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Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study

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Abstract

Introduction

This study aimed to provide the first real-world description of the characteristics, treatments, dosing patterns, and early outcomes of patients with ALK-positive non-small cell lung cancer (NSCLC) who received ceritinib in US clinical practice.

Methods

US oncologists provided data from medical charts of adult patients diagnosed with locally advanced or metastatic ALK-positive NSCLC who received ceritinib following crizotinib. Patient characteristics, treatment patterns, ceritinib dosing, early outcomes, and occurrence of gastrointestinal adverse events (AEs) by dose and instructions on food intake were assessed, and Kaplan–Meier analysis was used to describe clinician-defined progression-free survival (PFS) on ceritinib.

Results

Medical charts of 58 ALK-positive NSCLC patients treated with ceritinib were reviewed (median age 63 years; 41% male; 21% with prior chemotherapy experience). At ceritinib initiation, 44 patients had multiple distant metastases, most commonly in the liver (60%), bone (53%), and brain (38%). Initial ceritinib dose varied: 71% received 750 mg, 19% 600 mg, and 10% 450 mg. Although median follow-up after ceritinib initiation was short (3.8 months), most patients achieved either a complete or partial response (69%) on ceritinib, regardless of metastatic sites present at initiation or initial dose. Median PFS on ceritinib was 12.9 months. 17% of patients had a gastrointestinal AE reported during follow-up. The majority of events occurred in patients instructed to fast; no patients instructed to take a lower dose of ceritinib with food reported gastrointestinal AEs.

Conclusion

These early findings of ceritinib use in clinical practice suggest that ceritinib is effective at treating crizotinib-experienced ALK-positive NSCLC patients, regardless of metastatic sites or initial dose, and dosing ceritinib with food may lead to fewer gastrointestinal AEs. Future studies with larger sample size and longer follow-up are warranted, including an ongoing randomized trial to assess the gastrointestinal tolerability of ceritinib 450 and 600 mg with low-fat meals.

Funding

Novartis Pharmaceutical Corporation.

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Acknowledgements

Novartis Pharmaceutical Corporation sponsored this study (LDK 2015-03). The sponsor participated in conception and design of the study, analysis and interpretation of data, drafting of the manuscript or revising it critically for important intellectual content, and decision to submit the manuscript for publication. Novartis Pharmaceutical Corporation funded article-processing charges. Cinzia Metallo, Ph.D., an employee of Analysis Group, Inc., provided medical writing assistance. All authors made substantial contributions to all of the following: conception and design of the study, analysis and interpretation of data, drafting of the manuscript or revising it critically for important intellectual content. All authors had full access to all of the data in this study and take complete responsibility for the integrity of the data and accuracy of the data analysis. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.

Disclosures

Philip Galebach is an employee of Analysis Group, Inc., a company that has received consulting fees from Novartis Pharmaceuticals Corporation. Iryna Bocharova is an employee of Analysis Group, Inc., a company that has received consulting fees from Novartis Pharmaceuticals Corporation. Rebekah Foster is an employee of Analysis Group, Inc., a company that has received consulting fees from Novartis Pharmaceuticals Corporation. Annie Guérin is an employee of Analysis Group, Inc., a company that has received consulting fees from Novartis Pharmaceuticals Corporation. Alexander R. Macalalad is a former employee of Analysis Group, Inc. Anand A. Dalal is an employee of Novartis Pharmaceuticals Corporation. Kenneth Culver is an employee of Novartis Pharmaceuticals Corporation. Medha Sasane is an employee of Novartis Pharmaceuticals Corporation. Edmond Bendaly has received consultancy fees from Novartis Pharmaceuticals Corporation.

Compliance with Ethics Guidelines

This study did not collect any patient-identifying information and was exempt from review by the Western Institutional Review Board. This article does not contain any new studies with human or animal subjects performed by any of the authors.

Data Availability

The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

Previous Presentation

A synopsis of the current research was presented in poster format at the IASLC Chicago Multidisciplinary Symposium in Thoracic Oncology, which took place in Chicago, IL, September 22–24, 2016 and in poster format at the IASLC 17th World Conference on Lung Cancer in Vienna, Austria, December 4–7, 2016.

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Authors and Affiliations

  1. Marion General Hospital, Medical Oncology, Marion, IN, USA

    Edmond Bendaly

  2. Novartis Pharmaceutical Corporation, East Hanover, NJ, USA

    Anand A. Dalal, Kenneth Culver & Medha Sasane

  3. Analysis Group, Inc., Boston, USA

    Philip Galebach, Iryna Bocharova, Rebekah Foster, Alexander R. Macalalad & Annie Guérin

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  1. Edmond Bendaly
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  2. Anand A. Dalal
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Correspondence to Annie Guérin.

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Bendaly, E., Dalal, A.A., Culver, K. et al. Treatment Patterns and Early Outcomes of ALK-Positive Non-Small Cell Lung Cancer Patients Receiving Ceritinib: A Chart Review Study. Adv Ther 34, 1145–1156 (2017). https://doi.org/10.1007/s12325-017-0527-6

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