo

Florencia Perazzo

Centro de Educación Médica e Investigaciones Clínicas Norberto Quirno

Regina Esser

Merck (Germany)

Luis Fein

Instituto Alexander Fleming

Guillermo Lerzo

Instituto de Oncología de Rosario

Murry W. Wynes

International Association for the Study of Lung Cancer

Sylvie Lantuéjoul

Université Grenoble Alpes

Liliana Dalurzo

Hospital Italiano de Buenos Aires

Suresh S. Ramalingam

Emory University

K. Wood

University of Mississippi Medical Center

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Hospital Sírio-Libanês

Hospital Israelita Albert Einstein

Hospital São Paulo

University of Colorado Denver

Instituto Nacional do Câncer

Pontifícia Universidade Católica do Rio Grande do Sul

International Association for the Study of Lung Cancer

Centro de Pesquisas Oncológicas

University of Colorado Anschutz Medical Campus

University of Colorado Cancer Center

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Preliminary data from a phase II study of cetuximab with irinotecan in heavily pretreated patients with epidermal growth factor (EGFR)-expressing metastatic colorectal cancer (mCRC): LABEL

Journal of Clinical Oncology (2007)

Antônio C. Buzaid C. Mathias Florencia Perazzo Sérgio D. Simon Luis Fein

14521 Background: Cetuximab (Erbitux) is a monoclonal antibody directed against EGFR that is active in combination with irinotecan in patients (pts) with mCRC, who have progressed during or after a prior irinotecan therapy. Methods: This open, single-arm phase II Latin American study investigated this combination in pts with EGFR-expressing mCRC progressing on or within 3 months of chemotherapy containing at least 6 weeks (w) of irinotecan-based therapy. The primary objective was to assess the best overall confirmed response rate (RR). Sample size calculations were based on an expected rate of 20% (±8%). Planned enrollment was 100 pts. Secondary objectives were to explore the duration of response (DOR), progression-free survival (PFS) time, the 12-week PFS rate, and overall survival time. Pts were treated with cetuximab (initial dose 400 mg/m 2 then 250 mg/m 2 weekly), plus irinotecan at the same dose and schedule (including dose reductions) as pre-study. Preliminary Results: Of 151 pts from 14 centers screened and in the database, 106 (70%, 3 pts missing) were EGFR-expressing and, of these, 79/106 (75%) were treated on-study. Forty (51%) were male; median age was 59 years [27–82]; 70 (89%) pts had a Karnofsky performance status = 90 and 9 (11%) pts = 80. Nineteen (24%) pts had received = 3 prior treatment regimens, 42 (53%) were previously treated with an oxaliplatin-based regimen for metastatic disease. The confirmed overall RR was 26.6% [17.3–37.7]. Median DOR was 23.9 w [17.1–30], median PFS time was 17.7 w [11.7–18.9], and the 12-week PFS rate was 58% [47–69]. Thirty-three (42%) pts were alive at data cut-off. Median survival was 9.7 months [7.9–13.1]. Treatment was well tolerated with the most common grade 3/4 adverse events including: diarrhea, 20%; neutropenia,10%; acne-like rash, 9%. No grade 3/4 infusion-related reactions were reported. Conclusions: The overall confirmed RRs observed in this heavily pretreated population fully met the expectations for the primary endpoint of this study. LABEL confirmed in a Latin American setting the activity and safety of cetuximab plus irinotecan seen in previous studies. No significant financial relationships to disclose.

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Progression-free survival

10.1200/jco.2007.25.18_suppl.14521

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Cetuximab Plus Irinotecan in Pretreated Metastatic Colorectal Cancer Progressing on Irinotecan: The LABEL Study

Clinical Colorectal Cancer (2010)

Antônio C. Buzaid C. Mathias Florencia Perazzo Sérgio D. Simon Luis Fein

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Clinical endpoint

Progression-free survival

10.3816/ccc.2010.n.041

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Phase II study of capecitabine and irinotecan as first-line treatment in metastatic colorectal cancer: First trial of the Brazilian Oncology Consortium (BOC-CRC 001)

Journal of Clinical Oncology (2004)

Carlos H. Barrios Fabiana Viola Léa Camillo-Coura R. F. Silva A. Del Giglio

3725 Background: Capecitabine and Irinotecan have different mechanisms of action and are both active in colorectal cancer (CRC). Capecitabine is activated by intratumoral thymidine phosphorylase and this enzyme may be up-regulated by irinotecan. The combination of these two drugs is tested in this multicenter phase II trial, the first of a new cooperative group: Brazilian Oncology Consortium (BOC CRC-001). Methods: A total of 37 pts with measurable metastatic CRC were included. 21men (57%) and 16 women (43%); median age 53.6 (23–74). Most pts were ECOG PS 0 29/35 (82%), 5% were PS 2. Tumor differentiation was GII in 75% and GIII/IV in 14% of the cases. Liver involvement was present in 65% of the pts. 13/37 (35%) of the pts had received previous adjuvant 5FU/LV. The treatment regimen included Capecitabine 1000mg/m2 PO twice daily for 14 days and Irinotecan 75mg/m2 IVover 90 min d1and 8. Cycles repeated every 3 weeks. Patients >65 years old received lower doses of both agents (750/60) and were required to have PS ECOG 0–1. Results: A total of 222 chemotherapy cycles were delivered, median number: 6 (1–17). All pts were evaluable for toxicity. Most common AE (>5%) were diarrhea (15%), nausea (11%) and vomiting (7%). Only 5% of the AE were severe and only 11/37 (22%) pts required dose adjustments due to AE. All pts were available for response: RR 15/37 (40.5%) (95 CI 24–56%). Only 4/13 pts previously treated with adjuvant 5FU/LV responded (30.7%) while 11/24 pts without previous treatment responded (45.8%). 18/37 (48%) of the patients have died. Median survival was 363 days. Conclusions: Capecitabine and Irinotecan in this schedule are well tolerated, convenient and have activity in metastatic CRC. Patients previously treated with adjuvant chemotherapy may have a lower response rate. An independent radiology review is being performed to confirm the results. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Aventis Lilly Roche Aventis Aventis

Regimen

10.1200/jco.2004.22.90140.3725

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OA01.09 Comparing Regional Results from the IASLC Global Survey on Molecular Testing in Lung Cancer

Journal of Thoracic Oncology (2019)

Matthew Smeltzer Murry W. Wynes Sylvie Lantuéjoul Ross A. Soo Liliana Dalurzo

10.1016/j.jtho.2019.09.023

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3055 POSTER Cetuximab plus irinotecan in patients (pts) with metastatic colorectal cancer (mCRC) progressing on or after prior irinotecan therapy: final results of the LABEL study

European Journal of Cancer Supplements (2007)